U.S. Senate Majority Leader Mitch McConnell said Republican senators are making “good progress” on their efforts to come to agreement on retooled draft legislation aimed at repealing and replacing the 2010 Affordable Care Act.
FDA plans to reorganize its drug review staff and create a SWAT team to eliminate a backlog of drugs for rare diseases and speed reviews of future applications.
FDA approved LivaNova’s VNS Therapy system in patients as young as 4 years of age with partial-onset seizures that are refractory to antiepileptic medications.
Celltrion Inc. and Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration accepted for review the Biologics License Application for CT-P10, a proposed Monoclonal Antibody (mAb) biosimilar to Rituxan (rituximab), which is used to treat patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.
Switzerland-based Roche AG is tweaking its operations. The latest is an announcement that the company plans to eliminate 75 jobs in central Massachusetts.
A decision by the U.S. Food and Drug Administration can be a big boost – or a big negative – for biotech stocks. Keith Speights, writing for The Motley Fool, analyzes five biotech companies facing FDA decisions in July 2017.
AstraZeneca and Hutchison China MediTech said they had initiated a global late-stage clinical trial of the experimental drug savolitinib in a relatively rare type of kidney cancer.
Intouch Solutions announced the recent hires of Kim Middleton, senior vice president of client services, and Marc Sirockman, vice president of strategic development.
Pfizer plans to hire about 80 new staffers when the company completes construction of its new research-and-development campus in Chesterfield, Missouri.
U.S. Senate Republican leaders postponed a vote on a healthcare overhaul after resistance from members of their own party, and President Donald Trump summoned Republican senators to the White House to urge them to break the impasse.