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 […]

Sanofi and Regeneron Win FDA Approval of Kevzara for Rheumatoid Arthritis

Posted by Janet Tice
On May 25, 2017

“Today’s approval…not only underscores our ongoing commitment to making a difference in the lives of patients, but also demonstrates our drive to accelerate science and medicine in immunology.” So said Sanofi Chief Executive Officer Olivier Brandicourt as Sanofi and Regeneron Pharmaceuticals announced FDA approval of Kevzara® (sarilumab) for the treatment of adults with moderate to […]

Thermo Fisher Scientific to Acquire CMO Patheon

Posted by jwillard
On May 18, 2017

The boards of directors at Thermo Fisher Scientific and Patheon have approved Thermo Fisher’s acquisition of Patheon for $35.00 per share in cash. The transaction represents a purchase price of approximately $7.2 billion, which includes the assumption of approximately $2.0 billion of net debt. Patheon provides contract development and manufacturing services, primarily at facilities in […]

Deciding What Job Is Right For You? Informational Interviews Can Help…

Posted by rfeldt
On May 16, 2017

Most professionals are aware of the value of research and networking in the job search process. Savvy job seekers connect with the right people at ISPE meetings, on LinkedIn or other social media. They study corporate websites to learn more about the companies they’re most interested in and stay up-to-date on industry news and trends. […]

Breaking in the Spring with the Chapter’s Golf Outing

Posted by Dan Kenny
On May 16, 2017

On May 8th, the ISPE Boston Area Chapter’s Social Committee hosted the Annual Spring Golf Outing at Ledgemont Country Club in Seekonk, MA. With the event sold out, ISPE Chapter members and guests braved the blustering wind and enjoyed an invigorating day of golf. Although the sun was in and out all day, the rain […]

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