Drug Safety
The European Medicines Agency has requested updated safety warnings for Ixchiq’s product information after a case of aseptic meningitis was reported in a healthy young adult.
The European Medicines Agency has explained how companies can implement ICH E2D(R1), a revised guidance on post-approval safety data that aims to clarify how to manage safety data derived from solicited sources such as social media, market research programs, and patient support programs.
The use of animal testing alternatives in drug R&D has reached a “tipping point” which is driving a faster pace of acceptance among regulators and industry, an expert says. In addition, a senior figure at AstraZeneca explains how it is using NAMs to accelerate drug discovery.
The US FDA has formally removed boxed warnings from an initial group of menopausal hormone therapies, even as some critics had called on the agency to conduct a formal advisory committee meeting.
The European Medicines Agency and international pharmaceutical inspectorates are proposing to close the gaps in active substance manufacturing that came to light following the detection of cancer-causing nitrosamine impurities in sartan medicines.
The European Medicines Agency says drug companies can cut through the noise of irrelevant reports when searching for pregnancy-related adverse events about their products by adopting more precise identification methods.
Richard Pazdur, former US FDA Oncology Center of Excellence director, assured advocates that single-patient IND requests still are running smoothly at the FDA and urged an expansion of “Project Facilitate” into other areas.
Amgen's refusal to voluntarily withdraw the rare disease treatment could force the FDA to employ its formal process to remove it from the market.
The European Medicines Agency wants feedback on a reflection paper that aims to address a lack of “uniformity” in cardiovascular toxicity endpoints in clinical trials for cancer drugs.
The US FDA’s comprehensive review found no increased risk of suicidal ideation and behavior with the use of GLP-1s to treat obesity, leading the agency to request existing warnings based on older drugs be removed from labeling.
Alternatives to animal testing can replace lengthy, resource-intensive studies for drug developers, helping to lower costs for companies, but a lack of regulatory global alignment can be a barrier to reducing animal testing, an expert says.
The UK’s roadmap for reducing animal testing is a positive starting point, but greater transparency from the drug regulator and a more detailed workplan from government will be required to make the plans a reality, an expert from Cruelty Free International says.
As differences emerged between FDA staff and senior political leaders over its COVID-19 safety review, CBER Director Vinay Prasad added an old colleague and critic of US COVID-19 policy to the center.
After voting to change the recommendation for a hepatitis B vaccine birth dose, the CDC Advisory Committee On Immunization Practices laid the groundwork for for changes to adjuvant policy.
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.