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RSS FeedPosted by Michael Wonder on 18 Jul 2018
EU and Japan reinforce their collaboration on inspections of medicine manufacturers
18 July 2018 - Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals ...
Posted by Michael Wonder on 18 Jul 2018
Novartis Kisqali now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for pre-menopausal women; and as initial therapy with fulvestrant in postmenopausal women
18 July 2018 - Kisqali is now the only CDK4/6 inhibitor indicated in combination with an aromatase inhibitor as first-line treatment ...
Posted by Michael Wonder on 18 Jul 2018
Janssen announces U.S. FDA approval of Symtuza, the first and only complete darunavir-based single tablet regimen for the treatment of HIV-1 infection
17 July 2018 - Once daily, single-tablet regimen delivers the durability and high barrier to drug resistance of darunavir and the ...
Posted by Michael Wonder on 18 Jul 2018
$50 million to provide life-saving support to cancer patients
18 July 2018 - The Australian Government will provide $50 million to support some of Australia’s sickest patients, battling the most ...
Posted by Michael Wonder on 17 Jul 2018
Are 'breakthrough' drugs as safe as other FDA approved medicines?
17 July 2018 - New research questions the quality of drugs given the "breakthrough therapy" designation by the US FDA. ...
Posted by Michael Wonder on 17 Jul 2018
OPKO partner Vifor Fresenius receives marketing approval for Rayaldee in Canada
16 July 2018 - OPKO Health announced today that the Company’s partner Vifor Fresenius Medical Care Renal Pharma has received ...
Posted by Michael Wonder on 17 Jul 2018
Federal Government to announce $50 million custom cancer drug trial
17 July 2018 - Almost 600 Queenslanders will have their cancer’s DNA tested to identify the drugs that will keep ...
Posted by Michael Wonder on 17 Jul 2018
Congress ready to forbid drug price 'gag clauses' against pharmacies
16 July 2018 - Senator Susan Collins of Maine on Monday said Congress is ready and able to forbid “gag ...
Posted by Michael Wonder on 17 Jul 2018
Statement from FDA Commissioner on new efforts to empower consumers by advancing access to nonprescription drugs
17 July 2018 - At the FDA, we’re continuing to look at ways we can foster greater access to the ...
Posted by Michael Wonder on 17 Jul 2018
AbbVie announces Humira (adalimumab) patent license with Mylan
17 July 2018 - AbbVie announced today patent license agreements with Mylan over its proposed biosimilar adalimumab product. ...
Posted by Michael Wonder on 16 Jul 2018
Tonix Pharmaceuticals receives fast track designation from the U.S. FDA for TNX-102 SL for treatment of agitation in Alzheimer’s disease
16 July 2018 - Tonix Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to its investigational new ...
Posted by Michael Wonder on 16 Jul 2018
U.S. FDA extends review timeline for Invokana (canagliflozin) supplemental new drug application
13 July 2018 - The application seeks a new indication for Invokana to reduce the risk of major adverse cardiovascular ...
Posted by Michael Wonder on 16 Jul 2018
EMA’s proactive publication of clinical data a success
16 July 2018 - First report on unprecedented transparency policy shows high user satisfaction. ...
Posted by Michael Wonder on 15 Jul 2018
U.S. FDA approves Xtandi (enzalutamide) for the treatment of men with non-metastatic castration-resistant prostate cancer
13 July 2018 - First and only oral treatment FDA approved for both non-metastatic and metastatic castration-resistant prostate cancer. ...
Posted by Michael Wonder on 13 Jul 2018
Health Canada ordered to release confidential drug company data on HPV vaccines
13 July 2018 - Federal government insisted drug companies' clinical trial data is 'confidential business information'. ...