Spotlight On... France's ANSM orders French biotech Theravectys to suspend manufacturing; Potential buyer for Ranbaxy plant in Ireland drops out; India's Alkem says FDA signs off on a plant; and more...

Another French biotech has had its clinical supply manufacturing shut down by French drug regulator ANSM after inspectors found a number of serious problems. According to a recent report posted by the European Medicines Agency, ANSM inspectors in November took a look at Theravectys in Villejuif, France, a biotech which is producing lentiviral vectors for clinical development and doing cell work for chimeric antigen receptors (CARs) and T-cell receptor (TCR)-based cell therapies. The facility was only approved in April of last year. During the inspection, they found 45 deficiencies, 5 of which they deemed critical and 17 major. They included testing media fill with "unqualified equipment." Last year, regulators recommended the same action against TxCell, a French biotech working on T-cell treatments for chronic inflammatory and autoimmune diseases. TxCell has since transferred its manufacturing to a contractor. Access the EMA report here | More

> A potential buyer for a former Ranbaxy plant in Cashel, Ireland, that Sun Pharmaceutical is trying to sell has reportedly dropped out, but others remain interested. Report

> Nepali companies have warned they may shut down unless the government releases the executives that were arrested because their companies allegedly sold products at prices that exceeded price caps. Story

> Indian drugmaker Alkem Laboratories reported Monday to the Bombay Stock Exchange that the FDA has issued am Establishment Inspection Report for an active pharmaceutical ingredient plant in Gujarat following a September 2015 inspection. Filing

> A new report says that Indian companies continue to be the source for a large number of diverted narcotic and psychotropic drugs that end up for sale on illegal online pharmacies. Story

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