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Results For "MAA"

43 News Found

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate
News | December 05, 2022

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate

Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule


EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US
News | November 24, 2022

Evive enters license agreement with Acrotech Biopharma to commercialize Ryzneuta in US

Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)


We must bring logistics cost from 13% to single digit as soon as possible: Narendra Modi
Policy | September 19, 2022

We must bring logistics cost from 13% to single digit as soon as possible: Narendra Modi

The policy aspires to reduce cost of logistics in India to be comparable to global benchmarks by 2030


Thermo Fisher Scientific present new innovations to improve biopharmaceutical and proteomics workflows
News | August 30, 2022

Thermo Fisher Scientific present new innovations to improve biopharmaceutical and proteomics workflows

New mass spectrometry instrument and consumables launch during IMSC 2022


European Medicines Agency accepts Menarini’s application for Elacestrant
Drug Approval | August 20, 2022

European Medicines Agency accepts Menarini’s application for Elacestrant

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union


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


Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer
Biotech | April 08, 2022

Henlius' Serplulimab granted Orphan-Drug Designation for Small Cell Lung Cancer

The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC


BioPharma’s Herceptin biosimilar Phase 3 results positive
Biotech | March 12, 2022

BioPharma’s Herceptin biosimilar Phase 3 results positive

The study met its primary endpoint and showed equivalent efficacy and a comparable safety profile


AstraZeneca flags off ‘AZ Forest’ a mass sapling plantation campaign in Bengaluru
Sustainability | March 07, 2022

AstraZeneca flags off ‘AZ Forest’ a mass sapling plantation campaign in Bengaluru

Commits to plant 5000 trees in phase 1 with its partner SankalpTaru Foundation