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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How to correct this big Medicare mistake

10 September 2019 - It's a big mistake to assume that Medicare is the only health insurance you need in ...

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Germany may have the answer for reducing drug prices

11 September 2019 - American lawmakers attempting to stem spiraling drug costs might find inspiration in Germany, where the government’s ...

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Puma Biotechnology announces U.S. FDA acceptance of supplemental new drug application for neratinib to treat HER2-positive metastatic breast cancer

11 September 2019 - Puma Biotechnology announced that the U.S. FDA has accepted for review its supplemental new drug application for ...

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Anti-depressant medicine brand switch: 'They've been used as guinea pigs'

11 September 2019 - Emotions ran high at the Health Select Committee today, with MPs grilling Medsafe and the Ministry ...

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Government injects £130 million into cancer & debilitating illnesses

11 September 2019 - The UK government has announced an investment of over £130 million for new tech to tackle ...

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United Therapeutics announces FDA acceptance of Trevyent new drug application for review

11 September 2019 - United Therapeutics today announced that the U.S. FDA has accepted for review the new drug application for ...

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ICER releases draft evidence report on diabetes therapies

11 September 2019 - Public comment period now open until 8 October 2019; Requests to make oral comment during public meeting ...

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Biosimilar and interchangeable: inseparable scientific concepts?

4 September 2019 - As defined by the European Commission, the term interchangeability refers to “the possibility of exchanging one medicine ...

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The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018

10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...

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Canada OKs Celltrion's biosimilar

10 September 2019 - Celltrion said that Health Canada has given the go-ahead for Herzuma (trastuzumab), an anticancer antibody biosimilar, ...

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Merck announces FDA breakthrough therapy designation for investigational therapy tepotinib in patients with metastatic NSCLC with METex14 skipping alterations

11 September 2019 - Investigational oral MET inhibitor has previously received SAKIGAKE ’fast-track’ regulatory designation in Japan. ...

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Decision for funding in the immunosuppressant, cardiovascular and anti-nausea therapeutic areas

11 September 2019 - PHARMAC pleased to announce a decision to approve proposals relating to medicines in the immunosuppressant, cardiovascular ...

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Drug formulary managers' use of step therapy can lead to sub-optimal outcomes

9 September 2019 - Over the past two decades the use of step therapy or edits by health insurers has ...

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Erosion of physician and patient treatment choice continues - Alliance for Safe Biologic Medicines raises concerns for patients as British Columbia expands biologics forced switching policy

10 September 2019 - On 5 September, the Government of British Columbia announced that it would be forcibly switching 1,700 patients ...

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Drug prices get Washington’s attention ahead of 2020 election

10 September 2019 - Pelosi, Grassley push legislative measures, while Trump indicates he will issue an executive action. ...

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