News

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.

Regis Technologies announced it will unveil its new potent compound capabilities at InformEx 2015, Feb. 3-5.

Merck announced that the responsibility for its diabetes and thyroid brands will be shifted back to EMD Serono in Russia, removing the responsibility from its marketing partner, Takeda.

PSL will demonstrate its filtration and drying units, the GFD Lab Filter Dryer, and the SimpleFilter Dryer.

President Obama unveils his “Precision Medicine Initiative”.

Aesica announced that it received continuing approvals from FDA for its bulk manufacturing and packaging operations in Germany.

The Shantha facility will be Sanofi's second, in addition to its site in Frankfurt, for production of Insuman insulin.

InformEx 2015, to be held Feb. 3-5, 2015 in New Orleans, Louisiana, will feature speaker sessions on the future of the biopharma industry, facility safety, emerging markets, pharmaceutical manufacturing, and more.

CPhI Worldwide partners with InformEx to introduce the cGMP Zone, a dedicated zone for pharma buyers to connect to cGMP CRO/CMO services, intermediates, APIs, and process chemical technologies.

The 2016 White House Budget proposes a change to the data exclusivity period for biologics and the authority to influence drug pricing.

EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.

CPhI experts make predictions on pharma trends for 2015.