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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


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


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


Prevest DenPro Limited's IPO to open on BSE SME platform on September 15
Clinical Trials | September 14, 2021

Prevest DenPro Limited's IPO to open on BSE SME platform on September 15

The net proceeds from the issue will be utilised towards the purchase of machinery, modernising existing units and expansion of its R&D facilities


US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction
Biotech | September 12, 2021

US FDA grants Jardiance Breakthrough Therapy designation for heart failure with a preserved ejection fraction

The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction


Zymo Research receives CE Mark for new Covid-19 SafeCollect kits
Drug Approval | September 01, 2021

Zymo Research receives CE Mark for new Covid-19 SafeCollect kits

Self-collection devices designed for ease of use and safety


Japan approves AstraZeneca’s Forxiga for chronic kidney disease
Drug Approval | August 28, 2021

Japan approves AstraZeneca’s Forxiga for chronic kidney disease

Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


Johnson & Johnson booster dose indicate impressive results
Drug Approval | August 26, 2021

Johnson & Johnson booster dose indicate impressive results

New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.


Carbogen Amcis AG signs co-investment agreement
Biotech | August 25, 2021

Carbogen Amcis AG signs co-investment agreement

The co-investment of CHF 4 million will result in capacity expansion and support the market introduction of the customer's lead compound