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RSS FeedPosted by Michael Wonder on 04 Mar 2019
Akcea and Ionis receive positive EU CHMP opinion for Waylivra (volanesorsen)
1 March 2019 - First and only therapy approved for FCS, a serious and rare disease with no approved treatment options. ...
Posted by Michael Wonder on 04 Mar 2019
BioMarin receives positive CHMP opinion in Europe for Palynziq (pegvaliase injection) for treatment of patients with phenylketonuria aged 16 and older
1 March 2019 - Decision on marketing authorisation application expected Q2 '19. ...
Posted by Michael Wonder on 04 Mar 2019
European CHMP adopts positive opinion on Ondexxya (andexanet alfa) Portola Pharmaceuticals’ factor Xa inhibitor reversal agent
1 March 2019 - Portola Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion on ...
Posted by Michael Wonder on 02 Mar 2019
Hansa Biopharma announces European Medicines Agency accepts marketing authorisation application for Idefirix (imlifidase)
1 March 2019 - Hansa Biopharma announced today that the EMA has accepted the company's marketing authorisation application for review of ...
Posted by Michael Wonder on 02 Mar 2019
Lynparza receives positive EU CHMP opinion for use in germline BRCA-mutated HER2-negative advanced breast cancer
1 March 2019 - AstraZeneca and MSD today announced that the CHMP of the EMA has adopted a positive opinion, ...
Posted by Michael Wonder on 02 Mar 2019
CHMP recommends approval of Dupixent (dupilumab) for asthma indication
1 March 2019 - The European Medicines Agency’s CHMP has adopted a positive opinion for Dupixent (dupilumab), recommending its approval ...
Posted by Michael Wonder on 02 Mar 2019
CHMP recommends Zynquista (sotagliflozin) for the treatment of adults with type 1 diabetes
1 March 2019 - The European Medicines Agency’s CHMP has adopted a positive opinion on the marketing authorisation of Zynquista ...
Posted by Michael Wonder on 02 Mar 2019
AbbVie receives CHMP positive opinion for risankizumab (Skyrizi) for the treatment of moderate to severe plaque psoriasis
1 March 2019 - CHMP positive opinion, supported by data from the pivotal Phase 3 program evaluating more than 2,000 patients ...
Posted by Michael Wonder on 02 Mar 2019
Health Canada and CADTH launch new initiative to provide early parallel scientific advice
1 March 2019 - CADTH is pleased to announce a new collaboration with Health Canada and the Institut national d'excellence en ...
Posted by Michael Wonder on 02 Mar 2019
Pfizer receives positive CHMP opinion for Lorviqua (lorlatinib) for certain adult patients with previously-treated ALK-positive advanced non-small cell lung cancer
1 March 2019 - Pfizer today announced that the CHMP of the EMA has adopted a positive opinion for Lorviqua (lorlatinib, ...
Posted by Michael Wonder on 02 Mar 2019
Treatment effects in multi-centre randomised clinical trials
1 March 2019 - It is common for treatments to be evaluated in clinical trials that involve many sites or centres, ...
Posted by Michael Wonder on 01 Mar 2019
Esperion announces submissions of two NDAs and official completion of two MAA validations for both bempedoic acid and the bempedoic acid/ezetimibe combination tablet
28 February 2019 - Esperion today announced that the company has successfully completed important and key global marketing applications including ...
Posted by Michael Wonder on 01 Mar 2019
Patient access to cost-effective treatments increased with launch of new biosimilar in Canada
28 February 2019 - First-ever pegfilgrastim biosimilar approved by Health Canada launches across the country. ...
Posted by Michael Wonder on 01 Mar 2019
Astellas announces acceptance of Xospata (gilteritinib) for regulatory review by the European Medicines Agency
28 February 2019 - Astellas Pharma announced today that the submission for a marketing authorisation application for the oral once-daily ...
Posted by Michael Wonder on 28 Feb 2019
U.S. Senator Sanders urges FDA to allow older versions of $375,000 drug
28 February 2019 - U.S. Senator Bernie Sanders this week urged regulators to allow pharmacies and manufacturers to resume distributing unbranded, ...