GlaxoSmithKline's Booming Pipeline Under CEO Emma Walmsley
Since Emma Walmsley took over leadership at Glaxo, expectations have been both high and hypercritical. Source: BioSpace
Biogen Halts Plans to Develop Tysabri for Stroke After Phase IIb Trial Flop
Natalizumab did not demonstrate improvement in clinical outcomes compared to placebo. Source: BioSpace
Gottlieb Flags New Approaches to Opioids, Drug Pricing, Internal Challenges
FDA Commissioner Scott Gottlieb offered an update on the agency’s plans to address the opioid epidemic, encourage market competition, and tackle internal agency issues, in remarks Tuesday to the Alliance…
Federal Circuit Affirms Dismissal of AbbVie Lawsuit in MedImmune Patent Dispute
The Federal Circuit backed up a lower court ruling dismissing an AbbVie lawsuit seeking to invalidate a patent it licensed from MedImmune. Source: Drug Industry Daily
Penalties for Drug Falsification Vary Widely Between EU Members
Punishments for falsification of medicines in the European Union vary significantly between EU member states, according to a study carried out for the European Commission. Source: Drug Industry Daily
TGA Issues Risk Survey to Drugmakers Ahead of First Pharmacovigilance Inspections
Australia’s Therapeutic Goods Administration issued a survey to drugmakers asking about their pharmacovigilance activities with the intention of using the responses to prioritize inspections. Source: Drug Industry Daily
EMA Prevails Against Drugmakers Seeking to Block Release of Clinical Trial Data
A European Union court ruled that the European Medicines Agency can offer access to clinical trial data in a blow to three drugmakers who argued this would hurt their business.…
Celltrion Warned for Aseptic Practices, Training and Complaint Handling
The FDA flagged a problem with contaminated vial stoppers in a warning letter to Celltrion over deficiencies at its Incheon, South Korea facility, which manufactures Inflectra (infliximab-dyyb), the Ramicade biosimilar.…
MannKind Names Lilly Exec as New CMO
He will be based out of MannKind’s Westlake Village, California headquarters. Source: BioSpace
Celgene's Multiple Myeloma Triplet Succeeds in Key Phase III Trial
The international clinical study, OPTIMISMM, achieved its primary endpoint. Source: BioSpace
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