News

Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.

The Purple Book will list biologic and biosimilar products and will serve as a guide for interchangeability.

NIH continues funding for tissue chips to be used in the development of therapeutics.

FDA report details risk mitigation projects.

USP expresses its support for a consensus-based global approach to the naming of biologics.

Regulations, product protection, and cost management are top concerns of supply chain decision makers.

Merck KGaA will expand the reach of its EMD Millipore division with the purchase of life-sciences company Sigma-Aldrich.

PCI's acquisition of Biotech Services International expands the packaging services provider's presence in Europe.

Texas A&M dedicates national pandemic influenza vaccine manufacturing facility.

GSK is found guilty of offering bribes to doctors and is fined $489 million.

GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.

Baxter announced that its new biopharmaceutical company will be named Baxalta when the company separates into two publicly traded companies in mid-2015.

Baxter International initiated a US voluntary recall of one lot of potassium chloride injection due to mislabeled shipping carton.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

ProBioGen, a biopharmaceutical drug manufacturer in Berlin, spends ?20 million to double its workforce.

PDA will publish a technical report on quality risk management aspects of drug shortages in early 2015.

The companies plan to develop and commercialize duvelisib (IPI-145).

DPT Laboratories acquired Media Pharmaceuticals' Lakewood, New Jersey facilities, providing space for aseptic processing suites and filling equipment.

The new China facility will be Merck KGaA's biopharmaceuticals division's second largest worldwide.

FDA releases draft guidance on electronic submission of lot distribution reports.

Catalent's addition of an automated prefilled syringe clinical packaging line at its Philadelphia facility will support its work with Eli Lilly.

Pfizer announced that its investigational vaccine candidate for the treatment of Clostridium difficile has been granted the Fast Track designation from FDA.

Pfizer announced that FDA approved ELELYSO for treatment of Type 1 Gaucher disease in adult and pediatric patients.

ISPE released an advance look at the Introductory Summary of its Drug Shortages Prevention Plan.

PSC Investments announces the acquisition of a high potency, sterile fill/finish pharmaceutical manufacturing facility.

Attendees at the Bio-Process Systems Alliance annual summit discuss the benefits of single-use technology in biopharmaceutical manufacturing.

The BioPhorum Operations Group has published a resource to help the biopharmaceutical industry deliver a consistent approach to continued process verification.

Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.