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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


Biocon Biologics and Viatris launch Abevmy in Canada
Drug Approval | May 19, 2022

Biocon Biologics and Viatris launch Abevmy in Canada

Abevmy follows the launch of the company’s two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020


Janssen’s icare4u to assist people living with skin, joint and digestive disorders
Healthcare | May 19, 2022

Janssen’s icare4u to assist people living with skin, joint and digestive disorders

The icare4u program features a dedicated website, with comprehensive information about the diseases, videos with medical experts, and a social media community for patients and caregivers on Facebook and YouTube


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


Dr Mansukh Mandaviya promises to introduce `Made in India’ TB infection skin test kit
Public Health | May 19, 2022

Dr Mansukh Mandaviya promises to introduce `Made in India’ TB infection skin test kit

This cost-effective tool will be of immense benefit to other high burden countries as well.


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


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


ZS and Quartic to accelerate digitalization in life sciences and healthcare
Digitisation | May 18, 2022

ZS and Quartic to accelerate digitalization in life sciences and healthcare

ZS and Quartic will collaborate to help drive resilience, increase adoption of Industry 4.0 and improve predictive decision-making across manufacturing


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