Drugs
AstraZeneca says data from its FLAURA2 Phase 3 trial showed that Tagrisso (osimertinib) plus chemotherapy extended median progression-free survival by nearly nine months compared to Tagrisso alone for patients with locally advanced (Stage 3B-3C) or metastatic (Stage 4) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung
Drugs
FDA and Duke-Margolis Center for Health Policy are holding a 9/18-19 two-day public workshop to discuss pregnancy safety studies. The workshop is one of FDA’s continuing efforts to enhance postapproval pregnancy safety studies, “capitalizing on the increased availability of population-based healthcare data and advances
FDA Policy/General
Federal Register notice: FDA is announcing an opportunity to participate in its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot program, which is intended to evaluate expedited CMC development for products offering clinical benefit through earlier patient access. The pilot features increased communication between FDA and sponsors and explores
Devices
FDA has granted S4 Medical a de novo authorization to market its esolution esophageal deviation device. The authorization was based on data from the EASY AF (Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation) study which demonstrated the device’s 84% reduction in esophageal injuries, according to the company. The
Drugs
Novartis has recalled one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml due to crystal formation observed in some bottles, which could affect dosing. The drug is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The affected lot number
Drugs
U.S. Senators Joe Manchin (D-WV) and Mike Braun (R-IN) have reintroduced their bipartisan FDA Review of Efficacy EERW Double-Blinds (FREED) of Opioids Act, which would require an advisory committee to review the “controversial enriched enrollment randomized withdrawal (EERW) methodology used to approve new opioids and ensure
Drugs
House Energy and Commerce Committee chair Cathy McMorris Rodgers (R-WA) and Health Subcommittee chair Brett Guthrie (R-KY) have announced a 9/14 legislative hearing titled “Legislative Proposals to Prevent and Respond to Generic Drug Shortages.” The lawmakers are concerned about cancer patients who are facing growing drug shortages
Drugs
FDA has posted a guidance entitled “Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products.” The document says that IRB review of an expanded access (compassionate use) submission for an individual patient should focus on the key factors needed to assess the
Drugs
Roche’s Genentech will not be getting FDA approval this month for a subcutaneous formulation of its lung cancer drug Tecentriq (atezolizumab) after the agency requested that the company update the chemistry, manufacturing and controls (CMC) information in the supplemental BLA submission. The approval delay was revealed in a financial
Devices
At the request of several Congressional requestors, the Government Accountability Office (GAO) has released a new report examining FDA and FTC’s oversight of medical device direct-to-consumer (DTC) advertising. The report could be an early signal of increased interest on Capitol Hill on regulatory enforcement of medical product
Drugs
Danco Laboratories, which distributes the abortifacent drug Mifeprex (mifepristone), petitioned 9/8 the U.S. Supreme Court asking it to review last month’s decision (see earlier story) by the Fifth Circuit Court of Appeals that would restrict how the drug is used by, and distributed to, patients. The company’
Devices
FDA is providing further clarification about a safety alert issued earlier this year that recommended against the use of certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with some of their surgical and pediatric face masks. Laboratory tests show these masks “do not meet
Biologics
FDA says it is working closely with the Centers for Disease Control and Prevention to investigate reports of a tuberculosis (TB) outbreak caused by Mycobacterium tuberculosis that appears to be linked to a bone matrix product. An agency online post outlines risk mitigation strategies for human cell, tissue, and cellular
Devices
FDA has published a guidance, Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices—Part I: Evaluation and Testing Within a Risk Management Process, to provide further clarification and updated information on using the designated ISO standard to support applications to FDA. The agency says the document
Drugs
Reps. Dan Crenshaw (R-TX), Robert Latta (R-OH), and Debbie Dingell (D-MI) say FDA should not permit simultaneous marketing of the same prescription and over-the-counter (OTC) drug product involved in an Rx-to-OTC switch. In a 9/6 letter to CDER director Patrizia Cavazzoni, the
Devices
Royal Philips and its U.S. subsidiaries, including Philips Respironics, have allocated $615 million under an agreement to resolve all “economic loss claims” in the U.S. Multidistrict Litigation (MDL) related to Philips Respironics’ voluntary recall of certain sleep and respiratory care devices. This settlement, which is being filed in
Drugs
FDA has published a draft guidance entitled “Endogenous Cushing’s Syndrome: Developing Drugs for Treatment.” The document provides recommendations on clinical trial designs for drugs and biologics intended for treating Cushing’s syndrome in those where surgery is not an option or has not been curative. The agency says the
Drugs
Janssen Pharmaceutical has stopped, due to futility, its Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with chronic thromboembolic pulmonary hypertension. The decision to stop follows a recommendation by the study’s independent data monitoring committee after a pre-planned interim analysis. “Additionally, the pivotal Phase 3 UNISUS
Drugs
CymaBay Therapeutics says it will seek FDA approval for seladelpar after reporting positive data from its pivotal Phase 3 RESPONSE study that evaluated the drug for treating adult patients with primary biliary cholangitis (PBC). In the study, 61.7% of patients on seladelpar 10 mg (n=128) met the primary
Drugs
FDA has published a guidance, Application of Human Factors Engineering Principles for Combination Products: Questions and Answers, with questions and answers on applying human factor engineering (HFE) principles to developing combination products. The document finalizes a 2/2016 draft and clarifies how the unique aspects of a combination product influence
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it applauds efforts by the International Council for Harmonization (ICH) and FDA to facilitate harmonized scientific and regulatory considerations for Good Clinical Practice (GCP). Responding to FDA’s publication of the ICH E6(R3) draft guideline, PhRMA says it supports the revision
Biologics
Moderna says its updated Covid-19 vaccine, which is awaiting FDA approval, generated a strong immune response against the BA.2.86 (Pirola) variant that the Centers for Disease Control has said might be more likely to break through existing immunity from previous vaccinations because it has over 30 mutations.