Sanofi | MedPath

FDA Approves GSK's Nucala for COPD Treatment, Expanding Options for "Smoker's Lung"

15 hours ago

• The FDA has approved GSK's monoclonal antibody Nucala as an add-on treatment for patients with chronic obstructive pulmonary disease (COPD), commonly known as "smoker's lung." • In late-stage clinical trials, Nucala reduced COPD exacerbations by 21% compared to placebo when combined with standard inhaled maintenance therapy over a 104-week period. • The approval expands treatment options for COPD, joining Sanofi/Regeneron's Dupixent and Verona Pharma's Ohtuvayre in addressing this condition that is the fourth leading cause of death worldwide.

Sanofi to Acquire Vigil Neuroscience for Up to $600 Million, Expanding Alzheimer's Disease Pipeline

a day ago

• Sanofi has entered into a definitive merger agreement to acquire Vigil Neuroscience for $8.00 per share in cash upfront, with an additional $2.00 per share contingent value right tied to VG-3927's first commercial sale. • The acquisition strengthens Sanofi's neurology pipeline with VG-3927, a Phase 2-ready oral small molecule TREM2 agonist being developed for Alzheimer's disease, targeting microglial dysfunction in neurodegenerative disorders. • The transaction, valued at approximately $600 million including the potential CVR payment, is expected to close in the third quarter of 2025, with Vigil's monoclonal antibody program iluzanebart not included in the acquisition.

Moderna Withdraws FDA Application for Flu-COVID Combo Vaccine, Plans Resubmission Later This Year

2 days ago

• Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA. • The company plans to resubmit the application later in 2025 after obtaining vaccine efficacy data from an ongoing Phase 3 trial of its seasonal influenza vaccine candidate, mRNA-1010. • Interim data from the mRNA-1010 Phase 3 trial is expected to be available this summer, which will inform the resubmission strategy for the combination vaccine.

SK Bioscience Wins Patent Dispute Against Pfizer Over Pneumococcal Vaccine Components

2 days ago

• South Korea's Supreme Court ruled that SK bioscience's PCV13 components do not infringe on Pfizer's patent claims, allowing the company to export vaccine components to high-demand markets. • Despite the victory, SK bioscience remains restricted from selling its domestically developed SKYPneumo vaccine in South Korea until 2027 due to a separate patent dispute with Pfizer. • SK bioscience is simultaneously developing a more advanced 21-valent pneumococcal conjugate vaccine in collaboration with Sanofi, which entered global Phase 3 clinical trials in late 2024.

Riliprubart Shows Promise in CIDP Treatment with Significant Neurofilament Light Reduction

7 days ago

• Phase 2 study results reveal that Sanofi's investigational riliprubart reduced plasma neurofilament light levels by 31% in patients with chronic inflammatory demyelinating polyneuropathy. • Greater reductions in neurofilament light levels correlated with higher treatment response rates, with up to 69% of patients showing improvement in disability scores. • Riliprubart, a selective inhibitor of the classical complement pathway, is now being evaluated in two global Phase 3 trials (MOBILIZE and VITALIZE) across 28 countries.

UPC Dismisses Sanofi's Infringement Claim Against Amgen's Repatha in Landmark PCSK9 Inhibitor Ruling

10 days ago

• The Düsseldorf local division of the Unified Patent Court has dismissed Sanofi and Regeneron's infringement suit against Amgen, allowing continued sales of the PCSK9 inhibitor Repatha across five European countries. • In the UPC's first ruling on a second medical use patent, judges upheld the validity of Sanofi's EP 3 536 712 B1 patent but found Amgen's Repatha did not infringe on claims related to reducing lipoprotein(a) levels. • The decision marks another chapter in the decade-long legal battle between pharmaceutical giants over cholesterol-lowering drugs, with conflicting patent validity rulings between the UPC and European Patent Office creating further complexity.

Scribe Therapeutics to Present Novel CRISPR-Based Gene Therapy Data for Duchenne Muscular Dystrophy at ASGCT 2025

17 days ago

• Scribe Therapeutics will showcase its X-Editor (XE) technology targeting mutations in Duchenne Muscular Dystrophy at the upcoming ASGCT Annual Meeting in May 2025. • The company will present joint research with Prevail Therapeutics, a Lilly subsidiary, demonstrating self-inactivating AAV vectors that achieved potent, transient editing in the murine central nervous system. • These presentations highlight Scribe's "CRISPR by Design" approach to developing in vivo genetic medicines, following a recent milestone in their collaboration with Eli Lilly to address neurological and neuromuscular diseases.

Sanofi's Amlitelimab Shows Promising Results in Atopic Dermatitis Trial Following $1.45bn Kymab Acquisition

a month ago

• Sanofi's amlitelimab (formerly KY1005), acquired through its $1.45 billion Kymab purchase, demonstrated significant efficacy in a Phase 2a trial for moderate to severe atopic dermatitis with an 80% improvement in EASI scores at the low dose. • The OX40 ligand-targeting antibody showed durable effects, with two-thirds of patients maintaining clear or almost clear skin 24 weeks after the final dose, positioning it as a potential complement to Sanofi's blockbuster Dupixent. • Despite increasing competition in the atopic dermatitis market from biologics and JAK inhibitors, Sanofi is advancing amlitelimab to Phase 2b trials, emphasizing the need for diverse treatment options for this challenging condition.

