iHub News
4週前
Sanofi Halts Phase 3 CIDP Trial for Riliprubart Following Interim Review (SAN)June 10, 2026 5:48 AM
IH Market News Sanofi (NASDAQ:SNY) said on Wednesday that it has decided to discontinue the phase 3 MOBILIZE trial evaluating riliprubart in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) who have not responded to standard treatments. The decision follows an interim assessment conducted by an independent data monitoring committee, which concluded that the study was unlikely to achieve sufficient efficacy endpoints. The committee also reported that no safety concerns linked to riliprubart were identified during the review. Sanofi stated that it will assess the future of its other ongoing riliprubart programmes, including the phase 3 VITALIZE study involving CIDP patients currently receiving intravenous immunoglobulin (IVIg) therapy. The company will work closely with investigators and clinical sites to conclude the MOBILIZE trial and ensure enrolled participants are transitioned appropriately to alternative care. Sanofi also plans to undertake a comprehensive review of the study data to help guide future research and contribute to a broader understanding of CIDP. Management noted that ending the MOBILIZE study is not expected to result in any material financial impact, and the company reiterated that its 2026 financial guidance remains unchanged. Riliprubart is an IgG4 humanised monoclonal antibody designed to selectively block activated C1s within the classical complement pathway of the innate immune system. The treatment remains investigational, and its safety and effectiveness have not been approved by any regulatory authority. CIDP is a rare neurological disorder characterised by progressive muscle weakness and sensory dysfunction affecting the arms and legs. Around 30% of patients do not respond to currently available therapies, while approximately 70% of those who do respond fail to achieve a full recovery. More about Sanofi Sanofi is a global healthcare company focused on developing medicines and vaccines across a range of therapeutic areas, including immunology, rare diseases, oncology, neurology and vaccines. The group operates worldwide and invests heavily in research and development to advance innovative treatments for patients with unmet medical needs. Sanofi stock price Original: Sanofi Halts Phase 3 CIDP Trial for Riliprubart Following Interim Review (SAN)
US Market News
2月前
Sanofi Supports AlphaDetect to Accelerate Detection of Alpha-1May 6, 2026 12:42 PM
PR Newswire (US) The sponsorship helps expand proven Alpha-1 detection strategies, which will enable earlier patient identificationDURHAM, N.C., May 6, 2026 /PRNewswire/ -- AlphaDetect, the nonprofit organization powered and funded by the Alpha-1 Foundation, today announced Sanofi as one of its inaugural industry sponsors. This support further strengthens efforts to accelerate routine detection of Alpha-1 Antitrypsin Deficiency (Alpha-1), consistent with clinical practice guidelines. AlphaDetect is dedicated to identifying everyone at risk for this progressive, genetic condition by elevating awareness, removing barriers, and expanding adoption of testing recommendations in clinical practice guidelines, so that Alpha-1 detection becomes routine for patients impacted by lung and liver disease. The organization is increasing the availability of Alpha-1 detection tools and support at the practice level while partnering with healthcare providers to strategically advance protocols and technologies across healthcare systems."Sanofi is proud to support AlphaDetect's mission, as one of the inaugural sponsors, to increase and accelerate Alpha-1 detection," said Alaa Hamed, Global Head of Medical Affairs, Rare Diseases at Sanofi. "This effort represents a meaningful step forward in uncovering those at risk for this extremely underdiagnosed rare disease, which can have a devastating impact. This collaboration reflects our commitment to the Alpha-1 community, particularly in driving awareness and recognition. Ensuring that people who have this underlying genetic condition can uncover this diagnosis earlier in their care journey is fundamental to their chance of better outcomes. We look forward to working