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RSS FeedPosted by Michael Wonder on 22 Nov 2016
Mallinckrodt will initiate company-sponsored clinical trial of H.P. Acthar Gel in treatment of amyotropic lateral sclerosis
21 November 2016 - Investigational new drug application for use of H.P Acthar Gel in amyotropic lateral sclerosis awarded fast ...
Posted by Michael Wonder on 22 Nov 2016
U.S. FDA grants fast track designation for the development of Oragenics’ AG013 for oral mucositis
21 November 2016 - Oragenics today announced that the U.S. FDA granted fast track designation to AG013, the Company’s lead ...
Posted by Michael Wonder on 22 Nov 2016
Novo Nordisk receives US FDA approval for Xultophy 100/3.6
21 November 2016 - Novo Nordisk today announced that the US FDA has approved the new drug application for Xultophy 100/3.6. ...
Posted by Michael Wonder on 22 Nov 2016
Genmab announces U.S. FDA approval of Darzalex (daratumumab) for relapsed multiple myeloma
21 November 2016 - Darzalex (daratumumab) approved by U.S. FDA in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for ...
Posted by Michael Wonder on 21 Nov 2016
Intarcia submits new drug application to FDA for U.S. marketing approval of ITCA 650 in type 2 diabetes
21 November 2016 - ITCA 650 is the first investigational drug to use Intarcia’s disruptive Medici Drug Delivery System to ...
Posted by Michael Wonder on 21 Nov 2016
Regeneron CEO: A few ‘bad actors’ are raising drug prices for no reason
19 November 2016 - At an EY forum on Friday, the CEO of Regeneron Pharmaceuticals acknowledged that “really bad actors” ...
Posted by Michael Wonder on 21 Nov 2016
Amgen eyes spending caps to win payer nods on migraine prospect erenumab
21 November 2016 - Note to drugmakers negotiating with payers: it’s not the price tag that’s the problem, or at ...
Posted by Michael Wonder on 21 Nov 2016
Pfizer sues Texas health agency for releasing confidential pricing information
18 November 2016 - Pfizer has sued Texas' health agency, claiming it violated state and federal law by releasing the ...
Posted by Michael Wonder on 21 Nov 2016
GSK files regulatory submission in US for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD
21 November 2016 - GSK and Innoviva today announced the filing by GSK of a regulatory submission with the US ...
Posted by Michael Wonder on 21 Nov 2016
Many insured children lack essential health care, study finds
20 November 2016 - Margo Solomon has health insurance for herself and her four children. ...
Posted by Michael Wonder on 21 Nov 2016
GSK receives FDA approval for expanded indication for FluLaval Quadrivalent (influenza vaccine) for infants 6 months and older
18 November 2016 - GSK announced today it has received approval from the US FDA Center for Biologics Evaluation and ...
Posted by Michael Wonder on 19 Nov 2016
Spectrum Pharmaceuticals says FDA rejects its bladder cancer drug
18 November 2016 - Spectrum Pharmaceuticals said on Friday the U.S. FDA had rejected its bladder cancer treatment, apaziquone. ...
Posted by Michael Wonder on 18 Nov 2016
Seattle Genetics receives FDA breakthrough therapy designation for Adcentis (brentuximab vedotin) in mycosis fungoides and primary cutaneous anaplastic large cell lymphoma
10 November 2016 - Submission of supplemental biologics license application for Adcetris in CD30-expressing CTCL planned in first half of ...
Posted by Michael Wonder on 18 Nov 2016
U.S. FDA grants fast track designation for the development of Eisai's BACE inhibitor E2609 for early Alzheimer's disease
18 November 2016 - Eisai announced today that the U.S. FDA has granted fast track designation for the development of the ...
Posted by Michael Wonder on 17 Nov 2016
FDA research to help speed development of Zika virus vaccines and therapeutics
17 November 2016 - Neonatal mouse model provides a new platform for Zika virus research. ...