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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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), ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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NICE ‘ok’ for Bayer’s Xarelto

18 October 2019 - NICE has published the final appraisal determination for Xarelto (rivaroxaban). ...

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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 ...

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PHARMAC publishes draft agenda for November 2019 PTAC meeting

18 October 2019 -  Eight agenda items; not one new medicine/product. ...

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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. ...

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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. ...

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