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An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support in February, backing its approval for six different indications. Read More
The European Medicines Agency has launched its PRIority MEdicines initiative to accelerate breakthrough therapies that offer a major therapeutic advantage over existing treatments. Read More
Teva Pharmaceuticals scored FDA approval for its generic of the blockbuster erectile dysfunction drug Viagra, but it won’t be commercially available anytime soon. Read More
European regulators have signed off on Teva Pharmaceutical Industries’ planned $40.5 billion purchase of Allergan’s generics unit, provided the company sells off numerous overlapping product areas to address anti-competitive concerns. Read More
After a French Phase 1 clinical trial in January designed by Portuguese drugmaker Bial Laboratories left one patient dead and another six hospitalized, an Agency for Medicines and Health Products Safety-appointed committee determined that an “off-target effect” of the compound is a probable explanation of the tragedy. Read More
Amgen has targeted Sandoz over alleged patent infringement for pursuing FDA approval to produce a generic version of its blockbuster drug Enbrel. Read More
A federal report finds that specialty drugs are driving overall spending on prescription drugs higher, although the full extent of their impact is difficult to calculate due to a lack of agreement on what constitutes a “specialty” drug. Read More
Say “sayonara” to the status quo of pharmaceutical promotional review. That’s the consensus of industry experts weighing the implications of the FDA’s decision Tuesday to settle Amarin’s First Amendment lawsuit. Read More