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The Quality Lowdown: Cleaning Issues At Mylan, Blank Release Forms At API Plant In China, And More

 
• By Bowman Cox

Mylan can look forward to mopping up some major cleaning validation issues a large team from FDA found during an extensive inspection of the firm’s West Virginia plant. Meanwhile, an API firm in China found it should not have left blank product release forms lying around pre-stamped “Permitted to Leave Factory.”

The referee gave a red card for the player in stadium

When an eight-person team inspects a pharmaceutical manufacturing plant, it will be likely to observe all kinds of problems, and that certainly was the case with a massive Form 483 report that surfaced on FDA’s web site last week after a major inspection of Mylan’s plant in West Virginia.

Meanwhile, an active pharmaceutical manufacturing plant in China was found to have data integrity issues deserving of a warning letter,...

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• By Eliza Slawther

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The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

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• By Sue Sutter

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
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Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.

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• By Mandy Jackson and Sarah Karlin-Smith

Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.