News

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.

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.

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.

AstraZeneca releases designs for its new Global R&D center and corporate headquarters in Cambridge, UK.

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.

Aesica adds roller compaction unit for dry granulation production.

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

New International Council on Biotechnology Associations advocates biotechnology growth.

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.

FDA grants breakthrough therapy designation to Novartis chimeric antigen receptor therapy.

BioOutsource will expand its US presence, opening a new laboratory facility in Massachusetts to support the company's biosimilar and biosafety service offerings.

PlantForm and PharmaPraxis announce plans to develop six biopharmaceutical targets for the Brazilian market.

Genentech's $1.7 billion acquisition of Seargon Pharmaceutical includes portfolio of investigational next-generation oral selective estrogen receptor degraders.