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Asia Pacific

Set Alert for Asia Pacific

Anti-Globalism Policy Cannot Stifle International Cooperation, US FDA’s Califf Says

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

DIA Supply Chain

Korea’s Medical Vacuum Grows As Doctors Threaten Indefinite Walkout

Long-running protests by South Korean doctors against government reforms, including raising medical school admissions, continue to intensify with a one-day rally by community doctors and the threat of an indefinite walkout later this month. The pharma industry is also feeling the impact on clinical trials and sales. 

South Korea Policy

China Sets Clinical Trial Record But Starting Studies Can Be Challenging

Antibody-drug conjugates, GLP-1 receptor agonists and cell/gene therapies propelled a big increase in clinical trial registrations in China last year, but why do sponsors sometimes remain reluctant to actually start studies?

China Clinical Trials

Australia Proposes Clearer Labeling For Injectables To Ensure Safety & Efficacy

A targeted review of the rules on labeling for injectable medicines is being carried out in advance of a wider updating of labeling requirements that took effect in 2020.

Asia Pacific Australia

Global Pharma Guidance Tracker – May 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.

Guidance Documents Regulation

Japan Nods Include Torii's Vtama, Skyrizi In New Uses

Japan issues approval recommendations in new indications, including Torii's Vtama in atopic dermatitis and AbbVie's Skyrizi in ulcerative colitis. Separately, filing requirements for the use of concomitant therapies have been revised.

Japan Drug Review

Quotable: Top Experts On Policy Hot Topics

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

International Europe

Japan Aims To Broaden RWD Use By Allowing Pseudonymised Data

Japan has been promoting a revised law that will allow the broader use of real world data by allowing the use of both pseudonymised and anonymised data.

Japan Real-World Evidence

ANDA Suitability Petitions: The Timelines They Are A-Changin'

US suitability petition submissions see an uptick against the backdrop of GDUFA III new goals for the FDA's response to such petitions. The Pink Sheet tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

Regulation Generic Drugs

Citeline Japan Awards 2024 - Enter Now!

The 15 July entry deadline for the Citeline Japan Awards 2024 in Tokyo is fast approaching, so here's a reminder to take a look at the categories and criteria and be sure you get those submissions in by this date. Sponsorship opportunities and tables are also available. 

Japan Commercial

NGGT Progresses First US Gene Therapy Trials For Rare Conditions

Next Generation Gene Therapeutics is fast-tracking clinical trials in the US for its gene therapy candidates for Bietti's crystalline dystrophy and classic phenylketonuria, supported by China data, the Chinese venture's CEO says in an interview.

China Clinical Trials

'We Are Not Waiting To Be Replaced': Medical Affairs Pros Take On GPT-4o

Faster, more powerful and able to handle voices and visual images, newly released AI platform GPT-4o could potentially accelerate many tasks currently handled by pharma firms' medical affairs professionals, who are exploring ways to keep themselves relevant while embracing the unprecedented technology, DIA China hears.

Artificial Intelligence China

Japan Reimburses Zolbetuximab, To Cut Price Of Imfinzi, Others

The first-in-class anti-CLDN 18.2 antibody zolbetuximab will face cost-effectiveness assessment in Japan in the near future, as the country applies stricter reimbursement pricing policies to gain transparency in expenditure through its healthcare reimbursement structure.

Japan Pricing Strategies

Korea’s Clinical Trial Approvals Up 10%, But Still Below Pandemic Peak

South Korea’s clinical trial approvals rebounded in 2023, but remained lower than the peak levels in 2020-21 amid then robust R&D activity related to COVID-19. Last year's tally showed a mix of single-country and multinational trials and reflected the ongoing dominance of oncology in industry pipelines.

South Korea Clinical Trials

Vaccine Star's Surprise Downfall Indicative Of Trouble In China’s COVID Push?

Apparently months after his actual detention, news has finally surfaced that a key researcher behind China's rapid development of a homegrown COVID-19 vaccine is said to have "severely violated" Communist Party rules and regulations and is the subject of a probe for possible corruption.

China Policy

Industry Applauds AUD18.8m Funding For Australia’s ‘One Stop Shop’ For Clinical Trials

The plan is to create a single platform that would facilitate rapid and streamlined clinical trial approvals and address the challenges sponsors currently face in having to navigate different processes for clinical trials in each state and territory, and within area health services.

Australia Clinical Trials
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