Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis

18 September 2019 - In this study, the investigators examined the characteristics of randomised controlled trials that supported approval of cancer ...

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Accelerating the shift toward person-generated real world evidence

19 September 2019 - Evidence generated from randomised clinical trials and other clinical studies has long been the foundation for ...

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A new deal protects Australians chemists at the expense of patients

22 September 2019 - Australia’s 3000 pharmacy owners have a government guaranteed monopoly that is pushing up medicine prices and the ...

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Merck’s Pifelto (doravirine) and Delstigo (doravirine/lamivudine/tenofovir disoproxil fumarate) receive US FDA approval for use in appropriate adults living with HIV-1 who are virologically suppressed

20 September 2019 - Approvals based on findings from the Phase 3 DRIVE-SHIFT Trial evaluating a switch to Delstrigo. ...

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CHMP recommends approval of Dupixent (dupilumab) for severe chronic rhinosinusitis with nasal polyposis

20 September 2019 - The EMA’s CHMP has adopted a positive opinion for Dupixent®(dupilumab) in a third indication.  ...

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Humana CEO: competition and innovation lower drug prices better than just putting a cap on them

20 September 2019 - U.S. lawmakers should also include in their proposals rules that would facilitate greater competition and innovation, Humana ...

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FDA approves first oral GLP-1 treatment for type 2 diabetes

20 September 2019 - The U.S. FDA today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult ...

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Astellas receives positive CHMP opinion for Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation

20 September 2019 - If approved by the European Commission, gilteritinib would represent one of the few advances in Europe for ...

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CHMP adopts positive opinion for Bavencio (avelumab) plus axitinib for first-line treatment of patients with advanced renal cell carcinoma

20 September 2019 - Opinion based on Phase III data showing combination lowered risk of disease progression or death by 31% ...

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Highlights from the CHMP 16-19 September 2019 meeting

20 September 2019 - Seven new medicines recommended for approval. ...

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Addition of Kisqali to drug plan in Quebec expands access to treatment for metastatic breast cancer

19 September 2019 - Provincial reimbursement provides public access to treatment that may delay the progression of advanced breast cancer. ...

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SanBio granted regenerative medicine advanced therapy designation from the U.S. FDA for SB623 for the treatment of chronic neurological motor deficits secondary to traumatic brain injury

19 September 2019 - The SanBio Group today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation ...

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Emmaus Life Sciences announces withdrawal of marketing authorisation application to European Medicines Agency

19 September 2019 - Emmaus Life Sciences today announced the withdrawal of its marketing authorisation application to the European Medicines ...

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How an 'International Price Index' might help reduce drug prices

19 September 2019 - In gridlocked Washington, both Democrats and Republicans have signalled there's potential for a deal when it ...

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National pharmacare cheaper than healing people who can't afford their drugs

17 September 2019 - A national pharmacare program could potentially reduce prescription drug spending by aggregating the buying power of all ...

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First biosimilar of dornase alfa inhalation solution for CF approved in Russia, companies announce

19 September 2019 - A biosimilar of dornase alfa inhalation solution, with the same therapeutic activity as Pulmozyme, its reference ...

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