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RSS FeedPosted by Michael Wonder on 07 May 2018
FDA grants priority review to Roche’s cancer immunotherapy Tecentriq (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer
7 May 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 07 May 2018
As Trump prepares plan to lower drug prices, big pharma girds for a fight
6 May 2018 - In his State of the Union address in January and again in New Hampshire in March, ...
Posted by Michael Wonder on 06 May 2018
U.S. FDA approves Portola Pharmaceuticals’ Andexxa, first and only antidote for the reversal of factor Xa inhibitors
3 May 2018 - Breakthrough product is a major advance in the treatment of patients hospitalised with life-threatening bleeding. ...
Posted by Michael Wonder on 06 May 2018
Ferring signs global agreement to commercialise novel gene therapy for bladder cancer patients
3 May 2018 - The US FDA has granted fast track and breakthrough therapy designations to rAd-IFN/Syn3. ...
Posted by Michael Wonder on 05 May 2018
FDA grants PaxVax fast track designation for its Chikungunya vaccine
4 May 2018 - There are no licensed vaccines for chikungunya prevention and no specific treatments. ...
Posted by Michael Wonder on 05 May 2018
Novartis matches Gilead on price in new CAR-T use
3 May 2018 - Novartis’ CAR-T therapy Kymriah will be available in the US to adults with relapsed large B-cell ...
Posted by Michael Wonder on 05 May 2018
Gottlieb pushes back against criticism of ‘breakthrough’ designation
4 May 2018 - FDA Commissioner Scott Gottlieb defended his agency’s “breakthrough therapy” program, which speeds review of drugs that ...
Posted by Michael Wonder on 05 May 2018
FDA chief questions protections on drug rebates
3 May 2018 - U.S. FDA chief Scott Gottlieb on Thursday questioned whether rebates that drugmakers provide to health insurers should ...
Posted by Michael Wonder on 05 May 2018
Watchdog says Vertex cystic fibrosis drugs are not cost effective, but company calls analysis a ‘sham’
4 May 2018 - The oldest Vertex drug for cystic fibrosis, Kalydeco, lists for $311,000, while the newer treatment Orkambi lists ...
Posted by Michael Wonder on 05 May 2018
ICER releases draft evidence report on elagolix for endometriosis
4 May 2018 - Public comment period now open until 31 May; requests to make oral comment during public meeting also ...
Posted by Michael Wonder on 05 May 2018
FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer
4 May 2018 - The U.S. FDA approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid ...
Posted by Michael Wonder on 03 May 2018
How the U.S. compares to Europe on biosimilar approvals and products in the pipeline
2 May 2018 - FDA has not approved any biosimilar drug in 2018. ...
Posted by Michael Wonder on 03 May 2018
Coherus Biosciences re-submits biologics license application for CHS-1701 (pegfilgrastim biosimilar candidate)
3 May 2018 - Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the re-submission of its biologics license application (BLA) for CHS-1701, ...
Posted by Michael Wonder on 03 May 2018
Express Scripts, the good guy on drug prices? Not exactly
3 May 2018 - Its efforts to lower drug prices likely won't change much, and it probably knows that. ...
Posted by Michael Wonder on 03 May 2018
White House drug price initiative to include negotiation tools, list prices, Azar says
2 May 2018 - HHS Secretary Alex Azar revealed Wednesday that the White House's impending drug pricing strategy will include ...