Drugs
Bristol Myers Squibb (BMS) says CheckMate-274, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met its primary endpoints of improving disease-free survival versus placebo in both all randomized patients and in patients whose tumor cells express PD-
FDA Policy/General
Federal Register notice: FDA has made available three final guidance documents for its Accreditation Scheme for Conformity Assessment Pilot Program. The guidances describe the goals, scope, procedures, and framework for the pilot program, and provide information about two groups of consensus standards within the scope of the pilot program. To
Drugs
FDA has approved Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene that is responsive to KALYDECO based on clinical or in vitro assay
Drugs
FDA has approved GlaxoSmithKline’s Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease. The new indication for Nucala is the first approval for HES patients in nearly 14
Drugs
FDA has granted RemeGen a Breakthrough Therapy designation for disitamab vedotin (RC48), an anti-HER2 antibody drug conjugate for second-line treatment of patients with HER2 positive locally advanced or metastatic urothelial cancer who have also previously received platinum-containing chemotherapy treatment. Earlier this year, the agency approved the company’
Biologics
FDA Vaccines and Related Biological Products Advisory Committee chair Hana El Sahly has recused herself from reviewing any upcoming pandemic vaccines because of her role overseeing a Moderna clinical trial for its vaccine candidate. Sahly (see curriculum vitae) is an associate professor of virology and microbiology at Baylor College of
Devices
FDA has issued Assure Tech an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for Covid-19. The Assure Covid-19 IgG/IgM Rapid Test Device was first authorized for emergency use in July and the EUA is now being reissued for the POC
Devices
FDA is issuing three guidances finalizing the Accreditation Scheme for Conformity Assessment (ASCA) program. An agency Webinar on the guidances is set for 10/22, according to an online notice. The guidances are: * The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program says FDA believes the voluntary ASCA pilot may
Drugs
The House Committee on Oversight and Reform will hold two days of hearings with major drug company executives 9/30 and 10/1 to consider the companies’ pricing practices for some of the costliest drugs in the U.S. “These companies sell medications that are critical to our health and
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of five ANDAs because the application holders have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy. The notice also announces an opportunity for
Biologics
Just hours after FDA commissioner Stephen Hahn reassured Congress that FDA’s review and approval/authorization of a Covid-19 vaccine will be based on data and science without any political interference, president Trump said new stricter guidance proposed by the agency on the timing of when a vaccine application
Devices
FDA has released the FDA-483 issued following a 3/16-3/20 inspection at Front Range Laboratories, Loveland, CO. The three inspection observations were: * failing to establish the accuracy, specificity, and reproducibility of test methods; * failing to establish and write procedures designed to prevent microbiological contamination of drug products
Drugs
FDA has announced a two-day (10/15-16) public Webinar on “New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment.” The Webinar supports a new Questions & Answers to ICH E14 and S7B guidance, which were recently released by ICH as a draft guideline for public consultation.
Devices
FDA has issued updated recommendations saying that individuals who are part of seven groups thought to be at greater risk for potential harmful health effects of mercury vapor released from amalgam dental fillings should avoid getting dental amalgam whenever possible and appropriate. An agency statement identifies the high-risk groups
Drugs
A new FDA safety alert warns that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. It says there are reports of teenagers ending up in emergency rooms or dying after participating
Drugs
FDA has granted Leap Therapeutics a fast track designation for DKN-01 and its use in treating certain patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high Dickkopf-1 (DKK1) protein. DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of DKK1 protein,
Devices
A coalition of 49 attorneys general have announced a multistate agreement that requires C.R. Bard and its parent company, Becton, Dickinson, to pay $60 million for the “deceptive marketing of transvaginal surgical mesh devices that endangered the health of women across New York and the rest of the nation,
Drugs
The Justice Department says Gilead Sciences will pay $97 million to resolve allegations that it violated the False Claims Act by illegally using a foundation as a conduit to pay the copays of thousands of Medicare patients taking the firm’s Letairis pulmonary arterial hypertension drug. A department statement says
Drugs
In an abrupt break from decades of prior policy, FDA and HHS announced late 9/24 a final rule that allows FDA-authorized programs to import certain prescription drugs from Canada if specific conditions to ensure the importation poses no additional risk to public health and safety. A final guidance
Drugs
Novartis Gene Therapies says that based on an FDA recommendation it will undertake a pivotal confirmatory study to supplement the existing STRONG data on the intrathecal formulation of AVXS-101 in older patients with spinal muscular atrophy. The company says the agency acknowledged the potential of AVXS-101 IT in
Drugs
A North Carolina federal court decision dismissing all claims raised by Exela Pharma Sciences against Sandoz due to federal preemption is cited by attorney James Beck (Reed Shaw) as a primer for defense lawyers on the ways that preemption precludes private plaintiffs from second-guessing FDA decisions on the marketing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics” (OMB Control Number 0910–0850). The collection supports a guidance under the same title that describes an effort