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Product News: 11 2017

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Cyltezo

Boehringer Ingelheim Pharmaceuticals, Inc, announces US Food and Drug Administration approval of the biosimilar Cyltezo (adalimumab-adbm) in a prefilled syringe for the treatment of plaque psoriasis and psoriatic arthritis as well as other chronic inflammatory diseases. Cyltezo is not commercially available at this time. For more information, visit www.boehringer-ingelheim.us.

Facing Forward App

Cutanea Life Sciences, Inc, introduces Facing Forward, a mobile app for patients with acne to track their treatment with Aktipak (erythromycin and benzoyl peroxide) Gel 3%/5%. The app features a camera function for users to take photographs to track their progress, dosing reminders, prescription refill reminders, acne information resources, and a compliance report so that the physician can determine if the patient is using the medication properly. This app is available free through the App Store or Google Play. For more information, visit www.cutanea.com.

Glytone Dark Spot Corrector

Pierre Fabre Dermo Cosmetique USA introduces the Glytone Dark Spot Corrector, a brightening formula with hydroquinone 2% to help reduce the appearance of pigmentation changes due to pregnancy, use of oral contraceptives, skin aging, or photodamage. It also contains glycolic acid to exfoliate dead cells from the skin’s surface and kojic acid to brighten the skin. For more information, visit www.glytone-usa.com.

Loyon

IntraDerm Pharmaceuticals, a division of Sonoma Pharmaceuticals, Inc, announces US commercialization of Loyon to manage and relieve the scaling, erythema, and pruritus associated with various types of dermatoses including seborrhea and seborrheic dermatitis. Loyon is a combination of the dry emollient Cetiol CC and the medical silicone oil dimethicone. It is a fast and effective treatment for scaling associated with seborrheic dermatitis or psoriasis, which impacts patient quality of life. This product received 510(k) clearance from the US Food and Drug Administration in March 2017. For more information, visit www.intraderm.com.

Stelara

Janssen Biotech, Inc, announces US Food and Drug Administration approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adolescents (≥12 years of age) who are candidates for phototherapy or systemic therapy. Stelara was first approved for the treatment of plaque psoriasis in adults in 2009. For more information, visit www.stelarahcp.com.


If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

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Cyltezo

Boehringer Ingelheim Pharmaceuticals, Inc, announces US Food and Drug Administration approval of the biosimilar Cyltezo (adalimumab-adbm) in a prefilled syringe for the treatment of plaque psoriasis and psoriatic arthritis as well as other chronic inflammatory diseases. Cyltezo is not commercially available at this time. For more information, visit www.boehringer-ingelheim.us.

Facing Forward App

Cutanea Life Sciences, Inc, introduces Facing Forward, a mobile app for patients with acne to track their treatment with Aktipak (erythromycin and benzoyl peroxide) Gel 3%/5%. The app features a camera function for users to take photographs to track their progress, dosing reminders, prescription refill reminders, acne information resources, and a compliance report so that the physician can determine if the patient is using the medication properly. This app is available free through the App Store or Google Play. For more information, visit www.cutanea.com.

Glytone Dark Spot Corrector

Pierre Fabre Dermo Cosmetique USA introduces the Glytone Dark Spot Corrector, a brightening formula with hydroquinone 2% to help reduce the appearance of pigmentation changes due to pregnancy, use of oral contraceptives, skin aging, or photodamage. It also contains glycolic acid to exfoliate dead cells from the skin’s surface and kojic acid to brighten the skin. For more information, visit www.glytone-usa.com.

Loyon

IntraDerm Pharmaceuticals, a division of Sonoma Pharmaceuticals, Inc, announces US commercialization of Loyon to manage and relieve the scaling, erythema, and pruritus associated with various types of dermatoses including seborrhea and seborrheic dermatitis. Loyon is a combination of the dry emollient Cetiol CC and the medical silicone oil dimethicone. It is a fast and effective treatment for scaling associated with seborrheic dermatitis or psoriasis, which impacts patient quality of life. This product received 510(k) clearance from the US Food and Drug Administration in March 2017. For more information, visit www.intraderm.com.

Stelara

Janssen Biotech, Inc, announces US Food and Drug Administration approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adolescents (≥12 years of age) who are candidates for phototherapy or systemic therapy. Stelara was first approved for the treatment of plaque psoriasis in adults in 2009. For more information, visit www.stelarahcp.com.


If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

Cyltezo

Boehringer Ingelheim Pharmaceuticals, Inc, announces US Food and Drug Administration approval of the biosimilar Cyltezo (adalimumab-adbm) in a prefilled syringe for the treatment of plaque psoriasis and psoriatic arthritis as well as other chronic inflammatory diseases. Cyltezo is not commercially available at this time. For more information, visit www.boehringer-ingelheim.us.

Facing Forward App

Cutanea Life Sciences, Inc, introduces Facing Forward, a mobile app for patients with acne to track their treatment with Aktipak (erythromycin and benzoyl peroxide) Gel 3%/5%. The app features a camera function for users to take photographs to track their progress, dosing reminders, prescription refill reminders, acne information resources, and a compliance report so that the physician can determine if the patient is using the medication properly. This app is available free through the App Store or Google Play. For more information, visit www.cutanea.com.

Glytone Dark Spot Corrector

Pierre Fabre Dermo Cosmetique USA introduces the Glytone Dark Spot Corrector, a brightening formula with hydroquinone 2% to help reduce the appearance of pigmentation changes due to pregnancy, use of oral contraceptives, skin aging, or photodamage. It also contains glycolic acid to exfoliate dead cells from the skin’s surface and kojic acid to brighten the skin. For more information, visit www.glytone-usa.com.

Loyon

IntraDerm Pharmaceuticals, a division of Sonoma Pharmaceuticals, Inc, announces US commercialization of Loyon to manage and relieve the scaling, erythema, and pruritus associated with various types of dermatoses including seborrhea and seborrheic dermatitis. Loyon is a combination of the dry emollient Cetiol CC and the medical silicone oil dimethicone. It is a fast and effective treatment for scaling associated with seborrheic dermatitis or psoriasis, which impacts patient quality of life. This product received 510(k) clearance from the US Food and Drug Administration in March 2017. For more information, visit www.intraderm.com.

Stelara

Janssen Biotech, Inc, announces US Food and Drug Administration approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adolescents (≥12 years of age) who are candidates for phototherapy or systemic therapy. Stelara was first approved for the treatment of plaque psoriasis in adults in 2009. For more information, visit www.stelarahcp.com.


If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

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Product Update: Natera’s Panorama NIPT; Solosec from Symbiomix Therapeutics

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Product Update: Natera’s Panorama NIPT; Solosec from Symbiomix Therapeutics

NIPT SCREENING FOR TWIN ZYGOSITY AND GENETIC RISK FACTORS

The Natera® Panorama® non-invasive prenatal test (NIPT) now screens twin pregnancies for zygosity and chromosomal abnormalities. Natera says that Panorama is the first NIPT that can determine whether twins are monozygotic (identical) or dizygotic (non-identical/fraternal) as early as 9 weeks’ gestation.