Next-Generation Gene Therapies: Evolving Beyond Viral Vectors Towards More Affordable, Sustainable Solutions

2 months ago

• Despite 32 approved gene therapies globally, the industry faces significant challenges in safety, efficacy, and affordability, prompting development of novel delivery systems beyond traditional viral vectors. • Companies are advancing non-viral delivery platforms including exosomes, lipid nanoparticles, and hydrophilic nanoparticles that offer cost-effective alternatives with reduced immunogenicity and potential for repeat dosing. • Next-generation gene editing technologies like Prime Editing and CRISPR variants are emerging as more precise alternatives to traditional CRISPR-Cas9, with Prime Medicine's PM359 for chronic granulomatous disease advancing to clinical trials.

CureVac Wins Key Patent Validity Decision in Ongoing mRNA Litigation Against BioNTech

2 months ago

• European Patent Office largely upholds CureVac's patent EP 3 708 668 B1 for split poly-A tail technology, a foundational mRNA innovation, dismissing BioNTech's opposition challenge. • The ruling represents a significant milestone in the broader patent dispute between the two companies, with an infringement hearing scheduled for July 1, 2025, at the Regional Court Düsseldorf. • CureVac seeks recognition and compensation for its pioneering contributions to mRNA technology that enabled the development of COVID-19 vaccines.

NK Cell Therapy Market Poised for Significant Growth with Innovative Pipeline Developments

3 months ago

• The NK cell therapy market is experiencing robust growth driven by increasing interest in immuno-oncology and advancements in cell engineering technologies, with significant expansion expected through 2034. • Leading companies including Artiva Biotherapeutics, Glycostem, Fate Therapeutics, and Senti Biosciences are developing promising therapies such as AlloNK, oNKord, and FT522, with several receiving FDA designations for expedited development. • Off-the-shelf NK cell therapies are emerging as a key trend, offering advantages in manufacturing scalability, immediate availability, and potential applications beyond oncology into autoimmune diseases.

FDA Cancels Critical Flu Vaccine Advisory Meeting, Raising Production Timeline Concerns

3 months ago

• The FDA has unexpectedly canceled the March 13 meeting of its Vaccines and Related Biological Products Advisory Committee, which was scheduled to discuss next year's flu vaccine composition. • The cancellation could significantly impact the six-month flu vaccine production cycle, potentially disrupting the traditional June manufacturing start date. • Health experts and vaccine manufacturers express concern over the disruption to the established regulatory process for seasonal flu vaccine strain selection.

Tezepelumab Shows Remarkable 92% Reduction in Nasal Polyp Surgery Need in Phase 3 Trial

3 months ago

• Phase 3 WAYPOINT trial demonstrates tezepelumab significantly reduced nasal polyp severity and improved nasal congestion scores in patients with severe chronic rhinosinusitis with nasal polyps. • The study showed a dramatic 92% reduction in the need for nasal polyp surgery or systemic corticosteroid treatment compared to placebo over 52 weeks. • Patients receiving tezepelumab experienced significant improvements in multiple symptoms, including loss of smell and sino-nasal outcomes, with similar adverse event rates to placebo.

Novel Oral Psoriasis Therapies Show Promise: TYK2 Inhibitors Lead Breakthrough Advances

3 months ago

• Deucravacitinib demonstrates superior efficacy over apremilast in psoriasis treatment, with over 53% of patients achieving significant skin clearance at week 16. • Apremilast maintains its position as a key therapy for mild-to-moderate psoriasis, with 21% of bio-naïve patients achieving treatment goals in the ADVANCE trial. • Next-generation oral therapies, including JNJ-77242114 and zasocitinib, show promising results in clinical trials, potentially expanding treatment options for psoriasis patients.

FDA Approves First Rapid-Acting Insulin Biosimilar Merilog for Diabetes Management

3 months ago

• The FDA has granted approval to insulin-aspart-szjj (Merilog), marking the first rapid-acting insulin biosimilar for diabetes treatment, expanding treatment options for over 38 million Americans with diabetes. • Developed by Sanofi-Aventis as a biosimilar to Novo Nordisk's Novolog, Merilog is indicated for glycemic control in both adult and pediatric diabetes patients, available in pre-filled pens and multiple-dose vials. • The approval represents FDA's ongoing commitment to increase access to affordable insulin options, joining two previously approved long-acting insulin biosimilars from 2021.

Talquetamab and Teclistamab Combination Shows Promise in Relapsed/Refractory Multiple Myeloma

6 months ago

• A Phase Ib/II trial of talquetamab plus teclistamab shows promising antitumor activity and durable responses in relapsed/refractory multiple myeloma patients. • The combination therapy demonstrated an 80% response rate in patients administered the recommended Phase II dose, including those with extramedullary disease. • The study also reported a higher incidence of grade 3 or 4 infections compared to either drug as monotherapy, warranting further investigation. • These results suggest the dual-targeting combination therapy may be a valuable option for heavily pretreated multiple myeloma patients.