Drug Pipeline News

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.

JoAnn Vensko Pinkerton, MD, discusses how fezolinetant provides relief for postmenopausal women experiencing hot flashes and night sweats.

Daré Bioscience's DARE-PDM1 showcases promising safety, efficacy, and pharmacokinetic results in phase 1 trials, highlighting its potential to revolutionize primary dysmenorrhea treatment.

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 Supreme Court's upcoming decision on mifepristone, a key abortion medication, may alter access, introducing potential restrictions and impacting the landscape of abortion rights.

Daré Bioscience's tamoxifen-based therapy, DARE-VVA1, secures FDA clearance for an investigational new drug application, offering hope for women with contraindications to estrogen therapies suffering from the underdiagnosed condition of vulvar and vaginal atrophy.

Daré Bioscience has commenced a pivotal phase 3 clinical trial for ovaprene, an intravaginal contraceptive that releases a locally acting agent to prevent sperm entry into the cervical canal, marking a significant step towards a non-hormonal contraceptive option for women.

In a recent study, patients receiving Sildenafil Cream for female sexual arousal disorder reported improvements in arousal dysfunction.

Nanette F. Santoro, MD, chair of OBGYN at the University of Colorado School of Medicine, discusses new research on fezolinetant as a nonhormone method for managing hot flashes at the 2023 Menopause Society Annual Meeting.

A nationwide recall has been issued for ibrexafungerp products after a potential cross contamination with a non-antibacterial ß-lactam drug substance was discovered.

Ahead of the first fall and winter virus seasons in which vaccines are available for COVID-19, influenza, and respiratory syncytial virus (RSV), the Centers for Disease Control and Prevention is recommending Pfizer’s maternal vaccine to protect newborns from severe RSV illness.

If approved, cefepime-taniborbactam will provide treatment against complicated urinary tract infections in adults.

Daré Bioscience has published the results of a phase ½ trial on DARE-HRT1, indicating efficacy against moderate-to-severe vasomotor symptoms.

Zuranolone (SAGE-217; SAGE Therapeutics) has been granted priority review for treatment against postpartum depression and major depressive disorder symptoms.

Researchers have developed a method of administrating methotrexate through polymersomes for improved efficacy when treating ectopic pregnancy.

According to Pfizer, the investigational vaccine to protect against Group B Streptococcus (GBS) generated maternal antibody responses against 6 capsular polysaccharide serotypes and efficiently transferred antibodies to the infants. The announcement of this phase 2 data comes in July, which is International Group B Streptococcus Month.

Norgestrel (Opill; HRA Pharma) is the first nonprescription oral contraceptive approved for use in the United States.