Sanofi news - the latest biotech news from Labiotech.eu

FDA approves Beyfortus ahead of 2023-24 RSV season

Jim Cornall — Tue, 18 Jul 2023 08:28:06 +0000

The U.S. Food and Drug Administration (FDA) has approved Sanofi and AstraZeneca’s Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. The approval also covers children up to 24 months of age who remain vulnerable to severe […]

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SandboxAQ launches new division to boost drug development

Jim Cornall — Fri, 23 Jun 2023 08:13:19 +0000

After several years of stealth development, SandboxAQ has announced its bio-pharma molecular simulation division, AQBioSim, and some of its customers. The division is helping bio-pharma and research institutions achieve breakthroughs in treatments for cancer, Alzheimer’s, Parkinson’s, and other conditions. The company is currently working with biopharma companies and university research labs, including AstraZeneca, Sanofi and […]

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Sanofi drug reduces disease activity in relapsing MS

Jim Cornall — Thu, 01 Jun 2023 10:00:00 +0000

New data, being presented in a late-breaking session at the 2023 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, demonstrate that frexalimab, Sanofi’s novel second-generation investigational anti-CD40L antibody, with a unique mechanism of action, significantly reduced disease activity in a phase 2 trial of patients with relapsing multiple sclerosis (MS). Following 12 weeks of therapy, […]

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Sanofi adds diabetes drug through Provention Bio $2.9B acquisition

Jim Cornall — Mon, 13 Mar 2023 16:30:21 +0000

Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), have entered into an agreement under which Sanofi has agreed to acquire Provention Bio, Inc., for $25.00 per share in cash, representing an equity value of approximately $2.9 billion. The transaction adds […]

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5 steps to strategic partnerships for healthtech startups

External Contributor — Thu, 02 Mar 2023 11:41:48 +0000

By Varvara Melikhova, founder and CEO of Unison Innovations Strategic partnerships are a better way to build a product’s capabilities than outright acquisitions. While the M&A path is set out for the most mature successful startups, early-stage partnerships can enhance a product’s market value and provide access to Big Pharma expertise and infrastructure, which significantly […]

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Sanofi hemophilia drug gets FDA approval

Jim Cornall — Fri, 24 Feb 2023 09:45:14 +0000

The U.S. Food and Drug Administration (FDA) has approved Sanofi’s ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referred to as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy. ALTUVIIIO is indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia […]

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Dupixent gets EU nod for children with severe atopic dermatitis

Jim Cornall — Fri, 27 Jan 2023 11:22:03 +0000

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children six months to five years old who are candidates for systemic therapy. The European Commission is expected to announce a final […]

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CytoReason expands deal with Sanofi to look at IBD

Jim Cornall — Tue, 24 Jan 2023 09:04:39 +0000

CytoReason, which creates computational disease modeling, has announced an expansion of its collaboration with Sanofi. The multi-year collaboration will further fuel Sanofi’s target discovery efforts via CytoReason’s AI platform in the field of inflammatory bowel disease (IBD), to identify patient subtypes and pair them with IBD targets. In 2021, Cytoreason announced the initiation of a […]

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Positive Dupixent eosinophilic esophagitis phase 3 results

Jim Cornall — Thu, 22 Dec 2022 09:53:54 +0000

The New England Journal of Medicine has published results from a positive phase 3 trial showing adults and adolescents treated with Dupixent (dupilumab) 300 mg weekly experienced significant improvements in signs and symptoms of eosinophilic esophagitis (EoE), which were sustained for up to one year. EoE is a chronic, progressive inflammatory disease that damages the […]

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Sanofi and Innate Pharma expand natural killer cell deal

Jim Cornall — Mon, 19 Dec 2022 13:19:34 +0000

Sanofi and Innate Pharma SA have expanded their collaboration, with Sanofi licensing a natural killer (NK) cell engager program targeting B7H3 from Innate’s ANKET (Antibody-based NK Cell Engager Therapeutics) platform. Sanofi will also have the option to add up to two additional ANKET targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and […]

