Blog
RSS FeedPosted by Michael Wonder on 23 Oct 2017
GSK wins U.S. shingles vaccine approval, UK nod for gene therapy
23 October 2017 - GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three ...
Posted by Michael Wonder on 23 Oct 2017
Novartis combination adjuvant therapy Tafinlar and Mekinist receives FDA breakthrough therapy designation for stage III BRAF V600 mutation-positive melanoma patients
23 October 2017 - First targeted combination therapy to demonstrate a clinical benefit in patients with a BRAF V600E/K mutation in ...
Posted by Michael Wonder on 22 Oct 2017
Will the FDA add suffixes to approved biologics' names?
20 October 2017 - Back in January, the US FDA finalised guidance on how biosimilars and their biologic reference products' ...
Posted by Michael Wonder on 21 Oct 2017
Janssen receives two U.S. FDA approvals for Simponi Aria (golimumab) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis
20 October 2017 - Simponi Aria is the only fully-human anti-TNF-alpha infused therapy now approved for psoriatic arthritis, ankylosing spondylitis ...
Posted by Michael Wonder on 21 Oct 2017
Shingrix approved in the US for prevention of shingles in adults aged 50 and over
20 October 2017 - Pooled clinical trial results showed > 90 percent efficacy across all age groups. ...
Posted by Michael Wonder on 21 Oct 2017
FDA releases flurry of new, revised drug-specific guidance documents
19 October 2017 - The US FDA on Thursday released new draft guidances for 32 drugs, including for those companies ...
Posted by Michael Wonder on 20 Oct 2017
Antares Pharma receives complete response letter from the FDA for Xyosted
20 October 2017 - Antares Pharma announced that today it has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 19 Oct 2017
Breast cancer: BRCA study sent to Canada because U.S. thinks women can't handle genetic test results
19 October 2017 - Hundreds of spit samples have been traveling through the mail across the U.S.-Canadian border. Why? The ...
Posted by Michael Wonder on 19 Oct 2017
Teva announces submission of biologics license application for fremanezumab to the U.S. FDA
17 October 2017 - Key milestone reached for Teva to advance global fremanezumab program for the preventive treatment of migraine. ...
Posted by Michael Wonder on 19 Oct 2017
FDA approves another amazing and costly cancer-killing gene therapy
18 October 2017 - In 2010, Josh Feldman was on his honeymoon -- a globe-spanning trip that at one point ...
Posted by Michael Wonder on 19 Oct 2017
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
18 October 2017 - The U.S. FDA today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with ...
Posted by Michael Wonder on 18 Oct 2017
US FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants priority review
18 October 2017 - Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer. ...
Posted by Michael Wonder on 18 Oct 2017
Radius Health receives FDA fast track designation for elacestrant (RAD1901)
18 October 2017 - Radius plans to initiate Phase 2 clinical study of elacestrant as a third-line therapy for women with ...
Posted by Michael Wonder on 17 Oct 2017
Generic drug user fees reauthorisation: a victory for public health
17 October 2017 - We marked an important milestone in the U.S. generic drug program on 1 October 2017 – the ...
Posted by Michael Wonder on 17 Oct 2017
US FDA accepts supplemental biologics license application for Imfinzi in locally advanced unresectable non-small-cell lung cancer
17 October 2017 - Acceptance follows FDA’s breakthrough therapy designation. ...