Author Archives: Janet Tice

Sanofi and Regeneron Win FDA Approval of Kevzara for Rheumatoid Arthritis

By | 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… Read More »

Magenta Therapeutics Adds $50 Million for Stem Cell Development

By | 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… Read More »

Biogen Licenses Potential Alzheimer’s Drug from Bristol-Myers Squibb

By | 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… Read More »

EMD Serono Wins FDA Approval for Bavencio

By | 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… Read More »

Paratek Announces Positive Results of Phase 3 Study of New Antibiotic

By | 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… Read More »

Sanofi Genzyme and Regeneron Announce FDA Approval of First Targeted Biologic Therapy for Eczema

By | April 6, 2017

Sanofi and Regeneron Pharmaceuticals announced that the FDA has approved Dupixent, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD), a form of eczema, whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent is a human monoclonal antibody… Read More »