Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 151

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Biliary tract cancer drug Durvalumab approval key opportunity for AstraZeneca in India, says GlobalData
Drug Approval | February 27, 2023

Biliary tract cancer drug Durvalumab approval key opportunity for AstraZeneca in India, says GlobalData

The British-Swedish pharma major certainly has a strong competitive edge for BTC treatment in the country


Porton Advanced and Yinjia Biosciences partner to enhance CDMO technology platform
Biotech | February 27, 2023

Porton Advanced and Yinjia Biosciences partner to enhance CDMO technology platform

Yinjia Biosciences will provide Porton Advanced with high-quality core protein raw materials and testing reagent products for quality control and evaluation systems.


Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Drug Approval | February 25, 2023

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma


EMA recommends refusal of the marketing authorization for Lagevrio
News | February 25, 2023

EMA recommends refusal of the marketing authorization for Lagevrio

Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.


Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940
Drug Approval | February 23, 2023

Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940

Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial


Research underscores Beyfortus’ potential to prevent RSV disease in infants
News | February 23, 2023

Research underscores Beyfortus’ potential to prevent RSV disease in infants

The new Beyfortus data are consistent with all data accumulated to date and confirm its strong profile


USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


New data confirm survival benefits of darolutamide in patients with metastatic hormone-sensitive prostate cancer
Clinical Trials | February 21, 2023

New data confirm survival benefits of darolutamide in patients with metastatic hormone-sensitive prostate cancer

New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS)


Piramal Pharma starts production at new API facility in Riverview, Michigan
News | February 20, 2023

Piramal Pharma starts production at new API facility in Riverview, Michigan

New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)


Pfizer announces Talzenna and Xtandi combination data from phase 3 study
News | February 18, 2023

Pfizer announces Talzenna and Xtandi combination data from phase 3 study

Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI