#biosimilars — Public Fediverse posts
Live and recent posts from across the Fediverse tagged #biosimilars, aggregated by home.social.
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Alvotech gets FDA VAI classification for Iceland plant | ALVO SEC Filing
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16…
#Iceland #IS #Europe #Europa #EU #ALVO #Alvotech #AVT05 #AVT06 #AVT16 #biosimilars #Biotechnology #BLA #FDAInspection #iceland #island #VAIclassification
https://www.europesays.com/3162739/ -
Alvotech gets FDA VAI classification for Iceland plant | ALVO SEC Filing https://www.byteseu.com/2238323/ #ALVO #Alvotech #AVT05 #AVT06 #AVT16 #Biosimilars #Biotechnology #BLA #FDAInspection #Iceland #VAIClassification
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https://www.europesays.com/cz/123582/ Evropa ztrácí náskok. Brusel spouští plán, který má přivést nové léky rychleji k pacientům #AdamVojtěch #AktOBiotechnologiích #biosimilars #biotechnologie #EPSCO #EU #Europa #Europe #Evropa #Konkurenceschopnost #léky #OlivérVárhelyi
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https://www.europesays.com/cz/120382/ Evropa ztrácí náskok. Brusel spouští plán, který má přivést nové léky rychleji k pacientům #AdamVojtěch #AktOBiotechnologiích #biosimilars #biotechnologie #EPSCO #EU #Europa #Europe #Evropa #Konkurenceschopnost #léky #OlivérVárhelyi
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Teva Expands European biosimilars portfolio with launch
AHZANTIVE® (aflibercept) is an EMA-approved biosimilar to Eylea® (aflibercept) with demonstrated similarity in efficacy, safety and immunogenicity to the reference product The launch expands Teva’s biosimilars portfolio and presence in ophthalmology, in…
#Europe #EU #biosimilars #European #NYSE:TEVA #TevaPharmaceuticalIndustriesLtd #TevaPharmaceuticals
https://www.europesays.com/europe/60669/ -
We reposting an article of Monday about post-marketing surveillance for biosimilars.
#Biosimilars #Pharmacovigilance #ClinicalResearch #RealWorldEvidence #CDSCO #Pharma #CRO #ClinicalTrials
https://genelifecr.blogspot.com/2026/05/post-marketing-surveillance-for.html
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Biosimilar approval is not the finish line.
It's the point at which your pre-approval dataset — intentionally smaller than a novel biologic — meets real patients, real clinical practice, and real immune systems.PMS isn't overhead. It's the second half of your evidence strategy.
#Biosimilars #Pharmacovigilance #ClinicalResearch #Pharma #CRO #CDSCO #ClinicalTrials #genelife
https://genelifecr.blogspot.com/2026/05/post-marketing-surveillance-for.html
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Formycon to report 2025 results April 22 and boost investor outreach with major conferences in Q2 2026, including Jefferies Healthcare and UBS Life Sciences events. #Biosimilars #Pharma
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Formycon to report 2025 results April 22 and boost investor outreach with major conferences in Q2 2026, including Jefferies Healthcare and UBS Life Sciences events. #Biosimilars #Pharma
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Formycon to report 2025 results April 22 and boost investor outreach with major conferences in Q2 2026, including Jefferies Healthcare and UBS Life Sciences events. #Biosimilars #Pharma
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We published an article on Monday about India's biosimilar regulatory framework.
