Drugs
Evofem Biosciences says it is ending the development of its EVO100 to prevent chlamydia and gonorrhea infection in women. The company says the decision to stop the development program follows results from the Phase 3 EVOGUARD trial that failed to meet its endpoints. Company officials said they believe the trial
Drugs
FDA has released the form FDA-483 issued following a 7/18-8/5 inspection at Empower Clinical Services, doing business as Empower Pharmacy, a Houston, TX, outsourcing facility. The 17 inspection observations were: * failing to have in writing and fully follow the responsibilities and procedures applicable to the quality
Drugs
Harm Reduction Therapeutics (HRT) has begun a rolling NDA for RiVive (3 mg intranasal naloxone), indicated as an over-the-counter emergency treatment for opioid overdose. In July, FDA agreed to the company’s rolling review proposal after it granted the company fast track status, according to HRT. HRT describes
Drugs
Three Hyman, Phelps & McNamara attorneys say that despite the lack of a draft guidance on confirmatory evidence, FDA’s use of a confirmatory evidence standard in several drug approvals indicates the agency’s emerging, explicit interest in this portion of the Federal Food, Drug, and Cosmetic Act. “Even in
Drugs
A 4/12-4/27 FDA inspection at the Legacy Pharmaceutical Packaging drug manufacturing facility in Earth City, MO, identified significant violations of current good manufacturing practice (CGMP) regulations. A 10/3 Warning Letter says the specific violation was failing to thoroughly investigate any unexplained discrepancy or failure of a
Drugs
The Washington DC District Court has ruled against FDA in granting summary judgment to plaintiff Melinta Therapeutics that suspends the approval of a generic version of the company’s Minocin (minocycline), which treats bacterial infections, manufactured by Nexus Pharmaceuticals. In seeking FDA approval of its ANDA in 2020, a required
Drugs
CDER says it is proposing to refuse to approve a Vanda Pharmaceuticals sNDA for a new indication for its Hetlioz (tasimelteon). A Federal Register notice says Hetlioz is currently indicated to treat non-24-hour sleep-wake disorder. Vanda is seeking a new indication for treating jet lag disorder. The
Drugs
The Outsourcing Facilities Association (OFA), which represents FDA-registered 503B outsourcing facilities that compound medications, and FDA have reached a settlement agreement to compel the agency to “promptly review long-pending nominations for active pharmaceutical ingredients (API)” for use by such outsourcing facilities. In its complaint, OFA said that despite
Drugs
FDA investigators have found additional quality issues at the Lilly Branchburg, NJ, drug manufacturing facility, according to a Reuters exclusive story based on an FDA-483 obtained through a Freedom of Information request. The report says the new FDA-483 comes three years after the agency began documenting quality control
Drugs
FDA has accepted for priority review a Gilead Sciences supplemental BLA for Trodelv (sacituzumab govitecan-hziy) for treating adult patients with unresectable locally advanced or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer who have received endocrine-based therapy and at least two additional systemic
Drugs
A 4/18-4/19 FDA inspection at the Eksa Mills drug manufacturing facility in Zaragoza, Puebla, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/5 Warning Letter says specific violations were: * failing to clean, maintain, and, as appropriate for the nature
Drugs
Regeneron Pharmaceuticals and Sanofi say they will seek FDA approval next year for Dupixent (dupilumab) and its use in treating children with active eosinophilic esophagitis (EoE) after announcing positive results from a Phase 3 trial. EoE affects a child’s ability to eat, according to the companies, adding that common
Drugs
FDA has issued Supernus Pharmaceuticals a complete response letter on its NDA for SPN-830 (apomorphine) infusion device for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease. The letter requests “additional information and analysis related to the infusion device and drug product across several areas of
Drugs
Merck is reporting positive top-line results from a pivotal Phase 3 trial (STELLAR) evaluating the safety and efficacy of sotatercept, an investigational activin receptor Type IIA-Fc fusion protein being studied as an add-on therapy for treating pulmonary arterial hypertension. The company says the trial met its primary
Drugs
FDA has approved scPharmaceuticals’ Furoscix (furosemide injection), described as a proprietary formulation of furosemide delivered via an on-body infusor for treating congestion due to fluid overload in adults with New York Heart Association Class 2/3 chronic heart failure. The company says Furoscix is the first FDA-approved subcutaneous
Drugs
The American College of Obstetricians and Gynecologists and 48 other reproductive health organizations have petitioned FDA to ask Danco Laboratories to submit a supplemental NDA for Mifeprex (mifepristone), indicated for medical termination of pregnancy, to add “miscarriage management” to the drug’s indication. The petition also asks the agency to
Drugs
FDA has approved an Alnylam Pharmaceuticals supplemental NDA to expand the label for Oxlumo (lumasiran), an RNAi therapeutic indicated for treating primary hyperoxaluria Type 1 (PH1) to lower urinary oxalate (UOx) and plasma oxalate (POx) levels in pediatric and adult patients. The drug was originally approved 11/2020 for treating
Drugs
An FDA briefing document released in advance of a 10/17-19 advisory committee meeting to discuss whether the accelerated approval of Covis’ Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly) should be withdrawn argues strongly that the drug is not effective and has known risks. It was approved
Drugs
Yale University researchers say their review of drug safety signals identified from the FDA Adverse Event Reporting System (FAERS) between 2008 and 2019 suggested ways FDA could ensure timely and robust assessment of potential safety signals. Writing in the BMJ, the researchers offer three considerations: * set deadlines for reviewing safety
Drugs
CDER and CBER say they are partnering with the Critical Path Institute to begin planning for a consortium to develop tools appropriate for use in clinical development programs for alpha-1 antitrypsin deficiency (AATD). An FDA statement says there’s “an urgent need for biomarkers in AATD that would predict
Drugs
FDA has granted Eli Lilly a fast track designation for tirzepatide and its use for treating adults with obesity, or overweight with weight-related comorbidities. After obtaining input from the agency, Lilly says it will initiate a rolling NDA submission this year. It will be based on data from two
Drugs
Researchers from Harvard and Yale Universities and Kaiser Permanente say that among postmarket requirements and postmarket commitments issued to new FDA-approved drugs between 2013 and 2016, about 75% of those due by 2020 were not submitted on time. Writing in a JAMA Internal Medicine Research Letter, the researchers say