with AlphaDetect on this important effort.""Alpha-1 is a progressive, genetic lung and liver condition where delays in detection may have real, irreversible consequences, " said Julie Murray, CEO of AlphaDetect. "The ability to scale proven approaches to identifying at-risk patients, quickly and systematically, can inform timely decisions for those impacted. The support and commitment from Sanofi are important and appreciated as we continue to advance Alpha-1 detection."Alpha-1 remains significantly underdiagnosed, with more than 90% of affected individuals estimated to be unidentified. It is also the leading known genetic risk factor for COPD and is associated with liver disease in both children and adults. Importantly, detection also provides a point of entry into the Alpha-1 community, opening the door to the comprehensive information, support, and resources needed for the journey ahead."This support builds on Sanofi's commitment to rare disease and the Alpha-1 community," said Scott Santarella, CEO of the Alpha-1 Foundation. "It also represents an important step forward in how we approach detection. By expanding these efforts through AlphaDetect, we can identify more individuals earlier and deliver on the Alpha-1 Foundation's mission of improving their lives."The latest clinical guidelines recommend testing for Alpha-1 in all individuals with COPD, treatment-resistant asthma, or unexplained liver disease. Yet real-world results fall far short of this. AlphaDetect is committed to closing the gap. Sanofi's sponsorship and commitment will help AlphaDetect scale efforts to enhance provider education, broaden detection strategies, and work across the Alpha-1 community to identify individuals with Alpha-1.About AlphaDetect AlphaDetect, founded in 2025, accelerates detection to uncover everyone genetically at risk for Alpha-1. Located in Durham, NC, AlphaDetect will operate as a limited liability company and a non-profit subsidiary of Alpha-1 Foundation, holding tax-exempt status under Section 501(c)3 of the Internal Revenue Code. For more information, visit https://alpha1.org/alphadetect/Contact: Cindy Machlescmachles@alphadetect.orgAbout Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNYFor more information, visit www.sanofi.comContact: Evan Berlandevan.berland @ Foundation? The Alpha-1 Foundation, founded in 1995, is committed to finding a cure for Alpha-1 Antitrypsin Deficiency (Alpha-1) and to improving the lives of people affected by the condition worldwide. A1F has invested over $100 million to support Alpha-1 research and programs at 130 institutions in North America, Europe, the Middle East , and Australia.?? For more information, visit?alpha1.org? Contact: Jeanne Kushner? jkushner@alpha1.org View original content to download multimedia:https://www.prnewswire.com/news-releases/sanofi-supports-alphadetect-to-accelerate-detection-of-alpha-1-302764446.htmlSOURCE Alpha-1 Foundation Original: Sanofi Supports AlphaDetect to Accelerate Detection of Alpha-1
US Market News
3月前
Sanofi devient la détentrice de l'autorisation de mise en marché de Nuvaxovid(MD) au Canada, élargissant ainsi les choix de vaccins contre la COVID-19 pour la population canadienneApril 9, 2026 10:00 AM
PR Newswire (Canada)
Sanofi proposera Nuvaxovid, un vaccin non-ARNm contre la COVID-19, pour la saison automnale 2026-2027La disponibilité provinciale et territoriale sera confirmée après les discussions en cours et les évaluations provincialesLe transfert de l'autorisation de mise en marché de Novavax fait suite à l'entente stratégique entre Sanofi et cette entreprise signée en mai 2024Ce transfert souligne l'engagement de Sanofi envers la santé publique et l'innovation vaccinale au CanadaTORONTO, le 9 avril 2026 /CNW/ - Sanofi annonce aujourd'hui qu'elle est désormais la détentrice de l'autorisation de mise en marché au Canada de Nuvaxovid, un vaccin non-ARNm contre la COVID-19 à base de protéines. Nuvaxovid représente un nouveau jalon dans l'engagement de Sanofi à bâtir une gamme diversifiée de vaccins de premier ordre et à s'attaquer aux maladies respiratoires qui touchent la population canadienne tout au long de la vie. Sanofi proposera Nuvaxovid au Canada pour la saison automnale 2026-2027.