Building on its history as the only NIPT that can differentiate between the mother’s and the baby’s DNA, Panorama is now also the only NIPT to distinguish between each twin’s DNA, says Natera. Panorama’s unique technology enables it to determine zygosity and each twin’s gender while also allowing it to identify risk for more genetic conditions in twin pregnancies than other NIPTs, including monosomy X, sex chromosome trisomies, and 22q11.2 deletion syndrome.

FOR MORE INFORMATION, VISIT: http://www.panoramatest.com/panorama-test/



NEW DRUG FOR TREATING BACTERIAL VAGINOSIS

Solosec™ (secnidazole), a 5-nitroimidazole antibiotic, has been given FDA approval for treatment of bacterial vaginosis (BV) in adult women, according to manufacturer Symbiomix Therapeutics. The drug, consisting of oral granules, can be given as a single 2-g dose, and taken with or without a meal. Symbiomix Therapeutics says that Solosec is clinically proven to normalize BV symptoms of odor and discharge.

Symbiomix Therapeutics reported that FDA approval was supported by comprehensive studies that found the single-dose secnidazole 2g was efficacious. All treatment-emergent adverse effects were mild or moderate in intensity; no serious adverse events were reported. Solosec will be available to patients in the first quarter of 2018.

FOR MORE INFORMATION, VISIT: https://symbiomix.com/sym-1219/

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

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NIPT SCREENING FOR TWIN ZYGOSITY AND GENETIC RISK FACTORS

The Natera® Panorama® non-invasive prenatal test (NIPT) now screens twin pregnancies for zygosity and chromosomal abnormalities. Natera says that Panorama is the first NIPT that can determine whether twins are monozygotic (identical) or dizygotic (non-identical/fraternal) as early as 9 weeks’ gestation.

Building on its history as the only NIPT that can differentiate between the mother’s and the baby’s DNA, Panorama is now also the only NIPT to distinguish between each twin’s DNA, says Natera. Panorama’s unique technology enables it to determine zygosity and each twin’s gender while also allowing it to identify risk for more genetic conditions in twin pregnancies than other NIPTs, including monosomy X, sex chromosome trisomies, and 22q11.2 deletion syndrome.

FOR MORE INFORMATION, VISIT: http://www.panoramatest.com/panorama-test/



NEW DRUG FOR TREATING BACTERIAL VAGINOSIS

Solosec™ (secnidazole), a 5-nitroimidazole antibiotic, has been given FDA approval for treatment of bacterial vaginosis (BV) in adult women, according to manufacturer Symbiomix Therapeutics. The drug, consisting of oral granules, can be given as a single 2-g dose, and taken with or without a meal. Symbiomix Therapeutics says that Solosec is clinically proven to normalize BV symptoms of odor and discharge.

Symbiomix Therapeutics reported that FDA approval was supported by comprehensive studies that found the single-dose secnidazole 2g was efficacious. All treatment-emergent adverse effects were mild or moderate in intensity; no serious adverse events were reported. Solosec will be available to patients in the first quarter of 2018.

FOR MORE INFORMATION, VISIT: https://symbiomix.com/sym-1219/

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

NIPT SCREENING FOR TWIN ZYGOSITY AND GENETIC RISK FACTORS

The Natera® Panorama® non-invasive prenatal test (NIPT) now screens twin pregnancies for zygosity and chromosomal abnormalities. Natera says that Panorama is the first NIPT that can determine whether twins are monozygotic (identical) or dizygotic (non-identical/fraternal) as early as 9 weeks’ gestation.

Building on its history as the only NIPT that can differentiate between the mother’s and the baby’s DNA, Panorama is now also the only NIPT to distinguish between each twin’s DNA, says Natera. Panorama’s unique technology enables it to determine zygosity and each twin’s gender while also allowing it to identify risk for more genetic conditions in twin pregnancies than other NIPTs, including monosomy X, sex chromosome trisomies, and 22q11.2 deletion syndrome.

FOR MORE INFORMATION, VISIT: http://www.panoramatest.com/panorama-test/



NEW DRUG FOR TREATING BACTERIAL VAGINOSIS

Solosec™ (secnidazole), a 5-nitroimidazole antibiotic, has been given FDA approval for treatment of bacterial vaginosis (BV) in adult women, according to manufacturer Symbiomix Therapeutics. The drug, consisting of oral granules, can be given as a single 2-g dose, and taken with or without a meal. Symbiomix Therapeutics says that Solosec is clinically proven to normalize BV symptoms of odor and discharge.

Symbiomix Therapeutics reported that FDA approval was supported by comprehensive studies that found the single-dose secnidazole 2g was efficacious. All treatment-emergent adverse effects were mild or moderate in intensity; no serious adverse events were reported. Solosec will be available to patients in the first quarter of 2018.

FOR MORE INFORMATION, VISIT: https://symbiomix.com/sym-1219/

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

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Product Update: Histologics curettes, SculpSure, drchrono, Vuva Magnetic Dilators

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COLPOSCOPY BRUSHES SHOW BETTER TISSUE YIELD

A new study from the University of California–Riverside and Aurora Diagnostics in Palm Beach, Florida, evaluated 10,000 colposcopy workups and found that the disposable Histologics Soft-ECC and SoftBiopsy curettes were superior in tissue yield and offered a lower risk of cross contamination than metal curettes.

The Soft-ECC Endocervical Curette Tissue Collection System is used to biopsy the endocervical canal during colposcopy or evaluation for abnormal uterine bleeding. It gently frictionally abrades and collects transepithelial tissue samples into the Kylon fabric. The Soft-ECC-S has a smaller pad for the short, shallow, or stenotic cervix.

During exocervical biopsy with the SoftBiopsy Gynecological Biopsy Device, the Kylon fabric hooks rake across the tissue plane dislodging and shearing tissue strips and fragments from just below the basement membrane to collect in the fabric.

Both products have tips that are snapped off at the scored handle and placed in a fixative vial for transport to the laboratory.

FOR MORE INFORMATION, VISIT: https://www.histologics.com/

 

NONINVASIVE BODY CONTOURING

The Cynosure division of Hologic has just received US Food and Drug Administration (FDA) expanded clearance for SculpSure for noninvasive body contouring (lipolysis) of back, inner, and outer thighs. SculpSure is clinically proven to permanently eliminate fat cells and is already FDA-cleared to treat the abdomen and love handles (flanks).

According to Hologic, SculpSure uses a selective wavelength laser that precisely targets fat cells under the skin without affecting the skin’s surface. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return or regenerate. Hologic says that patients are able to achieve desired results, without downtime or surgery, through customized treatment plans, each lasting only 25 minutes. Results can be seen as quickly as 6 weeks; optimal results typically are seen at 12 weeks, they say.

