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The UK’s competition watchdog agency claimed the drugmaker Concordia overcharged the NHS by millions for its hypothyroid medication liothyronine, also known as Cytomel, following price increases of almost 6,000 percent over a decade. Read More
Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug Development. Read More
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More
The European Medicines Agency adopted a guideline for sponsors developing new products for autism spectrum disorder, providing recommendations on diagnostic criteria, target populations and clinical trial design. Read More
The International Generic Drug Regulators Programme released guidance for quality assessors in regulatory agencies on the preparation of quality assessment reports, and noted the guidance may be useful for anyone responsible for the preparation of quality information submitted to regulatory agencies. Read More
President Trump’s nominee for the next secretary of HHS, former Eli Lilly executive Alex Azar, told the Senate’s health committee he agrees prescription drug prices are too high, and would welcome congressional action if appointed to the post. Read More
The UK government announced a long-term strategy for the nation’s industries, including a multi-billion pound initiative to boost investment in the life sciences sector. Read More
UK’s MHRA reclassified Pfizer’s Viagra (sildenafil), allowing it to be sold over the counter without a prescription, branded as Viagra Connect. Previous versions of the tablet will still be available as a prescription medicine. Read More
The European Medicines Agency should upgrade its user testing of drug packaging inserts and other product information for patients over the next 18 months in carrying out recommendations from the European Commission, the agency said in an action plan. Read More
The European Medicines Agency adopted the fifth revision of its substantive guideline covering all stages of oncology drug development, expanding upon the previous version’s section on safety data. Read More