Manufacturing
The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.
Lilly is broadening the range of single-use vial dosage forms of its obesity drug and lowering prices of existing doses for self-paying customers, but maintains it can handle increased demand as compounding ends.
The explosion in pharmacy compounding as a source of GLP-1 weight loss medications has put the FDA in a tough spot to defend its drug shortage policies, but it is not the first time that compounding has posed a potentially significant threat to agency authorities.
Reporter and editors from the Pink Sheet and Medtech Insight discuss the impact of the FDA’s decision to call back many of the employees it laid off, the decision to cancel an upcoming FDA advisory committee meeting on flu vaccines, and Eli Lilly’s plans to increase domestic manufacturing.
Eli Lilly's move is said to be part of broader industry campaign to invest in America and avoid President Trump's tariffs, but the company also said tax reform is necessary to make the investments.
The Vaccines and Related Biological Products Advisory Committee meeting next month was scheduled to select strains for the 2025-2026 flu vaccine. The cancellation could mean delays in vaccine availability.
Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.
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.
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.
Efforts have stepped up to enhance Africa’s capacity to meet international good manufacturing practice standards, empower regulators across the continent, and drive sustainable growth in the pharmaceutical sector.
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.
Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.
The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.
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.
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.
2024 saw important regulatory changes in India including in areas such as GMP, clinical trials and efforts to rein in unethical marketing practices. Further action is expected to play out in the new year as well.