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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


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


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


Promising prospects for Indian pharma: CLSA
News | September 17, 2021

Promising prospects for Indian pharma: CLSA

CLSA, a capital market and investment group organised an Investors’ Forum where five Indian pharma companies participated. Excerpts from the report


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


Novavax to participate in Oxford university’s study on combining Covid-19 vaccines
Biotech | September 17, 2021

Novavax to participate in Oxford university’s study on combining Covid-19 vaccines

Study to explore heterologous regimen of COVID-19 vaccines from different manufacturers in adolescents 12-16 years of age


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


Lupin to settle litigations over diabetes drug
News | September 16, 2021

Lupin to settle litigations over diabetes drug

The board has approved the settlement of US $ 248 million towards Direct Purchaser group and Retailer Opt-Out group subject to court approval


Lancet study confirms Johnson & Johnson Ebola vaccine safe
Drug Approval | September 16, 2021

Lancet study confirms Johnson & Johnson Ebola vaccine safe

Data show the vaccine regimen induced neutralising antibody responses in nearly all participating adults and children 21 days after the second dose. Adults receiving booster shots two years after the initial vaccination regimen showed strong immune responses


Lupin launch a generic version of pain reliever for osteoarthritis in the US
Drug Approval | September 15, 2021

Lupin launch a generic version of pain reliever for osteoarthritis in the US

Ibuprofen and Famotidine tablets (Duexise) had estimated annual sales of US $ 765 million in the US as if July 21