FDA Update: Agency Takes New Steps to Encourage Development of Generics

Posted by Janet Tice
On June 29, 2017

The FDA is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where […]

Syntimmune Lands $50 Million for Autoimmune Drug Development

Posted by ispeblog
On June 27, 2017

Waltham-based Syntimmune, a clinical-stage biotechnology company focused on FcRn biology, has announced a $50 million Series B financing led by Apple Tree Partners, which has committed $48 million to the round, with additional participation from other existing investors. The proceeds will further advance Syntimmune’s clinical development program, which includes two ongoing Phase 1b/2a clinical trials […]

Posted by ispeblog
On June 20, 2017

Governor Baker will fly to California today to take part in the 2017 International BIO Conference. This follows on the heels of his proposal for a $500 million, 5-year extension of the life sciences initiative put in place by his predecessor in 2008. “BIO is a big opportunity for us to talk about the great […]

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 […]

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, […]

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 […]

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