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Results For "FDA"

1778 News Found

Lupin completes  successful Phase 3 trials for Lucentis biosimilar
Biotech | August 06, 2024

Lupin completes successful Phase 3 trials for Lucentis biosimilar

The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU


OneSource and BRL ink technology licensing agreement to deliver high-concentration biologics subcutaneously
News | August 06, 2024

OneSource and BRL ink technology licensing agreement to deliver high-concentration biologics subcutaneously

Revolutionary technology will further boost OneSource’s scientific services offerings


European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
Drug Approval | August 03, 2024

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept


GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s  CHMP opinion for adults aged 50-59
Drug Approval | July 30, 2024

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024


Briefs: Indoco Remedies and Alembic Pharmaceuticals
Drug Approval | July 29, 2024

Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe


Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate
Diagnostic Center | July 26, 2024

Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate

Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis


European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B
Drug Approval | July 26, 2024

European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B

A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)


Piramal Pharma Q1 FY25 net loss narrows
News | July 26, 2024

Piramal Pharma Q1 FY25 net loss narrows

EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24


Meitheal  acquires Contepo from Nabriva Therapeutics to expand specialty biopharmaceuticals portfolio
News | July 23, 2024

Meitheal acquires Contepo from Nabriva Therapeutics to expand specialty biopharmaceuticals portfolio

Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape


Bayer announces positive topline results for Nubeqa from Phase III trial in men with mHSPC
Diagnostic Center | July 23, 2024

Bayer announces positive topline results for Nubeqa from Phase III trial in men with mHSPC

Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT