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2784 News Found

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


CDSCO approves Jardiance for heart failure with preserved ejection fraction
Drug Approval | May 19, 2022

CDSCO approves Jardiance for heart failure with preserved ejection fraction

With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction


Piramal Pharma Solutions new API plant in Canada goes online
Biotech | May 19, 2022

Piramal Pharma Solutions new API plant in Canada goes online

It is part of the company's CAD $30 million capital investment in the Aurora, Canada site


Innovative AI software for detection of pancreatic diseases
Digitisation | May 18, 2022

Innovative AI software for detection of pancreatic diseases

As part of large-scale clinical studies prior to market introduction, the AI software has now gone into clinical test with patients, so-called first-in-human applications


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


Freudenberg Medical launches HelixFlex TPE tubing at Pharmapack 2022
Medical Device | May 18, 2022

Freudenberg Medical launches HelixFlex TPE tubing at Pharmapack 2022

TPE tubing from Freudenberg also offers many different sterilization options including autoclave, gamma irradiation, x-ray, and e-beam


City of Hope and Imugene dose patient in Phase 1 trial to test cancer-killing oncolytic virus
Biotech | May 18, 2022

City of Hope and Imugene dose patient in Phase 1 trial to test cancer-killing oncolytic virus

City of Hope is first in world to test oncolytic virus, CF33-hNIS, in people with metastatic solid tumours


Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years
Drug Approval | May 18, 2022

Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years

Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series