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1495 News Found

Novartis’ Kisqali data indicates longest median survival in advanced breast cancer
Drug Approval | September 20, 2021

Novartis’ Kisqali data indicates longest median survival in advanced breast cancer

With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting


BMS receives positive CHMP opinion for Opdivo
Drug Approval | September 18, 2021

BMS receives positive CHMP opinion for Opdivo

The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy


Roche receives positive CHMP opinion for Gavreto
Drug Approval | September 18, 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC


Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV
Biotech | September 18, 2021

Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV

Initiation of EBT-101 Phase 1/2 clinical trial expected later this year


LifeCell receives DCGI approval for Mesocel clinical trial to treat Covid-19
Biotech | September 17, 2021

LifeCell receives DCGI approval for Mesocel clinical trial to treat Covid-19

The clinical trial, to be conducted in two phases, will evaluate the safety and efficacy of Mesocel for the treatment of patients with moderate to severe Covid-19


PharmaZell and Novasep come together to form a formidable API and CDMO platform
Biotech | September 17, 2021

PharmaZell and Novasep come together to form a formidable API and CDMO platform

They enter into exclusive negotiations in a new drive to create a technology-driven leader for complex small molecules and ADCs of global scale


Biocon Biologics to offer Serum Institute of Life Sciences 15 pc stake at US $ 4.9 billion valuation
Biotech | September 17, 2021

Biocon Biologics to offer Serum Institute of Life Sciences 15 pc stake at US $ 4.9 billion valuation

BB will have access to 100 million doses of vaccines annually and commercialization rights of the SILS vaccine portfolio for global markets


Machine Learning to understand and prevent disease
Digitisation | September 17, 2021

Machine Learning to understand and prevent disease

Barbara Engelhardt moves her computational and statistics lab to Gladstone


U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test
Medical Device | September 16, 2021

U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test

It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations


Laurus Labs, Unitaid and Clinton Health Access Initiative to develop HIV medication for children
Public Health | September 14, 2021

Laurus Labs, Unitaid and Clinton Health Access Initiative to develop HIV medication for children

Laurus will be incentivised for a portion of its development and commercialisation costs. CHAI will also provide technical and regulatory support to enable accelerated generic development