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3734 News Found

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


Pharmapack Europe awards winners 2022
Packaging | May 19, 2022

Pharmapack Europe awards winners 2022

Pharmapack Europe recognizes excellence and innovation from exhibitors across connected devices, sustainability, supply chain logistics, route of administration, and packaging innovation, as well from the wider industry for patient-centric design and eco-design


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


Synexa Life Sciences acquires Finnish CRO Syrinx Bioanalytics
News | May 19, 2022

Synexa Life Sciences acquires Finnish CRO Syrinx Bioanalytics

Expansion of leading biomarker and bioanalysis company enhances bioanalytical solutions for targeted radiopharmaceuticals


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


Agilent companion diagnostic expands CE-IVD Mark in Europe to include cervical cancer
Medical Device | May 18, 2022

Agilent companion diagnostic expands CE-IVD Mark in Europe to include cervical cancer

Globally, cervical cancer is the fourth most common cancer among women, with approximately 30,447 new cases diagnosed in Europe in 2020


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


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


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