We are reposting the article again, in case you missed that:
#Biosimilars #ClinicalResearch #CRO #Pharma #Biologics #DrugDevelopment #CDSCO #RegulatoryAffairs #Pharmacovigilance #RWE
https://genelifecr.blogspot.com/2026/05/biosimilar-regulation-in-india-evolving.html
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Alvotech reports completion of FDA inspection in Iceland
Alvotech (NASDAQ:ALVO) announced Monday that the U.S. Food and Drug Administration (FDA) has completed a routine cGMP (current…
#Iceland #IS #Europe #Europa #EU #ALVO #Alvotech #BiologicsLicenseApplication #biosimilars #BLAResubmission #cGMPCompliance #FDAInspection #Form483 #iceland #island #ReykjavikFacility
https://www.europesays.com/2982475/ -
Alvotech reports completion of FDA inspection in Iceland https://www.byteseu.com/2011445/ #ALVO #Alvotech #BiologicsLicenseApplication #Biosimilars #BLAResubmission #CGMPCompliance #FDAInspection #Form483 #Iceland #ReykjavikFacility
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Our latest article explores the changing regulatory framework for biosimilars in India.
As the industry moves toward a more science-driven and risk-based approach, understanding the evolving biosimilar ecosystem becomes increasingly important for sponsors, researchers, and healthcare stakeholders.
#Biosimilars #ClinicalResearch #CRO #Pharma #Biologics #DrugDevelopment #CDSCO #RegulatoryAffairs #Pharmacovigilance #RWE
https://genelifecr.blogspot.com/2026/05/biosimilar-regulation-in-india-evolving.html
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https://www.europesays.com/be-nl/57239/ De overstap naar biosimilars: goedkoper, maar niet altijd probleemloos #BE #België #Belgium #biologicals #biosimilars #Gezondheid #Health #InstituutVerantwoordMedicijngebruik #kostenbesparing #MarjorieNelissen #MeldpuntMedicijnen #NoceboEffect
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Aurobindo Pharma Partners with STADA to Boost Biosimilars in EU Market, ETPharma
Mumbai: Aurobindo Pharma biosimilars arm, CuraTeQ Biologics has out-licensed its two products European market commercial rights to Germany’s…
#Europe #EU #AurobindoPharma #biosimilars #CuraTeQBiologics #Europeanmarket #EuropeanUnion #STADAArzneimittelAG
https://www.europesays.com/europe/623/ -
Avethera übernimmt Fraunhofer-GMP in Braunschweig
Es klingt gepflegt umschreibend, was die Ursache für einen Verkauf des Fraunhofer ITEM-Standortes in Braunschweig angeht: „Aufgrund des…
#Braunschweig #Deutschland #Deutsch #DE #Schlagzeilen #Headlines #Nachrichten #News #Europe #Europa #EU #Alvotech #AndreasHerrmann #AvetheraGmbH #Biosimilars #CDMO #Celonic #FahimeMahboudi #FraunhoferGesellschaft(FhG) #Germany #Hennigsdorf #HZI #Leva #Niedersachsen
https://www.europesays.com/de/901104/ -
𝗖𝗮𝗻 𝗯𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿𝘀 𝗺𝗮𝗸𝗲 𝗮𝗱𝘃𝗮𝗻𝗰𝗲𝗱 𝘁𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀 𝗺𝗼𝗿𝗲 𝗮𝗳𝗳𝗼𝗿𝗱𝗮𝗯𝗹𝗲?
Governments like South Korea are introducing pricing caps on 𝗯𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿𝘀, 𝗶𝗺𝗽𝗿𝗼𝘃𝗶𝗻𝗴 𝗮𝗰𝗰𝗲𝘀𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗯𝗼𝗼𝘀𝘁𝗶𝗻𝗴 𝗮𝗱𝗼𝗽𝘁𝗶𝗼𝗻 across APAC.
𝗥𝗲𝗮𝗱 𝗺𝗼𝗿𝗲: https://www.kenresearch.com/industry-reports/asia-pacific-biopharmaceuticals-market?utm_source=Mastadon&utm_medium=Social&utm_campaign=Aniket -
Alvotech Reports Positive PK Results for AVT80
Alvotech has announced top-line results from a pivotal pharmacokinetic study of AVT80, a proposed biosimilar to Entyvio (vedolizumab). The randomized, double-blind, 3-arm study assessed PK similarity, safety, and immunogenicity in healthy adults after a single 108 mg/0.68 mL subcutaneous injection. The data supports the development of the candidate for patients worldwide.
