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 […]

First New Treatment for ALS in More Than 20 Years Approved by FDA

Posted by jwillard
On May 11, 2017

MT Pharma America announced that the FDA has granted approval of Radicava (edaravone) to treat amyotrophic lateral sclerosis (ALS). ALS is a rapidly progressive neurodegenerative disease – the majority of patients die within two to five years of diagnosis. An estimated 6,000 Americans are diagnosed each year with ALS, an incurable disease that affects the […]

Posted by Janet Tice
On May 11, 2017

Cambridge-based Magenta Therapeutics, a biotech company developing therapies to improve and expand the use of curative stem cell transplantation, has announced completion of a $50 million Series B financing; in-licensing of a clinical-stage program from Novartis to support the use of stem cell transplantation in a variety of disease settings; and a strategic partnership with […]

Posted by Janet Tice
On May 11, 2017

At the end of April, Biogen reported first quarter 2017 financial results, including worldwide revenues of $47 million for Spinraza, a drug approved by the FDA in December 2016 for treatment of spinal muscular atrophy (SMA). “I am very pleased with the results of the first quarter. We saw continued stability in our MS business, […]

Page 113 of 119«‹111 112113114 115 ›»