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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
130 Results
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Business
Medicxi Combines Six Portfolio Companies with $100M to Launch Alys Pharma
Merging six of its portfolio biotechs, Medicxi on Monday unveiled Alys Pharmaceuticals, an immuno-dermatology focused company seeking to deliver up to 10 proof-of-concept readouts by the end of 2026.
February 12, 2024
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2 min read
·
Tristan Manalac
Deals
Bayer, Moderna-Backed Metagenomi’s Stock Crashes 31% in Friday IPO Debut
Shares of preclinical genetic medicines company Metagenomi tanked more than 30% on Friday afternoon in a disappointing debut for its initial public offering, bucking the trend of positive IPOs so far this year.
February 12, 2024
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2 min read
·
Tristan Manalac
Drug Development
FDA Approves First One-Time Cell Therapy for a Solid Tumor
On Friday, the regulator greenlit Iovance’s lifileucel to treat advanced melanoma. Prior to the approval, experts told BioSpace that tumor-infiltrating lymphocytes therapies also hold the potential to treat several other solid tumors.
February 12, 2024
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6 min read
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Aayushi Pratap and Heather McKenzie
Deals
Gilead to Buy CymaBay, Lead Liver Disease Asset Seladelpar for $4.3B
Gilead Sciences announced Monday it will purchase CymaBay Therapeutics and its investigational treatment seladelpar for primary biliary cholangitis, a type of liver disease that causes bile-duct damage.
February 12, 2024
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3 min read
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Tyler Patchen
Drug Development
CSL Heart Attack Hopeful Fails to Meet Primary Endpoint in Phase III Trial
CSL’s investigational cholesterol efflux enhancer CSL112 failed to reduce major adverse cardiovascular events within 90 days in patients who had just suffered a heart attack.
February 12, 2024
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2 min read
·
Tristan Manalac
Policy
Novo Claims First Victories in Legal Fight Against Compounded Semaglutide
Two Florida courts have sided with Novo Nordisk against Ekzotika and Effinger Health, agreeing that their compounded versions of semaglutide are against the law. The Danish pharma has reached confidential settlements with both companies.
February 12, 2024
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2 min read
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Tristan Manalac
FDA Accepts Xspray Pharma’s NDA-resubmission for Dasynoc® – PDUFA Date set to 31 July 2024
Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY): The U.S. Food and Drug Administration (FDA) has accepted the resubmission of Xspray Pharma’s New Drug Application (NDA) for Dasynoc ® , following a Complete Response Letter (CRL) where additional information was requested.
February 12, 2024
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2 min read
FDA
FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the U.S. for Eosinophilic Esophagitis (EoE)
Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE).
February 12, 2024
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16 min read
Biotech Bay
Sangamo Therapeutics Announces U.S. FDA Alignment on Abbreviated Pathway to Potential Approval and EMA Prime Eligibility for ST-920 in Fabry Disease
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced important U.S. and European regulatory updates for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease.
February 12, 2024
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8 min read
FDA
Ruxoprubart (NM8074) Scores FDA Orphan Drug Designation for Paroxysmal Nocturnal Hemoglobinuria (PNH) Treatment
NovelMed today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Ruxoprubart, an alternative pathway (AP) blocker anti-Bb antibody, for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).
February 12, 2024
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5 min read
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