News

Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.

Samsung BioLogics begins construction on their third facility in Songdo, Korea.

GENEWIZ signs definitive agreement to acquire Beckman Coulter's gene services business.

Recipharm has signed an agreement with Sweddish pharmaceutical company LIDDS for the production scale up and manufacture of LIDDS’ Liproca depot for the treatment of prostate cancer.

The aim of the collaboration is to advance the use of Cellectar’s phospholipid drug conjugate platform for targeted delivery of a selection of Pierre Fabre’s cytotoxics.

The National Institutes of Health released a strategic plan covering the fiscal years 2016-2020.

Synpromics announced collaborations with Avalanche Biotechnologies and Applied Genetic Technologies Corporation to use synthetic promoters to develop gene therapies, including adeno-associated virus technology for treating eye diseases.

The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.

Janet Woodcock, director of the Center for Drug Evaluation, highlights FDA's priority list for 2016.

The agency has launched a new web platform to foster scientific innovation.

Martin Shkreli, former chief executive officer of Turing Pharmaceuticals and KaloBios Pharmaceuticals Inc., was arrested on Dec. 17, 2015 at his apartment in New York City for securities fraud.According to a press release from the Eastern District of New York State Attorney’s Office, a seven-count indictment was unsealed on Dec. 17, 2015 in federal court in Brooklyn charging Shkreli with securities fraud, securities fraud conspiracy, and wire fraud conspiracy.

AstraZeneca announced the completion of a tender offer for all of the outstanding ZS Pharma shares.

The new arrangement draws from a consignment approach, in which Walgreens will sell-but not directly own-Valeant’s products.

Through a strategic alliance with WuXi AppTec and a $50 million facility investment, AstraZeneca plans biologics and small-molecule expansion in China.

AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.

Quotient Clinical announced on Dec. 16, 2015 that is has acquired Co-Formulate Limited.

Sanofi enters into exclusive negotiations with Boehringer Ingelheim on a business asset swap.

Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.

Researchers from Oregon State University develop a new three-drug delivery system for cancer treatment.

Grand River Aseptic Manufacturing expands disposable technology capabilities at aseptic facility.

AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.

Designed specifically for pharmaceutical companies, the online production management system focuses on plant operations so materials flow smoothly to help companies achieve right-first-time manufacturing and faster product release.

PSL has installed several advanced contained filtration and drying facilities as part of an expansion of a pharmaceutical manufacturing plant in Singapore.

FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.

EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.

Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.

Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.

FDA granted priority review status for XALKORI for the treatment of patients with NSCLC with ROS1-positive tumors.

Assembly Biosciences reported a successful clinical study validating the use of the Gemicel technology platform for the oral delivery of biologic medications.

The United States Pharmacopeial Convention announced the recipients of the 2015–2016 Global Fellowship Awards.