News

Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.

FDA approves the orphan drug Myalept for the treatment of leptin deficiency.

Novartis provides its second US university with Bexsero for the treatment of meningitis B.

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

Elanco acquires Germany-based Lohmann Animal Health.

FDA provides recommendations for submitting analytical procedures and methods validation data.

FDA and EMA set up regular meetings to harmonize drug safety actions.

Thirteen companies are accepted for participation in the supply chain program.

Ben Venue issues a voluntary patient level recall of Acetylcysteine Solution 10% due to glass particle in vial.

Ecolab's Shield Medicare division will now be called Ecolab Contamination Control.

Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.

Innovative Medicines Initiative will develop novel antibiotics against gram-negative pathogens in a project called ENABLE.

Agilent Technologies and Cell Line Genetics will collaborate on services for regenerative medicine and cancer research.

Debiopharm acquires Affinium's clinical and preclinical assets and its technology platform.

New medicines in development include treatments for type 1 and type 2 diabetes.

EMA releases an update on its flu vaccine guidance.

EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

Cobra Biologics' GMP Compliance Certification has been extended to include QC testing.

Shimadzu's new Solution Center features additional research space.

Cytovance Biologics continues to work on the expansion of a manufacturing operations and GMP warehousing facility in Oklahoma.

Shimadzu's new Solution Center features additional research space.

Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.

Aesica appoints Ian Muir to the newly created position of commercial managing director.

Sartorius appoints Michael Melingo to head marketing, sales, and services of the Lab Products & Services Division.

FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

NIH, 10 biopharmaceutical companies, and several nonprofit organizations form a partnership to develop new treatments earlier for Alzheimer's, type 2 diabetes, and autoimmune disorders.

Thermo Fisher Scientific outlines new business segments with acquisition of Life Technologies.

Edison and DSP partner to develop drugs targeting cellular energy metabolism.