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A California supplement maker is in hot water after being accused of making drug-like claims about its products and relying on improper production methods. Read More
Following a safety review, the FDA has added additional warnings to the labels of SGLT2 inhibitors for diabetes because they can cause the body to produce too much acid in the blood or lead to serious urinary tract infections. Read More
European officials are pushing for greater synchronicity between the U.S. and EU regulators on generic approval processes as part of broader trade negotiations. Read More
The European Medicines Agency has accepted Sandoz’s MAA for its biosimilar to Amgen’s Neulesta to help the body make white blood cells after receiving cancer medications. Read More
Incyte has discontinued a Phase 3 trial of Jakafi with capecitabine as a second-line treatment for patients with metastatic pancreatic cancer after the combination failed to show sufficient efficacy. Read More
Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months. Read More
The UK’s Department of Health and NHS England have failed to manage the Cancer Drugs Fund effectively by not carrying out its intended purpose and significantly outspending its budget, according to a report released by the UK Parliament’s House of Commons. Read More
New Zealand signing off on the Trans-Pacific Partnership on Feb. 3 should start the clock ticking for ratification of the treaty, which provides up to eight years of exclusivity for biologics. Read More
Roche says it is cooperating with inquiries from the Indian states of Gujarat and Telangana, where sales of its cancer drug Avastin were halted after 15 patients experienced pain and swelling in their eyes. Read More
The FDA issued a warning letter Jan. 15 to a Hong Kong drugmaker for allegedly significant cGMP violations that led to adulterated products and data issues. Read More