Sanofi

Sanofi Collaborates with Sirion to Develop Gene Therapy Treatment with Improved AAV Capsids

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Shots: The companies collaborated to develop improved tissue-selective AAV vectors to realize effective gene therapy treatments for multiple life-threatening disorders The focus of this agreement is to develop new and modified AAV capsids that exhibit a safe product profile with improved specificity and higher gene… Read More »Sanofi Collaborates with Sirion to Develop Gene Therapy Treatment with Improved AAV Capsids

Sanofi’s Dupixent (dupilumab) Receives Health Canada Approval as the First Biologic to Treat Atopic Dermatitis in Children

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Shots: Health Canada has approved Dupixent for the treatment of mod. to sev. AD in children aged 6 to 11yrs. whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable The approval marks the fifth indication for Dupixent… Read More »Sanofi’s Dupixent (dupilumab) Receives Health Canada Approval as the First Biologic to Treat Atopic Dermatitis in Children

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

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Shots: The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the 1L treatment with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or… Read More »Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

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Shots: The companies reported the initiation of a P-II dose-finding study assessing the safety, reactogenicity, and immunogenicity of two injections given 21 days apart in 720 adults aged ≥18yrs. The P-II study assesses the potential for refined antigen formulation to achieve an optimal immune response,… Read More »Sanofi and GSK Initiate P-II Study of their Adjuvanted Recombinant Protein-Based COVID-19 Vaccine

Sanofi Collaborates with i2O Therapeutics to Evaluate Oral i2O Therapeutics

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Shots: The companies collaborated to investigate oral delivery of Sanofi’s Nanobody based medicines, which are currently available in IV & SC formulations The collaboration will advance the formulation of therapies that are traditionally limited to injections. Nanobodies are the therapeutic proteins based on camelid-derived immunoglobulin… Read More »Sanofi Collaborates with i2O Therapeutics to Evaluate Oral i2O Therapeutics

PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

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Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment… Read More »PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

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Shots: The approval is based on two P-III studies assessing the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000 patients with influenza aged > 18yrs. Supemtek is 1st and only recombinant influenza vaccine approved in the EU The P-III efficacy study demonstrated… Read More »Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease

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Shots: The US FDA accepted for priority review the BLA of avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. The target action date for the FDA decision is May 18, 2021 The BLA is based on positive data… Read More »Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease

NICE okays Roche liver cancer immunotherapy, Sanofi’s rare disease drug

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Previously-untreated patients with hepatocellular carcinoma (HCC), a common form of liver cancer, will have an immunotherapy-based treatment option after NICE gave the nod to NHS funding of Roche’s Tecentriq and Avastin combination therapy. The decision by NICE comes shortly after Tecentriq (atezolizumab) and Avastin (bevacizumab)… Read More »NICE okays Roche liver cancer immunotherapy, Sanofi’s rare disease drug

Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s KEYTRUDA® (pembrolizumab) in Patients with Various Cancers

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Shots: Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors In preclinical studies,… Read More »Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s KEYTRUDA® (pembrolizumab) in Patients with Various Cancers

Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma

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Shots: The NICE has issued FAD which is based on the P-III ICARIA-MM trial assessing isatuximab + pom-dex vs pom-dex in patients prior treated with 3L treatment and at least 2L therapies including lenalidomide and a proteasome inhibitor with RRMM in 307 patients with RRMM… Read More »Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma

Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

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Shots: The companies reported the preclinical results of MRT5500 demonstrating the potential of the vaccine in neutralizing the Abs against SARS-CoV-2. The two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients The preclinical data support the advancement of… Read More »Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

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Shots: The Health Canada has approved a new indication as an add-on maintenance treatment with intranasal corticosteroids in patients with CRSwNP, inadequately controlled by systemic corticosteroids or surgery The approval is based on P-III studies (24wks. SINUS-24 and 52wks. SINUS-52) assessing Dupixent (300mg, q2w) +… Read More »Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

Sanofi acquires Principia; FDA’s Nod to Roche’s Enspryng; BMS, Dragonfly’s Licensing Deal

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New strategy, new outlook: Sanofi takes another step, gains full control over the Principia’s MS treatment  Sanofi has inked a definitive agreement with Principia Biopharma to acquire the company, all of its outstanding shares, and its BTK inhibitors in a deal worth USD 3.68 Billion.… Read More »Sanofi acquires Principia; FDA’s Nod to Roche’s Enspryng; BMS, Dragonfly’s Licensing Deal

Can llama antibodies beat COVID-19? Belgium’s ExeVir raises 23m euros to find out

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Belgium’s ExeVir Bio is to accelerate development of a new treatment for COVID-19 based on llama antibodies, after a 23 million euro ($27 million) financing round. ExeVir is a spin-out of Vlaams Instituut voor Biotechnologie (VIB), Belgium’s life sciences research institute and the company also… Read More »Can llama antibodies beat COVID-19? Belgium’s ExeVir raises 23m euros to find out