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RSS FeedPosted by Michael Wonder on 29 Mar 2017
Novartis announces first CAR-T cell therapy BLA for paediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review
29 March 2017 - Priority review for investigational CTL019 (tisagenlecleucel-T), a novel therapy that is manufactured for each individual patient using ...
Posted by Michael Wonder on 29 Mar 2017
FDA approves Roche’s Ocrevus (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis
29 March 2017 - First and only approved disease-modifying therapy for primary progressive form of multiple sclerosis – one of the ...
Posted by Michael Wonder on 29 Mar 2017
Drop in US drug approvals but no similar trend in the EU
28 March 2017 - NDA Group announced findings from their fourth annual comparison of drug approvals in Europe and the ...
Posted by Michael Wonder on 29 Mar 2017
AstraZeneca shares progress on Lynparza (olaparib) tablets in the US
28 March 2017 - FDA grants priority review for maintenance setting in ovarian cancer patients with PDUFA set for Q3 ...
Posted by Michael Wonder on 28 Mar 2017
Tesaro won’t reveal price of ovarian cancer drug. But it’ll likely be near $14,000 a month.
28 March 2017 - Zejula’s main rivals cost around $13,700 and $12,600 a month, but Tesaro might be able to justify ...
Posted by Michael Wonder on 28 Mar 2017
Severe eczema drug is approved by FDA; price tag is $37,000 a year
28 March 2017 - The FDA on Tuesday approved a drug to treat people with a serious form of eczema, ...
Posted by Michael Wonder on 28 Mar 2017
FDA approves new eczema drug Dupixent
28 March 2017 - The U.S. FDA today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent ...
Posted by Michael Wonder on 28 Mar 2017
FDA grants priority review for Eagle Pharmaceuticals’ Ryanodex NDA for the treatment of exertional heat stroke
27 March 2017 - Eagle Pharmaceuticals announced today that their 505(b)(2) new drug application for Ryanodex (dantrolene sodium) for the treatment ...
Posted by Michael Wonder on 28 Mar 2017
FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers
27 March 2017 - The U.S. FDA today approved Zejula (niraparib) for the maintenance treatment of adult patients with recurrent ...
Posted by Michael Wonder on 25 Mar 2017
Symbiomix Therapeutics announces FDA’s acceptance of new drug application for Solosec with priority review status
23 March 2017 - Symbiomix today announced that the US FDA has accepted for filing the Company’s new drug application for ...
Posted by Michael Wonder on 25 Mar 2017
FDA approves Symproic (naldemedine) once daily tablets C-II for the treatment of opioid-induced constipation in adults with chronic non-cancer pain
23 March 2017 - Shionogi and Purdue Pharma announced today that the U.S. FDA approved Symproic (naldemedine) 0.2 mg tablets ...
Posted by Michael Wonder on 24 Mar 2017
FDA grants breakthrough therapy designation for Rituxan (rituximab) in pemphigus vulgaris
23 March 2017 - Fifteenth breakthrough therapy designation granted to Genentech medicines since 2013. ...
Posted by Michael Wonder on 23 Mar 2017
An FDA program incentivising rare disease drugs will be investigated for abuses
23 March 2017 - In late 1982, Congress overwhelmingly passed the Orphan Drug Act, which was then signed into law ...
Posted by Michael Wonder on 23 Mar 2017
FDA approves first treatment for rare form of skin cancer
23 March 2017 - The U.S. FDA today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric ...
Posted by Michael Wonder on 23 Mar 2017
Shire receives FDA fast track designation for recombinant ADAMTS13 (SHP655) for treatment of hereditary thrombotic thrombocytopenic purpura
22 March 2017 - Shire today announced that the United States FDA has granted fast track designation for recombinant ADAMTS13 (SHP655 ...