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Canadian drugs sold to consumers in the U.S. via the internet last year were half what they were the year before, according to IMS Health researchers who blamed a variety of market factors for the dramatic plunge in sales volume.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a bulletin providing new guidance on reporting and disseminating information about adverse incidents involving medical devices.
Sponsors wishing to test new high-risk drugs for the first time in human subjects are advised to conduct additional preliminary studies in some circumstances under a new draft guideline from the European Medicines Agency (EMEA).
Canadian drugs sold to consumers in the U.S. via the internet last year were half what they were the year before, according to IMS Health researchers who blamed a variety of market factors for the dramatic plunge in sales volume.
The European Medicines Agency (EMEA) recommended adding a warning for patients and doctors about Roche’s flu drug Tamiflu after the agency learned of new reports of neuropsychiatric adverse events occurring with the use of Tamiflu in Japan.
GlaxoSmithKline (GSK) could see a boost to sales for its antiviral treatment Relenza following reports of a Japanese Health Ministry recommendation against Tamiflu use in teenagers because of reports of abnormal behavior.
Clinical trial sponsors should be aware of differing recommendations from various government agencies and international organizations regarding what information to disclose on registries.
Language in newly entered free trade agreements covering data exclusivity and patent extension could delay generic drug entry in foreign markets where access to low-cost medicines is highly needed, a bipartisan group of lawmakers contend.
Ranbaxy may have joined the bidding war for Merck KGaA’s generic drugs division, according to a company source that confirmed reports of the generic firm’s interest in acquiring the billion-dollar division.
Companies should create strong policies to monitor and regulate compliance with the Foreign Corrupt Practices Act (FCPA), as the number of cases in the healthcare industry is growing, an industry expert said.