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Alvotech Reports Positive PK Results for AVT80
Alvotech has announced top-line results from a pivotal pharmacokinetic study of AVT80, a proposed biosimilar to Entyvio (vedolizumab). The randomized, double-blind, 3-arm study assessed PK similarity, safety, and immunogenicity in healthy adults after a single 108 mg/0.68 mL subcutaneous injection. The data supports the development of the candidate for patients worldwide.
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Alvotech Reports Positive PK Results for AVT80
Alvotech has announced top-line results from a pivotal pharmacokinetic study of AVT80, a proposed biosimilar to Entyvio (vedolizumab). The randomized, double-blind, 3-arm study assessed PK similarity, safety, and immunogenicity in healthy adults after a single 108 mg/0.68 mL subcutaneous injection. The data supports the development of the candidate for patients worldwide.
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Alvotech Reports Positive PK Results for AVT80
Alvotech has announced top-line results from a pivotal pharmacokinetic study of AVT80, a proposed biosimilar to Entyvio (vedolizumab). The randomized, double-blind, 3-arm study assessed PK similarity, safety, and immunogenicity in healthy adults after a single 108 mg/0.68 mL subcutaneous injection. The data supports the development of the candidate for patients worldwide.
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Alvotech Reports Positive PK Results for AVT80
Alvotech has announced top-line results from a pivotal pharmacokinetic study of AVT80, a proposed biosimilar to Entyvio (vedolizumab). The randomized, double-blind, 3-arm study assessed PK similarity, safety, and immunogenicity in healthy adults after a single 108 mg/0.68 mL subcutaneous injection. The data supports the development of the candidate for patients worldwide.
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Alvotech Secures Global Settlement for Aflibercept Biosimilar
Alvotech reached a settlement to market its biosimilar globally. Entry starts Jan 1, 2026, in the UK and Canada. The EEA and other regions follow May 1, 2026. Japan allows full indications by Nov 1, 2026. Combined with a US Q4 2026 license, the company secures worldwide rights to supply partners, subject to regulatory approval.
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Alvotech Secures Global Settlement for Aflibercept Biosimilar
Alvotech reached a settlement to market its biosimilar globally. Entry starts Jan 1, 2026, in the UK and Canada. The EEA and other regions follow May 1, 2026. Japan allows full indications by Nov 1, 2026. Combined with a US Q4 2026 license, the company secures worldwide rights to supply partners, subject to regulatory approval.
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Alvotech Secures Global Settlement for Aflibercept Biosimilar
Alvotech reached a settlement to market its biosimilar globally. Entry starts Jan 1, 2026, in the UK and Canada. The EEA and other regions follow May 1, 2026. Japan allows full indications by Nov 1, 2026. Combined with a US Q4 2026 license, the company secures worldwide rights to supply partners, subject to regulatory approval.
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Alvotech Secures Global Settlement for Aflibercept Biosimilar
Alvotech reached a settlement to market its biosimilar globally. Entry starts Jan 1, 2026, in the UK and Canada. The EEA and other regions follow May 1, 2026. Japan allows full indications by Nov 1, 2026. Combined with a US Q4 2026 license, the company secures worldwide rights to supply partners, subject to regulatory approval.
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Alvotech Secures Global Settlement for Aflibercept Biosimilar
Alvotech reached a settlement to market its biosimilar globally. Entry starts Jan 1, 2026, in the UK and Canada. The EEA and other regions follow May 1, 2026. Japan allows full indications by Nov 1, 2026. Combined with a US Q4 2026 license, the company secures worldwide rights to supply partners, subject to regulatory approval.
