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Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate
Clinical Trials | 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)


Emmes partners with Miimansa AI to accelerate adoption of Generative AI in clinical research
Digitisation | July 25, 2024

Emmes partners with Miimansa AI to accelerate adoption of Generative AI in clinical research

The partnership will focus on creating capabilities for quickly and accurately processing vast amounts of clinical data


Syngene reports drop in Q1 FY25 revenue to Rs. 790 Cr
News | July 24, 2024

Syngene reports drop in Q1 FY25 revenue to Rs. 790 Cr

Reported profit after tax declined 19% year-on-year to Rs 76 crores


USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau
Drug Approval | July 24, 2024

USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau

The inspections concluded with no Form 483 observations or significant critical findings


Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP
Drug Approval | July 23, 2024

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP

Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension


Industry hails Union Budget 2024-25
Policy | July 23, 2024

Industry hails Union Budget 2024-25

The Central government’s decision to exempt three more cancer medicines from customs duty is a commendable step towards making cancer drugs more affordable


Budget 2024-25: Industry expects push for reforms, R&D and fiscal incentives
News | July 22, 2024

Budget 2024-25: Industry expects push for reforms, R&D and fiscal incentives

Finance Minister Nirmala Sitharaman is set to present the full budget for the current financial year on July 23


Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD
Drug Approval | July 19, 2024

Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD

Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration


Unichem gets 5 observations from USFDA for Goa formulation facility
Drug Approval | July 17, 2024

Unichem gets 5 observations from USFDA for Goa formulation facility

The inspection closed with five observations which were more of procedural changes with none of these related to data integrity