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3014 News Found

Amneal enters U.S. biosimilars market with approval of Releukotm
Drug Approval | March 02, 2022

Amneal enters U.S. biosimilars market with approval of Releukotm

First of three Amneal biosimilars expected for U.S. approval and launch in 2022


Boehringer Ingelheim partners with Lifebit to capture health data
Biotech | March 01, 2022

Boehringer Ingelheim partners with Lifebit to capture health data

This collaboration aims at capturing translational disease insights from large external healthcare biobanks and maximizing value of data for drug discovery and precision medicine


Singapore first to top WHO’s classification of medical regulator
News | March 01, 2022

Singapore first to top WHO’s classification of medical regulator

Achieving ML 4 brings Singapore closer to becoming a WHO listed authority, a new scheme that will be operational later this year and will list the world’s regulators of reference


Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review
Biotech | March 01, 2022

Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review

If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.


Innovent Biologics and AnHeart Therapeutics receive NMPA breakthrough designation for taletrectinib
Biotech | March 01, 2022

Innovent Biologics and AnHeart Therapeutics receive NMPA breakthrough designation for taletrectinib

The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors


South Korea's OCI acquires 11% stake in Bukwang Pharmaceutical
Biotech | March 01, 2022

South Korea's OCI acquires 11% stake in Bukwang Pharmaceutical

Company has bought 7.73 million shares for KRW 146.1 billion thus securing the largest shareholder status in Bukwang Pharmaceutical


Lupin launches Sevelamer Hydrochloride tablets in the United States
Drug Approval | March 01, 2022

Lupin launches Sevelamer Hydrochloride tablets in the United States

Sevelamer Hydrochloride tablets, 800 mg is a generic equivalent of Renagel tablets, 800 mg


USFDA approves CITI Biopharma’s Vonjo
Drug Approval | March 01, 2022

USFDA approves CITI Biopharma’s Vonjo

Vonjo is the first approved therapy to specifically address the needs of adult cytopenic myelofibrosis patients


Biocon Biologics acquires Viatris’ biosimilar assets for up to US $ 3.3 billion
News | February 28, 2022

Biocon Biologics acquires Viatris’ biosimilar assets for up to US $ 3.3 billion

BBL will gain Viatris’ global biosimilars business whose revenues are estimated to be USD 1 billion next year, along with its portfolio of in-licensed biosimilar assets


China’s NMPA accepts supplemental NDA for Carteyva
Drug Approval | February 28, 2022

China’s NMPA accepts supplemental NDA for Carteyva

The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China