News

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.

Celgene announced that its drug, Revlimid, gained FDA approval for the treatment of newly diagnosed multiple myeloma.

The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.

Tooling can be damaged by poor handling or problems in process design or material choice.

The company announces that FDA has closed out a 2012 warning letter.

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

The agency releases five draft guidance documents related to drug compounding and repackaging.

FDA announced that it approved Lenvima to treat patients with differentiated thyroid cancer after it was submitted under a priority review and orphan drug programs.

FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

Five months after PCI acquired Biotec International Services , PCI has completed a complete rebranding of the UK-based Biotec.

Romaco Group announced that it had finished the acquisition of Innojet Herbert Hüttlin, a German company specializing in coating and granulation.

The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.

Genzyme will partner with Voyager Therapeutics for the discovery, development, and commercialization of novel gene therapies for central nervous system disorders.

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

The industry reacts to the departure of Commissioner Margaret Hamburg.

Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.

FDA has approved Genetech’s Lucentis to treat retinopathy in patients with diabetic macular edema.

Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.

AstraZeneca announced that it would strengthen its respiratory pipeline with the acquisition of Actavis’ branded respiratory business in the US and Canada.

The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.

Thermo Fisher Scientific adds Advanced Scientific’s custom single-use systems and equipment to its bioprocessing offerings.

Margaret Hamburg announced on Feb. 5, 2015 that she will step down as FDA Commissioner after serving in the position for almost six years.

The deal may offset billions of dollars in waning sales from Pfizer drugs slated to lose patent protection and provides Pfizer with a whole portfolio of biosimilar products.

The Medicines Company announced that it acquired all the remaining equity of Annovation Biopharma, including its novel anesthetic ABP-700.

FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.

The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.

Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.

Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.