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Emerging Markets Regulatory Tracker: Australia, Brazil, India (Vol. 4 No. 23)

 
• By Louise Zornoza

Australia’s TGA proposes new warning labels for pediatric OTC cough medicines and decongestants. Brazil requires 12-month notice before withdrawing products from the market and India’s CDSCO specifies format for fixed-dose combination drug submissions.

The Emerging Markets Regulatory Tracker is prepared for PharmAsia News by RegLink Associates, which tracks regulatory, policy and health technology assessments around the world for biopharma and medical device executives.

Read all Breaking News from RegLink.

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Sun’s Alopecia Treatment Debuts In US - Can It Make Up For Lost Time?

 
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While ASKA plans to dilute the holding of largest investor Dalton by issuing new shares, the US investment firm continues to push a management buyout option to the mid-sized Japanese pharma company.

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Big pharma is increasingly looking east to restock its pipelines, a process that is helping to forge a new generation of mid-sized R&D-based companies in China and is reflected in their stock price performance.

Q2 Korea Biotech Roundup: Licensing Deals End, Trials Progress, IPOs Recover

 
• By Jung Won Shin

Aside from several sizable global out-licensing deals, South Korean bioventures saw a cancellation of other alliances, updated their pipelines with losses and gains and reported clinical trial progress in the second quarter, while domestic IPO sentiment also improved.

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Finance Watch: Karyopharm Cuts Jobs In Cash Crunch; Pacira’s Layoffs Attributed To Efficiency

 
• By Mandy Jackson

Restructuring Edition: Karyopharm is reducing its workforce by 20% as it seeks alternatives to extend its cash runway, but Pacira’s production improvements created efficiency that necessitate an 8% layoff in manufacturing. Jasper, Century, Sage, Leap and Prothena also cut jobs.

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With China’s Hengrui reporting successful Phase III data for its dual GLP-1/GIP agonist, licensee Kailera is readying plans to demonstrate better efficacy than current obesity drugs.

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