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Product News October 2021

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Product News October 2021

Opzelura FDA Approved for Atopic Dermatitis Incyte

Corporation announces US Food and Drug Administration (FDA) approval of Opzelura (ruxolitinib) cream 1.5% for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis (AD) in nonimmunocompromised patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Opzelura is formulated with ruxolitinib, a selective Janus kinase (JAK) 1/JAK2 inhibitor, to target key cytokine signals believed to contribute to itch and inflammation. For more information, visit www.opzelurahcp.com/.

Twyneo FDA Approved for Acne Vulgaris

Sol-Gel Technologies, Ltd, announces US Food and Drug Administration (FDA) approval of Twyneo (tretinoin 0.1% /benzoyl peroxide 3%) cream for the treatment of acne vulgaris in adult and pediatric patients 9 years and older. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The formulation of Twyneo uses silica (silicon dioxide) core shell structures to separately microencapsulate tretinoin crystals and benzoyl peroxide crystals, enabling inclusion of the 2 active ingredients in the cream. For more information, visit www.sol-gel.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

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Opzelura FDA Approved for Atopic Dermatitis Incyte

Corporation announces US Food and Drug Administration (FDA) approval of Opzelura (ruxolitinib) cream 1.5% for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis (AD) in nonimmunocompromised patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Opzelura is formulated with ruxolitinib, a selective Janus kinase (JAK) 1/JAK2 inhibitor, to target key cytokine signals believed to contribute to itch and inflammation. For more information, visit www.opzelurahcp.com/.

Twyneo FDA Approved for Acne Vulgaris

Sol-Gel Technologies, Ltd, announces US Food and Drug Administration (FDA) approval of Twyneo (tretinoin 0.1% /benzoyl peroxide 3%) cream for the treatment of acne vulgaris in adult and pediatric patients 9 years and older. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The formulation of Twyneo uses silica (silicon dioxide) core shell structures to separately microencapsulate tretinoin crystals and benzoyl peroxide crystals, enabling inclusion of the 2 active ingredients in the cream. For more information, visit www.sol-gel.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

Opzelura FDA Approved for Atopic Dermatitis Incyte

Corporation announces US Food and Drug Administration (FDA) approval of Opzelura (ruxolitinib) cream 1.5% for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis (AD) in nonimmunocompromised patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Opzelura is formulated with ruxolitinib, a selective Janus kinase (JAK) 1/JAK2 inhibitor, to target key cytokine signals believed to contribute to itch and inflammation. For more information, visit www.opzelurahcp.com/.

Twyneo FDA Approved for Acne Vulgaris

Sol-Gel Technologies, Ltd, announces US Food and Drug Administration (FDA) approval of Twyneo (tretinoin 0.1% /benzoyl peroxide 3%) cream for the treatment of acne vulgaris in adult and pediatric patients 9 years and older. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The formulation of Twyneo uses silica (silicon dioxide) core shell structures to separately microencapsulate tretinoin crystals and benzoyl peroxide crystals, enabling inclusion of the 2 active ingredients in the cream. For more information, visit www.sol-gel.com.

If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].

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Placental allograft, cytology processor, cell-free RNA testing, and male infertility

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Human placental allograft

Revita, an allograft composed of human placental membrane, developed by Stimlabs, is available to ObGyns and other health care professionals for many uses including surgery and wound care. The human placental membrane is composed of 3 layers, with single- and dual-layer placental allografts available since the 1990s, notes Stimlabs. Revita reserves all 3 layers, however, to include the intermediate layer, which contains hyaluronic acid and additional proteins. By including this jelly-like layer, the natural components of the native placental tissue are maximized, says Stimlabs, offering 6.55 times more growth factors and 4.3 times more protein content, and an overall thicker allograft, than competing products. The advantage is that many of the cytokines, growth factors, extracellular components, and cell communication signals the body uses to heal, protect, and grow tissues are retained.

For case reports involving Revita and for more information, visit https://www.stimlabs.com/revita.

