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GSK Receives Offer for its Thrombosis Brands and Related Manufacturing Site
A proposed deal with Aspen includes the company’s site in Notre-Dame-de-Bondeville, France.
Elan Proceeds with Formal Sale Process of Company; Royalty Pharma Drops Bid
The move follows rejection of Elan shareholders of certain key deals and withdrawal of Royalty Pharma bid.
Cobra Biologics Announces Development Projects
Cobra Biologics announced several product development projects with Novolytics, Recopharma, and Vaccibody.
Supreme Court: Human Genes Are Not Patentable
The US Supreme Court ruled that naturally occurring isolated biological material is not patentable, but a synthetic version of gene material may be patented.
ISPE Study Reports on Root Causes for Drug Shortages
ISPE study reveals quality systems of manufacturing as the leading cause of drug shortages.
EMA Revises Biosimilars Guideline
EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.
GlaxoSmithKline Acknowledges Misrepresentation in Scientific Article
One employee is dismissed, another has resigned, and three others are put on administrative leave.
Pfizer Partners with CytomX for Antibody Drug Conjugates
The multimillion deal focuses on oncology.
Elan Board Rejects Multibillion Takeover Bid from Royalty Pharma
Elan urges its shareholders to reject bid in an upcoming meeting on June 17.
USP Forms Elemental Impurities Advisory Group
USP appoints regulatory experts to elemental impurities implementation advisory group.
FDA Issues Warning Letter to Baxter Healthcare
FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.
AstraZeneca to Acquire Pearl Therapeutics
Acquisition will strengthen AstraZeneca?s respiratory portfolio with a potential new treatment for chronic obstructive pulmonary disease.
Janssen and Second Genome Partner on Microbiome Drug Discovery
Agreement seeks to advance novel drug targets and focus on therapies for ulcerative colitis.
Boehringer Ingelheim Plans Biopharmaceuticals Facility in China
Facility will use mammalian cell-culture technology and be ready for operations by 2016.
FDA Discovers Microbial Contamination in Compound Pharmacy Products
Novartis Receives FDA Warning Letter for cGMP Violations at Austrian Plant
The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.
Celerion Adds Containment Room
Modular containment room at Belfast facility allows studies of biologics and vaccines.
Sanofi Ends Development of Two Phase III Drugs
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MorphoSys and GSK Partner in Antibody Pact
The agreement is worth up to $552 million, depending on meeting set milestones.
MorphoSys and GlaxoSmithKline Partner in Antibody Pact
ISTA Pharmaceuticals Inc. Pleads Guilty to Federal Felony Charges
ISTA will pay $33.5 million to resolve criminal liability and false claims allegations.
FDA Fights Drug Shortage with Import of Injectable Nutrition Drugs
FDA addresses shortages of drugs needed to treat premature infants and patients unable to eat or drink by mouth.
BT and Accelrys Unlock Value in Big Data
Cloud-computing solutions and software enable researchers to garner insight from large, public-health datasets.
GSK Acquires Vaccine Platform Tech Company Okairos
GSK expands its vaccines platform technology expertise by acquiring Okairos, a Swiss-based company.
Institution of Chemical Engineers Discusses Process Safety
Competence in process safety is important for preventing accidents.
FDA Issues Draft Guidance on Contract Manufacturing
The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.
FDA Issues Warning Letter to Boehringer Ingelheim for cGMP Violations
Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.
USP Defers Implementation of Elemental Impurities Provisions
USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.
EMD Millipore Collaborates with PharmaCell on Large-Scale, Cell-Culture Systems
Project will optimize expansion and harvest of human cells in bioreactors.
SCHOTT Introduces Cartridge Design for High-Speed Filling
New design meets new process requirements.
