News

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FDA releases draft guidance on electronic submission of lot distribution reports.

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.

GlobalData's report looks at the growth of monoclonal antibodies in the market for acute coronary syndrome treatment.

Allied-Bristol Life Sciences will focus on converting university research into therapeutic candidates.

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

Pfizer announced an agreement to acquire Baxter International?s marketed vaccines for $635 million.

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

Redbiotec and GE Healthcare Life Sciences develop a novel manufacturing process for virus-like particles.

SGS to add testing laboratories for biotechnology, extractables and leachables, and elemental impurities to Shanghai facility.

Bristol-Myers Squibb and Ono Pharmaceutical will jointly develop and commercialize immuno-oncology drugs for Japan, South Korea, and Taiwan.

Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.

CPI invests &34 million to develop a Biologics Factory of the Future due to open in 2017.

Unique Pharmaceuticals has issued a voluntary recall of sterile compounded preparations, but aired concerns about FDA?s recall demand.

AbbVie's relocation to Ireland following Shire's acquisition could lower its annual tax expense by as much as 7% over the next 15 years.