FOR MORE INFORMATION, VISIT: http://www.sculpsure.com

 

SOFTWARE PLATFORM FOR OBGYNS

drchrono offers software platforms for medical offices, including electronic health records (EHR), practice management, medical billing, revenue cycle management (RCM), and health care application programming interface (API) tools for iPad, iPhone, and web. Products are available for small and large practice groups, urgent care centers, and specialties, including ObGyns. A patient can complete forms and schedule visits through the Patient Portal as well as receive educational materials through HIPAA-compliant messaging and face-to-face telemedicine.

drchrono says its cloud-based platform allows ObGyns to chart in seconds using customizable medical forms, medical speech-to-text, and photo/drawing tools. ObGyn-specific ICD10, Current Procedural Terminology, and E&M codes can autopopulate into forms. Prenatal flow sheets and other clinical forms can be sent to L&D, other providers, or billing departments using drchrono’s direct messaging integration with the local hospital EHR or e-Fax. Prenatal and blood testing, ultrasounds, paper charts, and photographs can be ordered, tracked, and shared with patients and providers.

FOR MORE INFORMATION, VISIT: https://www.drchrono.com/

 

MAGNETIC DILATOR THERAPY FOR DYSPAREUNIA

The VuVa Magnetic Dilator Therapy is a nonsurgical, nonprescription program that VuVatech announces has been proven to relieve pelvic pain and dyspareunia caused by vaginismus, vulvodynia, and vaginal atrophy.

The VuVa Vaginal Dilator Set contains more than 60 neodymium magnets. With iron a component of blood that carries oxygen, when the magnet is placed next to a painful area, it draws fresh oxygenated blood to the nerves and surrounding muscles for increased blood circulation that accelerates healing while reducing pain. When a VuVa Magnetic Vaginal Dilator is used 20 minutes before intercourse, soft tissue lengthens, relaxing and calming muscles, ligaments, and nerves.

A nonmagnetic full dilator set is available for women who are trying to get pregnant and for women with pacemakers or defibrillators.

This product is not FDA approved, is not sold as a medical device, and is not intended to diagnose, treat, cure, or prevent any disease. Effectiveness varies, according to the manufacturer.

FOR MORE INFORMATION, VISIT: https://www.vuvatech.com/

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

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COLPOSCOPY BRUSHES SHOW BETTER TISSUE YIELD

A new study from the University of California–Riverside and Aurora Diagnostics in Palm Beach, Florida, evaluated 10,000 colposcopy workups and found that the disposable Histologics Soft-ECC and SoftBiopsy curettes were superior in tissue yield and offered a lower risk of cross contamination than metal curettes.

The Soft-ECC Endocervical Curette Tissue Collection System is used to biopsy the endocervical canal during colposcopy or evaluation for abnormal uterine bleeding. It gently frictionally abrades and collects transepithelial tissue samples into the Kylon fabric. The Soft-ECC-S has a smaller pad for the short, shallow, or stenotic cervix.

During exocervical biopsy with the SoftBiopsy Gynecological Biopsy Device, the Kylon fabric hooks rake across the tissue plane dislodging and shearing tissue strips and fragments from just below the basement membrane to collect in the fabric.

Both products have tips that are snapped off at the scored handle and placed in a fixative vial for transport to the laboratory.

FOR MORE INFORMATION, VISIT: https://www.histologics.com/

 

NONINVASIVE BODY CONTOURING

The Cynosure division of Hologic has just received US Food and Drug Administration (FDA) expanded clearance for SculpSure for noninvasive body contouring (lipolysis) of back, inner, and outer thighs. SculpSure is clinically proven to permanently eliminate fat cells and is already FDA-cleared to treat the abdomen and love handles (flanks).

According to Hologic, SculpSure uses a selective wavelength laser that precisely targets fat cells under the skin without affecting the skin’s surface. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return or regenerate. Hologic says that patients are able to achieve desired results, without downtime or surgery, through customized treatment plans, each lasting only 25 minutes. Results can be seen as quickly as 6 weeks; optimal results typically are seen at 12 weeks, they say.

FOR MORE INFORMATION, VISIT: http://www.sculpsure.com

 

SOFTWARE PLATFORM FOR OBGYNS

drchrono offers software platforms for medical offices, including electronic health records (EHR), practice management, medical billing, revenue cycle management (RCM), and health care application programming interface (API) tools for iPad, iPhone, and web. Products are available for small and large practice groups, urgent care centers, and specialties, including ObGyns. A patient can complete forms and schedule visits through the Patient Portal as well as receive educational materials through HIPAA-compliant messaging and face-to-face telemedicine.

drchrono says its cloud-based platform allows ObGyns to chart in seconds using customizable medical forms, medical speech-to-text, and photo/drawing tools. ObGyn-specific ICD10, Current Procedural Terminology, and E&M codes can autopopulate into forms. Prenatal flow sheets and other clinical forms can be sent to L&D, other providers, or billing departments using drchrono’s direct messaging integration with the local hospital EHR or e-Fax. Prenatal and blood testing, ultrasounds, paper charts, and photographs can be ordered, tracked, and shared with patients and providers.

FOR MORE INFORMATION, VISIT: https://www.drchrono.com/

 

MAGNETIC DILATOR THERAPY FOR DYSPAREUNIA

The VuVa Magnetic Dilator Therapy is a nonsurgical, nonprescription program that VuVatech announces has been proven to relieve pelvic pain and dyspareunia caused by vaginismus, vulvodynia, and vaginal atrophy.

The VuVa Vaginal Dilator Set contains more than 60 neodymium magnets. With iron a component of blood that carries oxygen, when the magnet is placed next to a painful area, it draws fresh oxygenated blood to the nerves and surrounding muscles for increased blood circulation that accelerates healing while reducing pain. When a VuVa Magnetic Vaginal Dilator is used 20 minutes before intercourse, soft tissue lengthens, relaxing and calming muscles, ligaments, and nerves.

A nonmagnetic full dilator set is available for women who are trying to get pregnant and for women with pacemakers or defibrillators.

This product is not FDA approved, is not sold as a medical device, and is not intended to diagnose, treat, cure, or prevent any disease. Effectiveness varies, according to the manufacturer.

FOR MORE INFORMATION, VISIT: https://www.vuvatech.com/

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

COLPOSCOPY BRUSHES SHOW BETTER TISSUE YIELD

A new study from the University of California–Riverside and Aurora Diagnostics in Palm Beach, Florida, evaluated 10,000 colposcopy workups and found that the disposable Histologics Soft-ECC and SoftBiopsy curettes were superior in tissue yield and offered a lower risk of cross contamination than metal curettes.

The Soft-ECC Endocervical Curette Tissue Collection System is used to biopsy the endocervical canal during colposcopy or evaluation for abnormal uterine bleeding. It gently frictionally abrades and collects transepithelial tissue samples into the Kylon fabric. The Soft-ECC-S has a smaller pad for the short, shallow, or stenotic cervix.

During exocervical biopsy with the SoftBiopsy Gynecological Biopsy Device, the Kylon fabric hooks rake across the tissue plane dislodging and shearing tissue strips and fragments from just below the basement membrane to collect in the fabric.

Both products have tips that are snapped off at the scored handle and placed in a fixative vial for transport to the laboratory.

FOR MORE INFORMATION, VISIT: https://www.histologics.com/

 

NONINVASIVE BODY CONTOURING

The Cynosure division of Hologic has just received US Food and Drug Administration (FDA) expanded clearance for SculpSure for noninvasive body contouring (lipolysis) of back, inner, and outer thighs. SculpSure is clinically proven to permanently eliminate fat cells and is already FDA-cleared to treat the abdomen and love handles (flanks).

