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RSS FeedPosted by Michael Wonder on 20 Mar 2025
Australia defends PBS as US companies urge Trump to impose reciprocal tariffs
19 March 2025 - American medical giants have labelled the federal government's PBS "egregious and discriminatory" and have pressed US ...
Posted by Michael Wonder on 20 Mar 2025
Big pharma’s plea to Trump to punish Australia for cheaper medicines
19 March 2025 - American medical giants have slammed the $18 billion pharmaceutical benefits scheme in a plea to US ...
Posted by Michael Wonder on 20 Mar 2025
Travere Therapeutics submits sNDA to FDA for approval of Filspari (sparsentan) for the treatment of focal segmental glomerulosclerosis
17 March 2025 - sNDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of Filspari in focal ...
Posted by Michael Wonder on 20 Mar 2025
Alvotech and Dr. Reddy’s announce FDA acceptance of biologic license application for AVT03, a proposed biosimilar to Prolia and Xgeva
18 March 2025 - Dr. Reddy’s Laboratories and Alvotech today announced that the US FDA has accepted a 351(k) biologic license ...
Posted by Michael Wonder on 20 Mar 2025
Global pharma gives up reimbursement in Korea, and this is a serious concern
19 March 2025 - "We believe convincing our headquarters is no longer feasible, and we have no plans to apply ...
Posted by Michael Wonder on 19 Mar 2025
Linzagolix choline in endometriosis: comparative data are lacking
18 March 2025 - There are no comparative studies with established active ingredients in endometriosis; placebo comparisons are unsuitable for assessing ...
Posted by Michael Wonder on 19 Mar 2025
Scienture announces the US FDA approval of its NDA for SCN-102 to be launched as Arbli (losartan potassium) 10 mg/mL oral suspension
18 March 2025 - Scienture is pleased to announce the US FDA has approved SCN-102 with the brand name Arbli (losartan ...
Posted by Michael Wonder on 19 Mar 2025
Nipocalimab, the first and only investigational treatment to be granted US FDA breakthrough therapy designation for the treatment of adults with moderate to severe Sjögren’s disease, has now received fast track designation
18 March 2025 - This marks the fourth nipocalimab FDA fast track designation. ...
Posted by Michael Wonder on 19 Mar 2025
US FDA grants priority review for new indication of finerenone for patients with common form of heart failure
17 March 2025 - Regulatory submission is based on positive results from the Phase 3 FINEARTS-HF study, which is part of ...
Posted by Michael Wonder on 18 Mar 2025
Zorvye cream 0.15% approved by Health Canada for the treatment of mild to moderate atopic dermatitis in adults and children as young as six years of age
17 March 2025 - Once daily, steroid free topical treatment designed to rapidly reduce itch and proactively support long term disease ...
Posted by Michael Wonder on 18 Mar 2025
Pfizer's Ixifi will be available in Canada as of 1 April 2025
17 March 2025 - Ixifi is available in more than 20 countries and was approved by Health Canada in December 2021. ...
Posted by Michael Wonder on 18 Mar 2025
Skyclarys (omaveloxolone) approval by Health Canada ushers in a new era for Friedreich's ataxia treatment in Canada
17 March 2025 - As the only approved treatment to address disease progression, Skyclarys addresses a long standing gap in the ...
Posted by Michael Wonder on 17 Mar 2025
Government delivering even more choice for women's contraception, endometriosis, and IVF journeys
16 March 2025 - The Government is delivering even more choice for Australian women with new and amended listings for contraception, ...
Posted by Michael Wonder on 17 Mar 2025
Imfinzi approved in the EU as first and only immunotherapy for limited-stage small cell lung cancer
17 March 2025 - Approval based on ADRIATIC Phase 3 trial results which showed a 27% reduction in the risk ...
Posted by Michael Wonder on 17 Mar 2025
Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
14 March 2025 - In the TRANSCEND FL trial, 97.1% of patients responded to Breyanzi , with 94.2% of patients achieving ...