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Vega Life Sciences Warning Letter Shows Difficulty Of Applying Drug GMPs To API Solvent Recyclers

 
• By Bowman Cox

Recycling offers economic and environmental benefits, but risks introducing potentially carcinogenic impurities. Company barred from US market.

Warning hazard sign and signage man falling
a point of no return • Source: Shutterstock

A recent US Food and Drug Administration warning letter provides more insight into how difficult it will be for active pharmaceutical ingredient manufacturers to retain the economic and environmental benefits of solvent recycling without risking the introduction of potentially carcinogenic impurities such as nitrosamines into drug products.

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• By Francesca Bruce

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Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 
• By Eliza Slawther

Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.