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RSS FeedPosted by Michael Wonder on 26 Feb 2019
'Wacky' drug price system keeps costs high for patients paying for prescriptions, FDA chief says
26 February 2019 - "The sick people are helping to subsidise the healthy people. That's not how insurance is supposed to ...
Posted by Michael Wonder on 26 Feb 2019
A small drug maker settles charges for paying others to submit its FDA applications
26 February 2019 - A small drug maker was fined $4 million for striking deals with two tiny companies to ...
Posted 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
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
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 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. ...
Posted by Michael Wonder on 23 Feb 2019
FDA grants priority review and accepts sBLA of Soliris (eculizumab) as a treatment for patients with neuromyelitis optica spectrum disorder
22 February 2019 - FDA sets action date of 28 June 2019. ...
Posted by Michael Wonder on 22 Feb 2019
Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad
22 February 2019 - At the FDA, protecting patient and consumer health is our highest priority. Assessing and mitigating risks ...
Posted by Michael Wonder on 21 Feb 2019
The fighter, the saint, and the odd man out: the executives who will defend pharma before Congress
21 February 2019 - One’s a college dropout. One’s a self-proclaimed street fighter. And one survived a presidential tweetstorm. ...