STAT+: Pharmalittle: We’re reading about GSK and leucovorin, China’s API production, and more

Rise and shine, everyone, another busy day is on the way. We can tell by the hum of traffic and construction work within earshot since we are still on the road. This makes foraging for a worthy cup of stimulation something of a challenge, but we are up to the task. Meanwhile, we have assembled the latest menu of tidbits to help you on your own quest for inspiration. We hope your day is productive and meaningful. And of course, do keep in touch. We always appreciate feedback, criticism, and suggestions. …

GSK chief executive officer Emma Walmsley maintained the company has had a minimal role in an effort by the U.S. Food and Drug Administration to update the prescribing information of a long-shelved drug so that it can be used to treat a condition often associated with autism, STAT writes. The FDA request that GSK update the prescribing information for its decades-old therapy leucovorin is “an administrative request,” she said. “We have no commercial interest, we have no scientific research, and we’re not pursuing it. So it’s just the administration at this stage.” Leucovorin, originally sold as Wellcovorin, was approved in 1983 to treat toxicities associated with certain therapies. GSK stopped marketing the drug in 1997, and generics are now available. Last month, though, GSK agreed to an FDA request to submit an application for leucovorin to treat cerebrate folate deficiency, a neurological condition that can have overlapping symptoms with autism. Although GSK no longer makes the drug, updating the label will allow generic manufacturers to do so as well.

AstraZeneca got a rare sell rating on Thursday as Deutsche Bank AG analysts downgraded the drugmaker, taking a more skeptical view on the company’s drug pipeline, in particular for breast cancer treatments, Bloomberg News informs us. Analyst Emmanuel Papadakis cut the stock from hold and reduced his price target to $140, the lowest among analysts tracked by Bloomberg. That implies a 16% drop from current levels following the stock’s strong gains in the first half of this month. “With AstraZeneca at the top of its recent trading range, we take the opportunity to turn more explicitly negative,” Papadakis wrote in a note. Last time he had a buy recommendation on the stock was in July 2023. According to the analyst, AstraZeneca’s key breast cancer drug, camizestrant, is unlikely to show meaningful benefits over peers. Current valuations might be too stretched as patent expiration pressures are also starting to mount, he added.