Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 154

Results For "EMA"

2402 News Found

Ascentage Pharma gets IND clearance by the US FDA for novel EED Inhibitor APG-5918
Drug Approval | July 02, 2022

Ascentage Pharma gets IND clearance by the US FDA for novel EED Inhibitor APG-5918

This multicenter, open-label Phase I study is designed to assess the safety and tolerability


Akebia Therapeutics regaining rights to Vadadustat in the US, Europe and China
News | July 01, 2022

Akebia Therapeutics regaining rights to Vadadustat in the US, Europe and China

Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia


NADMED brings first CE-marked NAD+ analysis kit to the market
Medical Device | June 30, 2022

NADMED brings first CE-marked NAD+ analysis kit to the market

NADMED technology is based on proprietary extraction and the individual measurement of NAD metabolites


MTPA announces long-term findings from post-marketing safety study of Radicava
News | June 30, 2022

MTPA announces long-term findings from post-marketing safety study of Radicava

Analysis of Post-Marketing Safety Data Shows Consistent Findings with Safety Profile Reported in Clinical Trials of Edaravone


Pfizer and BioNTech inks new agreement with US Government to provide additional doses of COVID-19 vaccine
News | June 30, 2022

Pfizer and BioNTech inks new agreement with US Government to provide additional doses of COVID-19 vaccine

105 million 30 µg, 10 µg and 3 µg doses to be delivered into Q4 2022, with an option for the U.S. Government to purchase up to 195 million additional doses


Wacker to build biotechnology center in Munich
Biotech | June 28, 2022

Wacker to build biotechnology center in Munich

The research here will mainly concentrate on the manufacturing process of biopharmaceuticals, especially in the area of advanced medicines, as well as the fermentation-based manufacture of ingredients for foods and food supplements


Balaxi Pharmaceuticals' Hyderabad factory to be operational by March 2024
News | June 28, 2022

Balaxi Pharmaceuticals' Hyderabad factory to be operational by March 2024

This facility will produce higher efficacy products that enjoy greater acceptance and enhanced profit marginsg


Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer
Drug Approval | June 28, 2022

Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival in patients


Astellas’s update on the Fortis clinical trial of AT845 in adults for pompe disease
Drug Approval | June 27, 2022

Astellas’s update on the Fortis clinical trial of AT845 in adults for pompe disease

The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects


Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron
News | June 27, 2022

Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron

Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine