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Sun Pharma to Acquire Ranbaxy

April 7, 2014

Sun Pharma acquisition of Ranbaxy Laboratories will create the fifth-largest specialty generics company in the world.

Baxter to Split Into Biopharmaceuticals and Medical Products Companies

March 27, 2014

Baxter announces plans to split into two independent companies by mid-2015.

Pfizer Receives Breakthrough Therapy Designation for Meningococcal B Vaccine Candidate

March 26, 2014

Pfizer intends to submit a biologics license application for its investigational Meningococcal B vaccine candidate, Bivalent rlp2086, to FDA by mid-2014.

Novartis Launches Lucentis Prefilled Syringe in Europe

March 20, 2014

Novartis has launched the prefilled syringe formulation of Lucentis (ranibizumab) in Germany, with other markets to follow throughout 2014. The prefilled syringe formulation has been specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.

European Medicines Agency Announces Adaptive Licensing Pilot Project

March 19, 2014

Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development.

FDA Releases Guidance on Vial Fill Size

March 13, 2014

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

FDA Details National Vaccine Plan

March 11, 2014

HHS plan makes progress in ensuring availability of safe vaccines.

FDA and EMA Extend QbD Parallel-Assessment Pilot Program

March 6, 2014

Agencies extend successful pilot program to further harmonization of QbD topics.

Novartis calls for more research to understand and find treatments for rare disease.

March 4, 2014

Novartis calls for more research to understand and find treatments for rare disease.

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