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RSS FeedPosted 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
Democrats take aim at big business and drug prices in new economic campaign
24 July 2017 - Democrats unveil "A Better Deal" economic platform. ...
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
Shift to political left seen on health care
20 July 2017 - Americans were never too thrilled with "Obamacare" and they definitely disapprove of Republican alternatives in Congress, ...
Posted by Michael Wonder on 23 Jul 2017
With John McCain out, McConnell still plans a Senate health care vote next week
20 July 2017 - Senate Majority Leader Mitch McConnell is still expected to hold a vote to proceed on some ...
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 ...
Posted by Michael Wonder on 23 Jul 2017
Braeburn and Camurus announce submission for CAM2038 for opioid use disorder
20 July 2017 - Priority review of the NDA has been applied for which, if granted, would shorten the review process ...
Posted by Michael Wonder on 20 Jul 2017
Keeping the U.S. prescription drug supply chain among the safest in the world
20 July 2017 - The U.S. prescription drug supply is among the safest in the world, but it can be challenging ...
Posted by Michael Wonder on 20 Jul 2017
GOP's Obamacare repeal cuts insured by 32 million, CBO says
20 July 2017 - Estimate comes after McConnell vows vote on fully undoing ACA. ...
Posted by Michael Wonder on 20 Jul 2017
FDA may publicly shame drug makers for thwarting generic rivals
19 July 2017 - Attention brand-name drug makers: the FDA may soon publicly shame you for thwarting generic rivals. ...