Was it really a smart move for the FDA to approve a ‘smart pill’ for treating schizophrenia?

18 July 2019 - In late 2017, the FDA approved the first so-called smart pill, ushering in a new era ...

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PBAC Public Summary Documents (first time rejections and deferrals) - March 2019 meeting

19 July 2019 - The Public Summary Documents (first time rejections and deferrals) from the March 2019 PBAC meeting are now ...

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FDA approves Merck’s Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with complicated urinary tract and complicated intra-abdominal bacterial infections where limited or no alternative treatment options are available

17 July 2019 - Merck  today announced that the U.S. FDA has approved Recarbrio (imipenem, cilastatin, and relebactam) for injection, 1.25 ...

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Drug Utilisation Sub-Committee outcome statement

17 July 2019 - The outcome statement from the June 2019 Drug Utilisation Sub-Committee meeting is now available. ...

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Knight Therapeutics announces Health Canada has approved Nerlynx for early-stage breast cancer

16 July 2019 - Knight Therapeutics announced today that Health Canada has approved Nerlynx (neratinib) for the extended adjuvant treatment of ...

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FDA approves Bayer's Gadavist (gadobutrol) injection as the first and only contrast agent for use in cardiac magnetic resonance imaging in adult patients with known or suspected coronary artery disease

15 July 2019 - Coronary artery disease is an important public health issue-- a disease that affects 16.5 million Americans. ...

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Teva announces FDA approval of AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) inhalation powder

15 July 2019 - The first digital maintenance asthma inhaler therapy with integrated sensors joins Teva’s digital rescue inhaler therapy to ...

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NICE recommends Skyrizi, Forxiga

15 July 2019 - NICE has recommended two new drugs on the NHS, AbbVie’s Skyrizi (risankizumab) and AstraZeneca’s Forxiga (dapagliflozin) ...

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Update on US regulatory decision for Farxiga in type 1 diabetes

15 July 2019 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the supplemental ...

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Eton Pharmaceuticals provides update on EM-100 program

12 July 2019 - Eton Pharmaceuticals today announced that the U.S FDA provided Eton’s partner with a complete response letter relating ...

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Early benefit assessment reveals weaknesses in the development of new drugs

11 July 2019 - Analysis of 216 AMNOG assessments in the BMJ / Proposals for more targeted drug development ...

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Esperoct is now approved in Canada for the treatment of haemophilia A in both children and adults

12 July 2019 - New treatment can help Canadians living with haemophilia A better manage their bleeding episodes ...

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Aimmune statement on ICER final report on AR101 for peanut allergy

11 July 2019 - Exclusion of long-term desensitization and patient quality-of-life data by ICER fails to recognize the full value AR101 ...

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NICE recommends innovative treatment for type 1 diabetes

12 July 2019 - It’s estimated that around 90,000 people could be eligible for treatment with dapagliflozin. ...

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ICER publishes evidence report on treatments for Duchenne muscular dystrophy

11 July 2019 - No price can be suggested as a fair value-based price for eteplirsen or golodirsen because no persuasive ...

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