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#FDA #Eli Lilly and Company #Johnson&Johnson #FDA Approval #Clinical Data #Cancer #Quarterly Results #Novo Nordisk

Category: News

Regulatory Business Healthcare & Pharmaceuticals News

Eli Lilly Responds to EMA’s Donanemab Marketing Authorization Rejection

  • By Athulya B S
  • 29 March 2025
Eli Lilly and Company

Eli Lilly and Company’s (LLY) donanemab is not recommended for marketing authorization for the treatment of early symptomatic Alzheimer’s disease, according to an opinion released [Read More…]

Tagged Alzheimer's, Donanemab, Eli Lilly and Company, EMA
Business Clinical Trials Healthcare & Pharmaceuticals News

Bayer and Puhe BioPharma With Global License Agreement For Clinical Phase I PRMT5 Inhibitor for Brain Tumors

  • By Ajmal Aseem
  • 26 March 2025
The Bayer Cross in Leverkusen

For the clinical phase, Bayer has acquired the sole global license for an MTA-cooperative PRMT5 inhibitor that targets MTAP-deleted tumors selectively.

Tagged Bayer, Phase 1 Clinical Trials, PRMT5 Inhibitor
Regulatory Approval Business Healthcare & Pharmaceuticals News

U.S. FDA Approved GSK’s Blujepa (gepotidacin) for Treatment of Uncomplicated Urinary Tract Infections (uUTIs) for Female Adults and Paediatric Patients 12 years of Age and Older

  • By Athulya B S
  • 25 March 2025
GSK - GlaxoSmithKline

Approval based on data from the pivotal phase III EAGLE-2 and EAGLE-3 trials.

Tagged FDA
Clinical Trials Healthcare & Pharmaceuticals News

Opthea Released COAST Phase 3 Clinical Trial Results

  • By Athulya B S
  • 24 March 2025
COAST phase 3 clinical trial

articipants receiving sozinibercept combination therapy with a dosing regimen of every four weeks or every eight weeks.

Tagged COAST, Opthea, Phase 3 Trial
Clinical Trials Healthcare & Pharmaceuticals News

Insulet Released RADIANT Trial Results of Their Omnipod® 5 Automated Insulin Delivery System

  • By Athulya B S
  • 22 March 2025
Insulet Insulet

In addition to being the first to examine the safety and effectiveness of an automated insulin delivery (AID) system in conjunction with an Abbott FreeStyle Libre® 2 family sensor

Tagged Diabetes, Insulet Corporation, Insulin, Insulin Delivery
Business Healthcare & Pharmaceuticals News

Eli Lilly Launches Their Blockbuster Weight-loss and Diabetes Drug Mounjaro in India

  • By Athulya B S
  • 21 March 2025
Eli Lilly and Company

Mounjaro, the First and Only GIP and GLP-1 Receptor Agonist Approved for Type 2 Diabetes.

Tagged Eli Lilly and Company, Mounjaro
Clinical Trials Business Healthcare & Pharmaceuticals News

GSK Released EMBRACE a Phase 2b Clinical Trial Data of an Investigational Broadly Neutralising Antibody for HIV

  • By Editor's Desk
  • 18 March 2025
GSK - GlaxoSmithKline

The findings support the increasing amount of data showing that N6LS is a strong antiviral that may be used as part of an all-encompassing antiretroviral treatment plan.

Tagged GSK, HIV
Clinical Trials Healthcare & Pharmaceuticals News

AstraZeneca Released Satisfactory Results of 24 Weeks CALYPSO Phase III Trial for Eneboparatide

  • By Editor's Desk
  • 17 March 2025
AstraZeneca

Trial continues as planned to 52 weeks to further characterize the risk-benefit profile.

Tagged AstraZeneca, CALYPSO, Phase III Trial
Clinical Trials Healthcare & Pharmaceuticals News

Amgen Released Phase 3 MINT Trial Data Evaluating the Efficacy and Safety of UPLIZNA® (inebilizumab-cdon)

  • By Editor's Desk
  • 14 March 2025
amgen

The trial achieved its primary endpoint, as previously revealed at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting.

Tagged Amgen, inebilizumab, UPLIZNA®
Healthcare & Pharmaceuticals Clinical Trials News

Merck Announces Positive Results of Phase 3 Trials for Their HIV-1 Investigational Two-Drug Regimen Doravirine/Islatravir

  • By Editor's Desk
  • 13 March 2025
Merck MSD

Islatravir, Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), inhibits HIV-1 replication through a variety of mechanisms

Tagged HIV, Investigational Drug, Merck & Co

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Thermo Fisher Scientific Microbiology Business Sale to Astorg Reaches Completion at $1.075 Billion
Merger & Acquisitions Healthcare & Pharmaceuticals News

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Legal and Patent Affairs Business Healthcare & Pharmaceuticals News

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12 August 202614 August 2026
Legal and IP Desk
Novo Nordisk Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes, Now Available Nationwide in the US
Regulatory Approval Healthcare & Pharmaceuticals News

Novo Nordisk Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes, Now Available Nationwide in the US

11 August 202612 August 2026
Regulatory Intelligence Desk
Charles River Laboratories Q2 2026 Earnings: Revenue Hits $1.00 Billion as Company Raises Full-Year Guidance
Business CRO Healthcare & Pharmaceuticals News

Charles River Laboratories Q2 2026 Earnings: Revenue Hits $1.00 Billion as Company Raises Full-Year Guidance

8 August 20268 August 2026
BiotechReality Business Intelligence Desk
Moderna mFLUSIVA FDA Approval: Moderna Receives U.S. FDA Approval for Seasonal Influenza Vaccine mFLUSIVA
Regulatory Approval Healthcare & Pharmaceuticals News Vaccines

Moderna mFLUSIVA FDA Approval: Moderna Receives U.S. FDA Approval for Seasonal Influenza Vaccine mFLUSIVA

7 August 20267 August 2026
Regulatory Intelligence Desk
Eli Lilly Q2 2026 Earnings Jump 48% as Mounjaro, Zepbound Fuel Growth; Company Raises Full-Year Guidance
Business Healthcare & Pharmaceuticals News

Eli Lilly Q2 2026 Earnings Jump 48% as Mounjaro, Zepbound Fuel Growth; Company Raises Full-Year Guidance

6 August 20267 August 2026
BiotechReality Business Intelligence Desk
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