Paris-based Sanofi SA won FDA clearance of the intravenously given CD38-directed cytolytic antibody Sarclisa (isatuximab-irfc) in combination with pomalidomide (Pomalyst, Celgene Corp.) and dexamethasone (dex) for adults with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene Corp.) and a proteasome inhibitor.
SAN DIEGO – At Biocom's 10th Annual Global Life Sciences Partnering Conference, a panel of players intimately familiar with last year's approval of myelofibrosis treatment Inrebic (fedratinib) explained the backstory of how they got the JAK2 kinase inhibitor off an FDA clinical hold, wrangled the rights to the drug back from the big pharma owner that had acquired the drug from Targegen Inc. and eventually helped the drug gain FDA approval after selling the rights to another large company.
Paris-based Sanofi SA, responding to increasing medicine shortages and drugmakers' heavy reliance on active pharmaceutical ingredients (APIs) sourced from Asia, said it plans to create a major new API manufacturer headquartered in France.
Paris-based Sanofi SA, responding to increasing medicine shortages and drugmakers' heavy reliance on active pharmaceutical ingredients (APIs) sourced from Asia, said it plans to create a major new API manufacturer headquartered in France.
Sanofi SA said an investigational Bruton's tyrosine kinase (BTK) inhibitor it licensed from Principia Biopharma Inc. in 2017 significantly reduced disease activity associated with multiple sclerosis (MS) as measured by magnetic resonance imaging, meeting the trial's primary endpoint.
The National Institute of Allergy and Infectious Diseases has stopped a late-stage HIV vaccine study it sponsored after an interim review by the trial's independent data and safety monitoring board (DSMB) found the regimen failed to prevent HIV.
Nurix Therapeutics Inc. landed its second big pharma collaboration in seven months when it signed with Sanofi SA to discover, develop and commercialize a pipeline of protein degradation therapies. In the Sanofi deal, Nurix receives $55 million up front and is eligible for up to about $2.5 billion in total payments based on achieved milestones. To start, Nurix will design small molecules to induce degradation in three specific targets while Sanofi has the option to up the ante to five targets. Sanofi receives exclusive rights and will handle clinical development and commercialization and Nurix retains the option to co-develop and co-co-promote up to two products in the U.S.
ORLANDO, Fla. – New research on sutimlimab, an investigational complement pathway inhibitor under development by Sanofi SA's Bioverativ unit, showed substantial benefits for people with the rare autoimmune disorder cold agglutinin disease (CAD).
DUBLIN – Sanofi SA is paying a hefty 172% premium to acquire Synthorx Inc. for $68 per share, or $2.5 billion in all, to add a clinical-stage immuno-oncology asset to its pipeline and a platform technology that will enable it to optimize cytokine-based drugs for cancer and autoimmune disease.
Baxter International Inc., of Deerfield, Ill., has entered an agreement to acquire Seprafilm adhesion barrier and related assets from Paris-based Sanofi SA.
