Drugs
An 11/18-11/22/19 FDA inspection at Cosmaceutical Research Lab, Surrey, BC, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. A 5/29 Warning Letter says the firm also manufactures two over-the-counter drug products, one of which
Drugs
A UK National Institute for Health Research-funded and supported study called RECOVERY (Randomized Evaluation of Covid-19 Therapy) has shown that the steroid dexamethasone can improve survival rates in certain coronavirus patients. The study, conducted at the University of Oxford, found that dexamethasone reduced the risk of dying by
Drugs
FDA says it has issued Warning Letters to four companies for selling unapproved injectable drug products labeled as homeopathic that the agency says can pose serious risks to patient health and violate federal law. An agency statement says FDA is particularly concerned about unapproved injectable drug products labeled as homeopathic
Drugs
The DC Circuit Court of Appeals has upheld a federal district court decision rejecting an HHS rule that broadly required drug manufacturers to disclose in their TV ads the wholesale acquisition cost of many prescription drugs and biologics for which payment is available under Medicare or Medicaid. The appeals court
Drugs
FDA says it has granted accelerated approval to Jazz Pharma’s Zepzelca (lurbinectedin) for adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy. An agency announcement says the drug’s efficacy was demonstrated in a multi-center trial enrolling 105 patients who
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Cosmaceutical Research Lab, Surrey, Canada (5/29): FDA inspected the firm 11/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to ensure that
Drugs
An FDA 11/18-11/26/19 inspection at Takeda 4720, Yamaguchi, Japan, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 6/9 Warning Letter says specific violations were: * failing to establish adequate written responsibilities and procedures applicable to the quality control unit and
Drugs
FDA has made available a guidance entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.” The document addresses how stakeholders (patients, researchers, medical product developers, and others) can collect and submit information on the patient experience for medical product development and regulatory decision making. It is part of a
Drugs
Acadia Pharmaceuticals has submitted a supplemental NDA to support a potential new indication for Nuplazid (pimavanserin) — treating hallucinations and delusions associated with dementia-related psychosis. The agency previously granted a breakthrough therapy designation for the indication. Nuplazid was approved in the U.S. in 2016 as the first and only
Drugs
FDA has revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with Covid-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible. In announcing
Drugs
FDA has approved Merck’s Gardasil 9 (human papillomavirus (HPV) 9-valent vaccine, recombinant) for preventing oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The accelerated-approval indication was based on effectiveness data showing prevention of HPV-related anogenital
Drugs
A new FDA safety alert is warning health care providers about a newly discovered potential drug interaction with Gilead Sciences’ investigational antiviral drug remdesivir, which has received emergency use authorization for treating hospitalized Covid-19 patients with severe disease (see earlier story). “Based on a recently completed non-clinical laboratory
Drugs
Eli Lilly says it has enrolled the first patient in a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with Covid-19. Baricitinib, marketed as Olumiant, is approved in 70 countries
Drugs
Some 51 states and U.S. territories have filed their third complaint in Connecticut federal court stemming from an ongoing antitrust investigation into what is described as a “widespread conspiracy by generic drug manufacturers to artificially inflate and manipulate prices, reduce competition, and unreasonably restrain trade for generic drugs sold
Drugs
FDA says that Apotex, Amneal, Marksans, Lupin, and Teva have recalled certain extended-release metformin products because the agency’s testing showed N-Nitrosodimethylamine above the acceptable intake limit in certain lots. “There are additional companies that manufacture ER metformin and supply a significant portion of the U.S. market,
Biologics
Officials from CDER and CBER told a Biotechnology Innovation Organization digital conference that they anticipate a busier agency workload after the emphasis on the Covid-19 pandemic eases. An online report on the meeting posted by the Regulatory Affairs Professionals Society says that while drug companies and FDA officials are
Drugs
FDA has approved ViiV’s Tivicay (dolutegravir) tablets and Tivicay PD tablets for suspension to treat HIV-1 infection in pediatric patients at least four weeks old and weighing at least 6.61 pounds in combination with other antiretroviral treatments. An agency statement says the drug is intended for patients
Drugs
FDA has approved Mylan’s Semglee (insulin glargine) indicated to improve glycemic control in adult and pediatric patients with Type 1 diabetes and in adults with Type 2 diabetes. Upon approval, the NDA was deemed to be an approved BLA and thus it can be a reference product for a
Drugs
IntelGenx says that a 6/10 meeting with FDA was “very productive” and the company is completing the work required to resubmit its Rizaport VersaFilm NDA as a treatment for migraine headaches. The company had received a 3/27 complete response letter indicating that the Rizaport VersaFilm NDA could not
Drugs
Following a meeting with FDA staff on the Lannett clinical advancement program for its biosimilar insulin glargine product candidate, the company says it received positive feedback on the clinical and CMC (chemistry, manufacturing, and controls) advancement of its product. “Our path forward is clear with regard to what is expected
Drugs
Three Mintz Levin attorneys say the next phase of the over-the-counter (OTC) reform process coming from provisions in the CARES Act “will entail sweeping changes to the process for bringing OTC drugs to market and will impose some significant burdens on FDA and manufacturers alike.” Writing in a
Drugs
The Alliance for Natural Health USA is asking FDA to issue a regulation requiring all makers of proton pump inhibitors for humans to expand the existing label Warnings to include information about an increased risk of pneumonia. The group’s petition says “the causes of PPI-associated pneumonia are believed