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RSS FeedPosted by Michael Wonder on 17 Oct 2019
Health Minister Greg Hunt considering 'supervised prescribing' by pharmacists
17 October 2019 - Health Minister Greg Hunt is considering "supervised prescribing" by pharmacists to ease pressure on the health ...
Posted by Michael Wonder on 19 Oct 2019
Criticism won’t slow targeted cancer drug reviews: FDA official
18 October 2019 - FDA’s accelerated approval pathway has faced criticism it’s not really helping patients. ...
Posted by Michael Wonder on 19 Oct 2019
Janssen receives positive CHMP opinion for Spravato (esketamine) nasal spray for adults with treatment-resistant major depressive disorder
18 October 2019 - If approved by the European Commission, esketamine nasal spray will offer the first new mechanism of action ...
Posted by Michael Wonder on 19 Oct 2019
Merck receives EU CHMP positive opinion for investigational V920 Ebola Zaire vaccine for protection against Ebola virus disease
18 October 2019 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending a conditional ...
Posted by Michael Wonder on 19 Oct 2019
Alexion receives FDA approval for Ultomiris (ravulizumab-cwvz) for atypical haemolytic uremic syndrome
18 October 2019 - At 26 weeks, 54% of adults and 71% of children treated with Ultomiris demonstrated complete thrombotic microangiopathy ...
Posted by Michael Wonder on 19 Oct 2019
Cipher Pharmaceuticals receives Health Canada approval for Trulance (plecanatide)
18 October 2019 - Cipher Pharmaceuticals today announced it has received Health Canada approval, on 10 October 2019, for Trulance (plecanatide), ...
Posted by Michael Wonder on 19 Oct 2019
Foamix receives FDA approval of Amzeeq topical minocycline treatment for millions of moderate to severe acne sufferers
18 October 2019 - Amzeeq is the first ever FDA approved topical form of minocycline. ...
Posted by Michael Wonder on 18 Oct 2019
Pelosi finds a way to save billions by cutting drug prices, but big pharma pushes back
18 October 2019 - A measure being pushed by House Speaker Nancy Pelosi is challenging the Washington assumption that bringing ...
Posted by Michael Wonder on 18 Oct 2019
Merck receives positive EU CHMP opinion for two new regimens of Keytruda (pembrolizumab) as first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma
18 October 2019 - Opinion supports use of Keytruda, as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy, in patients ...
Posted by Michael Wonder on 18 Oct 2019
Nplate (romiplostim) now approved for earlier use in adults with immune thrombocytopenia
18 October 2019 - Amgen today announced that the U.S. FDA approved Amgen's supplemental biologics license application for Nplate (romiplostim) to ...
Posted by Michael Wonder on 18 Oct 2019
Evenity (romosozumab) receives positive CHMP opinion for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture
18 October 2019 - Amgen and UCB today announced that following a re-examination procedure, the CHMP of the EMA has adopted ...
Posted by Michael Wonder on 18 Oct 2019
NICE ‘ok’ for Bayer’s Xarelto
18 October 2019 - NICE has published the final appraisal determination for Xarelto (rivaroxaban). ...
Posted by Michael Wonder on 18 Oct 2019
AbbVie receives CHMP positive opinion for upadacitinib (Rinvoq) for the treatment of adults with moderate to severe active rheumatoid arthritis
18 October 2019 - CHMP positive opinion, supported by data from the pivotal Phase 3 SELECT rheumatoid arthritis program evaluating more ...
Posted by Michael Wonder on 18 Oct 2019
PHARMAC publishes draft agenda for November 2019 PTAC meeting
18 October 2019 - Eight agenda items; not one new medicine/product. ...
Posted by Michael Wonder on 18 Oct 2019
Paratek withdraws European marketing authorisation application for oral and intravenous Nuzyra in skin infections and pneumonia
17 October 2019 - Application approvable by EMA for skin infections based on two Phase 3 studies. ...
Posted by Michael Wonder on 18 Oct 2019
Bausch Health announces updated Health Canada safety information for Elidel
17 October 2019 - Topical atopic dermatitis treatment Elidel now available for children three months and over. ...