One day after BridgeBio Pharma struck a nearly $1 billion oncology pact with Bristol Myers Squibb, the California-based company announced plans to sell a priority review voucher received in February.
Eisai and Biogen completed the rolling submission of a Biologics License Application for their proposed Alzheimer’s disease drug to the U.S. Food and Drug Administration.
Novartis was granted fast-track reviews of its cell therapy Kymriah for blood cancers in the United States and Europe.
Boehringer Ingelheim announced that the supplemental New Drug Application for Gilotrif (afatinib) was accepted for filing and granted Priority Review by the U.S. Food and Drug Administration.
Feb. 12, 2018, is the day the U.S. FDA is expected to review Gilead Sciences’ HIV treatment that some analysts suggest could become a blockbuster.
Eli Lilly reported an increase of 8 percent in second-quarter 2017 revenue, but the real shake-up is what the company plans to do with its pipeline.
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration accepted its supplemental New Drug Application to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension formulation of Sprycel. The application is under priority review with an action date of November 9, 2017.
German drugmaker Bayer won the U.S. Food and Drug Administration’s priority review status for an experimental drug for a difficult to treat type of blood cancer, bolstering its development pipeline.
Sanofi and Regeneron said results from a one-year test of Dupixent aimed at adults with eczema or moderate-to-severe atopic dermatitis had been positive.
Merck & Co. has pulled ahead of rivals in the race to combine immunotherapy with other drugs as a treatment for lung cancer,.