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European Commission approves Dupixent as first and only targeted prurigo nodularis medicine

Jim Cornall — Thu, 15 Dec 2022 10:55:11 +0000

The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials […]

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Neuraxpharm’s expansion into the Netherlands takes it from two to 20 countries in six years

Liza Laws — Wed, 07 Dec 2022 22:19:57 +0000

Neuraxpharm Group, a European pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, has announced the establishment of Neuraxpharm Netherlands, increasing its presences from two to 20 countries in six years. The company says the expansion into the Dutch market allows it to continue on its pathway to become the number one […]

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FDA clears insulin pen medical device

Jim Cornall — Wed, 07 Dec 2022 12:39:21 +0000

BIOCORP, a French company specialized in the design, development, and manufacturing of innovative medical devices, has received 510(K) clearance from the U.S. Food & Drug Administration (FDA) to market Mallya, its smart medical device that connects insulin pens. Eric Dessertenne, CEO of BIOCORP, said: “This approval is a major achievement for BIOCORP and all of […]

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TrialSpark acquires immunodermatology portfolio and creates Libertas Bio

Jim Cornall — Wed, 30 Nov 2022 06:23:32 +0000

TrialSpark has announced the formation of Libertas Bio following the acquisition of a majority position in a portfolio of immunodermatology assets from Asana BioSciences. The Libertas Bio pipeline now includes global rights to gusacitinib, an oral phase 3-ready dual JAK/SYK inhibitor in development for chronic hand eczema (CHE), and ASN008, a phase 2-ready topical sodium […]

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Sanofi’s Enjaymo for hemolytic anemia given marketing authorization by EC

Liza Laws — Fri, 18 Nov 2022 15:21:39 +0000

Sanofi’s treatment, Enjaymo, for hemolytic anemia in adult patients with cold agglutinin disease (CAD), has been granted marketing authorization by the European Commission (EC). Enjaymo is the first and only approved therapeutic option for the rare, serious and chronic autoimmune disease where the body mistakenly attacks healthy red blood cells and causes their rupture, known […]

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In depth interview: AstraZeneca/Sanofi RSV drug Beyfortus

Jim Cornall — Mon, 14 Nov 2022 10:56:12 +0000

AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the European Union (EU) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. Beyfortus is the first and only single-dose RSV passive immunization for the broad infant population, including those born healthy, at term […]

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Prurigo nodularis treatment recommended for EU approval

Jim Cornall — Fri, 11 Nov 2022 13:42:38 +0000

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent (dupilumab) in the European Union (EU) to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Dupilumab is being jointly developed by Sanofi and Regeneron. The European Commission is expected […]

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Sanofi and GSK Covid-19 booster vaccine approved by European Commission

Jim Cornall — Thu, 10 Nov 2022 17:22:35 +0000

Sanofi and GSK’s Covid booster vaccine has been approved in Europe. After the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn Beta, the vaccine was approved by the European Commission, as a booster for the prevention of Covid-19 in adults 18 years of age and older. […]

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Sanofi and AstraZeneca drug, Beyfortus, for RSV in babies and children approved

Liza Laws — Fri, 04 Nov 2022 16:18:44 +0000

A drug being developed jointly by Sanofi and AstraZeneca for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants was approved today (November 4). The European Commission has approved Beyfortus which is so far the first and only broadly protective option against the virus. Thomas Triomphe, executive vice president, […]

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Late-breaking data shows significant remission in children with EoE

Liza Laws — Tue, 11 Oct 2022 20:29:14 +0000

Late-breaking positive results from a phase 3 trial have shown that children with eosinophilic esophagitis (EoE) given a higher dose of Dupixent showed histological disease remission and signs of weight gain. At week 16, 68% of children aged one to 11 years with active EoE on the higher dose displayed the positive results during the […]

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