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1569 News Found

Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe
News | May 21, 2022

Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe

The European Commission granted CMA in December 2021 for use of Nuvaxovid in individuals aged 18 and over, and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in March 2022


AbbVie submits NDA for treatment of advanced Parkinson’s disease
Biotech | May 21, 2022

AbbVie submits NDA for treatment of advanced Parkinson’s disease

If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of carbidopa/levodopa prodrugs


Glenmark receives sANDA approval for Abiraterone Acetate tablets
Drug Approval | May 20, 2022

Glenmark receives sANDA approval for Abiraterone Acetate tablets

According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million


Bristol Myers Squibb highlights progress in treatment for cancer and blood disorders
Biotech | May 20, 2022

Bristol Myers Squibb highlights progress in treatment for cancer and blood disorders

First disclosure from PILOT study of Breyanzi in second-line large B-cell lymphoma underscores important role of cell therapy earlier in treatment paradigm


Driving sustainable, enterprise-wide performance acceleration
Opinion | May 19, 2022

Driving sustainable, enterprise-wide performance acceleration

Leading pharma companies are achieving rapid, large-scale performance improvements using a multifaceted approach that realizes short-term gains & builds long-term capabilities at the same time


Grand Opening of Kodiak Sciences’ bioconjugation facility
Biotech | May 19, 2022

Grand Opening of Kodiak Sciences’ bioconjugation facility

Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases


Don’t be left short-changed post approval – plan in change orders early for accelerated pathways: Stephanie Gaulding
News | May 19, 2022

Don’t be left short-changed post approval – plan in change orders early for accelerated pathways: Stephanie Gaulding

A post approval change order is often necessary, but innovators should plan and prepare for this pre-approval. Planning alongside outsourcing partners will help ensure that only a small-scale study is needed—not a new full clinical study


WHO validates Convidecia vaccine for Covid-19
News | May 19, 2022

WHO validates Convidecia vaccine for Covid-19

The vaccine was found to have 64% efficacy against symptomatic disease and 92% against severe Covid-19


Cytel designed and led TOGETHER trial wins Clinical Trial award
News | May 18, 2022

Cytel designed and led TOGETHER trial wins Clinical Trial award

Leading this effort was Cytel’s principal research scientist and Professor of Health Research Methods at McMaster University in Canada, Dr. Edward Mills


Singapore based Inspired Technology receives WHO certification
Medical Device | May 18, 2022

Singapore based Inspired Technology receives WHO certification

The latest certification endorses product for cold chain monitoring across 194 WHO member countries