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RSS FeedPosted by Michael Wonder on 27 Jun 2021
Samsung Bioepis and Biogen receive positive CHMP opinion for ranibizumab biosimilar, Byooviz
25 June 2021 - Samsung Bioepis and Biogen today announced that the EMA's CHMP has adopted a positive opinion for Byooviz, ...
Posted by Michael Wonder on 27 Jun 2021
Highlights from 21-24 June CHMP meeting
25 June 2021 - EMA’s CHMP recommended eight medicines for approval at its June 2021 meeting. ...
Posted by Michael Wonder on 27 Jun 2021
In an about face, Health Canada allows a controversial rare disease drug back on the market
26 June 2021 - In yet another twist in a complicated tale, Health Canada has reinstated approval of a rare ...
Posted by Michael Wonder on 26 Jun 2021
Vertex announces new portfolio reimbursement agreement in Italy including Kaftrio, Symkevi and additional indications of Orkambi and Kalydeco for eligible patients with cystic fibrosis
25 June 2021 - Reimbursement agreement also includes certain future indication extensions across all Vertex cystic fibrosis medicines. ...
Posted by Michael Wonder on 26 Jun 2021
CHMP recommends approval of Rinvoq (upadacitinib) for the treatment of atopic dermatitis
25 June 2021 - Positive opinion based on three global Phase 3 pivotal clinical trials evaluating the safety and efficacy of ...
Posted by Michael Wonder on 26 Jun 2021
AbbVie provides update regarding Rinvoq (upadacitinib) in psoriatic arthritis and ankylosing spondylitis in the U.S.
25 June 2021 - AbbVie today announced that the U.S. FDA has informed the company that the FDA will not ...
Posted by Michael Wonder on 26 Jun 2021
Mirati Therapeutics' adagrasib receives breakthrough therapy designation from U.S. FDA for patients with advanced non-small cell lung cancer harbouring the KRASG12C mutation
24 June 2021 - Mirati Therapeutics announced today that the U.S. FDA has granted breakthrough therapy designation to adagrasib for ...
Posted by Michael Wonder on 25 Jun 2021
Aquestive Therapeutics resubmits new drug application for Libervant (diazepam) buccal film
24 June 2021 - Anticipates FDA PDUFA goal date in late 2021. ...
Posted by Michael Wonder on 25 Jun 2021
Rivaroxaban application submitted to U.S. FDA for approval to treat VTE and to prevent VTE in children
23 June 2021 - Application seeks two paediatric indications, including an age-appropriate new weight-based oral suspension formulation. ...
Posted by Michael Wonder on 25 Jun 2021
Changes to cost recovery arrangements from 1 July 2021
25 June 2021 - The 2021-22 PBS and NIP cost recovery implementation statement is now available. ...
Posted by Michael Wonder on 25 Jun 2021
Vericiguat approved in Japan to treat patients with chronic heart failure
23 June 2021 - Heart failure affects approximately 1.2 million people in Japan. ...
Posted by Michael Wonder on 24 Jun 2021
ALS association wants more commitment from the FDA
24 June 2021 - In a response letter to the ALS Association, the U.S. FDA has recognised the unmet therapeutic ...
Posted by Michael Wonder on 24 Jun 2021
PMPRB risks harming the health of Canadians by reducing access to new medicines
23 June 2021 - On June 21, Innovative Medicines Canada submitted six recommendations to the federal government as part of the ...
Posted by Michael Wonder on 24 Jun 2021
Evrysdi approved in Japan for the treatment of spinal muscular atrophy
23 June 2021 - 48th country that approved Evrysdi. ...
Posted by Michael Wonder on 24 Jun 2021
Teva announces Ministry of Health, Labour and Welfare approves Ajovy (fremanezumab) injection in Japan for the preventive treatment of migraine in adults
23 June 2021 - Ajovy developed by Otsuka in Japan through exclusive license agreement. ...