Sanofi US News

- The 0.5 mL dose is now approved for use in children 6 months through 35 months of age

* First and only vaccine approved in the U.S. for repeat vaccination 8 years or more after the first vaccination to help protect against tetanus, diphtheria and pertussis, offering flexibility for health care providers to help manage their immunization schedules(2)

-HERCULES Phase 3 trial met its primary endpoint, demonstrating that treatment with Cablivi resulted in a significantly faster time to platelet count response in patients with acquired thrombotic thrombocytopenic purpura (aTTP) when administered in conjunction with plasma exchange and immunosuppression

Provention is currently developing PRV-101 as a vaccine for acute coxsackie infection and to potentially prevent the onset of T1D

* Mortality risk reduction greater in patients treated for at least 3 years or those with baseline LDL-C levels of at least 100 mg/dL

Conference Call and Live Audio Webcast Scheduled for Today at 8:30 a.m., ET

* Praluent significantly reduced major adverse cardiovascular events by 15% (p<0.001)

- Top-line data from the "PULSE" clinical trial expected in the second quarter of 2019

-- Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype

- Dupixent significantly reduced nasal polyp size, nasal congestion severity, and need for systemic corticosteroids and/or surgery

* Libtayo is the third anti-PD-1 approved in the U.S.

* FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy

Industry executive adds considerable financial expertise as audit committee chairperson

- First therapeutic approved for the treatment of aTTP, a rare blood-clotting disorder

- Provention strengthens its strategic platform in type 1 diabetes (T1D) interception and prevention

Nearly 70 million doses to be manufactured this season

- Company invests €66 million in Chengdu, Sichuan province, China

- Toujeo (insulin glargine injection 300 Units/mL) met primary endpoint in lowering blood sugar levels and was non-inferior to insulin degludec in adults with type 2 diabetes not previously on insulin

-- Patients treated with cemiplimab experienced robust anti-tumor effects

* In steroid-sparing VENTURE trial, Dupixent-treated patients substantially reduced use of oral corticosteroids, yet had fewer exacerbations and improved lung function compared to placebo.

* U.S. regulatory submission for patients ages 12-17 planned for third quarter 2018

-- Agreement provides Praluent at lower net price and enables streamlined patient access based on physician attestation

- If approved, health care professionals will be able to use the same 0.5 mL dose of Fluzone Quadrivalent vaccine with all patients ages 6 months and older for whom flu vaccination is recommended - which may provide more flexibility and convenience to immunizers.

* Max SoloStar holds more insulin than any other long-acting insulin pen

- Sanofi teams up with television personality Adam Savage and allergist Dr. Neeta Ogden to help dispel common allergy misconceptions with facts

* Precision medicine approach will focus efforts on high-risk patients, such as those who have had heart attacks or unstable angina and cannot reduce their LDL-C below 100 mg/dL despite maximally-tolerated statins

* ODYSSEY OUTCOMES trial met its primary endpoint, demonstrating that high-risk patients who added Praluent® (alirocumab) Injection to maximally-tolerated statins experienced significantly fewer major adverse cardiovascular events compared to those on maximally-tolerated statins alone

Companies also announce submission of dupilumab supplemental BLA for uncontrolled, persistent asthma

High and durable response rate in disease without any FDA-approved therapies

* First FDA-approved follow-on mealtime insulin

Phase 3 trials will evaluate isatuximab, an anti-CD38 antibody, in combination with other cancer treatments 

First head-to-head randomized clinical trial comparing the efficacy and safety of Toujeo (insulin glargine 300 Units/mL) versus insulin degludec

Two large real-world analyses compared adults with type 2 diabetes who were switched to Toujeo (insulin glargine injection 300 Units/mL) to those switched to insulin degludec

First study with a biologic to show benefit in severe steroid-dependent asthma population that enrolled patients regardless of blood eosinophil levels or any other Type 2 biomarkers at baseline

- Late-breaking oral abstract presented at the World Congress of Gastroenterology -

- Understand AD: A Day in the Life, Raises Awareness of Atopic Dermatitis by Sharing Real Stories from the AD Community, Driving Empathy and Understanding of this Unrelenting, Chronic Disease -

- Praluent continues to be available to patients in the U.S. -

- First targeted biologic in the European Union to receive marketing authorization for use in atopic dermatitis -

- In preclinical studies, trispecific antibodies show exceptional potency against diverse HIV viruses -

- Investigational RNAi Therapeutic Patisiran Meets Primary and All Secondary Endpoints, with Highly Significant Reduction In Neuropathy Progression and Improvement in Quality of Life at 18 Months Relative to Placebo -

- Late-breaking oral abstract of Phase 3 CAFÉ study presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress -

-- More adults reached HbA(1c) target at 8 and 12 weeks versus those receiving insulin glargine 100 Units/mL --

- Investigational dupilumab reduced severe asthma attacks and improved lung function -

- An innovative quadrivalent influenza vaccine will complement Sanofi Pasteur vaccine portfolio -

- Health care providers anticipating initial shipments by early August to kick off influenza immunization season -

- Acquisition adds recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio -

- Data presented at the 77th Scientific Sessions of the American Diabetes Association (ADA) -

- New DELIVER 3 Real-World Toujeo® Observational Study Confirms Reduction of Hypoglycemia in Real-Life Setting -

- All subgroups treated with Soliqua 100/33 achieved a mean HbA1c of below 7 percent after 30 weeks -

- Oral presentation provides first REGN2810 data in patients with advanced cutaneous squamous cell carcinoma (CSCC) -

- Kevzara is now available to U.S. patients -

-- New Initiative Encourages Americans to Help Reduce Air Pollution & Enjoy the Outdoors this Spring Allergy Season --

Op-Ed by Olivier Brandicourt

- New U.S. survey reveals significant unmet needs when it comes to treatments and support for those living with RA -

- New action date for Kevzara U.S. BLA is May 22, 2017 -

- Monthly dosing schedule now approved in both United States and European Union -

- New U.S. indication approved for Thymoglobulin [anti-thymocyte globulin (rabbit)]; first since 1998 -

- New toothpaste introduced by the trusted leader in mouthwashes for more than 30 years helps motivate kids to brush their teeth -

- DELIVER 2 Data Showed Reduction in Hypoglycemic Events Related to Inpatient or Emergency Department Visits -

- Dupixent will be available later this week to U.S. patients suffering from this chronic and debilitating form of eczema -

- During Multiple Myeloma Month Sanofi Genzyme is Reinforcing its Commitment to Help Patients Live with the Second Most Common Blood Cancer in the World -

The makers of Xyzal® Allergy 24HR, now available over-the-counter (OTC) at full prescription strength, are teaming up with Dr. Neeta Ogden to Encourage Allergy Sufferers to 'Wise Up, Rise Up'

Respiratory Syncytial Virus is the most common cause of lung inflammation and pneumonia in infants

- Late-breaking oral abstract to be presented today at the Annual Meeting of the American Academy of Dermatology -