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RSS FeedPosted by Michael Wonder on 27 Jul 2017
Ablynx receives fast track designation from the FDA for caplacizumab for the treatment of acquired TTP
26 July 2017 - Ablynx today announced that the U.S. FDA has granted fast track designation for caplacizumab, the Company’s ...
Posted by Michael Wonder on 27 Jul 2017
Sequoia Sciences receives FDA fast track designation for vaccine for urinary tract infections caused by multidrug-resistant bacteria
26 July 2017 - Non-antibiotic treatment approach may reduce the development of antibiotic resistance and promote antibiotic stewardship. ...
Posted by Michael Wonder on 26 Jul 2017
Trump's FDA Commissioner on drug prices, regulations, science
25 July 2017 - U.S. FDA Commissioner Scott Gottlieb spoke with Bloomberg News about drug pricing, new medicine and regulations. ...
Posted by Michael Wonder on 26 Jul 2017
UCB and Dermira announce U.S. and EU regulatory submissions for Cimzia (certolizumab pegol) for the treatment of moderate-to-severe chronic plaque psoriasis
25 July 2017 - The regulatory submissions for this new indication seek to expand the use of Cimzia for the treatment ...
Posted by Michael Wonder on 26 Jul 2017
FDA grants fast track designation to Flex Pharma’s FLX-787 for the treatment of severe muscle cramps associated with AL
25 July 2017 - Prioritising US phase 2 COMMEND trial; exploratory Australian ALS study to end early. ...
Posted by Michael Wonder on 26 Jul 2017
Orchard Therapeutics announces that OTL-101 has received a rare paediatric disease designation
25 July 2017 - Orchard Therapeutics is delighted to announce today that the US FDA granted a rare paediatric disease designation ...
Posted by Michael Wonder on 25 Jul 2017
Practical improvements for medical device evaluation
25 July 2017 - Passage of the Medical Device Amendments Act in 1976 confirmed the US FDA’s primary responsibility for evaluating ...
Posted by Michael Wonder on 25 Jul 2017
Lilly and Incyte provide update on baricitinib
25 July 2017 - Eli Lilly and Incyte Corporation announced today that a resubmission to the U.S. FDA for the ...
Posted by Michael Wonder on 25 Jul 2017
Valneva receives FDA fast track designation for its Lyme disease vaccine candidate VLA15
24 July 2017 - The company aims to accelerate VLA15’s development and plans to initiate a Phase II trial in ...
Posted by Michael Wonder on 25 Jul 2017
GSK submits US regulatory filing of Arnuity Ellipta in children with asthma
24 July 2017 - GSK today announced the filing of a supplementary new drug application to the US FDA for the ...
Posted by Michael Wonder on 24 Jul 2017
Merck announces U.S. launch of Renflexis (infliximab-abda), a biosimilar of remicade, for all eligible indications
24 July 2017 - Merck today announced the U.S. launch of Renflexis (infliximab-abda), a biosimilar of the originator biologic medicine ...
Posted by Michael Wonder on 24 Jul 2017
U.S. FDA accepts Bristol-Myers Squibb’s applications for Opdivo (nivolumab) four-week dosing schedule across all approved indications
24 July 2017 - Bristol-Myers Squibb today announced that the U.S. FDA accepted its supplemental biologics license applications to update ...
Posted by Michael Wonder on 24 Jul 2017
Companies rush to develop ‘utterly transformative’ gene therapies
23 July 2017 - The approval of gene therapy for leukaemia, expected in the next few months, will open the ...
Posted by Michael Wonder on 24 Jul 2017
U.S. FDA expands approval of Yervoy (ipilimumab) to include paediatric patients 12 years and older with unresectable or metastatic melanoma
24 July 2017 - First Bristol-Myers Squibb immuno-oncology approval for adolescents 12 years and older reflects the company’s commitment to the ...
Posted by Michael Wonder on 23 Jul 2017
GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus
21 July 2017 - GSK announced today that the US FDA has approved a new subcutaneous formulation of Benlysta (belimumab) for ...