News

The Developability Assessment Platform evaluates manufacturability and safety in discovery and early-stage biological drug development.

The multimillion investment in a facility in Cambridge is part of the company’s move to create strategic global R&D centers in the UK, US and Sweden.

A proposed deal with Aspen includes the company’s site in Notre-Dame-de-Bondeville, France.

The move follows rejection of Elan shareholders of certain key deals and withdrawal of Royalty Pharma bid.

Cobra Biologics announced several product development projects with Novolytics, Recopharma, and Vaccibody.

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 reveals quality systems of manufacturing as the leading cause of drug shortages.

EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

One employee is dismissed, another has resigned, and three others are put on administrative leave.

Elan urges its shareholders to reject bid in an upcoming meeting on June 17.

USP appoints regulatory experts to elemental impurities implementation advisory group.

FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.

Acquisition will strengthen AstraZeneca?s respiratory portfolio with a potential new treatment for chronic obstructive pulmonary disease.

Agreement seeks to advance novel drug targets and focus on therapies for ulcerative colitis.

Facility will use mammalian cell-culture technology and be ready for operations by 2016.

FDA Discovers Microbial Contamination in Compound Pharmacy Products

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

Modular containment room at Belfast facility allows studies of biologics and vaccines.

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The agreement is worth up to $552 million, depending on meeting set milestones.

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ISTA will pay $33.5 million to resolve criminal liability and false claims allegations.

FDA addresses shortages of drugs needed to treat premature infants and patients unable to eat or drink by mouth.

Cloud-computing solutions and software enable researchers to garner insight from large, public-health datasets.

GSK expands its vaccines platform technology expertise by acquiring Okairos, a Swiss-based company.

Competence in process safety is important for preventing accidents.

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.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.