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Australia’s Therapeutic Goods Administration (TGA) has set a September deadline for companies to adopt a common technical document format for OTC regulatory submissions. Read More
Israeli drugmaker Teva announced Thursday it has reached a settlement with Pfizer to hold back marketing generic Celebrex (celecoxib) in the U.S. until December. Read More
U.S. and EU regulators have both determined that Boehringer Ingelheim’s volasertib for acute myeloid leukemia is an orphan drug, the German drugmaker said Thursday. Read More
Baxter said Wednesday that its Bax 111 treatment for Von Willebrand disease met its primary endpoint in a pivotal clinical trial, setting it up for NDA filing later this year. Read More
A group of generic drugmakers is urging the U.S. Supreme Court to let them introduce generic versions of Teva Pharmaceutical’s Copaxone multiple-sclerosis drug next month. Read More
The UK’s National Institute for Health and Care Excellence has recommended Ferring Pharmaceuticals’ Firmagon as a cost-effective treatment for advanced hormone dependent prostate cancer in people with spinal metastases and signs or symptoms of spinal cord compression. Read More
The FDA has approved another under-the-tongue hay fever treatment, putting a second product on the market that will replace the routine injections currently prescribed to control symptoms. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American drugmakers. Read More
Boehringer Ingelheim and Eli Lilly said Monday that the FDA has accepted their NDA for a first-in-kind drug combination to treat type 2 diabetes. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to verify that the information used to gain marketing authorization in the EU remains valid in practice. Read More
GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More