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RSS FeedPosted by Michael Wonder on 23 May 2019
Health Canada approves Mylan and Biocon's Ogivri, the first trastuzumab biosimilar, for the treatment of HER2-positive breast and gastric cancers
22 May 2019 - Ogivri is a part of Mylan's robust portfolio of 20 biosimilar and insulin analog products. ...
Posted by Michael Wonder on 23 May 2019
TGA fees and charges: summary from 1 July 2019
23 May 2019 - The TGA is required to recover its costs for all activities that fall within the scope ...
Posted by Michael Wonder on 23 May 2019
Avadel Pharmaceuticals announces FDA acceptance of new drug application for AV001
22 May 2019 - AV001 granted priority review. ...
Posted by Michael Wonder on 22 May 2019
Agile Therapeutics announces FDA acceptance of the NDA resubmission of Twirla
22 May 2019 - FDA assigns Prescription Drug User Fee Act goal date of 16 November 2019. ...
Posted by Michael Wonder on 22 May 2019
FDA approves Sorilux for adolescent plaque psoriasis
22 May 2019 - Mayne Pharma is pleased to announce that the US FDA has approved Sorilux (calcipotriene) foam, 0.005% ...
Posted by Michael Wonder on 22 May 2019
House Committee proposes 6% increase in FDA funding for FY 2020
22 May 2019 - The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the ...
Posted by Michael Wonder on 22 May 2019
U.S. FDA grants priority review of Invokana (canagliflozin) sNDA for the treatment of chronic kidney disease in patients with type 2 diabetes
22 May 2019 - Application was submitted in March 2019 based on landmark phase 3 CREDENCE renal outcomes study published in ...
Posted by Michael Wonder on 22 May 2019
Lilly selling half-price version of popular Humalog insulin
22 May 2019 - A half-price version of Eli Lilly's popular Humalog insulin is now available, following the company's promise in ...
Posted by Michael Wonder on 22 May 2019
PolyPid receives a second QIDP designation for D-PLEX100 in abdominal surgery
21 May 2019 - PolyPid Ltd announced today that the United States FDA has granted a second qualified infectious disease product ...
Posted by Michael Wonder on 21 May 2019
FDA replaces withdrawn biosimilar guidance with new one on quality-related considerations
21 May 2019 - A week after finalizing guidance on developing interchangeable biosimilars, the US FDA has drafted guidance for ...
Posted by Michael Wonder on 21 May 2019
Google sister company Verily is teaming with big pharma on clinical trials
21 May 2019 - Pharma companies are looking to work with Verily, which is part of the Alphabet umbrella, as they ...
Posted by Michael Wonder on 21 May 2019
Framework for the regulation of regenerative medicine products
21 May 2019 - The U.S. FDA has published four final guidance documents that are part of a comprehensive policy framework ...
Posted by Michael Wonder on 21 May 2019
South Africa's Aspen sells Australian prescription portfolio to Mylan
20 May 2019 - Aspen Pharmacare has said that Mylan had exercised an option to buy the South African drug ...
Posted by Michael Wonder on 21 May 2019
New made-in-Canada technique could revolutionise vaccine transportation
21 May 2019 - Researchers in Ontario have developed a new method of transporting life-saving vaccines to remote and impoverished ...
Posted by Michael Wonder on 21 May 2019
Emergent BioSolutions announces granting of marketing authorisation in Five EU countries for its oral typhoid vaccine; expands availability across Europe
20 May 2019 - Emergent BioSolutions announced today that it has successfully obtained marketing authorization for its oral typhoid vaccine Vivotif ...