Medroxyprogesterone acetate

Amneal Launches Authorized Generic for Xyrem® (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter

Retrieved on: 
Monday, July 3, 2023

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL) is a generic version of Precedex® Injection.

Key Points: 
  • Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL (200 mcg/50 mL and 400 mcg/100 mL) is a generic version of Precedex® Injection.
  • For full prescribing information, see package insert located here .
  • Nelarabine injection, 250mg/50mL (5mg/mL) is a generic version of Arranon® Injection.
  • Patients must be enrolled in the XYWAV and XYREM REMS to receive Sodium Oxybate Oral Solution.

Global Contraceptives Market 2022 to 2027: Players Including Church & Dwight, Veru, Mayer Laboratories and Pfizer - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 31, 2023

The market for contraceptives is anticipated to witness healthy growth over the next five years.

Key Points: 
  • The market for contraceptives is anticipated to witness healthy growth over the next five years.
  • Moreover, the growing government focus in many countries on population control has further created business growth opportunities for market players over the next five years.
  • The growing working-class female population is also a key factor supplementing the market growth over the next five years.
  • By geography, the global market for contraceptives is distributed in North America, South America, Europe, the Middle East and Africa, and the Asia Pacific.

Settlement Agreement Reached in the Canadian Depo-Provera Class Action

Retrieved on: 
Tuesday, September 14, 2021

MONTREAL, Sept. 14, 2021 /CNW/ - A Canada-wide settlement agreement was recently reached in a class action related to the use of Depo-Provera, an injectable form of birth control, and bone mineral density loss.

Key Points: 
  • MONTREAL, Sept. 14, 2021 /CNW/ - A Canada-wide settlement agreement was recently reached in a class action related to the use of Depo-Provera, an injectable form of birth control, and bone mineral density loss.
  • If the Court approves the settlement, class members who meet the eligibility criteria will receive compensation for osteopenia, osteoporosis, and fragility fractures.
  • In order to object to the settlement or to legal fees, class members must send a written objection to [email protected] no later than October 16, 2021.
  • Class members can register now with the Claims Administrator at www.depoprovera.ca to be notified when they will be able to submit their claim.

Relmada Therapeutics Announces Top-Line Results of Study Evaluating REL-1017 vs Oxycodone for Abuse Potential

Retrieved on: 
Tuesday, July 27, 2021

The study comparing REL-1017 to oxycodone is the first of two clinical trials to assess abuse potential per FDA guidance as part of the planned REL-1017 NDA for the treatment of MDD.

Key Points: 
  • The study comparing REL-1017 to oxycodone is the first of two clinical trials to assess abuse potential per FDA guidance as part of the planned REL-1017 NDA for the treatment of MDD.
  • The scheduling of a drug depends on the analysis of several parameters (receptor studies, animal studies, human studies, history of abuse).
  • Oxycodone, the active control, was administered at the dose of 40 mg, a standard dose in HAP studies.
  • Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Daré Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene®, an Investigational Hormone-Free Monthly Contraceptive

Retrieved on: 
Monday, July 12, 2021

The agreement will allow Dar to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD.

Key Points: 
  • The agreement will allow Dar to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD.
  • The pivotal Phase 3 study will be supported by the NICHDs Contraceptive Development Program (CDP).
  • Under the CRADA, Dar has also agreed to contribute $5.5 million toward the total estimated cost to conduct the pivotal Phase 3 study, which will be payable in four payments.
  • The multi-center, single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene will evaluate its effectiveness as a contraceptive device along with its safety and usability.

Affron Associated with Improvements in Psychological Symptoms of Menopause According to New Study

Retrieved on: 
Tuesday, June 15, 2021

The saffron extract, administered for 12 weeks at 28 mg at day, was associated with greater improvements in psychological symptoms.

Key Points: 
  • The saffron extract, administered for 12 weeks at 28 mg at day, was associated with greater improvements in psychological symptoms.
  • Affron is produced and marketed by Pharmactive using green proprietary technology to extract pure, highly concentrated saffron.
  • "This is the first study of affron examining menopause symptoms in average perimenopausal women," explains Alberto Espinel, Manager of Strategic R&D in Active and Functional Natural Ingredients for Pharmactive.
  • "This means that in comparison to other botanical extracts that target menopause symptoms, affron doesn't have undesirable estrogenic effects.

Use of Takeda's Entyvio SC in Inflammatory Bowel Disease Has Slowed Considerably in the EU5 as Gastroenterologists Eye Potential New Launches Later This Year

Retrieved on: 
Tuesday, June 8, 2021

While not overt, there are several data points that suggest efficacy concerns for Entyvio SC have increased among EU5 gastroenterologists in the past six months.

Key Points: 
  • While not overt, there are several data points that suggest efficacy concerns for Entyvio SC have increased among EU5 gastroenterologists in the past six months.
  • While not unusual for a newly-launched therapy, the discontinuation rate for Entyvio SC increased in both UC and CD as compared to the previous wave.
  • Similarly, "concerns about efficacy" increased as a barrier to Entyvio SC prescribing in UC and CD.
  • The percentage of severe UC patients who are considered candidates for Entyvio SC in UC decreased by eleven points since the last wave.

Deciphera Pharmaceuticals Presents Data from QINLOCK® and Rebastinib Programs at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Friday, June 4, 2021

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced two e-poster presentations at the 2021 ASCO Annual Meeting.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced two e-poster presentations at the 2021 ASCO Annual Meeting.
  • As of a March 19, 2021 cutoff date, 38 patients with endometrial cancer initiated treatment with rebastinib in combination with weekly paclitaxel 80 mg/m2.
  • Of the 38 patients with endometrial cancer who initiated treatment with rebastinib, the median duration of treatment was 3.7 months.
  • QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.

Radius Health Business Update

Retrieved on: 
Wednesday, June 2, 2021

TYMLOS new patient adds in April: modest growth vs. previous 4-month trailing averages

Key Points: 
  • TYMLOS new patient adds in April: modest growth vs. previous 4-month trailing averages
    Meaningful FDA guidance on generic peptide requirements published on May 19, 2021
    Anticipate abaloparatide depot formulation technical development work to commence 2H, 2021
    BOSTON, June 02, 2021 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Radius or the Company) (NASDAQ: RDUS), provided a business update covering continued progress for the Company.
  • Additional business updates will be provided as progress is achieved.
  • Radius views this new guidance as meaningful in assessing the probability of a generic synthetic peptide being filed and gaining market entry.
  • Radius lead product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

Menopause to Become the Next Game-changer in the Global Femtech Solutions Industry by 2025

Retrieved on: 
Wednesday, June 2, 2021

The global femtech solutions industry market is estimated to hit $1.15 billion by 2025 from $648 million in 2020, registering a compound annual growth rate (CAGR) of 12.2%.

Key Points: 
  • The global femtech solutions industry market is estimated to hit $1.15 billion by 2025 from $648 million in 2020, registering a compound annual growth rate (CAGR) of 12.2%.
  • Market expansion is being boosted by the fertility, pregnancy, and menstrual care solutions segments, along with a surge in the menopausal solutions segment, which is gaining traction with new services and solutions.
  • The study also details the femtech funding landscape and top femtech companies to watch.
  • Femtech startups should address the symptoms of menopause in innovative ways to improve life for older women.