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RSS FeedPosted by Michael Wonder on 22 Apr 2020
New U.S. treatment guidelines for COVID-19 don’t see much progress
21 April 2020 - A panel of experts said there was insufficient evidence about many drugs that have been considered as ...
Posted by Michael Wonder on 22 Apr 2020
Mallinckrodt announces U.S. FDA filing acceptance of new drug application for terlipressin for treatment of hepatorenal syndrome type 1
22 April 2020 - Terlipressin would be the first FDA approved treatment option in the United States for adult patients with ...
Posted by Michael Wonder on 22 Apr 2020
FDA approves new therapy for triple negative breast cancer that has spread, not responded to other treatments
22 April 2020 - Today, the U.S. FDA granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients ...
Posted by Michael Wonder on 22 Apr 2020
Novartis Kymriah receives FDA regenerative medicine advanced therapy designation in follicular lymphoma
22 April 2020 - US regulatory filing for Kymriah in relapsed/refractory follicular lymphoma anticipated in 2021. ...
Posted by Michael Wonder on 22 Apr 2020
MMR vaccine commonly used to protect against mumps, measles and rubella could be effective against coronavirus
22 April 2020 - Doctors believe a childhood vaccine commonly used to protect against mumps, measles and rubella could be effective ...
Posted by Michael Wonder on 22 Apr 2020
Wockhardt receives US FDA qualified infectious disease product designation for WCK 6777, a first ever once-a-day β-lactam enhancer class antibiotic
20 April 2020 - WCK 6777 is a once-a-day combination antibiotic based on Wockhardt’s NCE zidebactam, which imparts WCK 6777 ...
Posted by Michael Wonder on 21 Apr 2020
Director of U.S. agency key to vaccine development leaves role suddenly amid coronavirus pandemic
21 April 2020 - Rick Bright, one of the nation’s leading vaccine development experts and the director of the Biomedical ...
Posted by Michael Wonder on 21 Apr 2020
Myovant Sciences Submits new drug application to the FDA for once daily, oral relugolix for the treatment of men with advanced prostate cancer
21 April 2020 - Myovant expects to submit a second application for relugolix combination tablet for women with uterine fibroids in ...
Posted by Michael Wonder on 21 Apr 2020
DOJ clears U.S. drug companies to distribute hydroxychloroquine to coronavirus patients
21 April 2020 - The U.S. Department of Justice on Monday cited "extreme urgency" in clearing U.S. pharmaceutical distributors from ...
Posted by Michael Wonder on 21 Apr 2020
Swiss deal on cystic fibrosis drugs could change price negotiations
21 April 2020 - The deal is expected to help 400 eligible cystic fibrosis patients in Switzerland. ...
Posted by Michael Wonder on 21 Apr 2020
Here’s why a COVID-19 vaccine could end up costing you a small fortune
21 April 2020 - Things have gone from bad to worse for Brian Helstien. For a decade, he’s been grappling ...
Posted by Michael Wonder on 21 Apr 2020
Human trials to begin on COVID-19 vaccine by Thursday
21 April 2020 - A million doses of their experimental coronavirus vaccine could be ready as early as September, Oxford scientists ...
Posted by Michael Wonder on 21 Apr 2020
Launch of enhanced monitoring system for availability of medicines used for treating COVID-19
21 April 2020 - EMA, together with the pharmaceutical industry and the EU Member States, has launched its enhanced fast-track ...
Posted by Michael Wonder on 21 Apr 2020
Imbruvica (ibrutinib) receives 11th FDA approval
21 April 2020 - Granted under FDA's real-time oncology review pilot program, Project Orbis and priority review. ...
Posted by Michael Wonder on 21 Apr 2020
Coronavirus puts big pharma’s IP regime to the test
21 April 2020 - “Chaotic” is how Jorge Contreras, a law professor at the University of Utah, describes a struggle ...