Drug Pipeline News

Bayer has submitted a New Drug Application for elinzanetant, following positive results from the OASIS studies, showing significant safety and efficacy in treating moderate-to-severe vasomotor symptoms in menopausal women.

These results indicated a significant reduction of CPP from 12 weeks of ZY5301 treatment. Investigators recommended a ZY5301 600 mg/d dose be investigated in a phase 3 trial.

Femlyv, containing norethindrone acetate and ethinyl estradiol, offers a new oral contraceptive option for individuals with swallowing difficulties, expanding access and convenience.

Reunion Neuroscience Inc. initiates phase 2 trial of RE104, a novel short-duration psychedelic treatment for postpartum depression, aiming to provide rapid and effective relief for affected mothers.

Serac Healthcare’s 99mTc-maraciclatide, a new radio-labelled tracer, gains FDA Fast Track Designation for its potential to improve non-invasive diagnosis of superficial peritoneal endometriosis in patients aged 16 and older.

Review some of the top stories from the Contemporary OB/GYN website over the last week, and catch up on anything you may have missed.

In a unanimous ruling, the Supreme Court rejected a challenge by antiabortion doctors, maintaining nationwide access to mifepristone for medication abortions and reversing a lower court's decision to restrict the pill's availability.

Gilead Sciences has announced FDA approval of an updated Biktarvy label, showcasing safety and efficacy data from a phase 1b trial, positioning it as a pivotal treatment option for pregnant individuals with HIV-1 and suppressed viral load.

Explore the efficacy of Pivya (pivmecillinam; Utility Therapeutics) tablets in managing uncomplicated urinary tract infections in female adults, supported by controlled clinical trials and safety considerations.

Review some of the top stories from the Contemporary OB/GYN website over the last week, and catch up on anything you may have missed.

As a potential alternative to antibiotic treatments, this investigational immunization offered protection for several years.

Learn from Paige Meizlik, MD, MSTR, about the FDA's Fast Track Designation for nipocalimab, offering hope for addressing the critical unmet needs in treating fetal neonatal alloimmune thrombocytopenia and advancing maternal-fetal immunology research.

Review some of the top stories from the Contemporary OB/GYN website over the last week, and catch up on anything you may have missed.

The FDA's Fast Track Designation for nipocalimab marks a significant step in addressing fetal neonatal alloimmune thrombocytopenia risk in pregnant patients, potentially revolutionizing treatment for this severe condition with unmet medical needs.

Online orders began this week for the first over the over-the-counter contraceptive, Opill (norgestrel; Perrigo).

Bayer's OASIS 3 trial affirmsed the safety and efficacy of elinzanetant in reducing moderate to severe vasomotor symptoms, bolstering confidence in its potential as a non-hormonal solution for menopause-related issues.

Review some of the top stories from the Contemporary OB/GYN website over the last week, and catch up on anything you may have missed.

Walgreens and CVS pharmacies are set to dispense mifepristone in select states, aiming to address legal complexities and enhance accessibility amidst ongoing regulatory and legal battles.

Enmetazobactam (Exblifep; Orchid Pharma) gains FDA approval for treating complicated urinary tract infections in adults after demonstrating superiority over piperacillin-tazobactam in clinical cure and microbiological eradication in a global phase 3 trial.

The FDA has issued a Complete Response Letter for the New Drug Application of cefepime-taniborbactam, requesting additional chemistry, manufacturing, and controls data.

Nipocalimab, a monoclonal antibody targeting maternal alloantibodies, has received FDA Breakthrough Therapy Designation for treating severe hemolytic disease of the fetus and newborn.

A phase 3 trial demonstrated that oteseconazole (VIVJOA; Mycovia Pharmaceuticals) capsules exhibit improved therapeutic and mycological cure rates to fluconazole for treating severe vulvovaginal candidiasis.

Review some of the top stories from the Contemporary OB/GYN website over the last week, and catch up on anything you may have missed.

Bayer has initiated the phase 2 trial NIRVANA to evaluate elinzanetant's potential in treating sleep disturbances in menopausal women, addressing a prevalent yet unmet need in women's health.

Elinzanetant demonstrated positive safety and efficacy data in managing menopausal vasomotor symptoms, highlighting its potential as a treatment for improving women's quality of life during menopause.