Drugs
FDA has extended by three months the user fee review action dates on two bluebird bio BLAs for its lentiviral vector gene therapies – betibeglogene autotemcel (beti-cel) for β-thalassemia and elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy. The new review action target dates for beti-cel and eli-cel
Drugs
FDA has approved a Glenmark Specialty NDA for Ryaltris (olopatadine HCl and mometasone furoate) a fixed-dose (metered) nasal spray for treating seasonal allergic rhinitis symptoms in adults and pediatric patients 12 years of age and older. Each nasal spray unit contains 665 mcg of olopatadine HCL, a histamine-1
Drugs
An 8/2021 FDA outsourcing facility inspection of Eagle Pharmacy (Hoover, AL) has led to a five-page Form FDA 483 that cited several GMP deficiencies. For example, the agency said aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, the 483 says environmental surface sampling
Drugs
FDA has approved a Pfizer NDA for Cibinqo (abrocitinib), an oral Janus kinase 1 inhibitor for treating adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics.The drug is approved for recommended doses of 100 mg
Drugs
A new Government Accountability Office (GAO) report finds that FDA needs better planning for its recruitment and retention of medical product staff. The GAO examination was required as part of the 2016 21st Century Cures Act that provided additional flexibilities regarding FDA’s recruitment and retention of medical product staff.
Drugs
Cato Institute senior fellow Jeffrey Singer, a general surgeon, and American Council on Science and Health director of chemical and pharmaceutical science Josh Bloom say two FDA requirements that are part of the emergency use authorizations for two Covid-19 antiviral drugs “all but guarantee that most people who need
Drugs
FDA has informed Denali Therapeutics that it has placed a clinical hold on the firm’s DNL919 IND, an Alzheimer’s candidate. Denali says an agency e-mail indicated that an official clinical hold letter would be provided in about 30 days.
Drugs
GlaxoSmithKline and Vir Biotechnology have asked FDA to approve an expanded emergency use authorization (EUA) for the Covid-19 monoclonal antibody treatment sotrovimab to include intramuscular administration. FDA approved the sotrovimab EUA 5/2021 as an investigational single-dose intravenous infusion for the early treatment of SARS-CoV-2. The
Drugs
A Miami, FL, woman who co-owned Unlimited Medical Research, a clinical research site, pleaded guilty 1/12 to obstructing a 2017 FDA regulatory inspection with an alleged scheme to fraudulently falsify clinical trial data. The Department of Justice says that as part of a plea agreement, Olga Torres admitted
Drugs
FDA has cleared a G-Tech Medical 510(k) for its Wireless Patch System for myoelectric activity measurement. The device is intended to provide gastric and intestinal myoelectrical activity measurements to aid in the diagnosis and evaluation of gastrointestinal disorders. “Gastrointestinal motility is the underlying factor in a wide range
Drugs
FDA has released the FDA-483 issued following a 9/16-9/28/21 inspection at SSM Health Care St. Louis, doing business as SSM St. Clare Health Center, a Fenton, MO, outsourcing facility. The four inspection observations were: * written records of investigations into the failure of a batch or
Drugs
FDA is warning patients and prescribers about the potential for dental problems associated with buprenorphine drugs dissolved in the mouth to treat opioid use disorder and pain. An agency statement says problems including tooth decay, cavities, dental abscesses/infection, tooth erosion, and, in some cases, total tooth loss, have been
Drugs
FDA has accepted for priority review a Mitsubishi Tanabe Pharma America NDA for edaravone (MT-1186) for treating amyotrophic lateral sclerosis (ALS). The company says that oral edaravone has been developed to have a similar clinical profile compared to the intravenous formulation of Radicava (edaravone), which was approved by the
Drugs
Washington University in St. Louis law professor Rachel Sachs says the Center for Medicare and Medicaid Services (CMS) decision to propose restricting Medicare coverage of Biogen’s Aduhelm (aducanumab) “is likely … to fuel criticism of FDA’s accelerated approval program and its relationship to payers.” Writing in an online Health
Drugs
Novartis and Molecular Partners are planning to seek an FDA emergency use authorization after reporting results from the EMPATHY clinical trial that compared single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate, compared with placebo in treating Covid-19. Trial data showed that the therapy met the primary endpoint
Drugs
Harvard Medical School researchers say the FDA process of allowing generic drug manufacturers to market versions with so-called skinny labels that exclude patent-protected indications allowed generic versions of Novartis’ Gleevec (imatinib) to enter the market before patent protections for treating gastrointestinal stromal tumors (GIST) expired. Writing in the
Drugs
FDA has accepted a PharmaTher investigator-initiated IND to proceed with a Phase 2 trial to evaluate ketamine to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The company says the agency previously had granted an orphan drug designation for ketamine to treat ALS. If the
Drugs
FDA has released the FDA-483 issued following a 7/7-7/27/21 inspection at Med Shop Total Care, a Longview, TX, producer of sterile and non-sterile drugs. The specific observations were: * failing to make adequate product evaluation and take remedial action where actionable microbial contamination was found
Drugs
FDA and the Duke-Margolis Center for Health Policy published 12/15/21 the summary of a 10/2019 workshop “Enhancing the Accessibility and Utility of Drug Interaction Information in Prescription Drug Labeling.” The summary highlights the discussion of workshop participants about challenges in managing drug interactions in the clinical
Drugs
Two professors in the University of Pennsylvania Perelman School of Medicine and Boston University School of Law say the FDA accelerated approval process is “worth saving, but fixes are needed to make sure companies quickly follow through on rigorous confirmatory studies” of the drugs receiving accelerated approval. Writing in a
Drugs
A 6/16-6/24/21 FDA inspection at the Hubei Kangzheng Pharmaceutical Company drug manufacturing facility in Hubei Province, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 11/23/21 Warning Letter says specific violations were: * failing to establish and
Drugs
FDA has released the FDA-483 issued following a 7/7-7/21/21 inspection at Tailstorm Health, a Chandler, AZ, 503B outsourcing facility. The inspection observations were: * written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up; * laboratory controls do not include the