According to Hologic, SculpSure uses a selective wavelength laser that precisely targets fat cells under the skin without affecting the skin’s surface. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return or regenerate. Hologic says that patients are able to achieve desired results, without downtime or surgery, through customized treatment plans, each lasting only 25 minutes. Results can be seen as quickly as 6 weeks; optimal results typically are seen at 12 weeks, they say.

FOR MORE INFORMATION, VISIT: http://www.sculpsure.com

 

SOFTWARE PLATFORM FOR OBGYNS

drchrono offers software platforms for medical offices, including electronic health records (EHR), practice management, medical billing, revenue cycle management (RCM), and health care application programming interface (API) tools for iPad, iPhone, and web. Products are available for small and large practice groups, urgent care centers, and specialties, including ObGyns. A patient can complete forms and schedule visits through the Patient Portal as well as receive educational materials through HIPAA-compliant messaging and face-to-face telemedicine.

drchrono says its cloud-based platform allows ObGyns to chart in seconds using customizable medical forms, medical speech-to-text, and photo/drawing tools. ObGyn-specific ICD10, Current Procedural Terminology, and E&M codes can autopopulate into forms. Prenatal flow sheets and other clinical forms can be sent to L&D, other providers, or billing departments using drchrono’s direct messaging integration with the local hospital EHR or e-Fax. Prenatal and blood testing, ultrasounds, paper charts, and photographs can be ordered, tracked, and shared with patients and providers.

FOR MORE INFORMATION, VISIT: https://www.drchrono.com/

 

MAGNETIC DILATOR THERAPY FOR DYSPAREUNIA

The VuVa Magnetic Dilator Therapy is a nonsurgical, nonprescription program that VuVatech announces has been proven to relieve pelvic pain and dyspareunia caused by vaginismus, vulvodynia, and vaginal atrophy.

The VuVa Vaginal Dilator Set contains more than 60 neodymium magnets. With iron a component of blood that carries oxygen, when the magnet is placed next to a painful area, it draws fresh oxygenated blood to the nerves and surrounding muscles for increased blood circulation that accelerates healing while reducing pain. When a VuVa Magnetic Vaginal Dilator is used 20 minutes before intercourse, soft tissue lengthens, relaxing and calming muscles, ligaments, and nerves.

A nonmagnetic full dilator set is available for women who are trying to get pregnant and for women with pacemakers or defibrillators.

This product is not FDA approved, is not sold as a medical device, and is not intended to diagnose, treat, cure, or prevent any disease. Effectiveness varies, according to the manufacturer.

FOR MORE INFORMATION, VISIT: https://www.vuvatech.com/

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

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Product News: 08 2017

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Product News: 08 2017

Avène A-OXitive

Pierre Fabre Dermo-Cosmetique introduces Avène A-OXitive Antioxidant Defense Serum and Avène A-OXitive Antioxidant Water-Cream to fight against oxidative stress. Stable forms of time-released vitamin E and vitamin C work synergistically to defend against environmental aggressors without irritation. Both products contain hyaluronic acid to visibly plump and firm the skin and soothing Avène thermal spring water to soften and restore the skin’s balance. To preserve stability, each formula comes in an airless pump bottle. For more information, visit www.aveneusa.com.

Orencia

Bristol-Myers Squibb Company announces US Food and Drug Administration approval of Orencia (abatacept) for the treatment of adults with active psoriatic arthritis. Orencia is available in both intravenous and subcutaneous injection formulations. It should not be administered concomitantly with tumor necrosis factor antagonists and is not recommended for use with other biologic rheumatoid arthritis therapy. Orencia also is indicated for the treatment of adult rheumatoid arthritis and juvenile idiopathic arthritis. For more information, visit www.orenciahcp.com.

Tremfya

Janssen Biotech, Inc, announces US Food and Drug Administration approval of Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Tremfya is a biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Tremfya is administered as a 100-mg subcutaneous injection every 8 weeks, following 2 starter doses at weeks 0 and 4. Clinical studies documented skin clearance at week 16 and up to week 48. For more information, visit www.tremfyahcp.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

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Avène A-OXitive

Pierre Fabre Dermo-Cosmetique introduces Avène A-OXitive Antioxidant Defense Serum and Avène A-OXitive Antioxidant Water-Cream to fight against oxidative stress. Stable forms of time-released vitamin E and vitamin C work synergistically to defend against environmental aggressors without irritation. Both products contain hyaluronic acid to visibly plump and firm the skin and soothing Avène thermal spring water to soften and restore the skin’s balance. To preserve stability, each formula comes in an airless pump bottle. For more information, visit www.aveneusa.com.

Orencia

Bristol-Myers Squibb Company announces US Food and Drug Administration approval of Orencia (abatacept) for the treatment of adults with active psoriatic arthritis. Orencia is available in both intravenous and subcutaneous injection formulations. It should not be administered concomitantly with tumor necrosis factor antagonists and is not recommended for use with other biologic rheumatoid arthritis therapy. Orencia also is indicated for the treatment of adult rheumatoid arthritis and juvenile idiopathic arthritis. For more information, visit www.orenciahcp.com.

Tremfya

Janssen Biotech, Inc, announces US Food and Drug Administration approval of Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Tremfya is a biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Tremfya is administered as a 100-mg subcutaneous injection every 8 weeks, following 2 starter doses at weeks 0 and 4. Clinical studies documented skin clearance at week 16 and up to week 48. For more information, visit www.tremfyahcp.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

Avène A-OXitive

Pierre Fabre Dermo-Cosmetique introduces Avène A-OXitive Antioxidant Defense Serum and Avène A-OXitive Antioxidant Water-Cream to fight against oxidative stress. Stable forms of time-released vitamin E and vitamin C work synergistically to defend against environmental aggressors without irritation. Both products contain hyaluronic acid to visibly plump and firm the skin and soothing Avène thermal spring water to soften and restore the skin’s balance. To preserve stability, each formula comes in an airless pump bottle. For more information, visit www.aveneusa.com.

Orencia

Bristol-Myers Squibb Company announces US Food and Drug Administration approval of Orencia (abatacept) for the treatment of adults with active psoriatic arthritis. Orencia is available in both intravenous and subcutaneous injection formulations. It should not be administered concomitantly with tumor necrosis factor antagonists and is not recommended for use with other biologic rheumatoid arthritis therapy. Orencia also is indicated for the treatment of adult rheumatoid arthritis and juvenile idiopathic arthritis. For more information, visit www.orenciahcp.com.

Tremfya

Janssen Biotech, Inc, announces US Food and Drug Administration approval of Tremfya (guselkumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Tremfya is a biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Tremfya is administered as a 100-mg subcutaneous injection every 8 weeks, following 2 starter doses at weeks 0 and 4. Clinical studies documented skin clearance at week 16 and up to week 48. For more information, visit www.tremfyahcp.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

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Product Update: Hologic Aptima HSV Assay, Cianna SAVI SCOUT, Olympus Hystero-Resectoscope, and Clarius Ultrasound Scanners

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Product Update: Hologic Aptima HSV Assay, Cianna SAVI SCOUT, Olympus Hystero-Resectoscope, and Clarius Ultrasound Scanners

DIAGNOSE HERPES SIMPLEX VIRUS

Hologic now offers the Aptima Herpes Simplex Virus (HSV) 1 & 2 molecular assay. This nucleic acid amplification test detects and differentiates between HSV-1 and HSV-2 strains in anal and genital lesions. Specimens are collected using the Aptima Multitest Swab Specimen Collection Kit or commercially available viral transport media. The Centers for Disease Control and Prevention (CDC) recommends that all patients with first-episode genital herpes be tested for strain type. According to Hologic, studies show that HSV molecular diagnostics like the Aptima HSV assay are 3 to 5 times more sensitive than live culture samples.

