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RSS FeedPosted by Michael Wonder on 27 Oct 2020
Incyte announces Health Canada acceptance of the new drug submission for pemigatinib as a treatment for patients with cholangiocarcinoma
26 October 2020 - Incyte today announced that Health Canada has accepted its new drug submission for pemigatinib, a selective fibroblast ...
Posted by Michael Wonder on 27 Oct 2020
Information specialist collaboration in Europe: collaborative methods, processes, and infrastructure through EUnetHTA
21 October 2020 - The history of European health technology assessment goes back more than 30 years. Almost as old as ...
Posted by Michael Wonder on 26 Oct 2020
Santen announces U.S. FDA filing acceptance of new drug application for cyclosporin 0.1% topical ophthalmic emulsion for the treatment of severe vernal keratoconjunctivitis in patients ages 4-18
26 October 2020 - Santen today announced that the U.S. FDA has accepted the new drug application for cyclosporin 0.1% topical ...
Posted by Michael Wonder on 26 Oct 2020
Forte Biosciences announces the FDA has granted fast track designation to FB-401 for the treatment of atopic dermatitis
26 October 2020 - Forte Biosciences today announced that the U.S. FDA has granted fast track designation to FB-401 for the ...
Posted by Michael Wonder on 26 Oct 2020
Janssen submits application to U.S. FDA for new indication to expand use of Xarelto (rivaroxaban) in patients with peripheral artery disease
26 October 2020 - Application seeks approval of Xarelto plus aspirin to reduce the risk of major thrombotic vascular events in ...
Posted by Michael Wonder on 26 Oct 2020
Spectrum Pharmaceuticals announces that the FDA is deferring its action on the BLA for Rolontis (eflapegrastim)
26 October 2020 - Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel ...
Posted by Michael Wonder on 26 Oct 2020
TLV is reconsidering the subsidy for hepatitis C drugs with side agreements
23 October 2020 - The current side agreements for hepatitis C drugs signed by the companies and the regions expire in ...
Posted by Michael Wonder on 26 Oct 2020
ICR urges change as NICE rejects Keytruda plus chemotherapy
23 October 2020 - The Institute for Cancer Research has called for change in the way immunotherapy drugs are researched ...
Posted by Michael Wonder on 26 Oct 2020
NICE recommends Bayer’s Nubeqa (darolutamide), a new treatment option for non-metastatic castration-resistant prostate cancer
23 October 2020 - Positive recommendation based on Phase 3 ARAMIS trial data in which darolutamide plus androgen deprivation therapy showed ...
Posted by Michael Wonder on 25 Oct 2020
New medicines for Australians with multiple sclerosis, lymphoma, carcinoma and reproductive cancers
25 October 2020 - Australians living with multiple sclerosis, and various forms of cancer will benefit from an Australian Government investment ...
Posted by Michael Wonder on 24 Oct 2020
MS patients granted lifeline with ‘effective’ drug listed on PBS
24 October 2020 - Patients who develop the second progressive stage of multiple sclerosis will only have to pay $41 for ...
Posted by Michael Wonder on 24 Oct 2020
Health Canada releases final version of controversial regulations for controlling drug prices
23 October 2020 - After months of delay, Health Canada has released a final version of new regulations that are ...
Posted by Michael Wonder on 24 Oct 2020
Kiwis hit by medication shortages
24 October 2020 - Pharmacists and doctors in New Zealand are scrambling to find ways to manage global medication shortages because ...
Posted by Michael Wonder on 24 Oct 2020
New cancer treatment with the precision drug Vitrakvi is included in the high-cost protection
23 October 2020 - For the first time in Sweden, a cancer drug against a specific genetic change, instead of against ...
Posted by Michael Wonder on 23 Oct 2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...