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RSS FeedPosted by Michael Wonder on 24 Jul 2019
FDA approves first treatment for severe hypoglycaemia that can be administered without an injection
24 July 2019 - The U.S. FDA today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment ...
Posted by Michael Wonder on 24 Jul 2019
FDA seeks input on biomarker, endpoint glossary
24 July 2019 - Two-and-a-half years after its release, the US FDA is asking for input from the public on ...
Posted by Michael Wonder on 24 Jul 2019
U.S. dependence on China for medicine is a major problem
21 July 2019 - As tensions with China have escalated over the past year, Washington, D.C., is finally waking up ...
Posted by Michael Wonder on 24 Jul 2019
Merck's biosimilar to AbbVie's Humira wins FDA approval
24 July 2019 - The U.S. FDA approved Merck & Co Inc’s biosimilar to AbbVie's blockbuster rheumatoid arthritis treatment Humira, ...
Posted by Michael Wonder on 23 Jul 2019
Merck and Eisai receive third breakthrough therapy designation from FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination treatment
23 July 2019 - Designation granted for potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma not amenable to loco-regional ...
Posted by Michael Wonder on 23 Jul 2019
U.S. District Court orders FDA to reconsider application for final approval of Brixadi (buprenorphine) extended release injection for the treatment of opioid use disorder
23 July 2019 - The U.S. District Court for the District of Columbia granted Braeburn’s motion for summary judgment, vacating ...
Posted by Michael Wonder on 23 Jul 2019
Imfinzi (durvalumab) US label updated with overall survival data in unresectable, Stage III non-small cell lung cancer
22 July 2019 - Imfinzi is the only immunotherapy approved to treat patients in this curative-intent setting following chemoradiation therapy. ...
Posted by Michael Wonder on 23 Jul 2019
Baxter announces U.S. FDA approval of Myxredlin, the first and only ready-to-use insulin for IV infusion
22 July 2019 - Offers extended shelf life of 30 days at room temperature or 24 months refrigerated. ...
Posted by Michael Wonder on 23 Jul 2019
FDA reinforces need for applicants to submit thorough and timely safety information for combination medical products
22 July 2019 - Today, the U.S. FDA released a final guidance, “Post-marketing Safety Reporting for Combination Products,” for applicants ...
Posted by Michael Wonder on 22 Jul 2019
FDA approves first generics of Lyrica
22 July 2019 - On July 19, the U.S. FDA approved multiple applications for first generics of Lyrica (pregabalin) for the ...
Posted by Michael Wonder on 22 Jul 2019
Vertex submits new drug application to the U.S. FDA for triple combination regimen of VX-445 (elexacaftor), tezacaftor and ivacaftor in cystic fibrosis
22 July 2019 - Application supported by positive results from two global Phase 3 studies in people with CF ages 12 ...
Posted by Michael Wonder on 21 Jul 2019
Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
21 July 2019 - The objective was to develop and pilot a tool to measure and improve pharmaceutical companies’ clinical trial ...
Posted by Michael Wonder on 20 Jul 2019
Ted Cruz bill would speed FDA approval of drugs OK'd in other countries
18 July 2019 - Drugs and medical devices that have been authorised in other developed countries would face fast-track approval ...
Posted by Michael Wonder on 20 Jul 2019
Pear Therapeutics announces FDA submission for Somryst, a prescription digital therapeutic for the treatment of adults with chronic insomnia and depression
18 July 2019 - The pending submission is supported by data from two randomised controlled clinical trials of more than 1,400 ...
Posted by Michael Wonder on 20 Jul 2019
Biohaven's Nurtec (riluzole) 505(B)2 application for amyotrophic lateral sclerosis affected by issues related to Apotex plant: complete response letter received from FDA
20 July 2019 - FDA cited issues with the active pharmaceutical ingredient used in the Biohaven 2017 bioequivalence study that was ...