According to the CDC, infections with HSV-2 affect more than 24 million Americans. Patients with HSV-2 strain are at increased risk for contracting and transmitting HIV. Pregnant women infected with HSV-2 are at risk of transmitting the virus to their babies, with increased risk for neurologic complications in the child. 

FOR MORE INFORMATION, VISIT: http://www.hologic.com/search/site/aptima%20hsv

 

PRECISELY TARGET TISSUE DURING LUMPECTOMY OR BIOPSY

Cianna Medical designed the SAVI SCOUT Radar Localization System using radar instead of wires or radiation to help surgeons target tissue during breast lumpectomy or surgical biopsy. According to Cianna Medical, a reflector smaller than a grain of rice is placed into the breast up to 30 days before surgery. During the procedure, the SCOUT guide detects the reflector, allowing surgeons to precisely focus on the affected tissue. SCOUT's detection range is 1 mm to 50 mm. Cianna Medical says that this localization level allows for better surgical planning that may improve cosmetic results as less tissue may need to be removed. 

Cianna Medical reported recent data showing that, when compared with wire localization, the SCOUT reduces breast surgery operating room (OR) delay times by 72.5%, resulted in an average 29- minute reduction in OR waiting time, and significantly improved workflow efficiency.

FOR MORE INFORMATION, VISIT: https://www.ciannamedical.com/savi-scout/

 

PLASMA HYSTEROSCOPIC RESECTION

The 8.5-mm Hystero-Resectoscope and others in the Olympus plasma hysteroscopic resection and vaporization product portfolio have recently received US Food and Drug Administration clearance. Olympus asserts that bipolar electrosurgery featured in the plasma hysteroscopic resection and vaporization system has lower risks of electrolyte imbalance (hyponatremia) compared with monopolar electrosurgery. In addition to improved patient outcomes, Olympus says that its system benefits include cutting precision, better visibility, and cost-savings potential by using a variety of plasma-enabled electrodes in multiple hysteroscopic procedures.

During gynecologic procedures, the Olympus 8.5-mm hystero-resectoscope uses a combination of radio frequency, energy, and saline to create plasma, an electrically conductive gas cloud of vapor and charged particles. Due to its conductivity, plasma allows energy to cross into targeted tissue at lower energy levels than with more traditional approaches. This effect leads to lower operating temperatures and therefore less thermal spread.

FOR MORE INFORMATION, VISIT:  http://olympusmedical.com.sg

 

APP-BASED HANDHELD ULTRASOUND

Clarius Mobile Health is offering Point-and-Shoot Ultrasound Scanners that operate with any iOS or Android smart device using an app. Clarius says its wireless, handheld ultrasound scanners help ObGyns perform quick scans or are used to guide short procedures at bedside without having to rely on the availability of a cart-based ultrasound system. The Clarius C3 Scanner is designed for scanning all parts of the patient's torso, including the heart. The Clarius L7 Linear Array Ultrasound Scanner is ideal for guiding procedures. Both scanners have automated gain and frequency settings.

High-resolution images can be saved, reviewed, and managed on the secure Clarius Cloud. Built with a durable magnesium shell, each device has an IPX7 immersion rating so it can be sterilized. Power is obtained from a rechargeable battery that will last for more than 45 minutes of scanning; 2 batteries come with each Clarius device.

FOR MORE INFORMATION, VISIT: https://www.clarius.me/

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

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DIAGNOSE HERPES SIMPLEX VIRUS

Hologic now offers the Aptima Herpes Simplex Virus (HSV) 1 & 2 molecular assay. This nucleic acid amplification test detects and differentiates between HSV-1 and HSV-2 strains in anal and genital lesions. Specimens are collected using the Aptima Multitest Swab Specimen Collection Kit or commercially available viral transport media. The Centers for Disease Control and Prevention (CDC) recommends that all patients with first-episode genital herpes be tested for strain type. According to Hologic, studies show that HSV molecular diagnostics like the Aptima HSV assay are 3 to 5 times more sensitive than live culture samples.

According to the CDC, infections with HSV-2 affect more than 24 million Americans. Patients with HSV-2 strain are at increased risk for contracting and transmitting HIV. Pregnant women infected with HSV-2 are at risk of transmitting the virus to their babies, with increased risk for neurologic complications in the child. 

FOR MORE INFORMATION, VISIT: http://www.hologic.com/search/site/aptima%20hsv

 

PRECISELY TARGET TISSUE DURING LUMPECTOMY OR BIOPSY

Cianna Medical designed the SAVI SCOUT Radar Localization System using radar instead of wires or radiation to help surgeons target tissue during breast lumpectomy or surgical biopsy. According to Cianna Medical, a reflector smaller than a grain of rice is placed into the breast up to 30 days before surgery. During the procedure, the SCOUT guide detects the reflector, allowing surgeons to precisely focus on the affected tissue. SCOUT's detection range is 1 mm to 50 mm. Cianna Medical says that this localization level allows for better surgical planning that may improve cosmetic results as less tissue may need to be removed. 

Cianna Medical reported recent data showing that, when compared with wire localization, the SCOUT reduces breast surgery operating room (OR) delay times by 72.5%, resulted in an average 29- minute reduction in OR waiting time, and significantly improved workflow efficiency.

FOR MORE INFORMATION, VISIT: https://www.ciannamedical.com/savi-scout/

 

PLASMA HYSTEROSCOPIC RESECTION

The 8.5-mm Hystero-Resectoscope and others in the Olympus plasma hysteroscopic resection and vaporization product portfolio have recently received US Food and Drug Administration clearance. Olympus asserts that bipolar electrosurgery featured in the plasma hysteroscopic resection and vaporization system has lower risks of electrolyte imbalance (hyponatremia) compared with monopolar electrosurgery. In addition to improved patient outcomes, Olympus says that its system benefits include cutting precision, better visibility, and cost-savings potential by using a variety of plasma-enabled electrodes in multiple hysteroscopic procedures.

During gynecologic procedures, the Olympus 8.5-mm hystero-resectoscope uses a combination of radio frequency, energy, and saline to create plasma, an electrically conductive gas cloud of vapor and charged particles. Due to its conductivity, plasma allows energy to cross into targeted tissue at lower energy levels than with more traditional approaches. This effect leads to lower operating temperatures and therefore less thermal spread.

