Drug Safety
At a CDC vaccine advisory committee criticized for “promoting an anti-vaccine agenda,” the new CDER director championed the committee’s plans and suggested the FDA would make more frequent vaccine label updates due to revised safety frameworks.
New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.
However, the agency updated warnings on myocarditis risk and mitigation for the gene therapy, including more specific information about its severity and timeframe for occurrence in Duchenne muscular dystrophy patients.
The European Commission says it will soon publish an updated study on the impact of the Urban Waste Water Treatment Directive on the pharmaceutical and cosmetics industry and that it would support member states in avoiding “unintended consequences.”
Incentives are “probably the only solution” to encouraging companies to optimize cancer drugs, but this will require funding and systemic changes, the chair of the European Medicines Agency’s oncology working party says.
The labeling recommendation that Duchenne muscular dystrophy patients should maintain proximity to an appropriate healthcare facility for at least two months following infusion will add to the treatment burden.
After two deaths tied to the gene therapy, Sarepta and the FDA agreed to new labeling for Elevidys, adding a black box warning about liver injury along with suggested liver and cardiac monitoring.
Changes to the US FDA’s MedWatch form also could help reduce the amount of missing information and make AE reports more useful in assessing postmarketing drug safety, members of the Pediatric Advisory Committee say.
AI is moving from blue-sky potential to specific applications in drug development, streamlining pharmacovigilance and clinical trial design, but strong governance remains essential to ensure transparency and reliability.
The requested changes to the class-wide warnings for hormone replacement therapies mark the first time one of Makary’s expert panels sparked regulatory action and could lead to broader scrutiny of their use.
A federal judge in Hawaii ruled the FDA failed to consider statutory factors relevant to the REMS and provide a “reasoned explanation” for its restrictive treatment of the drug, but remand could result in an agency determination that more extensive restrictions are needed.
A new government-backed initiative is set to explore the use of AI in predicting side effects from drug interactions – a development that could cut costs and late-stage trial failures for pharma companies.
Pharma companies are being asked for their views on a scientific reflection paper from the European Medicines Agency that discusses alternatives to using non-human primates in drug safety studies.
The “Simple Reform” initiative would reverse a 2017 move to ensure FDA investigators were experts in the commodity they inspected or in clinical research regulations.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended Insmed’s Brinsupri and Sanofi’s Wayrilz for pan-EU approval but turned down Sanofi’s Rezurock based on trial results that cast doubt on the drug’s efficacy.
Hong Kong is pushing forward with its vision to build an “internationally renowned” regulatory authority of drugs and medical devices. Meanwhile, the Department of Health’s 1+ drug registration mechanism has received over 620 enquiries from over 160 pharmaceutical companies.
Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.
The ACIP put hepatitis B and MMRV vaccines on its agenda, despite having no new reason to relitigate the products, worrying public health experts that more anti-vaccine moves are coming.
Intercept will voluntarily take Ocaliva off the market at the request of the US FDA, which put the clinical trials of the primary biliary cholangitis drug on a clinical hold.
Argentina has implemented a nation-wide traceability system for medicines for the first time.