Pharmaceutical Technology Editors

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

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 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.

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.

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.

Bristol-Myers Squibb and Johnson & Johnson announced FDA-approval of Evotaz and Prezcobix, combination HIV-1 infection treatments.

Vetter has announced that the first phase of the expansion of its Ravensburg Schuetzenstrasse site has been completed after 16 months of construction. The company has invested EUR26 million into this facility, which will be equipped with a data center, high-tech laboratories, and workplaces for Vetter Development Service. The new multi-functional six-story building is expected to be ready for operation by the beginning of 2016.

Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.

PPD announced that it completed an expansion to its Athlone, Ireland facility, resulting in 20,000-square-feet of dedicated space for warehousing and distribution purposes.

AstraZeneca and the University of Texas MD Anderson Cancer Center announced a plan to collaborate for the improvement of patient outcomes in clinical trials with investigational therapies.

Recipharm has completed a serialization project for China on behalf of one of its customers.

FDA has approved the Ash Steven’s manufacturing facility in Riverview, MI for the manufacture of Amotosalen.

PwC released a report based on surveys completed by consumers and senior industry leaders, which focuses on FDA procedures.

Hovione announced that it appointed a vice-president of R&D to work directly with client drug development projects.

The new facility will feature dry powder cell-culture media capabilities.

The new facility will feature new research and development capabilities.

The company has installed and validated new instruments for structural analysis of proteins.

Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.

The agency creates an electronic central repository to facilitate drug safety assessment reports.