FOR MORE INFORMATION, VISIT:  http://olympusmedical.com.sg

 

APP-BASED HANDHELD ULTRASOUND

Clarius Mobile Health is offering Point-and-Shoot Ultrasound Scanners that operate with any iOS or Android smart device using an app. Clarius says its wireless, handheld ultrasound scanners help ObGyns perform quick scans or are used to guide short procedures at bedside without having to rely on the availability of a cart-based ultrasound system. The Clarius C3 Scanner is designed for scanning all parts of the patient's torso, including the heart. The Clarius L7 Linear Array Ultrasound Scanner is ideal for guiding procedures. Both scanners have automated gain and frequency settings.

High-resolution images can be saved, reviewed, and managed on the secure Clarius Cloud. Built with a durable magnesium shell, each device has an IPX7 immersion rating so it can be sterilized. Power is obtained from a rechargeable battery that will last for more than 45 minutes of scanning; 2 batteries come with each Clarius device.

FOR MORE INFORMATION, VISIT: https://www.clarius.me/

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

DIAGNOSE HERPES SIMPLEX VIRUS

Hologic now offers the Aptima Herpes Simplex Virus (HSV) 1 & 2 molecular assay. This nucleic acid amplification test detects and differentiates between HSV-1 and HSV-2 strains in anal and genital lesions. Specimens are collected using the Aptima Multitest Swab Specimen Collection Kit or commercially available viral transport media. The Centers for Disease Control and Prevention (CDC) recommends that all patients with first-episode genital herpes be tested for strain type. According to Hologic, studies show that HSV molecular diagnostics like the Aptima HSV assay are 3 to 5 times more sensitive than live culture samples.

According to the CDC, infections with HSV-2 affect more than 24 million Americans. Patients with HSV-2 strain are at increased risk for contracting and transmitting HIV. Pregnant women infected with HSV-2 are at risk of transmitting the virus to their babies, with increased risk for neurologic complications in the child. 

FOR MORE INFORMATION, VISIT: http://www.hologic.com/search/site/aptima%20hsv

 

PRECISELY TARGET TISSUE DURING LUMPECTOMY OR BIOPSY

Cianna Medical designed the SAVI SCOUT Radar Localization System using radar instead of wires or radiation to help surgeons target tissue during breast lumpectomy or surgical biopsy. According to Cianna Medical, a reflector smaller than a grain of rice is placed into the breast up to 30 days before surgery. During the procedure, the SCOUT guide detects the reflector, allowing surgeons to precisely focus on the affected tissue. SCOUT's detection range is 1 mm to 50 mm. Cianna Medical says that this localization level allows for better surgical planning that may improve cosmetic results as less tissue may need to be removed. 

Cianna Medical reported recent data showing that, when compared with wire localization, the SCOUT reduces breast surgery operating room (OR) delay times by 72.5%, resulted in an average 29- minute reduction in OR waiting time, and significantly improved workflow efficiency.

FOR MORE INFORMATION, VISIT: https://www.ciannamedical.com/savi-scout/

 

PLASMA HYSTEROSCOPIC RESECTION

The 8.5-mm Hystero-Resectoscope and others in the Olympus plasma hysteroscopic resection and vaporization product portfolio have recently received US Food and Drug Administration clearance. Olympus asserts that bipolar electrosurgery featured in the plasma hysteroscopic resection and vaporization system has lower risks of electrolyte imbalance (hyponatremia) compared with monopolar electrosurgery. In addition to improved patient outcomes, Olympus says that its system benefits include cutting precision, better visibility, and cost-savings potential by using a variety of plasma-enabled electrodes in multiple hysteroscopic procedures.

During gynecologic procedures, the Olympus 8.5-mm hystero-resectoscope uses a combination of radio frequency, energy, and saline to create plasma, an electrically conductive gas cloud of vapor and charged particles. Due to its conductivity, plasma allows energy to cross into targeted tissue at lower energy levels than with more traditional approaches. This effect leads to lower operating temperatures and therefore less thermal spread.

FOR MORE INFORMATION, VISIT:  http://olympusmedical.com.sg

 

APP-BASED HANDHELD ULTRASOUND

Clarius Mobile Health is offering Point-and-Shoot Ultrasound Scanners that operate with any iOS or Android smart device using an app. Clarius says its wireless, handheld ultrasound scanners help ObGyns perform quick scans or are used to guide short procedures at bedside without having to rely on the availability of a cart-based ultrasound system. The Clarius C3 Scanner is designed for scanning all parts of the patient's torso, including the heart. The Clarius L7 Linear Array Ultrasound Scanner is ideal for guiding procedures. Both scanners have automated gain and frequency settings.

High-resolution images can be saved, reviewed, and managed on the secure Clarius Cloud. Built with a durable magnesium shell, each device has an IPX7 immersion rating so it can be sterilized. Power is obtained from a rechargeable battery that will last for more than 45 minutes of scanning; 2 batteries come with each Clarius device.

FOR MORE INFORMATION, VISIT: https://www.clarius.me/

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

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Product News: 07 2017

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Product News: 07 2017

Glytone Sunscreen Lotion Broad Spectrum SPF 40

Pierre Fabre Dermo-Cosmetique USA introduces Glytone Sunscreen Lotion Broad Spectrum SPF 40, a mineral-based formula for face and body with micronized zinc oxide, octinoxate, and octisalate. The lightweight formula is water resistant for up to 40 minutes and contains hyaluronic acid to nourish the skin and help boost natural moisture levels to visibly reduce the appearance of fine lines and wrinkles. For more information, visit www.glytone-usa.com.

proactivMD

The Proactiv Company launches the proactivMD Essentials System, a 3-step acne regimen that has been reformulated to include the topical retinoid adapalene. Step 1 is the Deep Cleansing Face Wash formulated to help clear dirt and debris from deep within the pores. Step 2 is the Balancing Toner, an alcohol-free formula that contains a light astringent to sweep away impurities leaving the skin feeling fresh and balanced. Step 3 consists of the Daily Oil Control Moisturizer (morning), which protects the skin and controls shine, and Adapalene Gel 0.1% (evening) to speed acne healing and prevent new acne from forming. For more information, visit www.proactiv.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

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Glytone Sunscreen Lotion Broad Spectrum SPF 40

Pierre Fabre Dermo-Cosmetique USA introduces Glytone Sunscreen Lotion Broad Spectrum SPF 40, a mineral-based formula for face and body with micronized zinc oxide, octinoxate, and octisalate. The lightweight formula is water resistant for up to 40 minutes and contains hyaluronic acid to nourish the skin and help boost natural moisture levels to visibly reduce the appearance of fine lines and wrinkles. For more information, visit www.glytone-usa.com.

proactivMD

The Proactiv Company launches the proactivMD Essentials System, a 3-step acne regimen that has been reformulated to include the topical retinoid adapalene. Step 1 is the Deep Cleansing Face Wash formulated to help clear dirt and debris from deep within the pores. Step 2 is the Balancing Toner, an alcohol-free formula that contains a light astringent to sweep away impurities leaving the skin feeling fresh and balanced. Step 3 consists of the Daily Oil Control Moisturizer (morning), which protects the skin and controls shine, and Adapalene Gel 0.1% (evening) to speed acne healing and prevent new acne from forming. For more information, visit www.proactiv.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

Glytone Sunscreen Lotion Broad Spectrum SPF 40

Pierre Fabre Dermo-Cosmetique USA introduces Glytone Sunscreen Lotion Broad Spectrum SPF 40, a mineral-based formula for face and body with micronized zinc oxide, octinoxate, and octisalate. The lightweight formula is water resistant for up to 40 minutes and contains hyaluronic acid to nourish the skin and help boost natural moisture levels to visibly reduce the appearance of fine lines and wrinkles. For more information, visit www.glytone-usa.com.

proactivMD

The Proactiv Company launches the proactivMD Essentials System, a 3-step acne regimen that has been reformulated to include the topical retinoid adapalene. Step 1 is the Deep Cleansing Face Wash formulated to help clear dirt and debris from deep within the pores. Step 2 is the Balancing Toner, an alcohol-free formula that contains a light astringent to sweep away impurities leaving the skin feeling fresh and balanced. Step 3 consists of the Daily Oil Control Moisturizer (morning), which protects the skin and controls shine, and Adapalene Gel 0.1% (evening) to speed acne healing and prevent new acne from forming. For more information, visit www.proactiv.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at cutis@frontlinemedcom.com.

