News

$2.6 billion transaction combines Patheon and DSM Pharmaceutical to create CDMO, DPx.

Almac expands technical, project, and operational resources in Asia.

HHS plan makes progress in ensuring availability of safe vaccines.

Johnson Controls launches Integrated Laboratory Services for R&D facility operations and scientific productivity.

CPhI report shows R&D market diversifying with increased partnerships, mergers, and revenue sharing models.

Cobra Biologics and BioCancell announce an agreement to manufacture BioCancell's BC-821 cancer drug.

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

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

New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

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.

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.

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.