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Singapore

Singapore ADC Specialist Axcynsis Nets Novel Payload To Address Drug Resistance

Singapore ADC Specialist Axcynsis Nets Novel Payload To Address Drug Resistance

Axcynsis is developing a derivative of the chemotherapy agent Yondelis as a new payload, which the Singapore venture will first apply to a Claudin 6-targeting ADC it plans to take into a Phase I trial in the US, its chairman, CEO and founder tells Scrip in an interview.

Global Pharma Guidance Tracker – September 2024

Global Pharma Guidance Tracker – September 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Singapore Releases eCTD Specification Package As Companies Prepare For Portal Launch

Singapore Releases eCTD Specification Package As Companies Prepare For Portal Launch

Companies will initially be able to submit their dossiers to the Health Sciences Authority via the eCTD portal on a voluntary basis.

Global Pharma Guidance Tracker – August 2024

Global Pharma Guidance Tracker – August 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Medtech Guidance Tracker: August 2024

Global Medtech Guidance Tracker: August 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.

Regulatory Recap: Generic Medicines Work-Sharing Initiative Outlines Foreign Comparator Acceptability

Regulatory Recap: Generic Medicines Work-Sharing Initiative Outlines Foreign Comparator Acceptability

Generics Bulletin reviews the latest regulatory events across the world.

Global Pharma Guidance Tracker – July 2024

Global Pharma Guidance Tracker – July 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Global Pharma Guidance Tracker – June 2024

Global Pharma Guidance Tracker – June 2024

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Major Boost For WHO-Listed Authority Scheme As US & EU Regulators Designated

Major Boost For WHO-Listed Authority Scheme As US & EU Regulators Designated

The US Food and Drug Administration and the European medicines regulatory network, which includes the European Commission, the European Medicines Agency and 30 national agencies, are now WHO-Listed Authorities under a framework launched in 2022.

Regulatory Reliance: Thai Program With Singapore Provides Cost-Savings, Earlier Innovations

Regulatory Reliance: Thai Program With Singapore Provides Cost-Savings, Earlier Innovations

The 25th IMDRF meeting in March 2024 agreed that regulatory reliance models save resources, encourage innovation, bring devices to the market faster and boost patient access. Singapore and Thailand have operated a model of mutual regulatory reliance for three years. Thailand also recently broached deeper collaboration with Brazil’s Anvisa.