Drug Pipeline News

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.

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.

Genevieve Neal-Perry, MD, PhD, talks about the recent approval of fezolinetant (Veozah; Astellas Pharma) and her latest phase 3 research presented at the 2023 ACOG Annual Clinical and Scientific Meeting.

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.

The federal agency set a Prescription Drug User Fee Act (PDUFA) action date of August 2023.

Results reported at CROI showed that 2 cohorts of the ongoing, phase 3 DELIVER study that this form of PrEP modality posed no differences in pregnancy and infant outcomes.

A look at contraceptive methods and how they are poised to affect women’s health.

The FDA has granted a regular approval to dostarlimab-gxly (Jemperli; GSK) for adult patients with mismatch repair–deficient, recurrent or advanced endometrial cancer that has progressed on or after a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.