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To avert drug shortages, Health Canada has partially lifted an import ban on products from three Indian manufacturing facilities that were barred from doing business in the country due to quality violations. Read More
The UK healthcare cost watchdog gave the final green light for national coverage of GlaxoSmithKline’s skin cancer drug Tafinlar, a decision that was made in record time, according to the drug’s evaluators. Read More
The president-elect of the European Commission said yesterday that oversight of EU drug policy will remain under the health directorate, marking an about face on a decision last month that would have switched the responsibility to the industry department. Read More
Johnson & Johnson has spent $200 million on production of an Ebola vaccine that is set to begin human testing in the U.S., Europe and Africa in January, but talk of potential collaboration with GlaxoSmithKline remains only theoretical at this point. Read More
Mylan recalled 15,966 bottles of the blood pressure drug metoprolol succinate tablets due to a product mix-up, the third recall in the past five months involving generic versions of AstraZeneca’s Toprol-XL. Read More
The FDA warned a partially defunct compounder for a multitude of quality violations such as using soap and water to clean parts of the production facility. Read More
FDA investigators will be able to photograph most areas of a facility during an inspection, including product labels and visible contamination of materials, according to a final guidance issued yesterday. Read More
AbbVie has called off its plans to merge with Ireland-based Shire, citing the U.S. Treasury Department’s recent efforts to dissuade so-called tax inversions. Read More
Indian regulators are establishing a panel of experts to conduct a comprehensive review of existing forms and procedures, and recommend improvements to make the drug application process more user-friendly. Read More
Sponsors of clinical trials for new migraine therapies should focus on enrolling more women of childbearing age early in the drug development process, as more women than men have the condition, according to a new FDA draft guidance. Read More
Dr. Reddy’s Laboratories has settled a class-action lawsuit over its alleged role in delaying generic entry of AstraZeneca’s heartburn drug Nexium in return for assisting plaintiffs in their case against AZ and the remaining generics manufacturer defendants. Read More