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Icelandic BioTech Alvotech secures €100 million term loan facility to bolster liquidity and R&D investment
Alvotech, a Reykjavík-based BioTech company specialising in the development and manufacture of biosimilar medicines, has secured a €100…
#Iceland #IS #Europe #Europa #EU #Alvotech #biosimilars #biotechstartup #GoldenTreeAssetManagement #iceland #island #reykjavik #RobertWessman
https://www.europesays.com/2673155/ -
Icelandic BioTech Alvotech secures €100 million term loan facility to bolster liquidity and R&D investment https://www.byteseu.com/1680675/ #Alvotech #Biosimilars #BiotechStartup #GoldenTreeAssetManagement #Iceland #Reykjavik #RobertWessman
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https://www.europesays.com/uk/615140/ Regulatory reform can unlock access to biosimilars #biosimilars #FDA #Health #Medication #Policy #STAT+ #UK #UnitedKingdom
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Regulatory reform can unlock access to biosimilars
Every day, I think about the patients waiting for medicines that could change, or even save, their lives.…
#NewsBeep #News #Medication #AU #Australia #biosimilars #FDA #Health #Policy #STAT+
https://www.newsbeep.com/au/330664/ -
Regulatory reform can unlock access to biosimilars
Every day, I think about the patients waiting for medicines that could change, or even save, their lives.…
#NewsBeep #News #US #USA #UnitedStates #UnitedStatesOfAmerica #Medication #Biosimilars #FDA #Health #Policy #STAT+
https://www.newsbeep.com/us/332415/ -
Regulatory reform can unlock access to biosimilars
Every day, I think about the patients waiting for medicines that could change, or even save, their lives.…
#NewsBeep #News #US #USA #UnitedStates #UnitedStatesOfAmerica #Medication #Biosimilars #FDA #Health #Policy #STAT+
https://www.newsbeep.com/us/332415/ -
https://www.europesays.com/ie/217172/ Regulatory reform can unlock access to biosimilars #biosimilars #Éire #fda #Health #IE #Ireland #Medication #Policy #STAT+
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https://www.europesays.com/uk/578501/ Why Biosimilars are Malaysia's next health investment – NST Online #biosimilars #Cancer #DrAbdulMueedKhan #Health #Malaysia #Medication #NSTInsight #UK #UnitedKingdom #us #WorldHealthOrganisation
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Why Biosimilars are Malaysia's next health investment – NST Online
Why Biosimilars are Malaysia’s next health investment NST OnlineEU Clears Path for Biosimilars in Diabetes & Bone Health MedscapeCHMP Positive…
#NewsBeep #News #US #USA #UnitedStates #UnitedStatesOfAmerica #Medication #Biosimilars #cancer #DrAbdulMueedKhan #Health #Malaysia #NSTInsight #WorldHealthOrganisation
https://www.newsbeep.com/us/299255/ -
Why Biosimilars are Malaysia's next health investment – NST Online
Why Biosimilars are Malaysia’s next health investment NST OnlineEU Clears Path for Biosimilars in Diabetes & Bone Health MedscapeCHMP Positive…
#NewsBeep #News #US #USA #UnitedStates #UnitedStatesOfAmerica #Medication #Biosimilars #cancer #DrAbdulMueedKhan #Health #Malaysia #NSTInsight #WorldHealthOrganisation
https://www.newsbeep.com/us/299255/ -
Why Biosimilars are Malaysia's next health investment – NST Online
Why Biosimilars are Malaysia’s next health investment NST OnlineEU Clears Path for Biosimilars in Diabetes & Bone Health MedscapeCHMP Positive…
#NewsBeep #News #Medication #biosimilars #cancer #DrAbdulMueedKhan #Health #malaysia #NSTInsight #UK #UnitedKingdom #us #WorldHealthOrganisation
https://www.newsbeep.com/uk/269750/ -
What are biologics and will the Trump administration’s plans make them cheaper?
If you watch TV and don’t mute ads, you’ve probably heard of a few biologics. They’re drugs such…
#NewsBeep #News #US #USA #UnitedStates #UnitedStatesOfAmerica #Medication #biologicalmedications #biologics #Biosimilars #drugprices #Health
https://www.newsbeep.com/us/296844/ -
What are biologics and will the Trump administration’s plans make them cheaper?
