Search Results for “Sanofi” – Page 2 – media

Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary. By Frank Vinluan A primary immunodeficiency whose rarity means it can go undiagnosed or misdiagnosed in a patient for years now has its first drug. The FDA has approved a once-daily therapy that addresses the underlying genetic problem driving the inherited disorder, known as WHIM syndrome. The regulatory decision announced Monday for the X4 Pharmaceuticals drug covers WHIM patients age 12 and older. The daily capsule, known in development as mavorixafor, will be commercialized under the brand name Xolremdi (pronounced “zohl-REM-dee”). The name WHIM is an acronym for warts, hypogammaglobulinemia, infections, and myelokathexis, which are the four common clinical presentations of the disease. But the disease is not limited to those symptoms and it presents differently from one patient to another. There is no standard ...
- Source: https://medcitynews.com/author/fvinluan/
- 91
- May 4, 2024
Sanofi, Denali Neuro Drug Fails Mid-Stage Trial in ALS; MS Study Is Continuing

Sanofi, which is leading development of the Denali Therapeutics-partnered molecule, disclosed little about the clinical trial results in ALS. But this Phase 2 failure follows the 2020 clinical trial pause of a different partnered molecule that addresses the same target. By FRANK VINLUAN Amyotrophic lateral sclerosis develops through multiple pathways, so drug research in this neuromuscular disorder has pursued multiple targets. One of those targets faces some doubts after an ALS drug candidate from partners Sanofi and Denali Therapeutics failed to meet the goal of a mid-stage clinical trial. Denali disclosed the Phase 2 clinical trial failure in a Friday regulatory filing. The South San Francisco-based biotech said Sanofi informed it that the brain-penetrating drug, known at Denali as DNL788 and renamed SAR443820 by the pharmaceutical giant, did not meet the main endpoint of showing a change in the ALS Functional Rating Scale-Revised, a scoring assessment for evaluating symptoms in ...
- Source: drugdu
- 149
- February 26, 2024
Sanofi’s investigational frexalimab shows promise in relapsing forms of MS

Sanofi has announced that its investigational anti-CD40L antibody frexalimab has shown potential as a “high-efficacy therapy” for relapsing multiple sclerosis (MS), according to mid-stage results published in The New England Journal of Medicine. Affecting approximately 2.8 million people worldwide, MS is a disabling, neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. Relapsing forms of MS are characterised by clearly defined, but unpredictable, attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared to 15% with progressive forms of the disease. Sanofi frexalimab has “a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion,” the company said. The phase 2 study of the candidate randomised ...
- Source: drugdu
- 103
- February 20, 2024
Regeneron and Sanofi’s Dupixent bags fifth drug label in Japan

Sanofi and Regeneron Pharmaceuticals have received yet another approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Dupixent (dupilumab), this time as a treatment of chronic spontaneous urticaria (CSU). The Japanese agency approved Dupixent in CSU patients ages 12 and older whose symptoms are inadequately controlled by H1-antihistamines. This is the first approval for the therapy in this indication. Dupixent, a monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, has been a high-grossing drug for Sanofi and Regeneron. In 2023, the therapy netted $11.59bn in global sales in 2023, as per Regeneron’s financials. GlobalData forecasts Dupixent sales to maintain their upward trajectory and generate $20.4bn in sales in 2030. Dupixent has been approved by the US Food and Drug Administration (FDA) and European Commission (EC) for five indications: atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis. ...
- Source: drugdu
- 150
- February 19, 2024
Sanofi’s ‘SR604 Injection’ Approved in China, ‘Yipian Lida’ Supports Lipid Management with ‘Dual Standards’

Sanofi announced that its rosuvastatin and ezetimibe tablets (I) (Yipian Lida®) have been approved by the National Medical Products Administration (NMPA) of China for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) patients. As the first approved and marketed combination formulation of rosuvastatin and ezetimibe in China, Yipian Lida® marks the beginning of a new era in potent combination lipid-lowering therapy. A single dose achieves a greater than 50% reduction in low-density lipoprotein cholesterol (LDL-C), effectively and continuously lowering LDL-C to target levels, supporting ‘Dual Standards’ in lipid management, and providing a new and powerful option for patients with lipid abnormalities. Academician Ge Junbo from Zhongshan Hospital, affiliated with Fudan University, stated, “In the face of the increasingly serious burden of cardiovascular diseases, effective control and management of risk factors are crucial. Only by controlling LDL-C to ideal levels early can we reduce the incidence of adverse events and ...
- Source: drugdu
- 172
- January 1, 2024
Sanofi Abandons Deal for Rare Disease Drug Amid FTC’s Monopoly Concerns

