A year after Bristol-Myers Squibb walked away from acquiring Promedior and its fibrotic treatment portfolio, Swiss pharma giant Roche has stepped in to acquire the company and its pipeline for up to $1.4 billion. At the heart of the deal…
BeiGene Announces FDA Approval of Brukinsa for Mantle Cell Lymphoma
China’s BeiGene announced that the U.S. Food and Drug Administration (FDA) had given its Brukinsa (zanabrutinib) accelerated approval for mantle cell lymphoma (MCL) in adults who had received at least one prior therapy. It is the first BeiGene-discovered drug to…
FDA Approves Shionogi’s cUTI Medicine Following Positive Advisory Support
The U.S. Food and Drug Administration (FDA) approved Shionogi’s Fetroja as a treatment for adult patients with complicated urinary tract infections caused by a number of Gram-negative microorganisms. The approval came only a few days after the U.S. Centers for…
Weight-loss surgery for Type 2 diabetes could cut major heart risks, study suggests
Dive Brief: Metabolic, or bariatric, weight-loss surgeries ought to be taken seriously as a means to reduce incidence of major adverse cardiovascular events like heart failure, atrial fibrillation and heart attack, according to new research funded partly by Medtronic. The retrospective study…
Landmark Apple Watch AFib study has mixed results
Dive Brief: Final results from the landmark Apple Heart Study, which studied if a heart-rate pulse sensor can be used to identify atrial fibrillation, were published by Stanford University researchers in the New England Journal of Medicine on Wednesday. The…
FDA experts weigh evidence on patients’ adverse reactions to common device metals
With help from a wide-reaching FDA advisory committee meeting starting Wednesday, FDA is looking to expand its potential “toolbox” of methods to assess how a patient might respond to a metal implant. “Our goal is to have a full set…
TrialAssure Launches Document Anonymization Software
November 7, 2019 | TrialAssure today launched the limited release of ANONYMIZE R, a first-in-class document anonymization software that uses machine learning, natural language processing, and artificial intelligence to protect patient privacy by automatically finding and removing personal information from text.…
Google partners with major U.S. health system, gaining access to vast patient data in the process
Google has quietly launched a project with one of the nation’s largest nonprofit health systems in which it has gained access to millions of patient records, including names and birth dates, to help deliver more targeted medical treatment. The initiative,…
Sarepta and StrideBio Announce Multi-target Strategic Collaboration to Advance Novel Gene Therapies
CAMBRIDGE, Mass. and RESEARCH TRIANGLE PARK, N.C., Nov. 14, 2019 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc., (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, and StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV) based gene…
Merck’s Ervebo is the World’s First Approved Ebola Vaccine
The European Commission approved the world’s first Ebola vaccine. The vaccine is manufactured by Merck and has a trade name of Ervebo. “The European Commission’s marketing authorization of Ervebo is the result of an unprecedented collaboration for which the entire…
