BioPharm International Editors

Phase I/II study to evaluate treatment of patients with melanoma using Pfizer’s palbociclib and GSK’s trametinib.

New CDMO to be formed from the combination of DSM Pharmaceutical Products and Patheon in a $2.6-billion transaction.

Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing based biosafety assessments to detect and identify viral contaminants within biologic compounds.

USP issues call for candidates for its 2015-2020 Council of Experts.

Ei Lilly announces investments in insulin manufacturing capacity for its sites in Indianapolis, Puerto Rico, France, and China.

Shire's agreement to acquire ViroPharma will strengthen its rare-disease portfolio.

AstraZeneca will build a new facility in the United Kingdom to produce Zoladex, an injectable prostrate cancer treatment.

Lyra Myers, associate director and value creation agent at Roche, has been elected DCAT president.

Grifols expands and diversifies portfolio with acquisition of diagnostic business.

Biotechnology Industry Organization President James Greenwood writes senators in support of Start-up Jobs and Innovation Act.

ISPE names Novartis' US Flu Cell Culture facility as award winner.

ISPE’s survey is industry’s first large-scale effort to collect data on patient experiences with clinical trial materials.

FDA releases guidance on pulmonary tuberculosis drugs.

Allegations include off-label marketing for Risperdal, Invega and Natrecor and kickbacks to doctors and pharmacists.

DSM Pharmaceutical signs manufacturing agreements with Opthea and Sanquin.

Repligen completes expansion of its manufacturing facilities at its Massachusetts headquarters.

Pfenex receives subcontract from Leidos to develop a production process for the malaria antigen Plasmodium falciparum reticulocyte-binding homolog 5 (Rh5).

KaloBios Pharmaceuticals receives FDA Orphan Drug Designation for KB001-A in treatment of cystic fibrosis patients.

FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.

A new report details FDA's role and responsibilities in personalized medicine.

Jeremy Levin, CEO and president of Teva Pharmaceutical Industries steps down , and interim successor named.

Hospira opens a new quality and analytical testing laboratory at its Rocky Mount, North Carolina plant.

WuXi PharmaTech has completed a cell culture capacity expansion, including two 2000 L disposable bioreactors.

GSK and the Gates Foundation will invest a combined $1.8 million in early stage research into vaccine thermostability.

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

SGS Life Science Services opens a Center of Excellence for Biophysical Analysis in the UK.

Big pharma companies Novartis, Amgen, and Bristol-Myers Squibb announce positive third-quarter 2013 results.

Beckman Coulter Life Sciences combines its particle characterization business with the Hach Company particle counting business.

Amarin cuts staff in half after an FDA committee rejects its product label expansion.

FDA has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.