If you watch TV and don’t mute ads, you’ve probably heard of a few biologics. They’re drugs such…
#NewsBeep #News #US #USA #UnitedStates #UnitedStatesOfAmerica #Medication #biologicalmedications #biologics #Biosimilars #drugprices #Health
https://www.newsbeep.com/us/296844/ -
https://www.europesays.com/ie/184990/ What are biologics and will the Trump administration’s plans make them cheaper? #BiologicalMedications #biologics #biosimilars #DrugPrices #Éire #Health #IE #Ireland #Medication
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https://www.europesays.com/uk/575149/ What are biologics and will the Trump administration’s plans make them cheaper? #BiologicalMedications #biologics #biosimilars #DrugPrices #Health #Medication #UK #UnitedKingdom
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What are biologics and will the Trump administration’s plans make them cheaper?
If you watch TV and don’t mute ads, you’ve probably heard of a few biologics. They’re drugs such…
#NewsBeep #News #Medication #biologicalmedications #biologics #biosimilars #drugprices #Health #UK #UnitedKingdom
https://www.newsbeep.com/uk/263240/ -
Nearly 70% of cancer patients face financial crises within one year after leaving hospital, highlighting urgent need for support. Hospital K suggests using biosimilars to reduce costs and improve treatment access.
#cancercare #financialcrisis #healthpolicy #access2medicine #unreadyposts #VietnamHealth #SustainableHealthcare #biosimilars #patientrights #VietnamNet
#ungthư #sứckhỏe #chínhsách y tế #khủnghoảngtàichính #dượcphẩmsinhhọc #tiếpcậnđiềutrị #bệnhviệnK #côngbằngy tế #sốngkhỏemạnh #vietn
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AbbVie's tight grip on Humira market raises concerns about biosimilars—As biotech recovers, venture firms’ preferences appear to shift — Boehringer, Zealand heat up MASH race with strong phase II data—http://bit.ly/w28kSd #abbvie #humira #biosimilars #funding #mash #nash #boehringeringelheim #ipos #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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AbbVie's tight grip on Humira market raises concerns about biosimilars—As biotech recovers, venture firms’ preferences appear to shift — Boehringer, Zealand heat up MASH race with strong phase II data—http://bit.ly/w28kSd #abbvie #humira #biosimilars #funding #mash #nash #boehringeringelheim #ipos #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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AbbVie's tight grip on Humira market raises concerns about biosimilars—As biotech recovers, venture firms’ preferences appear to shift — Boehringer, Zealand heat up MASH race with strong phase II data—http://bit.ly/w28kSd #abbvie #humira #biosimilars #funding #mash #nash #boehringeringelheim #ipos #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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AstraZeneca to pay Pfizer $107.5M in damages in Tagrisso patent tussle—FDA approves two biosimilars to blockbuster eye drug Eylea —Why AlphaFold 3 is stirring up so much buzz in pharma --http://bit.ly/w28kSd #astrazeneca #pfizer #patents #legal #biosimilars #fda #eylea #ai #googledeepmind #drugdevelopment #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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AstraZeneca to pay Pfizer $107.5M in damages in Tagrisso patent tussle—FDA approves two biosimilars to blockbuster eye drug Eylea —Why AlphaFold 3 is stirring up so much buzz in pharma --http://bit.ly/w28kSd #astrazeneca #pfizer #patents #legal #biosimilars #fda #eylea #ai #googledeepmind #drugdevelopment #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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AstraZeneca to pay Pfizer $107.5M in damages in Tagrisso patent tussle—FDA approves two biosimilars to blockbuster eye drug Eylea —Why AlphaFold 3 is stirring up so much buzz in pharma --http://bit.ly/w28kSd #astrazeneca #pfizer #patents #legal #biosimilars #fda #eylea #ai #googledeepmind #drugdevelopment #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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Titel: De Rol van Biosimilars in Kostenbesparing en Toekomstige Zorginnovatie