« Avec le lancement de Nuvaxovid, un vaccin non-ARNm contre la COVID-19 à base de protéines, Sanofi est maintenant en mesure d'offrir un plus grand choix à la population canadienne en matière de protection contre la COVID-19. La disponibilité de Nuvaxovid signifie que chaque Canadien et Canadienne aura la possibilité d'avoir accès au vaccin contre la COVID-19 de son choix », a déclaré Delphine Lansac, directrice générale, Vaccins, chez Sanofi. « La population canadienne a clairement exprimé le besoin d'avoir accès à une option non-ARNm en ce qui a trait à la protection contre la COVID-19. Grâce à ce transfert, Sanofi peut maintenant répondre à ce besoin. »Nuvaxovid est un vaccin non-ARNm à base de protéines indiqué pour l'immunisation active visant à prévenir la COVID-19 causée par le SARS-CoV-2 chez les personnes âgées de 12 ans et plus1. Il a été démontré qu'il présente un profil de tolérabilité favorable, adapté à la vaccination saisonnière2-4. Le vaccin repose sur une plateforme technologique éprouvée, à base de protéines et a également fait preuve d'une efficacité d'environ 90 % dans la prévention de la COVID-19 symptomatique, selon les résultats d'études cliniques pivots de phase III5-6.Sanofi supervisera la production, la distribution et la surveillance de l'innocuité du vaccin à titre de nouvelle détentrice de l'autorisation de mise en marché. Dans la perspective de la saison des virus respiratoires 2026-2027, Sanofi se prépare activement à répondre à la demande au Canada, en s'efforçant de garantir aux patients l'accès à ce vaccin unique contre la COVID-19, à base de protéines et non-ARNm, offrant ainsi une plus large gamme de vaccins respiratoires.À propos de la COVID-19La COVID-19 demeure une cause majeure de maladie, d'hospitalisation et de décès, ce qui représente un lourd fardeau pour le système de santé au Canada. Au cours de la saison automne-hiver 2024-2025, le Canada a enregistré plus de 120 718 cas confirmés de COVID-19, plus de 33 500 hospitalisations, 469 admissions en soins intensifs et plus de 2 300 décès dus à la COVID-197. La maladie a non seulement des conséquences immédiates sur la santé, mais elle augmente également le risque à long terme de complications cardiovasculaires, notamment de crises cardiaques et d'accidents vasculaires cérébraux8. Malgré ces risques persistants, 73,9 % des adultes canadiens n'ont pas été vaccinés en 2024-2025; une partie importante de la population reste donc vulnérable aux formes graves de la COVID-199. L'élargissement des options vaccinales pourrait contribuer à renforcer la confiance vis-à-vis des vaccins et à améliorer le taux de vaccination, ce qui permettrait, à terme, de réduire le fardeau de la COVID-19 pour la population et le système de santé canadien.À propos de Sanofi Sanofi est une société biopharmaceutique qui innove en recherche et développement et exploite l'IA. Elle est déterminée à améliorer la vie des gens et à être une solide source de croissance. Nous mettons à profit notre compréhension approfondie du système immunitaire pour inventer des médicaments et des vaccins qui traitent et protègent des millions de personnes dans le monde entier. Nos produits en développement représentent une lueur d'espoir pour des millions d'autres patients.Sanofi est le plus grand fabricant de produits biopharmaceutiques au Canada et investit, innove et opère dans l'ensemble de la filière des sciences de la vie. Nous comptons plus de 2 000 employés, investissons 20 % de nos revenus annuels dans la recherche biopharmaceutique et sommes en voie de réaliser, d'ici 2028, des investissements de plus de 2 milliards de dollars en nouvelles infrastructures. Sanofi est socialement active et collabore avec ses partenaires pour créer un écosystème durable et bâtir un Canada en meilleure santé.Sanofi est cotée sur EURONEXT : SAN et NASDAQ : SNY Références
MONOGRAPHIE DE NUVAXOVIDMD, 06 mars 2026.Marchese AM et al.?J Infect Dis. 2024;230(2):e496-e502.Atmar RL, Lyke KE, Deming ME et al. Homologous and heterologous Covid-19 booster vaccinations. N Engl J Med 2022; 386:1046-57. 27. Lyke KE, Atmar RL, Dominguez Islas C et al. Immunogenicity of NVX-CoV2373 heterologous boost against SARS-CoV-2 variants. NPJ Vaccines 2023; 8:98. Heath PT et al. N Engl J Med. 2021;385(13):1172-1183.Dunkle LM et al. N Engl J Med. 2022;386(6):531-543. Agence de la santé publique du Canada. (2026). Rapport canadien de surveillance des virus respiratoires. Santé infobase. Coup d'œil : Rapport canadien de surveillance des virus respiratoires — Canada.caAgence de la santé publique du Canada. Enquête sur la couverture vaccinale contre les infections respiratoires saisonnières. Ottawa : Agence de la santé publique du Canada; 2025-10-31. https://sante-infobase.canada.ca/vaccination/enquete-couverture-vaccinale-infections-respiratoires-saisonnieres/Xie Y et al. JAMA. 2024;331(22):1963-1965.
SOURCE Sanofi-Aventis Canada Inc.
Original: Sanofi devient la détentrice de l'autorisation de mise en marché de Nuvaxovid(MD) au Canada, élargissant ainsi les choix de vaccins contre la COVID-19 pour la population canadienne
tw0122
6年前
Innovation Pharmaceuticals Informed Next Phase of Brilacidin Coronavirus (COVID-19) Testing to Begin Week of May 4
Provided by GlobeNewswire
Apr 27, 2020 9:30 AM EDT
WAKEFIELD, Mass., April 27, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has been informed by researchers at the U.S. Regional Biocontainment Laboratory (RBL) that continued coronavirus (COVID-19) testing of Brilacidin, the Company’s defensin-mimetic drug candidate, is scheduled to begin the week of May 4.
john1311
6年前
Sanofi warns Europe on Covid-19 vaccine
French pharma group has two candidates in pipeline
https://www.ft.com/content/5884987a-e1d1-476a-b538-368e2a915480
Sanofi would be able to deliver an effective vaccine within the next 18 months but warned that the bigger challenge would be ramping up production to meet potentially massive demand.
Sanofi Pasteur vaccine division employs about 10,000 people and has 12 factories globally. It has two Covid-19 vaccines in development: one of which is a traditional protein-based vaccine, and another known as an mRNA vaccine, which is a new type that promises to be faster to manufacture but remains as yet unproven.
Sanofi is also testing the efficacy of two of its drugs already approved for other uses against Covid-19, including the malaria drug hydroxychloroquine and Kevzara, which is usually used to treat rheumatoid arthritis.
On Friday, the company confirmed its goal for earnings per share to rise 5 per cent this year, after reporting higher first-quarter sales and profits buoyed by people stockpiling its drugs during the Covid-19 outbreak.
That first-quarter stockpiling boost will be “largely offset” by an expected slowdown in the second quarter.
Like-for-like revenue rose 6.6 per cent to €8.97bn in the quarter to March 30 driven by higher sales of over-the-counter medicines for pain and fever, and eczema drug Dupixent.
Net income rose 16.1 per cent to €2bn.
tw0122
6年前
Small Trial Suggests Antimalarial Drugs Not Effective For Treating Coronavirus
KATHERINE SELEY-RADTKE, THE CONVERSATION
6 APRIL 2020
On Saturday the Food and Drug Administration approved the use of two antimalarial drugs, hydroxychloroquine and a related medication, chloroquine, for emergency use to treat COVID-19. The drugs were touted by President Trump as a "game changer" for COVID-19.
However, a study just published in a French medical journal provides new evidence that hydroxychloroquine does not appear to help the immune system clear the coronavirus from the body.
The study comes on the heels of two others - one in France and one in China - that reported some benefits in the combination of hydroxychloroquine and azithromycin for COVID-19 patients who didn't have severe symptoms of the virus.
