India Regulatory Reform: ‘Redeliberation’ At SECs Tightened, ‘Unnecessary Load’ Reduced

 

India continues to reform biopharma regulatory processes and widen digitization efforts. The regulator will curb "re-deliberations" at subject expert committee meetings unless applicants furnish new data.

Trump 2.0: India Pharma On A Good Wicket?

 

US President-elect Donald Trump’s second term is seen in general as “bad news” for Asia, especially China, by some analysts. But the outlook for India pharma appears upbeat, says a cross-section of experts.

China Race On For New Wave Of Novel Drugs

 

A new drug-hunting initiative funded by the Chinese government will focus on novel therapies for chronic diseases and encourage academia-industry collaboration.

KRSC Aims To Raise Korea’s Regulatory Science Game

 
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The head of the Korea Regulatory Science Center talks exclusively to the Pink Sheet about why regulatory science is crucial, the country's efforts to improve in the area and the center's strategic bridging role.


China Dominates APAC’s Emergence As Global Trials Hub

 
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Asia-Pacific continues to solidify its position as a key location for clinical trials, with China in particular dominating such activity in the region, and increasingly globally, a new Citeline White Paper shows.

Japan Pricing Update: Trodelvy, Tepezza Win Usefulness Premiums, Awiqli Struggles

 
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While Japan awarded relatively high premiums to several products newly listed for reimbursement, others were the subject of prolonged debate or are facing imminent cost-effectiveness assessment.

Japan Prices Kisunla Above Leqembi But May Cut In Future

 
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Japan has granted an initial reimbursement price for Kisunla slightly above that for Alzheimer's rival Leqembi, but is holding out the prospect of future price revisions.

China Opens Up Non-End-To-End Manufacturing Of Biologics Within, Across Border

 
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China implements a new pilot scheme allowing non-end-to-end manufacturing of certain biologics before possible nationwide implementation for all such products, with resource optimization and aligned quality management systems among the main goals.


Japan Adopts Early Approval Scheme For Infectious Disease Drugs

 
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Japan has implemented a streamlined regulatory system designed to enable speedier approvals of selected drugs for designated categories of infectious diseases, which does not require Japanese clinical data.

Korea Can Play To Strengths But Also Improve Regulatory Flexibility For Clinical Trials

 
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A session at the recent KoNECT conference in Seoul looked at Korea’s strengths in clinical trials but also at what's needed to further improve its global competitiveness as a location for studies.

Chinese Regulator Raises Red Flag On Clinical Trial Bribery

 

China has proposed new guidelines designed to head off potential bribery by pharma companies related to the conduct of clinical studies and possible manipulation of outcomes.

Japan Recommends Approval Of Brukinza, Balversa

 
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Along with several new positive approval recommendations, Japan's proceeding to grant Sakigake designation to two drugs including a DMD gene therapy discovered through public collaboration. Meanwhile, the PMDA has opened a new full-time office in the US.


ACCESS Consortium Exploring Clinical Trials Collaboration & Reliance, Says UK MHRA

 

The UK’s drug regulator, the MHRA, is exploring new opportunities to work closer with its counterparts from Australia, Canada, Singapore and Switzerland under the ACCESS Consortium group, with a focus on pre-submission scientific advice.

Astellas Praises EU & US Regulators For Collaboration In Gene Therapy Space

 

The move towards greater regulatory collaboration is a positive step for gene therapy developers, Astellas’ gene therapy strategy lead Richard Wilson says – adding, however, that pharma still needed to understand the Asian markets better.

Japan Eases Local Clinical Data Requirements For Rare Disease Drug Filings

 
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Japan is cautiously easing Japanese clinical data requirements for rare disease drugs to allow faster and more flexible approvals, including on a conditional basis supported by postmarketing studies.

Vaccine Misinformation: Meiji Considers Legal Action Amid Japan Launch Of Kostaive

 
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Dispute around the first-in-world license for a self-amplifying mRNA COVID-19 vaccine castes light on Japan’s ongoing dilemma between a government trying to build its own capabilities to attract, develop and manufacture new modalities and the anti-vax movement in the country.


BIOSECURing the Future: What an American Cold War with China Could Mean for the Pharma Industry

 
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Whether the legislation aimed at discouraging use of Chinese contractors passes in its current form or not, industry will continue to face more pressure to decouple its operations.

India Rare Diseases: Court Shows Path For Policy Action, Funding, Price Issues

 

A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to cause a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the companies that have been part of pricing discussions.

China’s Strategic Choices To Open Up CGT And Hospital Sectors

 
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China recently made strategic moves to allow direct foreign investments into cell and gene therapy development, as well as into hospitals in certain cities and regions across the country. Foreign firms are generally optimistic despite some challenges.

Coping Strategies For China Industry Amid BIOSECURE Overhang

 
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With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."