
PTSM: Pharmaceutical Technology Sourcing and Management
FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.

PTSM: Pharmaceutical Technology Sourcing and Management
FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.

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

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.

Baxter voluntarily recalls two lots of intravenous solutions due to particulates.

Jones Packaging and ThinFilm will collaborate on NFC OpenSense technology for pharmaceutical packaging.

Ionis Pharmaceuticals receives orphan drug designation for HTTRx for the treatment of Huntington’s disease.

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

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

The revised USP Chapter 1207 gives best practices for obtaining reliable data in container closure integrity testing.

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

Regulatory, corporate restructuring, and manufacturing issues will challenge bio/pharma to meet the needs and expectations of patients around the world.

Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.

PTSM: Pharmaceutical Technology Sourcing and Management
BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.

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.

PTSM: Pharmaceutical Technology Sourcing and Management
GENEWIZ signs definitive agreement to acquire Beckman Coulter's gene services business.

PTSM: Pharmaceutical Technology Sourcing and Management
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.