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Canadian regulators will have sweeping new powers to order drug recalls, require labeling changes and postmarket studies, and release confidential business information under a rewrite of the country’s drug safety law. Read More
Amgen and AstraZeneca said their experimental psoriasis compound brodalumab demonstrated better outcomes than Janssen’s therapy Stelara in a Phase III trial, a development that moves the drug one step closer to market in the competitive therapeutic area. Read More
Clinical trials of three experimental Ebola therapies are set to begin in West Africa next month with results due as soon as February, according to Doctors Without Borders. Read More
The FDA approved two sNDAs for Johnson & Johnson’s antipsychotic Invega Sustenna to treat patients with schizoaffective disorder, which will help the drugmaker offset lower sales of its neurological treatments due to generic competition. Read More
The FDA wants to know how a spouse may influence a partner’s perception of a direct-to-consumer drug advertisement, the second study examining a specific DTC ad scenario that the agency has announced this week. Read More
The FDA said two generic versions of Janssen’s attention deficit hyperactivity disorder drug Concerta may not be therapeutically equivalent to the brand, a decision that could result in the products being withdrawn. Read More
The FDA has slapped another Indian active pharmaceutical ingredient maker with a warning for data integrity weaknesses, including printing batch records from personal computers over which the company lacked adequate controls. Read More
Par Pharmaceutical said yesterday the FDA has approved its NDA for Vasostrict injection, making it the first product of its kind to win approval. Read More