ISPE and PDA Talk Shop with Validation Experts at Joint Meeting

Posted by ispeblog
On May 2, 2017

The ISPE Boston Area Chapter and the PDA New England Chapter are joining forces to present “Validation: The Bridge Between Engineering & Quality Assurance” on May 17. Don’t miss this unique opportunity to exchange ideas with an expanded industry cross section and hear from industry experts Sylvan Poeckh and Paul Stanovich on “The Role and […]

Sanofi and Lonza Partner to Build Biologics Production Facility in Switzerland

Posted by jwillard
On April 28, 2017

Lonza has announced that they will partner with Sanofi to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. The initial investment will be around CHF 290 million (€ 270 million), to be split equally between the companies. The initial phase of the facility will commence construction in […]

Posted by Janet Tice
On April 28, 2017

Biogen has announced an agreement to exclusively license an experimental medicine with potential to treat Alzheimer’s disease (AD) and progressive supranuclear palsy (PSP) from Bristol-Myers Squibb. The drug, known as BMS-986168, is an antibody targeting extracellular tau, the protein that forms the deposits, or tangles, in the brain associated with AD and other neurodegenerative tauopathies […]

Free Bioengineering Symposium at UNH on May 10

Posted by ispeblog
On April 27, 2017

The 2017 University of New Hampshire Bioengineering Symposium on Wednesday, May 10 is a full-day event featuring several talks by invited speakers in key areas that are at the forefront of cutting-edge research worldwide and broadly represent the field of bioengineering. Topics include: Engineering Total Joint Replacements; In Vitro Models of Tissue Morphogenesis and Disease […]

YPs Dish Up Good Conversation, Great Beer and Networking Bingo at Meadhall

Posted by Brian Kennedy
On April 26, 2017

The Young Professionals Spring Networking Event on April 6th at Meadhall in Cambridge was a big hit. This was the YPs first time holding an event at the popular Kendall Square bar and 37 young (and seasoned) professionals from a variety of local companies braved the torrential rain to enjoy Meadhall’s exquisite cuisine and wide […]

EMD Serono Wins FDA Approval for Bavencio

Posted by Janet Tice
On April 20, 2017

The FDA has granted EMD Serono accelerated approval for Bavencio (avelumab), a drug for the treatment of metastatic Merkel cell carcinoma (MCC) a rare, aggressive form of skin cancer. This is the first FDA-approved treatment for metastatic MCC. “While skin cancer is one of the most common cancers, patients with a rare form called Merkel […]

Posted by Janet Tice
On April 20, 2017

Paratek Pharmaceuticals has announced the second positive Phase 3 registration study of omadacycline, which will be used to support marketing applications to the FDA and EMA planned for 2018. The Phase 3 clinical study compares Paratek’s broad spectrum investigational antibiotic, omadacycline, to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia (CABP). “This successful […]

Governor Baker Signals Continued Support for Life Sciences

Posted by ISPE Boston
On April 20, 2017

Governor Charlie Baker once seemed skeptical about continuing the 10-year, $1 billion life sciences initiative launched by his predecessor, Deval Patrick. At the MassBio annual meeting on March 31, Baker left no doubt that he’s all-in, outlining an ambitious vision for extending the initiative after its initial term expires at the end of 2018, saying […]

FDA Gets High Marks for Speed of Drug Approval

Posted by Janet Tice
On April 20, 2017

In a letter to the editor published in the April 6, 2017 issue of the New England Journal of Medicine, researchers reported on results of a study comparing FDA and EMA review times for new therapeutic agents approved between 2011 and 2015. During this period, the FDA approved 170 new therapeutic agents and the EMA […]

Posted by ispeblog
On April 10, 2017

Competitive forces, changing marketplace dynamics, and regulatory pressures are generating greater demand and need for new and more effective automation technologies in the pharmaceutical and food industries. More than ever before, manufacturing companies are seeking solutions and methodologies that increase quality, safety, reliability, profitability, cost control and production throughput. On May 16-17 at the Sheraton […]

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