I am a medicinal chemist who has specialized in discovery and development of antiviral drugs for the past 30 years, and I have been actively working on coronaviruses for the past seven.
I am among a number of researchers who are concerned that this drug has been given too much of a high priority before there is enough evidence to show it is indeed effective.
There are already other clinical studies that showed it is not effective against COVID-19 as well as several other viruses. And, more importantly, it can have dangerous side effects, as well as giving people false hope.
The latter has led to widespread shortages of hydroxychloroquine for patients who need it to treat malaria, lupus and rheumatoid arthritis, the indications for which it was originally approved.
The idea that the combination of hydroxychloroquine with an antibiotic drug, azithromycin, was effective against COVID-19 gained more attention after a study published on March 17. This study described a trial of 80 patients carried out by Philippe Gautret in Marseille, France.
Although some of their results appeared to be encouraging, it should also be noted that most of their patients only had mild symptoms. Furthermore, 85 percent of the patients didn't even have a fever – one of the major telltale symptoms of the virus, thus suggesting that these patients likely would have naturally cleared the virus without any intervention.
In another study, posted on medRxiv, which has not yet been peer-reviewed, Chinese scientists from Renmin Hospital of Wuhan University, in Wuhan, China, gave hydroxychloroquine to patients with only mild infections who were free of medical issues, similar to the Gautret study. The results showed that the 31 patients who received the drug showed a lessening of their symptoms 24 hours earlier than patients in the control group.
In addition, pneumonia symptoms improved in 25 of the 31 patients versus 17 of 31 in the control group. As noted in several of the comments associated with the manuscript, there are issues related to the translation of the paper, thus clouding interpretations of some of the results. The paper also appears to focus more on pneumonia than COVID-19. However, these issues may be cleared up or addressed once the paper finishes the peer-review process.
But two other studies have conflicting results.
A second French group, led by Jean-Michel Molina, has now tested the hydroxychloroquine-azithromycin combination treatment in 11 patients at the Hôpital Saint-Louis in Paris, France, and their results were strikingly different.
Like the Marseille study, the Molina trial was also a small pilot study. Molina and colleagues used the same dosing regimen as Gautret. In contrast, however, to the Gautret study, eight of the 11 patients had underlying health conditions, and 10 of 11 had fevers and were quite ill at the time the dosing began.
These Paris researchers found that after five to six days of treatment with hydroxychloroquine (600 mg per day for 10 days) and azithromycin (500 mg on day 1 and 250 mg on days 2 to 5), eight of the 10 patients still tested positive for COVID-19.
Of these 10 patients, one patient died, two were transferred to the ICU and another had to be removed from the treatment due to serious complications.
In addition, a similar study in China also showed no difference in viral clearance after seven days either with or without the hydroxychloroquine with the patients in the trial. This supports Molina's findings.
Thus, despite the recent approval of this drug for use against COVID-19, questions remain as to the efficacy of this treatment.
As Molina and colleagues note: "Ongoing randomized clinical trials with hydroxychloroquine should provide a definitive answer regarding the alleged efficacy of this combination and will assess its safety."
Katherine Seley-Radtke, Professor of Chemistry and Biochemistry and President-Elect of the International Society for Antiviral Research, University of Maryland, Baltimore County.
Trend-Setter
8年前
Consortium partner tweeted:
"Upperton abstract, entitled Developing Cold Chain Independent Vaccines - Spray-drying of Virosomes to Produce Dry Powder Formulations, has been Accepted for Poster presentation at the 2018 AAPS Annual Meeting to be held November 4-7, 2018 in DC"
Upperton abstract, entitled Developing Cold Chain Independent Vaccines - Spray-drying of Virosomes to Produce Dry Powder Formulations, has been Accepted for Poster presentation at the 2018 AAPS Annual Meeting to be held November 4-7, 2018 in DC— Upperton Pharma Solutions (@UppertonLtd) July 20, 2018
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