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Sanofi


Новости

Amicus' muscle disorder therapy gets US FDA nod but restricted label drags shares

UPDATE 3-Amicus' muscle disorder therapy gets US FDA nod but restricted label drags shares Adds shares in paragraph 2, analyst's comments in paragraphs 5 and 7 By Sriparna Roy Sept 28 (Reuters) - Amicus Therapeutics' FOLD.O treatment for a rare muscle disorder called Pompe disease was approved by the U.S. health regulator, the drugmaker said on Thursday, ending its years-long efforts to launch the therapy.
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Wegovy, other weight-loss drugs scrutinized over reports of suicidal thoughts

INSIGHT-Wegovy, other weight-loss drugs scrutinized over reports of suicidal thoughts By Robin Respaut and Chad Terhune Sept 28 (Reuters) - Dawn Heidlebaugh felt trapped in a disturbing pattern while taking Ozempic, the popular drug used to treat diabetes and obesity. Each Sunday for more than a year, the 53-year-old Ohio real estate agent took her weekly injection to help control her blood sugar.
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EU regulator to discuss anaesthesia risk for weight-loss drugs

EU regulator to discuss anaesthesia risk for weight-loss drugs By Ludwig Burger FRANKFURT, Sept 26 (Reuters) - The European Medicines Agency (EMA) will discuss the risk that patients on Wegovy, Ozempic or similar drugs may suffer certain complications under anaesthesia that can lead to pneumonia, according to an agenda posted on the regulator's website.
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Regeneron Pharmaceuticals, Sanofi Say Dupixent® (Dupilumab) SBLA For Treatment Of Eosinophilic Esophagitis (EoE) Accepted For FDA Priority Review

BRIEF-Regeneron Pharmaceuticals, Sanofi Say Dupixent® (Dupilumab) SBLA For Treatment Of Eosinophilic Esophagitis (EoE) Accepted For FDA Priority Review Sept 26 (Reuters) - Regeneron Pharmaceuticals Inc REGN.O : DUPIXENT® (DUPILUMAB) SBLA FOR TREATMENT OF EOSINOPHILIC ESOPHAGITIS (EOE) IN CHILDREN AGED 1 TO 11 ACCEPTED FOR FDA PRIORITY REVIEW TARG
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Sanofi's Altuviiio Approved In Japan As Therapy For Hemophilia A

BRIEF-Sanofi's Altuviiio Approved In Japan As Therapy For Hemophilia A Sept 25 (Reuters) - Sanofi SA SASY.PA : ONCE-WEEKLY ALTUVIIIO® APPROVED IN JAPAN ASA NEW CLASS OF FACTOR VIII THERAPY FOR HEMOPHILIA A JAPANESE MINISTRY OF HEALTH, LABOR, AND WELFARE (MHLW) HAS GRANTED MARKETING AUTHORIZATION FOR ALTUVIIIO [ANTIHEMOPHILIC FACTOR (RECOMBINANT),
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Sanofi India Receives Demerger Scheme Observation Letters From BSE, India's NSE

BRIEF-Sanofi India Receives Demerger Scheme Observation Letters From BSE, India's NSE Sept 25 (Reuters) - Sanofi India Ltd SANO.NS : SANOFI INDIA ANNOUNCED SATURDAY THE RECEIPT OF OBSERVATION LETTERS FROM BSE LIMITED AND NATIONAL STOCK EXCHANGE OF INDIA LIMITED FOR THE SCHEME OF DEMERGER OF CONSUMER HEALTHCARE BUSINESS COMPANY RECEIVED OBSERVATION
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What you need to know about RSV and the new vaccines

EXPLAINER-What you need to know about RSV and the new vaccines Updates with CDC director signing off on Pfizer maternal vaccine By Michael Erman Sept 22 (Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) on Friday recommended Pfizer's PFE.N respiratory syncytial virus (RSV) vaccine for women in the middle of the third trimester of pregnancy to protect their babies from severe illness.
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What you need to know about RSV and the new vaccines

EXPLAINER-What you need to know about RSV and the new vaccines Updates with Friday's CDC panel vote; adds Sanofi/AstraZeneca drug By Michael Erman Sept 22 (Reuters) - Expert advisers to U.S. Centers for Disease Control and Prevention (CDC) on Friday recommended Pfizer's PFE.N respiratory syncytial virus (RSV) vaccine for women in the middle of the third trimester of pregnancy to protect their babies from severe illness.
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US CDC backs Pfizer's maternal RSV vaccine to protect infants

UPDATE 2-US CDC backs Pfizer's maternal RSV vaccine to protect infants Updates first paragraph with CDC recommendation, adds director comment in paragraph 3 By Sriparna Roy and Michael Erman Sept 22 (Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) on Friday backed Pfizer's PFE.N respiratory syncytial virus (RSV) vaccine for women in the middle of the third trimester of pregnancy to protect their babies from severe illness.
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Sanofi Says Preliminary Estimate Of Currency Impact On Q3 Sales To Be About Between -7.5% And -8.5%

BRIEF-Sanofi Says Preliminary Estimate Of Currency Impact On Q3 Sales To Be About Between -7.5% And -8.5% Sept 22 (Reuters) - Sanofi SA SASY.PA : 2023 EFFECTIVE TAX RATE IS EXPECTED TO BE AROUND 19% VERSUS 19.3% IN 2022 IMPROVEMENT OF GROSS MARGIN IS EXPECTED FOR FY 2023 PRELIMINARY ESTIMATE OF CURRENCY IMPACT ON Q3 2023 SALES IS APPROXIMATELY BETW
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US court upholds Roche win in patent case over blockbuster hemophilia drug

