Drugs
FDA says agency researchers have been improving (quantitative) structure-activity relationship (Q)SAR models that are used to help predict the mutagenicity of drug impurities and drug substances. An online Regulatory Science Impact Story post says that as a result of the improvements, there is increasing interest from drug developers
Drugs
The FDA Sentinel operations center at the Harvard Pilgrim Health Care Institute is working with TriNetX, a health research network that generates real-world evidence, to monitor priority drugs used for the care of hospitalized Covid-19 patients. A TriNetX statement says Harvard Pilgrim is leveraging TriNetX’s de-identified
Drugs
Biota Biosciences has recalled five lots of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables because they were marketed without FDA approval. The products are also considered misbranded because their labeling fails to bear adequate directions for use, a recall notice says. “Unapproved new drugs injected into the bloodstream
Drugs
The Stericycle Q1 2020 recall report projects a significant surge in FDA drug and medical device enforcement activity once the Covid-19 public health emergency dies down. The report says there is a good chance there will be a downturn in medical device recall activity in at least the second
Drugs
The Consumer Healthcare Products Association (CHPA) says an FDA draft guidance on flow restrictors for oral liquid drug products “reflects recommendations by the agency for which CHPA members are supportive for the most part.” The association’s comment letter includes input on the Directions for Use section of the guidance
Drugs
FDA has approved AztraZeneca and Merck’s Lynparza (olaparib) for treating adults with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide (Astellas and Pfizer’s Xtandi) or abiraterone (Janssen’s Zytiga). The companies
Drugs
FDA has conditionally accepted the proprietary brand name Gimoti for Evoke Pharma’s nasal spray product candidate to relieve symptoms in adult women with acute and recurrent diabetic gastroparesis as resubmitted in Evoke’s 505(b)(2) NDA. The company says the development of the name included research with physicians
Drugs
FDA has issued a guidance, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic, with recommendations for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. The document says the agency anticipates that during the current pandemic industry and FDA workforces may be
Biologics
FDA commissioner Stephen Hahn says that CDER director Janet Woodcock and CBER director Peter Marks will recuse themselves “from the supervisory chain of command in matters related to product review decisions for applications related to the areas that they are advancing that have a nexus to Covid-19.” Hahn issued
Drugs
Karyopharm Therapeutics has submitted a supplemental NDA for Xpovio (selinexor), its first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with previously treated multiple myeloma. The submission is based on data from the pivotal Phase 3 BOSTON study evaluating the combination of Xpovio
Drugs
FDA says it has agreed with Aetion to collaborate on advanced analytical techniques to answer urgent Covid-19 research questions. Aetion says it has developed “scientifically validated software for performing rapid analyses to generate real-world evidence at scale.” An online statement from principal deputy commissioner Amy Abernathy says FDA
Drugs
An 11/11-11/14/19 FDA inspection at Kumar Organic Products, Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 4/23 Warning Letter says specific violations were: * failing to use equipment in the manufacture, processing, packing, or holding of
Drugs
The Association for Accessible Medicines (AAM) says FDA should implement the REMS (Risk Evaluation and Management Strategy) requirements for drugs approved under ANDAs. Commenting on an agency draft guidance on the development of a shared system risk evaluation and mitigation strategy, AAM says that as a result of recent changes
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that an FDA draft guidance on best practices in drug and biological product postmarket safety surveillance for FDA staff “is an important step in FDA’s continuous efforts to enhance the efficiency of postmarket drug safety surveillance practices for drugs, biologics, combination
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Blaine Labs, Santa Fe Springs, CA (5/5): FDA inspected the firm 9/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly
Drugs
FDA has accepted for accelerated review an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Progeria and Progeroid Laminopathies. The agency set a user fee review action target date of 11/20, and Eiger says it was told that an advisory committee meeting to discuss the application is not being
Drugs
The HHS Biomedical Advanced Research and Development Authority has awarded an initial $354 million contract to Phlow, a Richmond, VA, drug manufacturing company, for advanced manufacturing of America’s most essential medicines at risk of shortage, including medicines for the Covid-19 pandemic response. The total contract value over 10
Drugs
FDA has announced a 6/9-10 Web cast entitled “Pharmacovigilance and Risk Management Conference — New Approaches, Tools, and Technologies.” An agency notice describes the training as being designed to provide participants with a “foundation in regulations, FDA guidances, and risk-based principles aimed at ensuring safety of marketed drug
Drugs
Teva Pharmaceutical Industries reportedly has abandoned settlement talks with the U.S. Justice Department’s antitrust division over an ongoing generic drug price-fixing investigation. If the probe reaches a criminal indictment against Teva, the company could face a large financial penalty and possible restrictions under Medicare, according to a
Drugs
FDA has granted accelerated approval for a Clovis Oncology NDA for Rubraca (rucaparib) for patients with deleterious BRCA-mutated (germline or somatic) metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor-directed therapy and a taxane-based chemotherapy. Approval was based on data from an
Drugs
Adamis Pharmaceuticals has resubmitted an NDA for Zimhi (naloxone HCI injection) for treating opioid overdose. The resubmission addresses an 11/2019 complete response letter that cited Chemistry, Manufacturing and Controls (CMC) information (see earlier story), according to the company. When the letter was issued, Adamis said it planned to expand
Drugs
President Trump told reporters at the White House 5/18 that he has been taking the controversial malaria drug hydroxychloroquine to prevent coronavirus. “I’ve been taking it for about a week and a half now and I’m still here,” he said. Last month, FDA issued a MedWatch safety