News

Charles River Laboratories entered into a definitive agreement to acquire WIL Research.

FDA approved 45 novel new drugs in 2015, led by therapies for orphan diseases and and expedited approvals.

The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.

The company has voluntarily recalled one lot of magnesium sulfate in water for injection because of incorrect labeling.

FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.

Takeda Pharmaceuticals announced the acquisition of a biopharmaceuticals manufacturing plant in Minnesota.

The Cell Therapy Catapult, University of Birmingham, and Cancer Research Technology collaborate on CAR-T cell immuno-oncology therapy development.

Health Canada approved AbbVie’s Humira for the treatment of adults with hidradenitis suppurativa.

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

More “me-betters” and more focused breakthroughs could enhance new drug development.

Merck KGaA, Pfizer, and Syndax enter into exclusive agreement to evaluate the use of avelumab and entinostat for ovarian cancer patients.

Infrastructure and payer decisions will determine drug choices in emerging and developed regions.

Valeant announced its CEO, J. Michael Pearson, will be on medical leave of absence after being hospitalized for pneumonia.

Mass Spec Lab, a privately owned analytical company, announced its official launch on Dec. 28, 2015 in Southern California.

GlaxoSmithKline acquires Bristol-Meyers Squibb’s late-stage HIV R&D assets.

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

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

This month marks the death of a pioneering, yet pragmatic, thinker whose work brought PAT and QbD to more pharmaceutical and biopharmaceutical companies around the world.

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The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.

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

Pharmaceutical CEO Martin Shkreli was arrested on Dec. 17, 2015 at his New York apartment and charged with securities fraud.Martin Shkreli, 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.

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.

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.

The company’s new version of its glycan analysis tool will help investigators determine the relative abundance of individual N-glycan structures in small biopharmaceutical samples.