News

The Pharma & Biopharma Outsourcing Association announced its support of legislation that would preserve FDA user fees from sequestration.

SGS Life Science Services adds analytical methods to identify amino acid impurities in bio/pharmaceutical manufacturing at facility in Germany.

Novasep has entered into an agreement with Celladon to provide scale-up and pre-validation studies for the drug substance for MYDICAR.

The upgrades will offer the opportunity for higher product yields and higher purity levels.

Proposals to make the decentralized procedure more efficient were discussed at the January 2015 EGA conference.

Kason’s K-Series screen replacement program for round vibratory screeners decreases downtime and cost and offers screens designed for any make or model of screener.

GEA Niro Soavi’s PandaPLUS 2000 is a tabletop laboratory homogenizer that is designed for the treatment of nanoparticles, nanodispersions, nanoemulsions, and cell disruption.

PolyScience’s recirculating chillers and refrigerated circulators control temperature with stabilities as precise as ±0.005 °C for analytical instrumentation.

Ross’ SysCon PLC-based Control Systems are designed for sequential control of automated processes including mixing, pumping, chemical dosing, water treatment, fractionation, and heat exchange.

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.

Remsima will now be available for patients in 12 additional countries in the European Union.

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.