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RSS FeedPosted by Michael Wonder on 29 Oct 2020
European Patent Office rules in favour of Sanofi and Regeneron concerning Praluent (alirocumab)
29 October 2020 - Ruling invalidates Amgen’s European patent claims directed to PCSK9 antibodies relevant to Praluent (alirocumab). ...
Posted by Michael Wonder on 29 Oct 2020
The regions have applied for a price change for Cimzia and Simponi
29 October 2020 - The regions have submitted an application for a price change for Cimzia (certolizumab pegol) and Simponi (golimumab). ...
Posted by Michael Wonder on 29 Oct 2020
Sales of cancer fighting drugs soared in Canada over the past decade
29 October 2020 - Canada is the only country with a universal health care system without coverage for prescription drugs. ...
Posted by Michael Wonder on 29 Oct 2020
White House to require insurers to post negotiated prices for medical care
29 October 2020 - Rule calls for gradually increasing disclosure requirements through 2024; health insurers say move could hurt competition, drive ...
Posted by Michael Wonder on 29 Oct 2020
PHARMAC needs a short, sharp dose of reality
29 October 2020 - Wiki Mulholland was diagnosed with breast cancer in 2018 and is fighting for PHARMAC to fund drugs ...
Posted by Michael Wonder on 29 Oct 2020
NICE announces start of review of nusinersen Managed Access Agreement
29 October 2020 - NICE has today announced that it has begun the process to review data collected as part of ...
Posted by Michael Wonder on 29 Oct 2020
FDA accepts for priority review Libtayo (cemiplimab-rwlc) for advanced non-small cell lung cancer with PD-L1 expression of ≥50%
29 October 2020 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the supplemental biologics license ...
Posted by Michael Wonder on 29 Oct 2020
European Commission grants marketing authorisation for Arikayce liposomal 590 mg nebuliser dispersion for the treatment of NTM lung infections caused by MAC in adult non-CF patients with limited treatment options
28 October 2020 - Arikayce is the first and only therapy approved in both the European Union and United States for ...
Posted by Michael Wonder on 29 Oct 2020
reVision Therapeutics announces US FDA grant of rare paediatric disease and orphan drug designation for REV-0100 for the treatment of Stargardt disease
28 October 2020 - reVision Therapeutics today announced that the US FDA has granted the Company's request to designate REV-0100 as ...
Posted by Michael Wonder on 29 Oct 2020
Passage Bio’s PBKR03 receives orphan drug and rare paediatric disease designations from FDA for treatment of Krabbe disease
28 October 2020 - Passage Bio today announced that the U.S. FDA has granted orphan drug and rare paediatric disease designations ...
Posted by Michael Wonder on 28 Oct 2020
Trump Administration acts to ensure coverage of life-saving COVID-19 vaccines & therapeutics
28 October 2020 - Under President Trump’s leadership, the Centers for Medicare & Medicaid Services (CMS) is taking steps to ensure ...
Posted by Michael Wonder on 28 Oct 2020
Leo Pharma is withdrawing the drug Picato (ingenol mebutate), used to treat skin lesions, due to the potential increased risk of skin cancer
27 October 2020 - At Health Canada's request, Leo Pharma is withdrawing Picato from the Canadian market. ...
Posted by Michael Wonder on 28 Oct 2020
KYE Pharmaceuticals announces commercial availability of Firdapse in Canada
28 October 2020 - KYE Pharmaceuticals today announced an important milestone, Firdapse (amifampridine phosphate), the first amifampridine product approved in Canada, ...
Posted by Michael Wonder on 28 Oct 2020
TLV reconsiders the subsidy of Cosentyx
28 October 2020 - TLV starts a reconsideration to investigate the current subsidy status for Cosentyx. ...
Posted by Michael Wonder on 28 Oct 2020
Enhertu granted priority review in the US for the treatment of HER2 positive metastatic gastric cancer
28 October 2020 - Only HER2 directed medicine to demonstrate significant improvement in overall survival compared to chemotherapy for previously ...