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FDA Issues Draft Guidance on Patient Counseling Info for Labeling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.

For the 2013-2014 academic year, three $50,000 USP Global Fellowship awards have been presented.

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.

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.

Takeda's drug vedolizumab is granted priority review status for the treatment of adults with moderately to severely active ulcerative colitis.

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.

MPI's new Imaging Center is set to open in Spring 2014 at the company's headquarters in Michigan.

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.

Horizon Pharma reports that FDA has approved the use of Sanofi's manufacturing site in Compiegne, France to manufacture DUEXIS.

Myriad Genetics and AstraZeneca expand their companion diagnostic pact for AztraZeneca?s investigational drug candidate olaparib.

Regulatory Authorities Discuss Elemental Impurities Standards