News

Astellas Pharma announced that it received FDA approval for its treatment of fatal invasive fungal infections in patients with blood cancers.

Mallinckrodt Pharmaceuticals has bought Ikaria, a privately-held critical care company, for $2.3 billion.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.

Baxter has bought SuppreMol, a German biopharmaceutical company that focuses on autoimmune treatments, for €200 million ($225 million USD).

BASF is expanding its Verbund site in Ludwigshafen to include production capacity for about 20 specialty amines.

AbbVie’s acquisition of Pharmacyclics establishes the combined company as an emerging leader in hematological oncology.

Survey reveals pharmaceutical and medical attitudes towards “KOL” terminology.

Patheon cites expanded API services with acquisition of IRIX Pharmaceuticals.

Teva announced that it would sell its Sellersville, Pennsylvania facility to G&W Laboratories.

Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.

Steve Nole joins Grand River Aseptic Manufacturing as director of manufacturing.

WellSpring Pharma Services has announced the appointment of David Mayers as president.

A facility expansion adds space for production of Repligen’s tangential flow system.

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.