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RSS FeedPosted 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. ...
Posted by Michael Wonder on 21 Feb 2019
Canadian shelves ‘would run dry’ if U.S. imports drugs
21 February 2019 - The president is joining liberals like Bernie Sanders in pushing to legalize pharmaceutical imports from Canada. ...
Posted by Michael Wonder on 21 Feb 2019
Indivior launches generic version of its Suboxone opioid drug
20 February 2019 - British drugmaker Indivior said on Wednesday it had launched a copycat version of its blockbuster opioid ...
Posted by Michael Wonder on 21 Feb 2019
Catalyst Pharmaceuticals defends $375,000 drug price after Bernie Sanders rebuke
22 February 2019 - Catalyst Pharmaceuticals rebuked by U.S. Senator Bernie Sanders for its high drug prices, on Thursday defended its ...
Posted by Michael Wonder on 21 Feb 2019
Cerecor receives fast track designation from FDA for CERC-801 for the treatment of PGM1 deficiency
19 February 2019 - Cerecor announced today that the U.S. FDA has designated fast track designation for CERC-801, an ultra-pure, oral ...
Posted by Michael Wonder on 21 Feb 2019
Neurelis announces that Intravail licensee ARS Pharmaceuticals intranasal epinephrine program given fast track designation
20 February 2019 - ARS Pharmaceuticals announced that ARS-1, an intranasal epinephrine spray in development to treat severe allergic reactions, was ...
Posted by Michael Wonder on 21 Feb 2019
Modis Therapeutics announces that MT1621 receives breakthrough therapy designation from FDA for the treatment of TK2 deficiency
19 February 2019 - Designation based on compelling data from initial clinical studies and high unmet need in thymidine kinase 2 ...