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Australia’s pharmaceutical regulatory body is looking to Europe for guidance on drug development, including clinical development of similar biological drugs, investigations of lipid disorder therapies and evaluations of bacterial infections. Read More
Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. And they urged drugmakers to step up their involvement. Read More
Two prominent generic drugmakers in Canada won a regulatory victory last month when a federal judge ruled that the country’s regulator of patented medicine prices has no jurisdiction over licensed generic drug pricing. Read More
Generic firm Mylan said June 2 that it had reached a settlement with Pfizer to market versions of Celebrex (celecoxib), marking the latest twist in the generic conversion of the blockbuster arthritis pain drug. Read More
Generic-maker Mylan has launched a version of Bristol-Myers Squibb’s advanced ovarian carcinoma drug Paraplatin Injection in 50 mg/5 ml multidose vials. Read More
Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant found quality control issues ranging from poor cleanliness to shoddy product testing and incomplete record-keeping, the FDA said. Read More
Teva cleared a major hurdle this month in its bid to launch a generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude after a federal appellate court upheld a lower court’s decision invalidating the drug’s patent. Read More
European regulators said they will reinstate a good manufacturing practice certification for Ranbaxy’s manufacturing facility in Toansa, India, following an inspection that found the generic drugmaker had addressed reported GMP violations. Read More
A federal judge tossed out claims over a patent in Sandoz’s bid to launch a generic version of United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin, but two more patent challenges remain. Read More