Blog
RSS FeedPosted by Michael Wonder on 20 Mar 2019
Biosimilar approval and adoption in the U.S. needs to be expedited
20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...
Posted by Michael Wonder on 20 Mar 2019
Iterum Therapeutics receives QIDP for oral and IV sulopenem in four additional indications as well as fast track designation
19 March 2019 - New designations in community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease demonstrate the ...
Posted by Michael Wonder on 20 Mar 2019
Novo Nordisk files oral semaglutide for US regulatory approval of glycaemic control, as well as for CV risk reduction for oral semaglutide and Ozempic
20 March 2019 - Novo Nordisk today announced the submission of two new drug applications to the US FDA for ...
Posted by Michael Wonder on 20 Mar 2019
FDA reform: it’s time to act, but not as an independent agency
19 March 2019 - In a rare exercise in bipartisan leadership, former FDA commissioners of both political parties called, in ...
Posted by Michael Wonder on 19 Mar 2019
FDA approves first treatment for post-partum depression
19 March 2019 - The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous use for the treatment ...
Posted by Michael Wonder on 19 Mar 2019
Biosimilars Forum and Medicines for Europe call for changes to the US biosimilars market
19 March 2019 - The Biosimilars Forum and Medicines for Europe today released a joint white paper that discusses how Europe ...
Posted by Michael Wonder on 19 Mar 2019
FDA approves Genentech’s Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer
18 March 2019 - First new initial treatment option approved by the U.S. FDA for people with ES-SCLC in more than ...
Posted by Michael Wonder on 19 Mar 2019
FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in paediatric patients, as part of efforts to end HIV infection
19 March 2019 - The U.S. FDA today issued two final guidances for industry to help product sponsors understand the ...
Posted by Michael Wonder on 19 Mar 2019
Biohaven secures priority review voucher to expedite regulatory review of Rimegepant Zydis ODT new drug application
18 March 2019 - Rimegepant Zydis orally disintegrating tablet is Biohaven's lead oral CGRP receptor antagonist drug candidate from its Nojection ...
Posted by Michael Wonder on 19 Mar 2019
GW Pharmaceuticals announces the sale of priority review voucher for $105 million
18 March 2019 - GW Pharmaceuticals today announced that GW Research Ltd. has entered into a definitive agreement to sell its ...
Posted by Michael Wonder on 19 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
18 March 2019 - Systemic sclerosis, also known as scleroderma, is a rare chronic connective tissue disease. ...
Posted by Michael Wonder on 18 Mar 2019
U.S. FDA accepts BLA filing of Aimmune Therapeutics’ AR101 for peanut allergy
18 March 2019 - If approved, AR101 will be the first medicine for this life-threatening condition. ...
Posted by Michael Wonder on 18 Mar 2019
Allergan announces FDA approval of Avycaz (ceftazidime and avibactam) for paediatric patients
18 March 2019 - Label now includes new data on use of Avycaz for treatment of cUTI and cIAI in paediatric ...
Posted by Michael Wonder on 18 Mar 2019
The policy initiatives Scott Gottlieb championed at the FDA will remain after he departs
18 March 2019 - The resignation of Scott Gottlieb as commissioner of the Food and Drug Administration raises a big ...
Posted by Michael Wonder on 18 Mar 2019
CytoDyn reaches historical milestone, submits first of three sections of BLA to FDA for leronlimab (PRO 140) as a combination therapy for HIV
18 March 2019 - FDA previously granted rolling review for BLA. ...