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RSS FeedPosted by Michael Wonder on 22 Feb 2019
Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad
22 February 2019 - At the FDA, protecting patient and consumer health is our highest priority. Assessing and mitigating risks ...
Posted by Michael Wonder on 21 Feb 2019
The fighter, the saint, and the odd man out: the executives who will defend pharma before Congress
21 February 2019 - One’s a college dropout. One’s a self-proclaimed street fighter. And one survived a presidential tweetstorm. ...
Posted by Michael Wonder on 21 Feb 2019
Canadian shelves ‘would run dry’ if U.S. imports drugs
21 February 2019 - The president is joining liberals like Bernie Sanders in pushing to legalize pharmaceutical imports from Canada. ...
Posted by Michael Wonder on 21 Feb 2019
Indivior launches generic version of its Suboxone opioid drug
20 February 2019 - British drugmaker Indivior said on Wednesday it had launched a copycat version of its blockbuster opioid ...
Posted by Michael Wonder on 21 Feb 2019
Catalyst Pharmaceuticals defends $375,000 drug price after Bernie Sanders rebuke
22 February 2019 - Catalyst Pharmaceuticals rebuked by U.S. Senator Bernie Sanders for its high drug prices, on Thursday defended its ...
Posted by Michael Wonder on 21 Feb 2019
Cerecor receives fast track designation from FDA for CERC-801 for the treatment of PGM1 deficiency
19 February 2019 - Cerecor announced today that the U.S. FDA has designated fast track designation for CERC-801, an ultra-pure, oral ...
Posted by Michael Wonder on 21 Feb 2019
Neurelis announces that Intravail licensee ARS Pharmaceuticals intranasal epinephrine program given fast track designation
20 February 2019 - ARS Pharmaceuticals announced that ARS-1, an intranasal epinephrine spray in development to treat severe allergic reactions, was ...
Posted by Michael Wonder on 21 Feb 2019
Modis Therapeutics announces that MT1621 receives breakthrough therapy designation from FDA for the treatment of TK2 deficiency
19 February 2019 - Designation based on compelling data from initial clinical studies and high unmet need in thymidine kinase 2 ...
Posted by Michael Wonder on 21 Feb 2019
Nabriva Therapeutics announces acceptance of new drug applications by the FDA for intravenous and oral lefamulin to treat community-acquired bacterial pneumonia in adults
19 February 2019 - PDUFA action date set for August 19, 2019. ...
Posted by Michael Wonder on 20 Feb 2019
Agios announces FDA acceptance of supplemental new drug application for Tibsovo (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukaemia with an IDH1 mutation not eligible for standard therapy
20 February 2019 - PDUFA date set for June 21 2019. ...
Posted by Michael Wonder on 20 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) monotherapy for third-line treatment of patients with advanced small cell lung cancer
20 February 2019 - Marks first application for Keytruda in SCLC. ...
Posted by Michael Wonder on 20 Feb 2019
Novo Nordisk receives US FDA approval of Esperoct (turoctocog alfa pegol, N8-GP)
19 February 2019 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Esperoct ...
Posted by Michael Wonder on 20 Feb 2019
FDA approves Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection
19 February 2019 - U.S. approval based on significant recurrence-free survival benefit demonstrated with Keytruda in Phase 3 EORTC1325/KEYNOTE-054 trial. ...
Posted by Michael Wonder on 20 Feb 2019
FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma
19 February 2019 - Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease. ...
Posted by Michael Wonder on 19 Feb 2019
Pfenex announces FDA acceptance of NDA for PF708
19 February 2019 - FDA sets PDUFA date of 7 October 2019. ...