Blog
RSS FeedPosted by Michael Wonder on 19 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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, ...
Posted by Michael Wonder on 11 Sep 2019
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, ...
Posted by Michael Wonder on 11 Sep 2019
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. ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 10 Sep 2019
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 ...
Posted by Michael Wonder on 10 Sep 2019
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 ...
Posted by Michael Wonder on 10 Sep 2019
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. ...