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RSS FeedPosted by Michael Wonder on 30 May 2017
AMO Pharma announces FDA fast track designation for AMO-02 for treatment of congenital myotonic dystrophy
30 May 2017 - AMO Pharma Limited today announced that the U.S. FDA has granted fast track designation for AMO-02, the ...
Posted by Michael Wonder on 30 May 2017
Novo Nordisk submits application in the US for including data from the DEVOTE trial in the Tresiba label
27 May 2017 - Novo Nordisk today announced the submission of a supplemental application to the US FDA for including ...
Posted by Michael Wonder on 30 May 2017
FDA approves first generic Strattera for the treatment of ADHD
30 May 2017 - The U.S. FDA today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder ...
Posted by Michael Wonder on 30 May 2017
jCyte receives regenerative medicine advanced therapy designation
2 May 2017 - Cell therapy company jCyte announced that the U.S. FDA has granted regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 29 May 2017
Athersys announces fast track designation by FDA for stroke program and other progress
9 May 2017 - Athersys today announced its financial results for the three months ended 31 March 2017. ...
Posted by Michael Wonder on 29 May 2017
Designing clinical trials that accept new arms: an example in metastatic breast cancer
22 May 2017 - The majority of randomised oncology trials are two-arm studies that test the efficacy of new therapies against ...
Posted by Michael Wonder on 28 May 2017
Sunovion announces FDA filing acceptance of new drug application for SUN-101/eFlow for the treatment of patients with chronic obstructive pulmonary disease
13 October 2016 - SUN-101/eFlow (glycopyrrolate) NDA is currently under review; if approved, it would represent the first available nebulised ...
Posted by Michael Wonder on 28 May 2017
U.S. FDA accepts for review supplemental new drug application for Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children 4 to 17 years of age
22 May 2017 - If approved, Aptiom would provide an important monotherapy or adjunctive therapy treatment option for pediatric patients who ...
Posted by Michael Wonder on 28 May 2017
Kite receives U.S. Food and Drug Administration priority review for axicabtagene ciloleucel
26 May 2017 - Biologics license application submission based on the primary analysis of the ZUMA-1 Phase 2 trial. ...
Posted by Michael Wonder on 28 May 2017
Sunovion receives complete response letter from FDA for SUN-101/eFlow (glycopyrrolate) new drug application for chronic obstructive pulmonary disease
26 May 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA issued a complete response letter for the new ...
Posted by Michael Wonder on 27 May 2017
Drug approvals bounce back as R&D labs churn out new winners
25 May 2017 - The number of new drugs approved for sale in United States and Europe has bounced back ...
Posted by Michael Wonder on 26 May 2017
Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer
26 May 2017 - In ALK-positive metastatic NSCLC patients, Zykadia median progression-free survival was 16.6 months, compared to 8.1 months with ...
Posted by Michael Wonder on 26 May 2017
CalciMedica receives fast-track designation for CM4620, a novel CRAC channel inhibitor to treat acute pancreatitis
24 May 2017 - Patient studies expected to begin in 2018. ...
Posted by Michael Wonder on 25 May 2017
FDA approves Merck’s Keytruda (pembrolizumab) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient cancer
23 May 2017 - Keytruda now approved for patients with MSI-H or mismatch repair deficient solid tumours that have progressed following ...
Posted by Michael Wonder on 24 May 2017
Accelerated approval and expensive drugs — a challenging combination
24 May 2017 - For serious or life-threatening disease, the FDA can approve drugs on the basis of surrogate end points ...