FDA approval for cytology processor

Hologic announces US Food and Drug Administration approval for its ThinPrep® Genesis™ processor for cytology processing and specimen transfer. The Genesis is part of the company’s ThinPrep product line, which is focused on cervical cancer screening and was launched in 1996. This latest processor is designed to streamline downstream workflows with advanced automation capabilities that combine cytology processing with sample aliquoting, which helps to prevent misidentification of samples and allows for more confidence in results, says Hologic. In addition they say that features such as automated uncapping/capping and optional tube and slide printers automate labeling to reduce hands-on time by lab operators, improving ergonomics and streamlining performance for laboratories of any size.

For more information, visit: https://www.hologic.com/.

Cell-free RNA testing for pregnancy complications

Noninvasive prenatal testing (NIPT), which uses a blood test to identify maternal and fetal cell-free DNA, is a relatively new technology that can identify fetal genetic abnormalities such as chromosomal disorders. But what about identifying the risk of potential complications that can occur during pregnancy that can adversely affect the baby as well as the mother—conditions like preterm birth, preeclampsia, and gestational diabetes (GD)? These complications affect an estimated 45 million women globally each year. Mirvie is a company focused on using cell-free RNA testing of a single blood sample from the mother to assess the mother’s risk of developing pregnancy complications (including preterm birth, preeclampsia, and GD). The RNA testing reflects the state of the mother, baby, and the placenta. Mirvie is founded by the inventor of NIPT, and the company says they are making rapid progress toward their RNA-testing goal.


Currently, Mirvie is recruiting for their Miracle of Life study, which requests that single gestation pregnant mothers who are not scheduled for cesarean delivery provide a blood sample during their second trimester. Women can see if they are eligible for study participation by visiting https://www.curebase.com/study/miracle/home.

For more information, visit: https://mirvie.com/.

Male fertility platform

Newly launched Posterity Health is a Male Factor Management PlatformTM designed to help men optimize their fertility. From lifestyle and behavioral changes to increase the chances of conception to at-home semen analysis and a comprehensive, personalized treatment plan, Posterity Health has the fertility support built in. The platform also provides for virtual second opinions and consultations for vasectomy reversal and sperm cryopreservation. Posterity Health partners with fertility centers and ObGyns and currently can serve patients living in California, Colorado, and New York, with plans to expand services to other states.

For more information, visit: https://posterityhealth.com/.

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Human placental allograft

Revita, an allograft composed of human placental membrane, developed by Stimlabs, is available to ObGyns and other health care professionals for many uses including surgery and wound care. The human placental membrane is composed of 3 layers, with single- and dual-layer placental allografts available since the 1990s, notes Stimlabs. Revita reserves all 3 layers, however, to include the intermediate layer, which contains hyaluronic acid and additional proteins. By including this jelly-like layer, the natural components of the native placental tissue are maximized, says Stimlabs, offering 6.55 times more growth factors and 4.3 times more protein content, and an overall thicker allograft, than competing products. The advantage is that many of the cytokines, growth factors, extracellular components, and cell communication signals the body uses to heal, protect, and grow tissues are retained.

For case reports involving Revita and for more information, visit https://www.stimlabs.com/revita.

FDA approval for cytology processor

Hologic announces US Food and Drug Administration approval for its ThinPrep® Genesis™ processor for cytology processing and specimen transfer. The Genesis is part of the company’s ThinPrep product line, which is focused on cervical cancer screening and was launched in 1996. This latest processor is designed to streamline downstream workflows with advanced automation capabilities that combine cytology processing with sample aliquoting, which helps to prevent misidentification of samples and allows for more confidence in results, says Hologic. In addition they say that features such as automated uncapping/capping and optional tube and slide printers automate labeling to reduce hands-on time by lab operators, improving ergonomics and streamlining performance for laboratories of any size.

For more information, visit: https://www.hologic.com/.

Cell-free RNA testing for pregnancy complications

Noninvasive prenatal testing (NIPT), which uses a blood test to identify maternal and fetal cell-free DNA, is a relatively new technology that can identify fetal genetic abnormalities such as chromosomal disorders. But what about identifying the risk of potential complications that can occur during pregnancy that can adversely affect the baby as well as the mother—conditions like preterm birth, preeclampsia, and gestational diabetes (GD)? These complications affect an estimated 45 million women globally each year. Mirvie is a company focused on using cell-free RNA testing of a single blood sample from the mother to assess the mother’s risk of developing pregnancy complications (including preterm birth, preeclampsia, and GD). The RNA testing reflects the state of the mother, baby, and the placenta. Mirvie is founded by the inventor of NIPT, and the company says they are making rapid progress toward their RNA-testing goal.


