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A journal article asking the FDA to defy its own policies concerning drug reimportation and mass compounding to combat rising drug prices comes from an unusual source: the agency’s former second-in-command. Read More
Takeda Pharmaceuticals is selling off some of its drugs in Japan in exchange for stock in a new venture to be helmed by Teva Pharmaceutical Industries. Read More
During a one-year period, the UK’s Medicines & Healthcare products Regulatory Agency conducted 47 inspections of pharma companies, during which they uncovered 27 critical findings, 169 major and 155 minor findings, according to a report. Read More
A House of Representatives committee is asking for a review of the FDA’s progress in ensuring the security of foreign facilities’ supply chains and toughening the agency’s approach to inspections at those facilities. Read More
Health Canada has agreed to comply with a Canadian court ruling quashing the agency’s import ban on drugs from a generics manufacturer. In a Nov. 2 statement, Health Canada retracted an update that prohibited imports from two Apotex facilities in India. Read More
The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. Read More
An international aid group has negotiated a multi-year licensing agreement with Bristol-Myers Squibb to produce generic hepatitis C medicines in many developing nations. Read More
India’s Central Drugs Standard Control Organization has unveiled three new guidelines that it says paves the way forward for more clinical trials in the country by reducing red tape for clinical research. Read More
The National Health Service of England and the National Institute for Health and Care Excellence have unveiled a proposal that could provide a new pathway for innovative drugs to be assessed and made available to patients. Read More
A new report is predicting that spending on prescription and OTC medications will climb 30 percent in the next five years, fueled largely by improved sales and access in emerging markets. Read More