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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 […]
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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 […]
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Magenta Therapeutics Adds $50 Million for Stem Cell Development

  • 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 […]
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Biogen Reports First Quarter 2017 Revenues of $2.8 Billion

  • 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, […]
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Sanofi and Lonza Partner to Build Biologics Production Facility in Switzerland

  • Posted by jwillard
  • On April 28, 2017
Lonza has announced that they will partner with Sanofi to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. The initial investment will be around CHF 290 million (€ 270 million), to be split equally between the companies. The initial phase of the facility will commence construction in […]
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Biogen Licenses Potential Alzheimer’s Drug from Bristol-Myers Squibb

  • Posted by Janet Tice
  • On April 28, 2017
Biogen has announced an agreement to exclusively license an experimental medicine with potential to treat Alzheimer’s disease (AD) and progressive supranuclear palsy (PSP) from Bristol-Myers Squibb. The drug, known as BMS-986168, is an antibody targeting extracellular tau, the protein that forms the deposits, or tangles, in the brain associated with AD and other neurodegenerative tauopathies […]
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EMD Serono Wins FDA Approval for Bavencio

  • Posted by Janet Tice
  • On April 20, 2017
The FDA has granted EMD Serono accelerated approval for Bavencio (avelumab), a drug for the treatment of metastatic Merkel cell carcinoma (MCC) a rare, aggressive form of skin cancer. This is the first FDA-approved treatment for metastatic MCC. “While skin cancer is one of the most common cancers, patients with a rare form called Merkel […]
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Paratek Announces Positive Results of Phase 3 Study of New Antibiotic

  • Posted by Janet Tice
  • On April 20, 2017
Paratek Pharmaceuticals has announced the second positive Phase 3 registration study of omadacycline, which will be used to support marketing applications to the FDA and EMA planned for 2018. The Phase 3 clinical study compares Paratek’s broad spectrum investigational antibiotic, omadacycline, to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia (CABP). “This successful […]
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Governor Baker Signals Continued Support for Life Sciences

  • Posted by ISPE Boston
  • On April 20, 2017
Governor Charlie Baker once seemed skeptical about continuing the 10-year, $1 billion life sciences initiative launched by his predecessor, Deval Patrick. At the MassBio annual meeting on March 31, Baker left no doubt that he’s all-in, outlining an ambitious vision for extending the initiative after its initial term expires at the end of 2018, saying […]
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FDA Gets High Marks for Speed of Drug Approval

  • Posted by Janet Tice
  • On April 20, 2017
In a letter to the editor published in the April 6, 2017 issue of the New England Journal of Medicine, researchers reported on results of a study comparing FDA and EMA review times for new therapeutic agents approved between 2011 and 2015. During this period, the FDA approved 170 new therapeutic agents and the EMA […]
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