Drugs
In FY 2020, FDA awarded 11 new research contracts and five new grants (not including supplements to existing projects) for innovative extramural research projects relevant to generic drugs. The FY 2020 GDUFA Science and Research Report from the CDER Office of Generic Drugs and Office of Pharmaceutical Quality says FDA
Drugs
FDA says its review of records supplied by Foshan Biours Biosciences Co., Guangdong Sheng, China, a registered manufacturer of over-the-counter drug products, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/10 Warning Letter says specific violations were: * failing to have, for
Drugs
FDA says its review of records supplied by Dibar Nutricional, a Morelia, Michoacan, Mexico, manufacturer of over-the-counter (OTC) drugs, determined significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/10 Warning Letter says the specific violations are: * failing to conduct at least one
Drugs
The inaugural annual report for the reorganized CDER Office of New Drugs (OND) says OND was able to meet or exceed its PDUFA goals, approve 53 new drugs, publish 31 new guidances, and maintain regulatory and programmatic operational responsibilities despite a significantly increased workload associated with the Covid-19 pandemic.
Drugs
Alvogen has filed suit in DC federal court asking it to order FDA to approve the firm’s ANDA for buprenorphine film in several strengths and to determine that Teva has forfeited any entitlement to 180-day marketing exclusivity for its buprenorphine film ANDAs. The suit says Alvogen submitted its
Drugs
In a 3/12 citizen petition, TherapeuticsMD asks FDA not to receive or approve any marketing application that references Annovera (segesterone acetate and ethinyl estradiol vaginal system) unless several specified conditions are met. The petition says a marketing application: * should only be submitted as an ANDA; * should cover an ANDA
Drugs
Sanofi and Regeneron are stopping early a Phase 3 clinical trial on PD-1 inhibitor Libtayo (cemiplimab) based on positive data and now plan an FDA submission later this year for treating cervical cancer. The data showed an overall survival benefit for Libtayo monotherapy compared to chemotherapy in patients previously
Drugs
FDA has issued PharmaEssentia a complete response letter (CRL) on its BLA for ropeginterferon alfa-2b-njft for treating polycythemia vera, a rare blood cancer, requesting the need for additional data about the administration format with the product. “Importantly, no concerns were raised about the clinical profile of the product,
Drugs
FDA has lifted a clinical hold against a Histogen IND application package for a planned Phase 1/2 clinical trial of its HST-003, intended to evaluate the safety and efficacy of human extracellular matrix implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage
Drugs
FDA has accepted for review a Marius Pharmaceuticals NDA for Kyzatrex (oral testosterone undecanoate) for primary and secondary male hypogonadism. The company says it is seeking an indication for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
Drugs
Boehringer Ingelheim has discontinued a Phase 2 trial of a first-in-class compound for reducing the risk or severity of acute respiratory distress syndrome (ARDS) in patients hospitalized with Covid-19 and requiring oxygen support. The decision follows a recommendation by trial’s independent data monitoring committee after an
Drugs
FDA has extended the PDUFA review date for Kadmon Holding’s belumosudil for treating chronic graft-versus-host disease (cGVHD) from 3/9 to 8/30. The agency told the company the extension allowed time to review additional information submitted by Kadmon in response to a recent agency information request.
Drugs
FDA has approved an Aveo Oncology NDA for Fotivda (tivozanib) for treating adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies. The approval of the next-generation vascular endothelial growth factor tyrosine kinase inhibitor was based on data from the
Drugs
FDA has announced a three-day (4/27-29) Oncologic Drugs Advisory Committee meeting to discuss the continued approval of six indications associated with three monoclonal antibodies that gained accelerated approval but failed to show clinical benefit in subsequent confirmatory trials. The panel meeting and FDA’s review is part
Drugs
FDA has released labeling revisions approved for ViiV’s Triumeq (abacavir/dolutegravir/lamivudine) to include dosing in patients with creatine clearance between 30 and 49 mL per min. An online post says additional drug interaction information for Triumeq and riociguat was included in the label. Similar changes were made to
Drugs
An online article written for the Parenteral Drug Association looks at how FDA initiatives are driving 21st century drug manufacturing technology. The article notes that the Covid-19 pandemic has demonstrated the consequences of inefficient manufacturing and supply chain challenges. It says that advanced manufacturing involves activities that use data-
Drugs
Attorneys for a former Eli Lilly senior human resources officer at the firm’s Branchburg, NJ, drug manufacturing facility say their client was a dedicated whistleblower who repeatedly pressed her superiors to address serious problems at the facility including staffing shortages, poor training, and record destruction and falsification. In a
Drugs
Sagent Pharmaceuticals has recalled three lots of phenylephrine hydrochloride injection, USP (10 mg/mL) due to sterility concerns. It was triggered by a customer complaint about potentially loose crimped vial overseals, which could result in a non-sterile product, a recall notice says. Phenylephrine hydrochloride injection is an alpha-1
Drugs
FDA has accepted for review an Idorsia NDA for its investigational dual orexin receptor antagonist, daridorexant, for treating adult patients with insomnia. The submission includes data from the company’s Phase 3 registration program, which the company says showed that daridorexant demonstrated statistically significant and clinically meaningful improvements in sleep
Biologics
A Pfizer facility in McPherson, KS, that is slated to start producing the company’s Covid-19 vaccine has a long history of mold and other contamination issues, according to inspection reports obtained by Kaiser Health News (KHN). The news service says “FDA investigators have repeatedly noted in reports that
Drugs
FDA has granted Vertex Pharmaceuticals a fast track designation for VX-880 for treating patients who have Type 1 diabetes with severe hypoglycemia and impaired hypoglycemic awareness. The company says the first clinical trial sites at the University of Miami Health System, the University of Pennsylvania and Massachusetts General Hospital
Drugs
Bryant Ranch Prepack has recalled four lots of spironolactone tablets after determining they have been mislabeled and display the incorrect strength. “Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain spironolactone 50 mg tablets,” a recall notice says.