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Charles River Laboratories Acquires WIL Research
Charles River Laboratories entered into a definitive agreement to acquire WIL Research.
Expedited Approvals and Orphan Drugs Dominated 2015 Novel New Therapies
FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.
FDA Issues Low Number of Violation Letters in 2015
The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.
SCORR Marketing and Applied Clinical Trials Release Results of Industry Survey
SCORR Marketing and Applied Clinical Trials release the results of EU clinical trials survey.
FDA Issues Warning Letter to Indian Manufacturing Company
FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.
Hospira Recalls One Lot of Magnesium Sulfate
The company has voluntarily recalled one lot of magnesium sulfate in water for injection because of incorrect labeling.
Takeda Acquires US Biologics Manufacturing Facility
Takeda Pharmaceuticals announced the acquisition of a biopharmaceuticals manufacturing plant in Minnesota.
UK Pharmaceutical Companies Collaborate on CAR-T Cell Immuno-oncology Therapies
The Cell Therapy Catapult, University of Birmingham, and Cancer Research Technology collaborate on CAR-T cell immuno-oncology therapy development.
Health Canada Approves AbbVie’s Humira
Health Canada approved AbbVie’s Humira for the treatment of adults with hidradenitis suppurativa.
FDA Releases Draft Guidance on Emerging Manufacturing Technology
FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.
Baxter Recalls IV Solutions
Baxter voluntarily recalls two lots of intravenous solutions due to particulates.
Jones Packaging Enters Commercial Parternship with ThinFilm
Jones Packaging and ThinFilm will collaborate on NFC OpenSense technology for pharmaceutical packaging.
Ionis Pharmaceuticals Receives Orphan Drug Designation for HTTRx
Ionis Pharmaceuticals receives orphan drug designation for HTTRx for the treatment of Huntington’s disease.
mAbs to Watch in 2016
BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.
Enhancing New Drug Development
More “me-betters” and more focused breakthroughs could enhance new drug development.
Merck KGaA, Pfizer, and Syndax Collaborate on Ovarian Cancer Treatment
Merck KGaA, Pfizer, and Syndax enter into exclusive agreement to evaluate the use of avelumab and entinostat for ovarian cancer patients.
Using Deterministic Container Closure Integrity Testing
The revised USP Chapter 1207 gives best practices for obtaining reliable data in container closure integrity testing.
Global Drug Directions
Infrastructure and payer decisions will determine drug choices in emerging and developed regions.
Bio/Pharma’s 2016 Agenda in Europe
Regulatory, corporate restructuring, and manufacturing issues will challenge bio/pharma to meet the needs and expectations of patients around the world.
A Call for Radical Reformation of the World Health Organization
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.
Collaboration Seeks to Reduce Animal Testing
BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.
Valeant Announces CEO on Medical Leave
Valeant announced its CEO, J. Michael Pearson, will be on medical leave of absence after being hospitalized for pneumonia.
Mass Spec Lab Announces Official Launch
Mass Spec Lab, a privately owned analytical company, announced its official launch on Dec. 28, 2015 in Southern California.
GSK Acquires Bristol-Myers Squibb R&D HIV Assets
GlaxoSmithKline acquires Bristol-Meyers Squibb’s late-stage HIV R&D assets.
Boehringer Ingelheim to Establish Biopharmaceutical Production Facility in Vienna
Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.
Samsung BioLogics Breaks Ground on Third Facility
Samsung BioLogics begins construction on their third facility in Songdo, Korea.
GENEWIZ Acquires Beckman Coulter Gene Services
GENEWIZ signs definitive agreement to acquire Beckman Coulter's gene services business.
Recipharm Signs Agreement to Manufacture Liproca Depot
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.
Cellectar Biosciences and Pierre Fabre Form Oncology Pact
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.
NIH Releases Strategic Five-Year Plan
The National Institutes of Health released a strategic plan covering the fiscal years 2016-2020.