Currently, Mirvie is recruiting for their Miracle of Life study, which requests that single gestation pregnant mothers who are not scheduled for cesarean delivery provide a blood sample during their second trimester. Women can see if they are eligible for study participation by visiting https://www.curebase.com/study/miracle/home.

For more information, visit: https://mirvie.com/.

Male fertility platform

Newly launched Posterity Health is a Male Factor Management PlatformTM designed to help men optimize their fertility. From lifestyle and behavioral changes to increase the chances of conception to at-home semen analysis and a comprehensive, personalized treatment plan, Posterity Health has the fertility support built in. The platform also provides for virtual second opinions and consultations for vasectomy reversal and sperm cryopreservation. Posterity Health partners with fertility centers and ObGyns and currently can serve patients living in California, Colorado, and New York, with plans to expand services to other states.

For more information, visit: https://posterityhealth.com/.

 

Human placental allograft

Revita, an allograft composed of human placental membrane, developed by Stimlabs, is available to ObGyns and other health care professionals for many uses including surgery and wound care. The human placental membrane is composed of 3 layers, with single- and dual-layer placental allografts available since the 1990s, notes Stimlabs. Revita reserves all 3 layers, however, to include the intermediate layer, which contains hyaluronic acid and additional proteins. By including this jelly-like layer, the natural components of the native placental tissue are maximized, says Stimlabs, offering 6.55 times more growth factors and 4.3 times more protein content, and an overall thicker allograft, than competing products. The advantage is that many of the cytokines, growth factors, extracellular components, and cell communication signals the body uses to heal, protect, and grow tissues are retained.

For case reports involving Revita and for more information, visit https://www.stimlabs.com/revita.

FDA approval for cytology processor

Hologic announces US Food and Drug Administration approval for its ThinPrep® Genesis™ processor for cytology processing and specimen transfer. The Genesis is part of the company’s ThinPrep product line, which is focused on cervical cancer screening and was launched in 1996. This latest processor is designed to streamline downstream workflows with advanced automation capabilities that combine cytology processing with sample aliquoting, which helps to prevent misidentification of samples and allows for more confidence in results, says Hologic. In addition they say that features such as automated uncapping/capping and optional tube and slide printers automate labeling to reduce hands-on time by lab operators, improving ergonomics and streamlining performance for laboratories of any size.

For more information, visit: https://www.hologic.com/.

Cell-free RNA testing for pregnancy complications

Noninvasive prenatal testing (NIPT), which uses a blood test to identify maternal and fetal cell-free DNA, is a relatively new technology that can identify fetal genetic abnormalities such as chromosomal disorders. But what about identifying the risk of potential complications that can occur during pregnancy that can adversely affect the baby as well as the mother—conditions like preterm birth, preeclampsia, and gestational diabetes (GD)? These complications affect an estimated 45 million women globally each year. Mirvie is a company focused on using cell-free RNA testing of a single blood sample from the mother to assess the mother’s risk of developing pregnancy complications (including preterm birth, preeclampsia, and GD). The RNA testing reflects the state of the mother, baby, and the placenta. Mirvie is founded by the inventor of NIPT, and the company says they are making rapid progress toward their RNA-testing goal.


Currently, Mirvie is recruiting for their Miracle of Life study, which requests that single gestation pregnant mothers who are not scheduled for cesarean delivery provide a blood sample during their second trimester. Women can see if they are eligible for study participation by visiting https://www.curebase.com/study/miracle/home.

For more information, visit: https://mirvie.com/.

Male fertility platform

Newly launched Posterity Health is a Male Factor Management PlatformTM designed to help men optimize their fertility. From lifestyle and behavioral changes to increase the chances of conception to at-home semen analysis and a comprehensive, personalized treatment plan, Posterity Health has the fertility support built in. The platform also provides for virtual second opinions and consultations for vasectomy reversal and sperm cryopreservation. Posterity Health partners with fertility centers and ObGyns and currently can serve patients living in California, Colorado, and New York, with plans to expand services to other states.

For more information, visit: https://posterityhealth.com/.

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