News

Combination product design takes second prize in the National Collegiate Inventors and Innovators Alliance Biomedical Engineering contest.

Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.

NIH awards $12.7 million for collaborations between nine academic research groups and pharmaceutical industry partners to explore new treatments.

Lundbeck and eight other pharmaceutical companies have been fined for delaying generic entry of the blockbuster antidepressant, Celexa (citalopram), into the market.

New production capabilities in Normandy, France will include a cleanroom.

A screening method predicts delamination in primary packaging.

Semi-automatic technology aids egg-based influenza vaccine production in smaller facility footprints.

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 GSK’s site in Notre-Dame-de-Bondeville, France.

The settlement comes after a nearly 10-year legal battle in which Pfizer and Nycomed (now part of Takeda) sought to enforce the patent for its blockbuster acid reflux medicine.

The billion-dollar deal provides strengthens J&J’s oncology portfolio.

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

PSL has developed a microsphere refiner for microsphere formulation, from small scale processes to commercial production.

The US Supreme Court ruled that naturally occurring isolated biological material is not patentable, but a synthetic version of gene material may be patented.

Eli Lilly has discontinued its Phase II study, which investigated the company's beta secretase (BACE) inhibitor, LY2886721, as a treatment for Alzheimer's disease. The decision to terminate the study was because of abnormal liver biochemical tests identified during routine monitoring.

Catalent is investing nearly $35 million in a major expansion of its controlled-release drug manufacturing facility in Winchester, Kentucky.

Almac has announced expansion of its UK facility and a new non-GMP drug development facility at the Craigavon site, representing an investment of $21.5 million.

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

USP appoints regulatory experts to elemental impurities implementation advisory group.

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.

The multimillion-dollar deal focuses oncology.

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

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

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

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

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

FDA Discovers Microbial Contamination in Compound Pharmacy Products

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

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