Bristol-Myers Squibb Celebrates Superior Overall Survival for Opdivo
Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.

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New Antibiotic Puts up a Fight Against Superbugs
NovoBiotic’s first-in-class antibiotic, teixobactin, proves strong in the battle to kill drug-resistant bacteria.

FDA Advisors Unanimously Approve Sandoz Biosimilar
An FDA expert committee has recommended approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

Shire Acquires NPS Pharma for $5.2 billion
Shire adds rare-disease portfolio with acquisition of NPS Pharma.

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Boehringer Ingelheim and Yale Collaborate to Investigate Immunotherapies
Boehringer Ingelheim announced that it would collaborate with Yale University to research novel therapeutic targets in immune-modulation.

Argos and Saint-Gobain Partner on Single-Use Components for Immunotherapy Manufacturing
Single-use components aid efficiency in automated personalized therapy manufacturing.

FDA Extends Enforcement Deadline for Track and Trace
A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

AMRI Acquires Two Aptuit Facilities
The acquisition of Aptuit's Glasgow, UK and Indiana, US facilities will add sterile injectable formulation development and expand AMRI's analytical services capabilities.

Impax Pharmaceuticals Announces FDA Approval of Parkinson’s Treatment
Impax Pharmaceuticals received FDA approval of Rytary for use in patients with Parkinson’s disease.

Cardio3 BioSciences Acquires OnCyte CAR T-Cell Portfolio for $180 million
Cardio3 BioSciences acquired Celdara Medical’s immuno-oncology platform, OnCyte, for up to $180 million in cash, stock, and royalties.

CDER Announces 2015 Guidance Plan
The FDA center released a list of the guidance documents it plans to publish in 2015.