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Sanofi, Regeneron RA Candidate Outperforms Humira in Phase 3 Study FDA to Host Workshop on Long-Term Pediatric Studies Xoma Cans Remaining Gevokizumab Development Activities Group Moves to Stop Pfizer’s Patent on the Pneumonia Vaccine in India Read More
The average cost of developing a new drug continues to rise, even as approval success rates continue to fall, according to a report that pegs the cost of ushering a candidate through FDA approval at an eye-popping $2.6 billion. Read More
Makers of protein-based biologics approved under the NDA pathway will lose all exclusivity rights in four years, and any NDA or ANDA that hasn’t been approved by March 23, 2020, will be voided. Read More
The European Medicines Agency has launched an investigation into Gilead Sciences’ cancer drug Zydelig following an increase in serious adverse events. Read More
AdComm Date for Sarepta’s Eteplirsen Pushed to April 25 Teva Recalls Injectable Due to Glass Presence FDA Dings I.V. Specialty Over Sterility AZ’s Neuromyelitis Optica Drug Garners Orphan Drug Designation 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
CMS Proposes Testing of Payment Models for Part B Drugs
FDA Removes Clinical Hold on Medivation’s Pidilizumab
Omeros’ OMS721 Gains Fast Track Status and Enters Phase 3 Program 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