UPDATE 1-US court upholds Roche win in patent case over blockbuster hemophilia drug Takeda unit said Roche's Hemlibra infringed antibody patent Roche's Genentech convinces appeals court to invalidate Baxalta patent Adds response from Takeda in paragraph 4 By Blake Brittain Sept 20 (Reuters) - Roche ROG.S subsidiary Genentech convinced a U.S. appeals court on Wednesday to affirm that its blockbuster hemophilia treatment Hemlibra does not infringe a patent owned by pharmaceutical rival Takeda's 45
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US court upholds Roche win in patent case over blockbuster hemophilia drug

US court upholds Roche win in patent case over blockbuster hemophilia drug Takeda unit said Roche's Hemlibra infringed antibody patent Roche's Genentech convinces appeals court to invalidate Baxalta patent By Blake Brittain Sept 20 (Reuters) - Roche ROG.S subsidiary Genentech convinced a U.S. appeals court on Wednesday to affirm that its blockbuster hemophilia treatment Hemlibra does not infringe a patent owned by pharmaceutical rival Takeda's 4502.T Baxalta unit.
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US FDA declines to approve first nasal spray equivalent of EpiPen

CORRECTED-UPDATE 4-Nasal spray alternative to EpiPen suffers setback as FDA seeks fresh study Corrects paragraph 7 to say Auvi-Q is sold by Kaleo, not Sanofi. The error had appeared in a previous version of the story. By Sriparna Roy and Jahnavi Nidumolu Sept 20 (Reuters) - The U.S. health regulator has declined to approve a nasal spray that would have been the first needle-free emergency treatment for allergic reactions, a surprise decision that sent shares of its developer ARS Pharmaceuticals
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US FDA declines to approve ARS' emergency nasal spray for allergic reactions

US FDA declines to approve ARS' emergency nasal spray for allergic reactions Sept 19 (Reuters) - The U.S. Food and Drug Administration (FDA) has declined to approve ARS Pharmaceuticals' SPRY.O nasal spray for allergic reactions, the company said on Tuesday. Reporting by Christy Santhosh and Sriparna Roy in Bengaluru; Editing by Maju Samuel and Dhan
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Moderna to cut mRNA drug substance production at Lonza facility

UPDATE 2-Moderna to cut mRNA drug substance production at Lonza facility Adds details on production and demand for COVID shots throughout Sept 19 (Reuters) - Moderna MRNA.O said on Tuesday it will cut production of mRNA drug substance for its COVID-19 vaccine at Lonza's LONN.S facility in Switzerland this quarter as part of a plan to align manufacturing of the shots with lower post-pandemic demand.
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Pharmanovia Acquires Global Central Nervous System Portfolio From Sanofi

BRIEF-Pharmanovia Acquires Global Central Nervous System Portfolio From Sanofi Sept 18 (Reuters) - PHARMANOVIA: PHARMANOVIA ACQUIRES GLOBAL CENTRAL NERVOUS SYSTEM (CNS) PORTFOLIO FROM SANOFI SASY.PA DEAL SEES PHARMANOVIA ACQUIRE 11 BRANDS WITHIN CNS, INCLUDING FRISIUM (CLOBAZAM) AND GARDENAL (PHENOBARBITAL) Source text for Eikon: ID:nBwc6kWrna Furt
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AstraZeneca succession sickness demands urgent fix

BREAKINGVIEWS-AstraZeneca succession sickness demands urgent fix The author is a Reuters Breakingviews columnist. The opinions expressed are her own. By Aimee Donnellan LONDON, Sept 15 (Reuters Breakingviews) - Can a CEO be worth $9 billion? That’s the question posed by the 4% fall in AstraZeneca’s AZN.L shares following an article stating boss Pascal Soriot may soon resign.
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U.S. STOCKS PFSweb, copper miners, cruise operators

BUZZ-U.S. STOCKS ON THE MOVE-PFSweb, copper miners, cruise operators Eikon search string for individual stock moves: STXBZ The Day Ahead newsletter: https://refini.tv/3LI4BU7 The Morning News Call newsletter: https://refini.tv/3dKUyB8 Wall Street's main indexes rose on Thursday as hotter-than-expected economic data did not dent hopes of a pause in rate hikes in September, while investors awaited Arm Holdings' stock market debut.
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First Wave Biopharma Says On September 13, Entered Into A License Agreement With Sanofi

BRIEF-First Wave Biopharma Says On September 13, Entered Into A License Agreement With Sanofi Sept 14 (Reuters) - First Wave BioPharma Inc FWBI.O : FIRST WAVE BIOPHARMA INC - ON SEPTEMBER 13, ENTERED INTO A LICENSE AGREEMENT WITH SANOFI FIRST WAVE BIOPHARMA - UNDER TERMS, SANOFI TO BE ELIGIBLE TO GET UP TO $46 MILLION IN POTENTIAL DEVELOPMENT AND R
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First Wave Biopharma Announces Exclusive Global License Agreement For Capeserod From Sanofi

BRIEF-First Wave Biopharma Announces Exclusive Global License Agreement For Capeserod From Sanofi First Wave BioPharma Inc FWBI.O : FIRST WAVE BIOPHARMA ANNOUNCES EXCLUSIVE GLOBAL LICENSE AGREEMENT FOR CAPESEROD FROM SANOFI FIRST WAVE BIOPHARMA INC: ANNOUNCED AN AGREEMENT WITH SANOFI FIRST WAVE BIOPHARMA- FIRST WAVE TO GET FROM SANOFI AN EXCLUSIVE,
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