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Results For "Orphan-Drug"

84 News Found

Swissmedic  approves BeiGene's Brukinsa
Drug Approval | February 17, 2022

Swissmedic approves BeiGene's Brukinsa

With this approval, Brukinsa is now approved in 44 markets as BeiGene continues to advance its global registration, including the EU, US, and Great Britain


BDR plans to enter the regulated markets this year: Raheel Shah, Director, BDR Group of Companies
interviews | February 15, 2022

BDR plans to enter the regulated markets this year: Raheel Shah, Director, BDR Group of Companies

BDR Pharmaceuticals is a home-grown company with operations in India and overseas. It’s known for its formulations portfolio and has a presence in specialty medicines. The company has ambitious plans as it has ramped up capacity and looking to foray into regulated markets. Raheel Shah, Director, BDR Group of Companies shares his insights in an interview with Thomas C Thottathil, Editor, Indian Pharma Post


USFDA approves IND application for Allied’s cancer treatment
Biotech | January 24, 2022

USFDA approves IND application for Allied’s cancer treatment

APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types


SPARC to present clinical data on vodobatinib
Biotech | December 11, 2021

SPARC to present clinical data on vodobatinib

Results from the ongoing vodobatinib clinical study are being presented for the second consecutive year at the ASH annual meeting, underlining the promising potential of the drug for the treatment of heavily pre-treated CML


Zydus receives  USFDA  approval for Phase2(b)/3 trial of Saroglitazar
Biotech | December 10, 2021

Zydus receives USFDA approval for Phase2(b)/3 trial of Saroglitazar

Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)


Fifty-five manufacturers selected for Pharma PLI sector
News | November 27, 2021

Fifty-five manufacturers selected for Pharma PLI sector

The appraisal of the applications has been carried out based on the ranking methodology laid down in the operational guidelines of the Scheme


Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah
Biotech | October 28, 2021

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah

Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications


Zydus announces update on a randomised trial of Saroglitazar Mg in NASH
Biotech | October 22, 2021

Zydus announces update on a randomised trial of Saroglitazar Mg in NASH

Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders


Imfinzi plus tremelimumab significantly improved overall survival in liver cancer
Biotech | October 18, 2021

Imfinzi plus tremelimumab significantly improved overall survival in liver cancer

The trial met the primary endpoint of overall survival with a single priming dose of tremelimumab plus Imfinzi every four weeks vs. sorafenib


RedHill Biopharma's Opaganib demonstrates strong inhibition of COVID-19 Delta variant
Drug Approval | August 26, 2021

RedHill Biopharma's Opaganib demonstrates strong inhibition of COVID-19 Delta variant

Opaganib, a leading novel small molecule investigational oral pill in development for Covid-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of the disease