BioPharm International Editors

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.

Conference sessions, keynote events, exhibits, and poster sessions cover different aspects of bioprocessing.

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.

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.

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.

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.

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.

International Society for Pharmaceutical Engineering will continue strategic plan initiated by Nancy Berg; search begins for replacement.

EMD Millipore's expands its Emprove raw materials portfolio to include 400 products.

PharmaCell enters an agreement purchase TiGenix therapy production facility.

EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.

NCI launches trial to assess the utility of genetic sequencing to improve patient outcomes.

Novozymes Biopharma has released new study data on extending the serum half-life of albumin in vivo.

FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location

In 2013, the EMA's Committee for Medicinal Products for Human Use recommended 81 medicines for human use for marketing authorization, compared with 57 in 2012.

Teva announced an agreement to acquire NuPathe and its migraine treatment patch.