Pharmaceutical Technology Editors

CDC says antibiotic resistance is a quickly growing and dangerous problem.

Aesica Pharmaceuticals has built a new high-capacity manufacturing facility specifically for the production of solid dose medications used in the treatment of type II diabetes at its UK site in Queenborough, Kent.

Takeda Pharmaceutical and Arbor Pharmaceuticals enter into a license, development and commercialization agreement for Edarbi (azilsartan medoxomil) and Edarbyclor (azilsartan medoxomil and chlorthalidone).

The Biomanufacturing Research Program (BioMAN) at Massachusetts Institute of Technology (MIT) has received $10.4 Million from the Defense Advanced Research Projects Agency (DARPA) to develop new technologies and manufacturing platforms that will provide an emergency supply of medicines for front-line military medics.

Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.

ScinoPharm Taiwan will provide commercial manufacturing of the API topiramate to Supernus Pharmaceuticals.

Theorem Clinical Research?s alliance with Charles River Laboratories will provide nonclinical testing programs in the areas of bioanalysis, immunogenicity, and immunology.

Sanofi withdraws its new drug application (NDA) in the US for lixisenatide and plans to file a NDA in 2015.

Unilife grants Sanofi long-term exclusivity for the use of Unilife?s prefilled syringe with Sanofi?s Lovenox.

Columbia Laboratories acquires Molecular Profiles in multimillion-dollar deal.

FDA Issues Draft Guidance on Patient Counseling Info for Labeling

The alliance with Teva will focus on mechanisms and molecular targets related to the emergence of treatment-resistant cancer cells.

EMA releases details of restructuring.

FDA issues import alert due to cGMP violations at Ranbaxy's facility in Mohali, India.

Roche nominates Christoph Franz, currently CEO of the Lufthansa Group, to succeed current Roche chairman Franz B. Hummer.

AMRI reported that Thomas E. D'Ambra, PhD. will retire as president and CEO.

FDA reports that Hospira initiated on July 12, 2013 a voluntary recall of certain lots of bupivacaine HCl due to particulates floating and/or in the glass vial.

EMD Millipore receives recertification of GMP compliance for Biodevelopment Centre in Martillac, France.

Hospira's Inflectra (infliximab), which is a biosimilar to the reference biologic product, Remicade, has been approved by the EC for the treatment of inflammatory conditions.

Catalent appoints David Heyens as President of Asia Pacific facility.

FDA updates guidance to reflect advances in technology.

Novartis? half-billion dollar investment in a new biologics production plant in Singapore represents a strategic commitment to its growing biologics portfolio.

New partnership aims to eliminate months from the typical transition time required to move chemistry from the laboratory into commercial applications.

Cargill invests to upgrade its alginate production plant in in Lannilis, Brittany, France.

An FDA Committee voted to support approval of GSK and Theravance?s umeclidinium/vilanterol for treatment of chronic pulmonary disease.

FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments.

The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests.

The device is an inexpensive, easy-to-use capsule-based DPI with high efficiency powder dispersion and has the versatility to treat a range of pulmonary diseases.

FDA revises boxed warnings for extended-release and long-acting opioid analgesics and postmarket study requirements.

VWR International has signed a global distribution agreement with Thermo Fisher Scientific.