Blog
RSS FeedPosted by Michael Wonder on 26 Feb 2019
The FDA's Oncology Center of Excellence — quantifying the patient experience
23 February 2019 - Cancer therapies are typically evaluated based on their ability to control the growth of a tumor ...
Posted by Michael Wonder on 26 Feb 2019
Procedural update on submission of Type I variations to EMA in March, April and May 2019
26 February 2019 - EMA is encouraging marketing authorisation holders intending to submit Brexit-related Type IA and Type IB variations ...
Posted by Michael Wonder on 26 Feb 2019
Bausch + Lomb announces FDA approval of Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38% for the treatment of post-operative inflammation and pain following ocular surgery
25 February 2019 - Lotemax SM is formulated with SubMicron technology for efficient penetration to key ocular tissues. ...
Posted by Michael Wonder on 26 Feb 2019
Themis Bioscience receives FDA fast track designation for Chikungunya vaccine candidate
25 February 2019 - Themis Bioscience announced today that the United States FDA has granted fast track designation to the ...
Posted by Michael Wonder on 25 Feb 2019
U.S. FDA grants breakthrough therapy designation to Amicus’ AT-GAA in late onset Pompe disease
25 February 2019 - First breakthrough therapy for an investigational treatment in Pompe disease. ...
Posted by Michael Wonder on 25 Feb 2019
Alkermes and Biogen announce U.S. FDA acceptance of diroximel fumarate new drug application for multiple sclerosis
25 February 2019 - Alkermes and Biogen today announced that the U.S. FDA has accepted for review the new drug ...
Posted by Michael Wonder on 25 Feb 2019
FDA approves Taiho Oncology's Lonsulf (trifluridine/tipiracil) for adult patients with previously treated advanced gastric or gastro-esophageal junction (GEJ) Adenocarcinoma
25 February 2019 - Taiho Oncology today announced that the United States FDA has approved Lonsulf as a treatment for adult ...
Posted by Michael Wonder on 25 Feb 2019
Roche has a $5 billion chance to lead on drug prices
25 February 2019 - A deal for gene-therapy developer Spark could help reset what’s now an exorbitant corner of the market. ...
Posted by Michael Wonder on 25 Feb 2019
Health Canada approves Otsuka and Lundbeck's Rexulti (brexpiprazole) as adjunctive treatment of major depressive disorder
22 February 2019 - Otsuka and Lundbeck announce that Health Canada issued a Notice of Compliance for Rexulti (brexpiprazole) for ...
Posted by Michael Wonder on 25 Feb 2019
Under representation of elderly in clinical trials: an analysis of the initial approval documents in the FDA database
25 February 2019 - A cross‐sectional, structured review of publicly available initial approval documents of FDA approved drugs was performed. ...
Posted by Michael Wonder on 24 Feb 2019
Paladin Labs announces approval of Envarsus PA (tacrolimus prolonged-release tablets) in Canada
22 February 2019 - Paladin Labs and Endo today announced Health Canada's approval of Envarsus PA (tacrolimus prolonged-release tablets) for ...
Posted by Michael Wonder on 24 Feb 2019
Shionogi receives European Union marketing authorisation for Rizmoic (naldemedine) for the treatment of opioid-induced constipation in adults previously treated with a laxative
22 February 2019 - The EC’s approval of Rizmoic is based on data from three Phase 3 efficacy and safety studies ...
Posted by Michael Wonder on 24 Feb 2019
Shionogi receives European Union Marketing Authorisation for lusutrombopag for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures
22 February 2019 - The approval of lusutrombopag is based on two pivotal Phase 3 randomised clinical trials, L-PLUS1 and L-PLUS2. ...
Posted by Michael Wonder on 23 Feb 2019
When biotechs get breakthrough therapy status, Mr. Market yawns
23 February 2019 - As a biotech consultant, I’ve heard many CEO’s tell me that a “drumbeat of news” is ...
Posted by Michael Wonder on 23 Feb 2019
Alder BioPharmaceuticals submits biologics license application to the U.S. FDA for eptinezumab
22 February 2019 - Significant milestone toward the commercialisation of eptinezumab, the first quarterly infusion therapy for migraine prevention. ...