Sanofi, which markets the two primary treatments for Pompe disease, was trying to add a third one by licensing rights to a Maze Therapeutics drug candidate with a different therapeutic approach. A Federal Trade Commission complaint alleges the deal amounts to a monopoly player taking out its competition. By FRANK VINLUAN Sanofi is walking away from a deal to license an experimental Maze Therapeutics drug for a rare enzyme deficiency after the Federal Trade Commission challenged the transaction as anti-competitive. The French pharmaceutical giant already markets Lumizyme and Nexviazyme for the disorder, called Pompe disease. Until this year, they were the only available Pompe treatments. In an administrative complaint filed Monday, the anti-trust regulator said Sanofi’s deal for Maze’s drug candidate amounts to a large company trying to eliminate a smaller competitor. Both Sanofi and Maze disagree with the FTC’s position. South San Francisco-based Maze said it is reviewing its ...
- Source: drugdu
- 103
- December 15, 2023
After leak of neurotoxin, Sanofi plant in France is under scrutiny again

A Sanofi manufacturing facility in France, which was temporarily closed five years ago for emitting dangerous emissions, is under the microscope again after a recent leak caused the release of the same neurotoxin, bromopropane. The plant, which produces epilepsy drug Depakine (sodium valproate), released 75 times the allowable amount of bromopropane in mid-November, according to a report in the French news outlet Le Monde. The facility, located in Mourenx, stopped production “immediately” after noting “inconsistent measurements” of bromopropane emissions, according to a Sanofi spokesperson. “We quickly identified that this isolated and very brief event was linked to the degradation of the treatment unit’s activated carbons following the bad weather and heavy rains that had affected the region in the preceding days,” Sanofi said. “The coals were replaced and bromopropane emissions returned to normal, enabling production to resume after approval from the authorities.” Bromopropane—which is used in the production of Depakine—is ...
- Source: drugdu
- 102
- December 14, 2023
Sanofi’s quiet Sarclisa chalks up a first-in-class win with eyes on a first-line multiple myeloma nod

In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little. Using Sarclisa on top of Takeda’s Velcade, Bristol Myers Squibb’s Revlimid and the steroid dexamethasone (VRd), significantly reduced the risk of disease progression or death versus VRd alone in patients with newly diagnosed multiple myeloma not eligible for transplant, Sanofi said Thursday. Sanofi’s phase 3 IMROZ readout comes as Sarclisa’s in-class rival, Johnson & Johnson’s Darzalex, is sharing a positive phase 3 for its VRd combo in transplant-eligible patients at the upcoming American Society of Hematology annual meeting. Still, the J&J data don’t prevent Sanofi from claiming the first phase 3 win for an anti-CD38 antibody with VRd in transplant-ineligible patients. Results from the IMROZ trial will be shared at a future medical meeting and will support a regulatory filing, Sanofi said. A ...
- Source: drugdu
- 104
- December 9, 2023
Sanofi/Regeneron’s Dupixent shows promise in chronic obstructive pulmonary disease

Sanofi and Regeneron have shared positive results from a late-stage trial of Dupixent (dupilumab) in chronic obstructive pulmonary disease (COPD). The phase 3 NOTUS trial has been evaluating the investigational use of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled COPD and evidence of type 2 inflammation. The trial met its primary endpoint, with Dupixent shown to reduce moderate or severe acute COPD exacerbations by 34% compared to placebo. Results from the interim analysis also demonstrated that Dupixent improved lung function from baseline by 139ml at 12 weeks compared to 57ml for placebo, with this benefit sustained at week 52. COPD is a chronic respiratory disease that causes lung function to progressively decline. Approximately 300,000 people in the US live with uncontrolled cases of the condition and evidence of type 2 inflammation. The positive readout from NOTUS builds on the previous results from the ...
- Source: drugdu
- 106
- November 29, 2023
With filing in Sanofi and Mylan insulin lawsuit, FTC amps up scrutiny on pharma’s patent tactics

The U.S. Federal Trade Commission isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. And it’s Sanofi’s turn to land in the crosshairs. The FTC is weighing in on an antitrust lawsuit that Viatris’ Mylan brought against Sanofi in May centered on the French pharma’s popular insulin product Lantus. Although the agency didn’t pick sides in the case, it’s using the lawsuit as an opportunity to criticize the type of behavior accused of Sanofi. Specifically, the FTC argues “improper” listings in the FDA’s “Orange Book” can “cause significant harm to competition, and that harm can extend beyond the delay” in access to a competing drug, the FTC said in an amicus brief filed in the case. In the lawsuit, Mylan accused Sanofi of running a “multifaceted monopolization scheme” to protect Lantus. One of the alleged illegal practices ...
- Source: drugdu
- 101
- November 23, 2023

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