Drugs
President Trump has appointed Yale epidemiologist Harvey Risch to chair the President’s Cancer Panel, a move that is raising alarm among cancer researchers and public health experts because of Risch’s past promotion of unproven Covid-19 treatments and speculation about links between vaccines and cancer, according to Wired.
Drugs
FDA has released the form FDA-483 issued following a 9/9-9/19 inspection at the ProRx outsourcing facility in Exton, PA. The seven inspection observations were: * failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
Biologics
A 3/31-4/6 FDA inspection at the Microvascular Tissue facility in San Diego, CA, determined that the company’s mVASC, derived from hypodermis recovered from donors and marketed for allogenic use, is an unapproved new drug and an unlicensed biological product. A 12/3 Warning Letter says the
FDA Policy/General
FDA commissioner Marty Makary sought to position himself as a supporter of vaccines while defending recent agency actions that have drawn scrutiny, including an internal memo on child deaths following Covid-19 vaccination and changes to hepatitis B vaccine recommendations for infants. In an interview with NPR, Makary said FDA
Biologics
FDA has “no plans” to add a Black Box Warning to Covid vaccines, FDA commissioner Marty Makary said in a Bloomberg TV interview, emphasizing that the agency’s focus is on transparency and updated risk assessments rather than broad changes to vaccine policy. Makary said the FDA’s safety and
Biologics
Vanda Pharmaceuticals has filed a BLA for imsidolimab and its use in treating generalized pustular psoriasis, a rare and potentially fatal inflammatory skin disease with no broadly effective long-term therapies. The disorder is driven in many cases by mutations in the IL36RN gene that disrupt the body’s natural
Drugs
FDA has proactively awarded Johnson & Johnson a national priority voucher for teclistamab in combination with daratumumab for treating relapsed or refractory multiple myeloma, citing strong late-stage clinical trial results. The award brings the total number of products selected under the Commissioner’s National Priority Voucher pilot program to
Drugs
Sanofi says it will not seek FDA approval for tolebrutinib in primary progressive multiple sclerosis (PPMS) after the drug failed to meet its primary endpoint in a pivotal Phase 3 trial, dealing a setback to the company’s ambitions for the brain-penetrant BTK inhibitor even as regulatory review continues
FDA Policy/General
FDA says it is removing a long-standing barrier to the use of real-world evidence (RWE) in regulatory reviews, signaling a significant shift in how the agency evaluates data submitted in drug and medical device applications. “In new guidance for certain types of medical device submissions, the agency states
FDA Policy/General
FDA has released two final guidances that provide recommendations to help clinical investigators comply with the safety reporting requirements for IND and IDE studies. The first guidance, “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices,” provides recommendations to help investigators identify drug-related serious adverse events that must be
Devices
The Government Accountability Office (GAO) is urging HHS to shore up staffing and reassess legal authorities at FDA after finding significant weaknesses in how the agency oversees medical device recalls, including lengthy delays in formally closing recalls of high-risk products. In a just-released report, GAO found that FDA
Drugs
FDA has approved Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Genentech’s pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, expanding treatment options for patients with advanced disease. The approval covers patients whose tumors are HER2-positive — defined
Drugs
FDA has released updated guidance calling on drug and biologics developers to broaden eligibility criteria, modernize enrollment practices, and adopt more flexible trial designs to ensure clinical studies better reflect the patients who will ultimately use approved medicines. The guidance, Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and
Drugs
A new analysis from University of California (UC) Riverside and UC Irvine researchers finds that the vast majority of pivotal clinical trials used to secure FDA drug approvals fail to reflect the racial and ethnic makeup of the U.S., and that representation has worsened in recent years. Published in
Drugs
FDA and drug-industry negotiators exchanged early feedback on the agency’s proposed “America First” fee incentives for domestic drug development during an 11/13 Prescription Drug User Fee Act (PDUFA) reauthorization steering committee meeting, according to newly released minutes. The proposal, first outlined by FDA at an 11/6
Drugs
FDA has approved Janssen’s Akeega — a fixed-dose combination of niraparib and abiraterone acetate — with prednisone for adults with metastatic castration-sensitive prostate cancer (mCSPC) harboring deleterious or suspected deleterious BRCA2 mutations. The approval requires use of an FDA-authorized companion diagnostic to confirm BRCA2 status. The decision marks
Biologics
FDA is preparing to add a Boxed Warning — the agency’s most stringent safety alert — to Covid-19 vaccines, according to two people familiar with the deliberations. The potential move marks a dramatic escalation in the Trump administration’s ongoing campaign to scrutinize and restrict use of the vaccines, which
Biologics
FDA has approved Amgen’s Uplizna (inebilizumab-cdon) for adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) or anti-MuSK antibodies, giving patients a new twice-yearly biologic option aimed at sustained disease control. Uplizna, already approved for treating neuromyelitis optica spectrum disorder (NMOSD)
Drugs
Senior FDA officials have urged agency reviewers to speed up the review of Eli Lilly’s NDA for its oral weight loss pill orforglipron after the drugmaker pushed for a faster review timeline, according to a report from Reuters. It says the shorter review would fall under the Commissioner’s
Drugs
FDA has released the form FDA-483 issued following a 6/2-6/6 inspection at the Astellas Pharma sterile drug manufacturing facility in Takaoka, Toyama, Japan. The two inspection observations were: * failure to establish adequate written procedures for production and process controls designed to assure that drug products have
Drugs
Eli Lilly’s investigational triple-agonist retatrutide produced substantial weight loss and meaningful reductions in knee osteoarthritis pain in a pivotal Phase 3 trial, positioning the once-weekly injectable as a potential next-generation therapy for obesity complicated by musculoskeletal disease, according to the company. In the 445-patient TRIUMPH-
Devices
The American College of Cardiology has joined the American Medical Association, the College of Healthcare Information Management Executives, and many other healthcare organizations in opposing a proposed change to U.S. cybersecurity policy. Cardiovascular Business reports the proposal, first developed under the Biden administration, claimed it would “better protect the