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Drug manufacturer Gordon Laboratories received a Form 483 from the FDA for labeling problems, written procedure issues and insufficient analyses of raw materials. Read More
India’s top drug regulatory body plans to fast-track approvals for combination products recommended by the World Health Organization to treat HIV and hepatitis B and C. Read More
A federal judge ruled that three generics manufacturers infringed on Novartis’ patents related to its Zortress treatment, used during kidney and liver transplants. Read More
Four major patents for Acorda Therapeutics’ successful MS treatment Ampyra were invalidated by a federal judge nearly a decade before they were set to expire — less than a month after they were upheld by the PTO. Read More
The Association of the British Pharmaceutical Industry found four drugmakers — Celgene, Takeda, Vifor Pharma and Pierre Fabre — violated the group’s code of practice by engaging in activities including inadequate quality management. Read More