BioPharm International Editors

FDA releases draft guidance on electronic submission of lot distribution reports.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

Researchers show TIM-1 proteins and lipids play role in blocking HIV-1 cells and Ebola from replicating.

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.

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.

Former healthcare association executive selected to lead International Society for Pharmaceutical Engineering.

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.

CPhI 2014 panel additions to provide global insights from the contract services sector.

After rejecting several bids, Shire has agreed to a merger with AbbVie valued at almost $55 billion.

Baxter investigates root cause of cellulosic fibers and/or plastics in four lots of IV solutions.

Mylan set to acquire Abbott's non-US developed markets specialty and branded generics business in an all-stock transaction.

New AbbVie proposal results in discussion with Shire about possible $53 billion deal.

Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.

ASTM International develops Committee E62, a new technical committee focused on industrial biotechnology.

Puncture in container and overwrap cause leak in intravenous solution, leading to recall by Hospira.

Covance reports two senior-level appointments to it clinical development services scientific leadership team.