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news.Santhera seeks Canadian approval for Friedreich’s ataxia drug
Following a recent meeting with the Therapeutic Products Directorate (TPD) of Health Canada, and after the receipt of the positive decision on eligibility, Santhera now has 60 days
Following a recent meeting with the Therapeutic Products Directorate (TPD) of Health Canada, and after the receipt of the positive decision on eligibility, Santhera now has 60 days
More than two-thirds of the total shares outstanding and entitled to vote at the shareholders' meeting were voted in favor of the transaction. In accordance with the terms
Massachusetts-based diagnostics products manufacturer Inverness completed the acquisition through the merger of a wholly-owned subsidiary with and into Cholestech, after Cholestech's shareholders approved the deal. Ron Zwanziger, chairman,
Dr Lesley Russell, executive vice president of worldwide medical and regulatory operations, said: “This is our first regulatory filing for Treanda and a significant milestone for our growing
The Court of Appeals for the Federal Circuit ruled that the New Jersey federal district court should not have granted summary judgment to the generic manufacturers, and that
According to Pfizer, grants will be awarded for research focusing on fostering a clearer understanding of cardiovascular risk-reduction strategies, such as educational programs, risk-assessment tools, screenings and clinical
According to the company, the committee's positive opinion for Vectibix is based on a positive benefit and risk assessment in a patient population that currently has few treatment
Bionovo expects to grant its underwriters a 30-day option to purchase up to 1.71 million shares at the public offering price to cover over-allotments, if any. BMO Capital
The company is aiming to become the first to offer chronic pain sufferers a patch that provides sustained-release oxycodone into the bloodstream. Dr Esra Ogru, executive vice president
During the two separately scheduled pre-NDA meetings, Pipex reviewed with the FDA the format and content of Pipex's planned new drug application (NDA) submission of preclinical, clinical, manufacturing,