De inzet van biosimilars heeft de laatste jaren aanzienlijke kostenbesparingen opgeleverd in de Nederlandse gezondheidszorg. Dit artikel belicht niet alleen de besparingen die zijn gerealiseerd, maar werpt ook een blik op de toekomstige ontwikkelingen en uitdagingen op
https://www.medicalfacts.nl/2024/05/03/titel-de-rol-van-biosimilars-in-kostenbesparing-en-toekomstige-zorginnovatie/
#Zorginnovatie #biosimilars -
Titel: De Rol van Biosimilars in Kostenbesparing en Toekomstige Zorginnovatie
De inzet van biosimilars heeft de laatste jaren aanzienlijke kostenbesparingen opgeleverd in de Nederlandse gezondheidszorg. Dit artikel belicht niet alleen de besparingen die zijn gerealiseerd, maar werpt ook een blik op de toekomstige ontwikkelingen en uitdagingen op
https://www.medicalfacts.nl/2024/05/03/titel-de-rol-van-biosimilars-in-kostenbesparing-en-toekomstige-zorginnovatie/
#Zorginnovatie #biosimilars -
J&J narrowly misses Q1 revenue on lower-than-expected Stelara sales—Humira biosimilar scripts take off—Intra-Cellular launches 26% to record high, breaking out after depression drug scores big--http://bit.ly/w28kSd #earnings #jnj #abbvie #humira #biosimilars #depression #clinicaltrials #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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5 successful phase III oncology trials in Q1—FDA gives nod to BrainStorm for ALS trial after Phase III flop—AbbVie’s Humira loses only 4% of market share to biosimilars--http://bit.ly/w28kSd #clinicaltrials #oncology #fda #als #abbvie #humira #biosimilars #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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Could pharma’s legal attack on the IRA succeed in killing price negotiations?—Gilead tries new triple-target T-cell engagers in $1.5B-plus Merus collab—Sandoz nabs FDA approvals for first two biosimilars for Amgen’s denosumab--http://bit.ly/w28kSd #inflationreductionact #medicare #drugpricing #gileadsciences #sandoz #biosimilars #amgen #fda #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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Could pharma’s legal attack on the IRA succeed in killing price negotiations?—Gilead tries new triple-target T-cell engagers in $1.5B-plus Merus collab—Sandoz nabs FDA approvals for first two biosimilars for Amgen’s denosumab--http://bit.ly/w28kSd #inflationreductionact #medicare #drugpricing #gileadsciences #sandoz #biosimilars #amgen #fda #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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Moderna posts surprise quarterly profit as it eyes RSV vaccine approval —Samsung joins biosimilar race for Merck & Co.'s Keytruda blockbuster—Zimmer receives FDA clearance for robotic shoulder system--http://bit.ly/w28kSd #moderna #rsv #vaccines #merck #samsung #biosimilars #keytruda #roboticsurgery #zimmerbiomet #fda #shoulderreplacement #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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AbbVie’s Humira maintains market dominance amid biosimilar launches —Bayer CEO Bill Anderson makes his mark with major restructuring, 'significant' job cuts — Novartis ends phase III peanut allergy trial --http://bit.ly/w28kSd #biosimilars #humira #abbvie #bayer #restructuring #layoffs #novartis #clinicaltrials #peanutallergy #novartis #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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R to @EMA_News: In 2023, we approved 8 #biosimilars for a wide range of diseases, including a rare genetic disease, #cancers, #multiplesclerosis.
The total of 9⃣7⃣ biosimilars that can be marketed in 🇪🇺 make treatments more accessible and can improve the quality of life for more #patients.
🐦🔗: https://nitter.cz/EMA_News/status/1747252697924006358#m
[2024-01-16 13:41 UTC]