A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Sessions address cell therapies, tableting, continuous processes, serialization, and more.

Several chromatographic resins are available for downstream purification.

A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.

Every now and then, you will hear about the rising costs of R&D, which in turn, translate into high prices for new drugs entering the market.

FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.

FDA approved Actavis’ antibiotic Avycaz designed to combat drug-resistant bacteria.

The company has increased capacity for cold storage and controlled drug substances handling at its European facilities.

Turing Pharmaceuticals announced the launch of its company, the acquisition of three assets from Retrophin, and a new senior management team.

Johnson & Johnson will pay $2.5 million to a plaintiff who developed gynecomastia after using Risperdal.

The company voluntarily recalls product due to FDA observations of potential sterility problems.

Aprecia Pharmaceuticals' new facility in Ohio will create 150 jobs.

SGS has invested in additional modules for its COBAS 6000 analysis system in a move to expand its biomarker analytical capabilities at its Poitiers facility in France.

Bristol-Myers Squibb announced that it reached an agreement to acquire Flexus Biosciences and has entered into a $309-million partnership with Rigel Pharmaceuticals.

Celltrion announced that its Remicade biosimilar, Rensima, could save France, Italy, and the UK up to €336 million in costs to treat Crohn’s disease.

Leased facilities in California will expand Kite Pharma's capacity for clinical T-cell therapies.

The agency cites Apotex’s Bangalore facility with quality system failures.

Valeant announced that it acquired Salix Pharmaceuticals for approximately $14.5 billion, which could result in annual cost savings of $500 million.

The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.

Celgene announced that its drug, Revlimid, gained FDA approval for the treatment of newly diagnosed multiple myeloma.

The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.

Tooling can be damaged by poor handling or problems in process design or material choice.

The company announces that FDA has closed out a 2012 warning letter.

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

The agency releases five draft guidance documents related to drug compounding and repackaging.