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Product Update: Intrarosa, ZEJULA, Signia Stapling System, TYMLOS, Videssa Breast

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Product Update: Intrarosa, ZEJULA, Signia Stapling System, TYMLOS, Videssa Breast

NONESTROGEN PRODUCT FOR DYSPAREUNIA

Intrarosa (prasterone 6.5 mg), from AMAG Pharmaceuticals and Endoceutics, Inc, is announced as the only FDA-approved, locally administered, daily, nonestrogen steroid for the treatment of moderate-to-severe dyspareunia, a common symptom of vulvovaginal atrophy due to menopause (also known as genitourinary syndrome of menopause). The two companies have recently entered into an agreement providing AMAG with the US commercial rights to Intrarosa. Prasterone, also known as dehydroepiandrosterone (DHEA), is an inactive endrogenous steroid that is converted locally into androgens and estrogens to help restore vaginal tissue, according to the manufacturer. The usual dose of Intrarosa is one insert placed into the vagina every day at bedtime.

FOR MORE INFORMATION, VISIT: http://www.amagpharma.com

ORAL MAINTENANCE TX FOR RECURRENT CANCER

ZEJULA (niraparib 100 mg) from TESARO, is a recently FDA-approved and available once-daily oral maintenance treatment for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Niraparib is a poly (ADP-ribose) polymerase (PARP) inhibitor. PARP is a family of proteins involved in many functions in a cell, says TESARO, including DNA repair, gene expression, cell cycle control, intracellular trafficking, and energy metabolism. According to the manufacturer, PARP inhibitors have shown activity as a monotherapy against tumors with existing DNA repair defects, such as BRCA1 and BRCA2 mutations, and as combination therapy with anticancer agents that induce DNA damage. The recommended dose of ZEJULA is 300 mg taken once daily with or without food.

FOR MORE INFORMATION, VISIT: http://www.zejula.com

MIGS STAPLING SYSTEM WITH REAL-TIME FEEDBACK

Medtronic reports that its new Signia Stapling System offers surgeons real-time feedback and automated responses to real-time data, one-handed staple firing, and Adaptive Firing technology that measures the firing force and adjusts the stapler’s speed based on tissue variability, allowing for consistent staple lines. Medtronic says the device chooses 1 of 3 firing speeds based on the clamped tissue’s variability and thickness and tells the surgeon, with audible and visual feedback on the handle’s LED screen, how it is adapting to tissue variability, before firing. The reposable handle is designed to provide the surgeon fully powered rotation, articulation, and firing with one hand. The Signia system has applications in open and minimally invasive gynecologic surgery.

FOR MORE INFORMATION, VISIT: http://www.medtronic.com

BONE BUILDING AGENT

Radius Health announces recent FDA approval for TYMLOS (abaloparatide) injection, a bone-building agent for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture. Those at high risk for fracture, says Radius, include women with a history of osteoporotic fracture, multiple risk factors for fracture, or have failed on or are intolerant to other available osteoporosis therapy. Results of the ACTIVE trial demonstrated that TYMLOS showed significant reductions in the relative risk of new vertebral (86%) and nonvertebral (43%) fractures compared with placebo (absolute risk reduction, 3.6% and 2.0%, respectively). The injection provides 3,120 µg/1.56 mL (2,000 µg/mL) in a single-patient-use prefilled pen. The pen delivers 30 daily doses of 80 µg abaloparatide in 40 µL of sterile, clear, colorless solution. Radius is also developing a transdermal application of abaloparatide based on 3M’s patented Microstructured Transdermal System technology.

FOR MORE INFORMATION, VISIT: http://www.radiuspharm.com

PROTEOMIC BREAST CANCER ASSAY

Using advanced proteomic technology, Provista Diagnostics has developed Videssa Breast, the first blood test of its kind that detects and analyzes multiple types of tumor protein biomarkers for improved cancer detection when mammography results are abnormal. Unlike other liquid biopsy techniques, breast cancer proteins are more abundant in the blood, according to the manufacturer; Videssa Breast uses proprietary technology to examine multiple serum protein biomarkers (SPBs) secreted by breast tumors and tumor-associated autoantibodies (TAAbs). Evaluating these biomarkers with patient clinical data generates a unique protein signature that detects breast cancer in the body. Through research and clinical trials, the top 11 SPBs known to provide the highest sensitivity and the top 28 TAAbs for early breast cancer detection have been identified. Videssa Breast incorporates 11 SPBs and 13 TAAbs in its assay.

FOR MORE INFORMATION, VISIT: http://www.provistadx.com

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

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NONESTROGEN PRODUCT FOR DYSPAREUNIA

Intrarosa (prasterone 6.5 mg), from AMAG Pharmaceuticals and Endoceutics, Inc, is announced as the only FDA-approved, locally administered, daily, nonestrogen steroid for the treatment of moderate-to-severe dyspareunia, a common symptom of vulvovaginal atrophy due to menopause (also known as genitourinary syndrome of menopause). The two companies have recently entered into an agreement providing AMAG with the US commercial rights to Intrarosa. Prasterone, also known as dehydroepiandrosterone (DHEA), is an inactive endrogenous steroid that is converted locally into androgens and estrogens to help restore vaginal tissue, according to the manufacturer. The usual dose of Intrarosa is one insert placed into the vagina every day at bedtime.

FOR MORE INFORMATION, VISIT: http://www.amagpharma.com

ORAL MAINTENANCE TX FOR RECURRENT CANCER

ZEJULA (niraparib 100 mg) from TESARO, is a recently FDA-approved and available once-daily oral maintenance treatment for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Niraparib is a poly (ADP-ribose) polymerase (PARP) inhibitor. PARP is a family of proteins involved in many functions in a cell, says TESARO, including DNA repair, gene expression, cell cycle control, intracellular trafficking, and energy metabolism. According to the manufacturer, PARP inhibitors have shown activity as a monotherapy against tumors with existing DNA repair defects, such as BRCA1 and BRCA2 mutations, and as combination therapy with anticancer agents that induce DNA damage. The recommended dose of ZEJULA is 300 mg taken once daily with or without food.

