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#Eli Lilly and Company #Johnson&Johnson #Clinical Data #FDA Approval #Quarterly Results #Phase 3 Trials #Cancer #Novo Nordisk
News Clinical Trials Healthcare & Pharmaceuticals

Gliead Releases the Results of Phase 3 ASCENT-04/KEYNOTE-D19 Trials Shows Positive Effect for Combinational Use of Trodelvy® Plus Keytruda®

  • By Ajmal Aseem
  • 22 April 2025
Gilead

The trial achieved its main goal with a statistically significant and clinically relevant improvement in PFS.

Tagged Gilead Sciences, Keytruda, Merck & Co
Regulatory Approval Healthcare & Pharmaceuticals News

European Commission Approves Roche’s Columvi® (glofitamab) For B-cell Lymphoma Based on the Phase III STARGLO Study Results

  • By Athulya B S
  • 20 April 2025
Roche

Columvi therapy provides a much-needed, off-the-shelf, fixed-duration alternative for transplant ineligible individuals.

Tagged Columvi, glofitamab, Hoffmann-La Roche
Regulatory Approval Healthcare & Pharmaceuticals News

Dupixent (Dupilumab), Sanofi’s New Targeted Therapy For Chronic Spontaneous Urticaria Approved by the U.S. FDA

  • By Ajmal Aseem
  • 19 April 2025
sanofi

Phase 3 tests showing Dupixent dramatically decreased itching and hives when compared to a placebo led to approval.

Tagged Dupilumab, Dupixent, Sanofi
Weight-loss Drugs Clinical Trials Healthcare & Pharmaceuticals News

Eli Lilly’s Orforglipron, an Investigational Oral GLP-1 Weight-loss and Diabetes Pill Shows Similar Efficacy Results of Their Injectable GLP-1

  • By Athulya B S
  • 18 April 2025
Eli Lilly and Company

In a Phase 3 trial, orforglipron, the first small molecule GLP-1, successfully reduced A1C by an average of 1.3% to 1.6% across dosages.

Tagged Diabetes, Eli Lilly and Company, GLP-1, Orforglipron
Regulatory Approval Healthcare & Pharmaceuticals News

European Union Grants Marketing Approval for Biogen’s Leqembi® an Amyloid-beta (Aβ) Monoclonal Antibody

  • By Ajmal Aseem
  • 17 April 2025
biogen

Lecanemab is the only approved Aβ monoclonal antibody that binds and clears hazardous protofibrils.

Tagged Biogen
Clinical Trials Healthcare & Pharmaceuticals News

Eyestem’s Eyecyte-RPE™ Trial Shows Vision Rescue for Geographic Atrophy Patients

  • By Editor's Desk
  • 15 April 2025
eyestem news

All nine subjects of phase 1 injected without any serious adverse events.

Tagged Eyecyte-RPE, Eyestem, Geographic Atrophy
Healthcare & Pharmaceuticals Business Clinical Investigation News

Pfizer Announces Development Discontinuation of Danuglipron an Oral GLP-1 Receptor Agonist

  • By Ajmal Aseem
  • 14 April 2025
pfizer news

Data from the danuglipron clinical development program will be presented at a scientific meeting or published in a peer-reviewed journal in the future.

Tagged Danuglipron, GLP-1 Receptor, Pfizer
Clinical Trials Healthcare & Pharmaceuticals

Sanofi’s Investigational New Drug Tolebrutinib for Multiple Sclerosis Shows Positive Results in Phase 3 Trials

  • By Athulya B S
  • 13 April 2025
sanofi

Tolebrutinib was generally well tolerated by all subjects across all study arms.

Tagged Investigational Drug, Multiple Sclerosis, Sanofi, Tolebrutinib
Clinical Trials Healthcare & Pharmaceuticals News

Amgen’s IMDELLTRA® Phase 3 Trials Demonstrated Superior Overall Survival in Small Cell Lung Cancer

  • By Ajmal Aseem
  • 12 April 2025
amgen

IMDELLTRA’s safety profile was consistent with the recognized profile. Detailed DeLLphi-304 results will be presented at an upcoming medical congress.

Tagged Amgen, IMDELLTRA®, Small Cell Lung Cancer
Regulatory Healthcare & Pharmaceuticals News

U.S. FDA to Phase Out Animal Testing for the Development of Monoclonal Antibodies and Other Drugs

  • By Ajmal Aseem
  • 11 April 2025
US FDA News

The FDA’s animal testing requirement will be decreased, modified, or potentially replaced utilizing a variety of methodologies.

Tagged Animal Testing, Drug Development, FDA, Monoclonal Antibodies

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Pfizer Q3 2026 Results: Pfizer Raises 2026 Guidance to $62–64 Billion as Launched Products Grow 32%
Business Healthcare & Pharmaceuticals News

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BiotechReality Business Intelligence Desk
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Business Healthcare & Pharmaceuticals News

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Biotechnology Business Manufacturing News

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Sandoz 2026 Sales Rise 5% at CC as Biosimilars Climb 19%; Core-EBITDA Margin Guidance Upgraded to 23.0-23.5%
Business Healthcare & Pharmaceuticals Manufacturing News

Sandoz 2026 Sales Rise 5% at CC as Biosimilars Climb 19%; Core-EBITDA Margin Guidance Upgraded to 23.0-23.5%

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BiotechReality Business Intelligence Desk
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