Governor Baker Proposes $500M Life Sciences Extension

Posted by ispeblog
On June 20, 2017

Governor Charlie Baker’s proposed $500 million extension of the life sciences initiative put in place by his predecessor in 2008 will put a greater emphasis on workforce building to support industries that have taken root in Massachusetts. On Monday, Baker put forward a plan to spend heavily over the next five years on capital grants […]

What Do Brewing, Brettanomyces and Biotech Have in Common?

Posted by Eric Felz
On June 19, 2017

The ISPE Boston Area Chapter kicked off the summer season with a standing-room-only event, “Brewing, Brettanomyces, and Biotech,” at Springdale Barrel Room by Jack’s Abby in Framingham. This sold-out event was met with great anticipation and attendees did not leave disappointed. The evening opened with a lively networking session with beer, food and great company. […]

Biogen Drug Approved in EU as First Treatment for Spinal Muscular Atrophy

Posted by Janet Tice
On June 13, 2017

The European Commission (EC) has granted a marketing authorization for Biogen drug Spinraza (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA). 5q SMA is the most common form of the disease and represents approximately 95 percent of all SMA cases. Spinraza is the first approved treatment in the European Union (EU) for SMA, […]

Posted by Chris Blackwell
On June 6, 2017

The local Chapters of ISPE and PDA joined forces on May 17th for a dinner program at the Hilton in Woburn. About 150 attendees turned out to wine, dine, network and learn about “Validation: The Bridge between Engineering & Quality Assurance” from invited speakers Sylvan Poeckh of Masy BioServices and Paul Stanovich of Process […]

What Do BMWs and Validation Have in Common? Engi•dati•ty Assurance!

Posted by Howard Sneider
On June 6, 2017

On May 17, the ISPE Boston Area Chapter joined the PDA New England Chapter for a combined ISPE/PDA dinner event under the banner “Validation: The Bridge Between Engineering & Quality Assurance” helmed by two superb presenters: Sylvan Poeckh of Masy BioServices and Paul Stanovich of Process Design Solutions. This topic was selected because effective validation […]

When Good Bugs Go Bad – Contamination Detection in a Mixed Fermentation Brewery

Posted by ksteblenko
On June 5, 2017

Fermentation is a science dating back to the first known civilizations on this Earth, and has helped to shape the world as it is today. From bread and beer to sauerkraut and yogurt, fermentation has shaped cultures and traditions across the world. The vast diversity in fermentation is being rediscovered in the beer industry as […]

Remembering Biotech Industry Pioneer Henri Termeer

Posted by Janet Tice
On June 1, 2017

Henri Termeer, one of the founding fathers of the biotech industry, died recently after collapsing in his Marblehead home. He led Genzyme from 1983 to 2011, the year Sanofi bought the company for more than $20 billion, and is credited with pioneering the much-imitated business model that would generate hundreds of medicines targeting rare diseases. […]

FDA Approves First Cancer Treatment Based on Tumor Biomarker

Posted by Janet Tice
On May 31, 2017

The FDA has granted accelerated approval for Merck’s Keytruda for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. “This is an important first for the cancer […]

Posted by jwillard
On May 31, 2017

ImmunGen, which develops antibody-drug conjugates (ADCs) for the treatment of cancer, announced that it has amended its license agreements with Sanofi covering all compounds in development by Sanofi using ImmunoGen’s technology. Under the terms of the amended 2003 collaboration and license agreement, ImmunoGen has granted Sanofi a fully-paid, exclusive license to develop, manufacture, and commercialize […]

Pfizer’s Epogen/Procrit Biosimilar gets FDA Advisory committee green light

Posted by jwillard
On May 26, 2017

Pfizer announced the FDA Oncologic Drugs Advisory Committee recommended approval of the Company’s proposed Epogen (Amgen) / Procrit (Johnson and Johnson) biosimilar across all indications. This is the first epoetin alfa biosimilar that has been recommended for approval by a U.S. FDA Advisory Committee. The product indications include treatment of anemia due to Chronic Kidney […]

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