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Novartis Phase 3 Trial Shows Anti-Inflammatory Drug Reduces Cardiovascular Risk

  • Posted by ispeblog
  • On July 12, 2017
Novartis has announced topline results from the global Phase 3 CANTOS study investigating the efficacy, safety and tolerability of ACZ885 (canakinumab) in combination with standard of care in people with a prior heart attack and inflammatory atherosclerosis. With more than 10,000 patients enrolled in the study over the last six years, CANTOS is one of […]
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FDA Update: Agency Takes Action to Eliminate Orphan Drug Backlog

  • Posted by Janet Tice
  • On June 29, 2017
The FDA has unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to […]
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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 […]
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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 […]
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High-Powered Team Pitching MA at BIO Conference

  • 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 […]
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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 […]
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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, […]
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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. […]
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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 […]
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Sanofi Pays ImmunoGen $30 Million in an Amended License Agreement

  • 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 […]
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