Novartis has started cutting ties with Chinese contractors amid a potential threat from the BIOSECURE Act. Neurocrine Biosciences is considering moving a depression drug candidate licensed from Takeda into phase 3 testing. AstraZeneca and Daiichi Sankyo's Enhertu is on the cusp of an important readout in HER2-low breast cancer. And more.
As the BIOSECURE Act threatens to block certain biotech equipment and service providers from China, Novartis has begun cutting ties with Chinese contractors. The company will mitigate the impact from the proposed legislation “in a very reasonable time frame” so that “by the time this comes into effect, we will have no exposure from our planning,” Novartis Chief Financial Officer Harry Kirsch told reporters on a call.
Neurocrine Biosciences said a phase 2 dose-finding study of its AMPA positive allosteric modulator, coded NBI-1065845, has met its primary and secondary endpoints in patients with previously treated major depressive disorder. Neurocrine got the once-daily oral drug, among other psychiatry candidates, from Takeda in 2020 as part of deal worth up to $2 billion.
3. AstraZeneca CEO says platform deals largely done after M&As in vaccines, radioligand, cell therapy
HER-targeted Enhertu generated $879 million in first-quarter sales for AstraZeneca and Daiichi Sankyo ahead of a key phase 3 readout. The two companies expect to report data from the DESTINY-Breast06 trial by June, which could move the antibody-drug conjugate one line earlier into second-line HER2-low breast cancer and potentially in patients whose tumors have even lower HER2 expression than the current HER2-low definition.
4. Leqembi launch hamstrung by physicians' 'therapeutic nihilism'
Biogen plots 30% Leqembi field force bump, omnichannel campaigns as launch enters new phase
A Reuters report suggested that Eisai and Biogen still have some convincing to do around their Alzheimer’s disease drug Leqembi. Some doctors who spoke to the news wire had doubts about the drug’s efficacy, cost and risks. Eisai’s chief administrative officer, Alex Scott, said the company is beginning to make progress with the skepticism. Meanwhile, Biogen plans to increase its Leqembi U.S. field force by about 30%, although the current size of the team is unknown.
5. FibroGen, former employees settle dispute over alleged trade secrets theft
FibroGen has resolved a trade secret suit it waged against two former employees around its HIF-PHI compounds such as Evrenzo, with no payment by either party, the defendants said. FibroGen filed the lawsuit in late 2022, alleging that two former employees, Dong Liu, Ph.D., and Shaojiang Deng, Ph.D., misused its intellectual property to feed their own related startups, Hangzhou Andao Pharmaceutical and Kind Pharmaceuticals. The settlement still allows Kind to develop its HIF-PHI candidates.
6. Dr. Reddy's recalls 6 lots of PKU drug due to possible potency problems
Dr. Reddy’s issued a voluntary recall of six lots of sapropterin dihydrochloride powder used to treat phenylketonuria due to potential potency issues. The recall is for 100-mg dosages of the drug, including five lots marketed under the name Javygtor and one lot that’s simply called sapropterin dihydrochloride powder for oral solution. The company said it hasn’t received any reports of adverse events.