Recent court cases initiated by the Swiss medicines regulator against “unbalanced” media reporting on GLP-1 drugs for weight loss highlights its zero tolerance for any form of misinformation that compromises patient safety.
President Trump imposed reciprocal tariffs on countries with duties on US exports 13 February. When asked on 7 February about the impact of US tariffs, Aurobindo said it has alternatives in place to deal with them.
The US FDA says in a legal memo that its new guidance on scientific information on unapproved uses (SIUU) is “speech-enabling” and argues that challenges should be interpreted as attempts to roll back the approval process.
Patient demand for compounded versions of FDA approved obesity drugs is unlikely to dissipate, even if semaglutide’s “shortage” status is resolved. The issue likely will continue to be a high profile concern for the brand industry.
Restrictions on commonly used chemicals, increased reporting requirements and enhanced environmental risk assessments are just some of the new EU sustainability and environmental rules pharmaceutical companies are potentially facing. While some measures are multi-sectoral, others are pharma specific. The Pink Sheet takes a look at some of the developments in 2024 and expectations for 2025 and beyond.
President Trump’s 10% tariff on active pharmaceutical ingredients and finished dosage forms could push some generic drug makers to exit therapeutic categories if they cannot absorb the new costs, which could lead to shortages.
At a lively AAM Access! conference in Florida, AAM President and CEO John Murphy acknowledged the negative effects of potential tariffs, but also suggested that the second Trump Administration could be an opportunity for the generics and biosimilars sectors to advance market reforms.
The European Commission’s new biotech and biomanufacturing hub will make it easier for innovative biotech companies to find legislative documents, funding information and guidance to help them bring new products to the market.
Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader talk about compliance requirements that pharma and global capability centers may need to consider as India strengthens the framework for the protection of digital personal data.
The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.
Lilly’s complaint to the National Advertising Division, a self-regulatory forum for industry, about an Oregon clinic’s claims expands the battlefront against widespread compounding of GLP-1 products for weight loss and diabetes treatment.
European regulators should develop a harmonized medicines shortages prevention and mitigation system and look to target the root causes of shortages, says pharmaceutical industry federation EFPIA.
Europe’s public-private Innovative Health Initiative is seeking contenders for two research projects relevant to pharmaceuticals, one relates to the incoming European Health Data Space Regulation and the other focuses on reducing exposure to medicines containing per- and polyfluoroalkyl substances.
New general texts to be published in the European Pharmacopoeia in July 2025 are intended to support the rapidly developing mRNA vaccine field, which has become an increasingly important technology in recent years.
The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.
During a virtual appearance at a CERSI meeting two days after announcing retirement plans, the CDER director also said she wished agency reviews of unapproved drugs could be published.
The UK’s “world-first” tailored regulatory framework for point of care manufacturing is set to enter into force this summer.
Now that one of the most controversial pharma M&As of 2024 has closed, the Pink Sheet looks at whether overtures to concerned customers and extended prenotification discussions helped Novo and Catalent seal the deal.
Viatris’ oral finished dose manufacturing facility in Indore, India, was slapped with a US Food and Drug Administration import alert and warning letter.
Final guidance on communicating scientific information on unapproved uses (SIUU) allows firm-generated presentations to be based on sources other than reprints, but says communications based on nonscientific content are not protected from enforcement.