Blog
RSS FeedPosted by Michael Wonder on 16 Dec 2020
Health Canada approves Venclexta (venetoclax) in combination with azacitidine or low dose cytarabine for untreated acute myeloid leukaemia
15 December 2020 - Health Canada's approval of Venclexta for newly diagnosed AML patients who are ineligible for intensive chemotherapy is ...
Posted by Michael Wonder on 15 Dec 2020
Big Pharma’s new CEOs must step up to erase inequities in drug access
16 December 2020 - I have been asked many times: Does the vision of the CEO have the power to ...
Posted by Michael Wonder on 15 Dec 2020
Trump’s plan for $200 Medicare drug cards advances, though hurdles remain
15 December 2020 - An industry group that ensures standards are met for health-benefit cards gave its approval for the $200 ...
Posted by Michael Wonder on 15 Dec 2020
Rafael Pharmaceuticals receives FDA fast track designation for CPI-613 (devimistat) for the treatment of acute myeloid leukaemia
15 December 2020 - Rafael Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 15 Dec 2020
U.S. FDA accepts new drug application for review, grants priority review for Takeda’s TAK-721 (budesonide oral suspension) for the treatment of eosinophilic oesophagitis
15 December 2020 - If approved, TAK-721 will be the first FDA approved treatment for the chronic inflammatory disease; Takeda plans ...
Posted by Michael Wonder on 15 Dec 2020
28 state Attorneys General demand HHS Secretary Azar enforce laws on 340B drug pricing
14 December 2020 - AIDS Healthcare Foundation praised 28 U.S. state attorneys general who have drawn a line in the sand ...
Posted by Michael Wonder on 15 Dec 2020
Almirall announces FDA approval of Klisyri (tirbanibulin), a new innovative topical treatment for actinic keratosis
15 December 2020 - In one of the largest Phase 3 clinical trial programs ever conducted for a topical actinic keratosis ...
Posted by Michael Wonder on 15 Dec 2020
Imfinzi recommended for approval in the EU by CHMP for less-frequent, fixed-dose use in unresectable non-small cell lung cancer
15 December 2020 - Option would extend dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 15 Dec 2020
FDA approves Genentech’s Ocrevus (ocrelizumab) shorter 2 hour infusion for relapsing and primary progressive multiple sclerosis
14 December 2020 - Approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional ...
Posted by Michael Wonder on 15 Dec 2020
AMAG Pharmaceuticals files submission in response to the FDA’s notice of opportunity for a hearing and proposal to withdraw approval of Makena (hydroxyprogesterone caproate injection)
14 December 2020 - AMAG Pharmaceuticals has submitted its response to the FDA’s Notice of Opportunity for a Hearing regarding the ...
Posted by Michael Wonder on 15 Dec 2020
Over-the-counter access to low dose cannabidiol
15 December 2020 - Today the Therapeutic Goods Administration announced a final decision to down-schedule certain low dose cannabidiol preparations ...
Posted by Michael Wonder on 14 Dec 2020
Public posting of a comprehensive surrogate endpoint table for CDER and CBER regulated products
11 December 2020 - The public posting of a surrogate endpoint table for both reasonably likely and validated surrogate outcomes was ...
Posted by Michael Wonder on 14 Dec 2020
Gannex received U.S. FDA fast track designation for its NASH drug candidate ASC42, an FXR agonist
13 December 2020 - Gannex announced today that it received fast track designation from the U.S. FDA for its non-alcoholic steatohepatitis ...
Posted by Michael Wonder on 14 Dec 2020
Novartis receives EU approval for Leqvio (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year
11 December 2020 - Leqvio (inclisiran) is the first and only approved small-interfering RNA (siRNA) low-density lipoprotein cholesterol lowering treatment in ...
Posted by Michael Wonder on 14 Dec 2020
NICE u-turn on Novartis' migraine drug Aimovig
14 December 2020 - In a rare move, NICE has reconsidered its position on Novartis migraine prevention treatment Aimovig (erenumab), ...