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RSS FeedPosted by Michael Wonder on 13 Feb 2019
Industry lauds FDA RWE framework, calls for tweaks
12 February 2019 - The US FDA regulatory framework for the use of real-world evidence drew positive reactions from biopharma ...
Posted by Michael Wonder on 13 Feb 2019
Lynparza (olaparib) granted breakthrough therapy designation by US FDA for treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer
28 January 2016 - AstraZeneca today announced that the US FDA has granted breakthrough therapy designation for the oral poly ...
Posted by Michael Wonder on 13 Feb 2019
Mylan launches Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder), at a list price 70% less than the brand
12 February 2019 - Unique pricing of Wixela Inhub immediately benefits patients and reduces overall cost to the U.S. health care ...
Posted by Michael Wonder on 13 Feb 2019
Genmab announces U.S. FDA approval of Darzalex (daratumumab) split dosing regimen
12 February 2019 - Provides healthcare professionals with option to split first Darzalex infusion over two consecutive days. ...
Posted by Michael Wonder on 13 Feb 2019
Neurotech Pharmaceuticals granted fast track designation from the US FDA for the treatment of macular telangiectasia type 2
12 February 2019 - Neurotech Pharmaceuticals announced today that the US FDA has granted fast track designation for the Company's development ...
Posted by Michael Wonder on 12 Feb 2019
Statement from FDA Commissioner on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic
12 February 2019 - The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA. ...
Posted by Michael Wonder on 12 Feb 2019
Catalyst Pharma sees net price of drug, once free, topping $300,000
12 February 2019 - Catalyst Pharmaceuticals said on Monday that it expects its drug for a rare disease, which had ...
Posted by Michael Wonder on 12 Feb 2019
Health Canada issues Notice of Compliance with Conditions for Idhifa the first oral targeted therapy for adult patients with relapsed or refractory acute myeloid leukaemia and an IDH2 mutation
11 February 2019 - Conditional approval validates Idhifa as the first and only oral, targeted inhibitor of IDH2. ...
Posted by Michael Wonder on 12 Feb 2019
Seattle Genetics achieves $30 million milestone payment for European Commission approval of Adcetris (brentuximab vedotin) in frontline Hodgkin lymphom
11 February 2019 - Seattle Genetics today announced that its collaborator Takeda has received approval from the European Commission to ...
Posted by Michael Wonder on 11 Feb 2019
FDA accepts sBLA and grants priority review for Bavencio (avelumab) plus Inlyta (axitinib) for the treatment of advanced renal cell carcinoma
11 February 2019 - Merck and Pfizer today announced that the US FDA has accepted for priority review the supplemental biologics ...
Posted by Michael Wonder on 11 Feb 2019
Apellis Pharmaceuticals’ APL-2 receives fast track designation from the FDA for the treatment of patients with paroxysmal nocturnal haemoglobinuria
11 February 2019 - New designation now includes all PNH patients. ...
Posted by Michael Wonder on 11 Feb 2019
‘One-and-done’ for new drugs could cut patent thickets and boost generic competition
11 February 2019 - In a perfect world, the system for conveying medications from their makers to patients should be ...
Posted by Michael Wonder on 11 Feb 2019
Clementia granted rare paediatric disease designation by FDA for palovarotene for fibrodysplasia ossificans progressiva
11 February 2019 - Clementia Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation to palovarotene for ...
Posted by Michael Wonder on 11 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma
11 February 2019 - Filing includes use of Keytruda in the first-line setting as monotherapy or in combination with chemotherapy. ...
Posted by Michael Wonder on 11 Feb 2019
Regeneron and Sanofi offer Praluent (alirocumab) at a new reduced U.S. list price
11 February 2019 - This is the latest step by the companies to help make Praluent more accessible and affordable for ...