Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 30

Results For "regulatory"

1221 News Found

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


Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Drug Approval | July 30, 2024

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance


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


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


dsm-firmenich to sell MEG-3 fish oil business to KD Pharma Group
News | July 22, 2024

dsm-firmenich to sell MEG-3 fish oil business to KD Pharma Group

dsm-firmenich decided to de-prioritize certain business segments, including the MEG-3 business


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


Elucid appoints Kelly Huang as CEO
People | July 22, 2024

Elucid appoints Kelly Huang as CEO

Experienced commercial leader takes helm to expand cardiovascular diagnostic company globally and commercialize company’s flagship plaque analysis software


Merck starts commercial production of first GMP-compliant manufacturing line for cell culture media in China
News | July 16, 2024

Merck starts commercial production of first GMP-compliant manufacturing line for cell culture media in China

€ 6.6 million investment at Nantong site expands production capabilities for cell culture media