BioPharm International Editors

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

The Alliance for Fair Trade with India is seeking action to resolve discriminatory trade practices and improved protection of intellectual property rights.

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.

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

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.

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

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.

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.

The multimillion deal focuses on oncology.

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

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.