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RSS FeedPosted by Michael Wonder on 21 Dec 2016
FDA extends review of application for Ocrevus (ocrelizumab)
20 December 2016 - Roche announced today that the U.S. FDA has extended the Prescription Drug User Fee Act date for ...
Posted by Michael Wonder on 21 Dec 2016
Astellas announces FDA fast track designation for ASP0892, DNA vaccine for mitigation of severe hypersensitivity reactions due to peanut allergy
20 December 2016 - Astellas and Immunomic Therapeutics today announced that the U.S. FDA has granted fast track designation for the ...
Posted by Michael Wonder on 21 Dec 2016
KemPharm granted "fast track" designation for KP201/IR
20 December 2016 - KP201/IR could be the first single entity (APAP-free), immediate release hydrocodone product for pain analgesia with ...
Posted by Michael Wonder on 21 Dec 2016
Apellis announces FDA fast track designation for APL-2 in PNH
20 December 2016 - C3 inhibitor is in development for the treatment of PNH, both in patients not previously treated ...
Posted by Michael Wonder on 20 Dec 2016
Juno Therapeutics' and Celgene Corporation's investigational drug JCAR017 granted breakthrough therapy designation from FDA and priority medicines eligibility from EMA for relapsed/refractory diffuse large B cell lymphoma
20 December 2016 - Early results recently announced with JCAR017 in non-Hodgkin lymphoma and pediatric acute lymphoblastic leukemia. ...
Posted by Michael Wonder on 20 Dec 2016
Novo Nordisk receives FDA approval of Tresiba (insulin degludec injection 100 U/mL, 200 U/mL) for use in children and adolescents with diabetes
19 December 2016 - Novo Nordisk today announced that the U.S. FDA approved an expanded indication for Tresiba (insulin degludec injection ...
Posted by Michael Wonder on 20 Dec 2016
Harnessing the U.S. taxpayer to fight cancer and make profits
19 December 2016 - Enthusiasm for cancer immunotherapy is soaring, and so is Arie Belldegrun’s fortune. ...
Posted by Michael Wonder on 20 Dec 2016
FDA grants Conatus fast track designation for development of emricasan in NASH cirrhosis
3 February 2016 - Conatus Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to the company's emricasan ...
Posted by Michael Wonder on 20 Dec 2016
Dynavax receives complete response letter from U.S. FDA for biologics license application for Heplisav-B
14 November 2016 - Dynavax Technologies today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 20 Dec 2016
ProMetic initiates rolling submission of its biologics license application for plasminogen with U.S. FDA
19 December 2016 - ProMetic Life Sciences announced today that it has initiated the rolling submission of its biologics license ...
Posted by Michael Wonder on 20 Dec 2016
Tonix Pharmaceuticals’ PTSD Phase 3 ready drug candidate, TNX-102 SL, granted breakthrough therapy designation by the FDA
19 December 2016 - Responding to AtEase study results in military-related PTSD population, FDA agrees to work closely with Tonix ...
Posted by Michael Wonder on 19 Dec 2016
AbbVie submits new drug application to U.S. FDA for its investigational regimen of glecaprevir/pibrentasvir for the treatment of all major genotypes of chronic hepatitis C
19 December 2016 - AbbVie's investigational regimen was granted breakthrough therapy designation by the FDA for genotype 1 patients not ...
Posted by Michael Wonder on 19 Dec 2016
FDA grants accelerated approval to new treatment for advanced ovarian cancer
19 December 2016 - The U.S. FDA today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain ...
Posted by Michael Wonder on 19 Dec 2016
Boehringer Ingelheim and Lilly welcome new recommendation for Jardiance (empagliflozin) tablets in updated American Diabetes Association's 2017 standards
16 December 2016 - Guidelines include new recommendation to consider the use of Jardiance in people with type 2 diabetes ...
Posted by Michael Wonder on 19 Dec 2016
20 states accuse generic drug companies of price fixing
15 December 2016 - A wide-ranging investigation into generic drug prices took its most significant turn yet on Thursday, as ...