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Manufacturers looking to speed up drug approvals in the EU and ensure that their products are covered by payers should initiate parallel conversations with the European Medicines Agency and health technology assessment bodies early in the development process, the EMA says. Read More
The UK’s National Institute for Health and Care Excellence (NICE) said it will cover Johnson & Johnson subsidiary Janssen-Cilag’s diabetes drug Invokana (canagliflozin) as a treatment for people with type 2 diabetes. Read More
FDA advisors want more clinical data before recommending a green light for AstraZeneca’s latest ovarian cancer treatment, dealing a blow to the British drugmaker’s promising oncology pipeline. Read More
Massachusetts has become the eighth state to pass a law enabling pharmacists to substitute a biosimilar for a branded biological product, earning praise from industry groups that believe such state laws are vital to biosimilar adoption. Read More
The FDA expects manufacturers of genetically engineered products that could be harmful if released into the wild to submit environmental assessments (EAs) along with their biologics applications. Read More
The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Sivextro, the second drug approved for acute bacterial skin and skin structure infections as part of the agency’s effort to encourage the development of new antibiotics as a bulwark against growing drug resistance. Read More
SAN DIEGO — Two years after it was launched, the FDA’s breakthrough therapy designation, and what qualifies as a breakthrough, continues to baffle drugmakers who have experienced a roughly 63 percent rejection rate in receiving the expedited designation. Read More
Sponsors of clinical trials in the European Economic Area must begin posting summary results on the EudraCT clinical trials database starting July 21, another move in Europe’s shift toward greater clinical trial transparency. Read More
SAN DIEGO — The FDA is racing to beat a fall deadline to release a string of new guidances for generics makers that it hopes will head off a potential torrent of rejected submissions. Read More