Drugs
Medical Device User Fee Act (MDUFA) investments made since 2002 have “paid off dividends with an increasing number of device innovators bringing their devices to the U.S. first, and a more robust pipeline of innovative new devices, which ultimately has led to more timely patient access,” CDRH director Jeff
Drugs
FDA says that sotrovimab is not authorized in HHS regions 5, 9, and 10 as of 3/30 because the Centers for Disease Control and Prevention says that the proportion of Covid-19 cases caused by the omicron BA.2 variant is above 50% in those regions. An agency statement
Drugs
FDA has issued a complete response letter for Akebia Therapeutics’ NDA for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor under review for treating anemia due to chronic kidney disease. The company says FDA concluded the data in the NDA do not support a favorable benefit/risk assessment
Drugs
FDA’s Peripheral and Central Nervous System Drugs Advisory Committee delivered a near mixed vote 3/30 on whether Amylyx Pharmaceuticals’ experimental amyotrophic lateral sclerosis (ALS) therapy AMX0035 should be approved. Panel members voted 6 to 4 that data from the single randomized, controlled trial and the open-label extension
Drugs
FDA has just released the FDA-483s issued following 1/16-1/19/2017 and 8/7-8/11/2017 inspections at Zhejiang Hisun Pharmaceutical Co., a Taizhou City, Zhejiang, China, active pharmaceutical ingredient manufacturer. The form for the January inspection had these observations: * failing to follow quality control laboratory
Drugs
A 10/21-11/3/21 FDA inspection at the Agropharma Laboratories Salinas, Puerto Rico, drug manufacturing facility found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/25 Warning Letter says the specific violations were: * failure of the quality control unit to exercise its
Drugs
An FDA records review determined that Dr Retter Ec Wladyslaw Retter, Mazowieckie, Poland, which is registered with FDA as a manufacturer of over-the-counter drug products, has significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/14 Warning Letter says specific violations are: * failing
Drugs
FDA has approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for treating HIV-1 in virologically suppressed adolescents who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either
Drugs
Several drug and medical device industry stakeholders have submitted comments on an FDA draft guidance on digital health technologies for remote data acquisition in clinical investigations. Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the agency’s ongoing efforts to facilitate the use of digital health technologies in
Drugs
FDA has approved a higher 2 mg dose of Novo Nordisk’s Ozempic (semaglutide) injection, a once-weekly glucagon-like peptide-1 analog indicated along with diet and exercise to improve blood sugar in adults with Type 2 diabetes and to reduce the risk of major cardiovascular events such as
Drugs
An FDA advisory committee briefing document on Amylyx Pharmaceuticals’ experimental amyotrophic lateral sclerosis (ALS) therapy AMX0035 provides no ringing endorsement from agency reviewers. Although the therapy is not under consideration for accelerated approval, many FDA watchers are painting another Biogen Aduhelm-type scenario due to patient advocacy group pressure urging
Drugs
FDA has amended a GlaxoSmithKline and Vir Biotechnology Emergency Use Authorization for sotrovimab, an investigational monoclonal antibody used in Covid-19 patients, because the 500mg therapy is unlikely to be effective against the Omicron BA.2 variant. The agency based its decision on the “totality of available evidence, including new
Drugs
Bristol-Myers Squibb (BMS) says it has resolved manufacturing constraints that led to “global supply challenges” for Abraxane (paciltaxel protein bound particles for injectable suspension). In a just-posted letter on steps it took to resolve the drug shortage, BMS says the drug product manufacturing site has now returned to
Drugs
FDA has discouraged MEI Pharma and Kyowa Kirin from seeking accelerated approval of a BLA for zandelisib, a phosphatidylinositol-3-kinase (PI3K) inhibitor drug candidate for treating patients with B-cell malignancies, based on data from their single-arm Phase 2 TIDAL study. In a recent meeting, FDA told the
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to conduct a study entitled “Accelerated Approval Disclosures on Direct-to-Consumer (DTC) Prescription Drug Websites.” A recent OPDP analysis of DTC Web sites for accelerated approval products found that 21% contained disclosures about the accelerated approval that used language
Drugs
FDA has approved a label update for Janssen’s Cabenuva (cabotegravir and rilpivirine) to give healthcare professionals and HIV patients the option to start its monthly or every-two-month injectable treatment without the need for an oral lead-in phase of daily Cabenuva tablets for one month. A company
Drugs
FDA has issued Eli Lilly and Innovent Biologics a complete response letter on its BLA for sintilimab injection, a me-too PD-1 inhibitor for use in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer (NSCLC). The letter
Drugs
The CDER/Small Business and Industry Assistance Generic Drugs Forum 2022 will be held 4/26-4/27 with the theme “The Current State of Generic Drugs.” A conference notice says the two keynote speakers will be CDER Office of Generic Drugs director Sally Choe and Office of Pharmaceutical Quality
Drugs
FDA approved 3/23 Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. An agency notice says concurrent approval was granted for the company’
Drugs
An Associated Press report on an upcoming advisory committee meeting to consider Amylyx Pharmaceuticals’ investigational amyotrophic lateral sclerosis (ALS) drug says the drug may cause the agency issues similar to those caused by its controversial approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease. Three advisory committee members
Drugs
PharmaTher says topline results from a dose-finding and tolerability clinical study of ketamine for treating levodopa-induced dyskinesia (LID) in Parkinson’s patients were sufficient for the company to engage FDA to establish next steps for a planned Phase 3 study to allow for ketamine’s approval under the
Drugs
A presentation by CDER Office of Manufacturing Quality branch chief Maan Abduldayem at the 46th Annual International GMP Conference in Athens, GA 3/8 provided the Center’s “Top Recent Warning Letter Citations” (FY 2019 to FY 2021). They are: * CFR 211.192 Production record review (cited in 61 Warning