Safety

As cut-price generic semaglutide versions flood the Indian market enabling widespread access to the GLP-1 receptor agonist, the national regulator is stepping up supply chain surveillance. KOLs have also underlined the need for device reliability and pharmacovigilance and postmarketing data.

Bart Heldreth, Cosmetic Ingredient Review executive director, reflects on the accomplishments of its expert safety panel, which has published safety assessments for more than 7,000 ingredients since CIR’s establishment in 1976.

Teva’s R&D chief Eric Hughes discusses the company’s long-acting injectable olanzapine program, how it could address adherence challenges in schizophrenia, and why the therapy forms a key pillar of the firm’s growing injectables franchise.

Investors appeared not to be bothered by Amgen’s Q4 product updates, including the US FDA’s request to pull rare disease drug Tavneos from the market and discontinuation of Phase III bemarituzumab.

“FDA’s proposed GRAS rule would move GRAS closer to the NDI model in at least one key respect, which is mandatory notification,” says attorney Ashish Talati. Proposed rule isn’t expected to require removal of ingredients available through self-GRAS processes.

The company said the FDA placed the hold on RGX-111 and RGX-121 after a patient in its RGX-111 trials developed a brain tumor, the cause of which remains under investigation.

When FDA warned Agebox about selling iKids-Growth IGF-1 Support supplements as unapproved drugs, agency along with CDC had for around a month been investigating outbreak of infant botulism linked to ByHeart formula.

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.

After two deaths tied to the gene therapy, Sarepta and the FDA agreed to new labeling for Elevidys, limiting treatment to ambulatory Duchenne muscular dystrophy patients.

Scientific literature on potential link between prenatal acetaminophen exposure and neurological conditions “now includes FDA’s most recent epidemiological review” completed in May saying research results “insufficient to support a causal association.”

The company’s third quarter earnings fell by $67.8m year-over-year, reflecting the tumultuous situation around its DMD therapy Elevidys in June.

In addition to Kenvue, complaint names as defendant J&J, which for decades marketed Tylenol oral analgesics before spinning Kenvue out in 2023. State asks court to order firms to pay $10,000 for each violation of state Deceptive Trade Practices-Consumer Protection Act.