FOR MORE INFORMATION, VISIT: http://www.zejula.com

MIGS STAPLING SYSTEM WITH REAL-TIME FEEDBACK

Medtronic reports that its new Signia Stapling System offers surgeons real-time feedback and automated responses to real-time data, one-handed staple firing, and Adaptive Firing technology that measures the firing force and adjusts the stapler’s speed based on tissue variability, allowing for consistent staple lines. Medtronic says the device chooses 1 of 3 firing speeds based on the clamped tissue’s variability and thickness and tells the surgeon, with audible and visual feedback on the handle’s LED screen, how it is adapting to tissue variability, before firing. The reposable handle is designed to provide the surgeon fully powered rotation, articulation, and firing with one hand. The Signia system has applications in open and minimally invasive gynecologic surgery.

FOR MORE INFORMATION, VISIT: http://www.medtronic.com

BONE BUILDING AGENT

Radius Health announces recent FDA approval for TYMLOS (abaloparatide) injection, a bone-building agent for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture. Those at high risk for fracture, says Radius, include women with a history of osteoporotic fracture, multiple risk factors for fracture, or have failed on or are intolerant to other available osteoporosis therapy. Results of the ACTIVE trial demonstrated that TYMLOS showed significant reductions in the relative risk of new vertebral (86%) and nonvertebral (43%) fractures compared with placebo (absolute risk reduction, 3.6% and 2.0%, respectively). The injection provides 3,120 µg/1.56 mL (2,000 µg/mL) in a single-patient-use prefilled pen. The pen delivers 30 daily doses of 80 µg abaloparatide in 40 µL of sterile, clear, colorless solution. Radius is also developing a transdermal application of abaloparatide based on 3M’s patented Microstructured Transdermal System technology.

FOR MORE INFORMATION, VISIT: http://www.radiuspharm.com

PROTEOMIC BREAST CANCER ASSAY

Using advanced proteomic technology, Provista Diagnostics has developed Videssa Breast, the first blood test of its kind that detects and analyzes multiple types of tumor protein biomarkers for improved cancer detection when mammography results are abnormal. Unlike other liquid biopsy techniques, breast cancer proteins are more abundant in the blood, according to the manufacturer; Videssa Breast uses proprietary technology to examine multiple serum protein biomarkers (SPBs) secreted by breast tumors and tumor-associated autoantibodies (TAAbs). Evaluating these biomarkers with patient clinical data generates a unique protein signature that detects breast cancer in the body. Through research and clinical trials, the top 11 SPBs known to provide the highest sensitivity and the top 28 TAAbs for early breast cancer detection have been identified. Videssa Breast incorporates 11 SPBs and 13 TAAbs in its assay.

FOR MORE INFORMATION, VISIT: http://www.provistadx.com

 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

NONESTROGEN PRODUCT FOR DYSPAREUNIA

Intrarosa (prasterone 6.5 mg), from AMAG Pharmaceuticals and Endoceutics, Inc, is announced as the only FDA-approved, locally administered, daily, nonestrogen steroid for the treatment of moderate-to-severe dyspareunia, a common symptom of vulvovaginal atrophy due to menopause (also known as genitourinary syndrome of menopause). The two companies have recently entered into an agreement providing AMAG with the US commercial rights to Intrarosa. Prasterone, also known as dehydroepiandrosterone (DHEA), is an inactive endrogenous steroid that is converted locally into androgens and estrogens to help restore vaginal tissue, according to the manufacturer. The usual dose of Intrarosa is one insert placed into the vagina every day at bedtime.

FOR MORE INFORMATION, VISIT: http://www.amagpharma.com

ORAL MAINTENANCE TX FOR RECURRENT CANCER

ZEJULA (niraparib 100 mg) from TESARO, is a recently FDA-approved and available once-daily oral maintenance treatment for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Niraparib is a poly (ADP-ribose) polymerase (PARP) inhibitor. PARP is a family of proteins involved in many functions in a cell, says TESARO, including DNA repair, gene expression, cell cycle control, intracellular trafficking, and energy metabolism. According to the manufacturer, PARP inhibitors have shown activity as a monotherapy against tumors with existing DNA repair defects, such as BRCA1 and BRCA2 mutations, and as combination therapy with anticancer agents that induce DNA damage. The recommended dose of ZEJULA is 300 mg taken once daily with or without food.

FOR MORE INFORMATION, VISIT: http://www.zejula.com

MIGS STAPLING SYSTEM WITH REAL-TIME FEEDBACK

Medtronic reports that its new Signia Stapling System offers surgeons real-time feedback and automated responses to real-time data, one-handed staple firing, and Adaptive Firing technology that measures the firing force and adjusts the stapler’s speed based on tissue variability, allowing for consistent staple lines. Medtronic says the device chooses 1 of 3 firing speeds based on the clamped tissue’s variability and thickness and tells the surgeon, with audible and visual feedback on the handle’s LED screen, how it is adapting to tissue variability, before firing. The reposable handle is designed to provide the surgeon fully powered rotation, articulation, and firing with one hand. The Signia system has applications in open and minimally invasive gynecologic surgery.

FOR MORE INFORMATION, VISIT: http://www.medtronic.com

BONE BUILDING AGENT

Radius Health announces recent FDA approval for TYMLOS (abaloparatide) injection, a bone-building agent for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture. Those at high risk for fracture, says Radius, include women with a history of osteoporotic fracture, multiple risk factors for fracture, or have failed on or are intolerant to other available osteoporosis therapy. Results of the ACTIVE trial demonstrated that TYMLOS showed significant reductions in the relative risk of new vertebral (86%) and nonvertebral (43%) fractures compared with placebo (absolute risk reduction, 3.6% and 2.0%, respectively). The injection provides 3,120 µg/1.56 mL (2,000 µg/mL) in a single-patient-use prefilled pen. The pen delivers 30 daily doses of 80 µg abaloparatide in 40 µL of sterile, clear, colorless solution. Radius is also developing a transdermal application of abaloparatide based on 3M’s patented Microstructured Transdermal System technology.

FOR MORE INFORMATION, VISIT: http://www.radiuspharm.com

PROTEOMIC BREAST CANCER ASSAY

Using advanced proteomic technology, Provista Diagnostics has developed Videssa Breast, the first blood test of its kind that detects and analyzes multiple types of tumor protein biomarkers for improved cancer detection when mammography results are abnormal. Unlike other liquid biopsy techniques, breast cancer proteins are more abundant in the blood, according to the manufacturer; Videssa Breast uses proprietary technology to examine multiple serum protein biomarkers (SPBs) secreted by breast tumors and tumor-associated autoantibodies (TAAbs). Evaluating these biomarkers with patient clinical data generates a unique protein signature that detects breast cancer in the body. Through research and clinical trials, the top 11 SPBs known to provide the highest sensitivity and the top 28 TAAbs for early breast cancer detection have been identified. Videssa Breast incorporates 11 SPBs and 13 TAAbs in its assay.

FOR MORE INFORMATION, VISIT: http://www.provistadx.com

 

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OBG Management - 29(7)
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OBG Management - 29(7)
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Product Update: Intrarosa, ZEJULA, Signia Stapling System, TYMLOS, Videssa Breast
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