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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
India is giving drug exporters some breathing space on track-and-trace requirements, with the length of the delay depending on the size of the operation. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended six medicines for marketing authorization — three new products and three generics. Read More
The UK’s National Institute for Health and Care Excellence has issued recommendations for NHS to reimburse the use of seven biologicals in treating severe rheumatoid arthritis, along with four new cancer treatments and a lung disease therapy. Read More
The European Medicines Agency is asking for feedback on a revised guideline for the treatment of Alzheimer’s disease and other types of dementia. Read More
Merck & Co. is suing German biotech and chemical giant Merck KGaA in federal court for alleged trademark infringement as part of a larger battle between the two companies over the rights to the Merck name. Read More