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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
Regulators around the world are joining forces as part of an investigation into why a patient died after being treated in a Phase 1 clinical study conducted by Biotrial, a French clinical research organization. Read More
The FDA repeatedly blasted overseas drugmakers last year for disregarding compliance orders and not living up to their own promises to carry out proper cGMP practices for active pharmaceutical ingredients. Read More