Drug Pipeline News

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.

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.

A blood test to determine the risks of preeclampsia and severe preeclampsia in pregnant patients has been given approval by the FDA.

Astellas has announced positive results of a trial evaluating the safety and efficacy of fezolinetant in menopausal women with moderate to severe vasomotor symptoms.

Johnson & Johnson has announced positive safety and efficacy results in a phase 2 trial evaluating nipocalimab against early-onset severe hemolytic disease of the fetus and newborn.

Daré Bioscience has published new data on the safety and pharmacokinetics of DARE-HRT1.

Daré Bioscience has announced positive results from a phase 2b trial analyzing the safety and efficacy of sildenafil cream, 3.6% in women with female sexual arousal disorder.

Fezolinetant (Veozah; Astellas Pharma) is now the first neurokinin 3 receptor antagonist approved for the treatment of vasomotor symptoms associated with menopause.

In a unanimous vote, norgestrel (Opill; HRA Pharma) has been backed by an FDA advisory panel as an over-the-counter birth control pill.

With an FDA approval, it would be the first new class of oral antibiotics for uncomplicated urinary tract infections (uUTI) in over 20 years.

In a recent phase 1 trial, DARE-HRT1 showed positive safety and acceptability results for treating moderate-to-severe vasomotor symptoms in postmenopausal women.

Following voluntary market withdrawal from Covis Pharma, the FDA has decided to withdraw the approval of Makena and its generics for reducing the risk of preterm birth.

Visby Medical has announced its second generation point of care test for detecting sexually transmitted diseases in women has received 510(k) clearance and a CLIA waiver from the FDA.

Newly published data from a phase 3 study demonstrate the safety and efficacy of fezolinetant (Astellas) for treatment of VMS due to menopause.

Covis, the manufacturer of the controversial preterm birth prevention drug Makena, has announced it will voluntarily withdraw the drug from the market after recommendations from the Center for Drug Evaluation and Research.

The therapy, bepirovirsen, is an antisense oligonucleotide that targets all Hepatitis B (HBV) messenger RNAs, and the company is hoping it will become a functional cure.

Individuals that did not respond had a lower percentage of naïve T cells compared to responders, while responders had a lower percentage of Th2 and CD4 central memory subsets before vaccination.

The wearable device received its original FDA go-ahead in 2019, and has since demonstrated effectiveness in preventive and acute care for migraine treatment in adolescents and adults.