The U.S. Department of Justice is targeting two co-founders of Taiwanese firm JHL Biotech in a trade secrets theft lawsuit as two ex-Genentech insiders pleaded guilty for their role in the scheme. Lundbeck sold off rights to a failed Alzheimer's disease drug to China's Denovo Biopharma. China's drug reviewers released a draft guidance for cancer drug R&D, causing concerns that it would be more difficult to conduct oncology clinical trials. And more.
Two ex-Genentech staffers have pleaded guilty to conspiring to steal trade secrets from the Roche subsidiary. The husband-and-wife team ferried confidential documents related to the company’s cancer drugs Rituxan, Herceptin and Avastin plus cystic fibrosis inhalation Pulmozyme to Taiwanese firm JHL Biotech, now called Eden Biologics. Two JHL co-founders now face a new indictment for profiting from the materials by way of a $101 million Sanofi licensing deal.
2. Lundbeck sells off flopped Alzheimer's drug as Aduhelm approval ups interest
Amid a gold rush to develop Alzheimer’s drugs after the FDA’s controversial approval of Biogen’s Aduhelm, China’s Denovo Biopharma has picked up a discarded candidate from Lundbeck. The biotech gained global rights to idalopirdine, a 5-HT6 receptor antagonist that failed three phase 3 trials in 2016 and 2017. The pact came on the heels of Simcere Pharma in-licensing greater China rights to German biotech Vivoryon Therapeutics’ amyloid-targeting candidates varoglutamstat and PBD-C06 for Alzheimer’s.
3. Is China's drug regulator suddenly raising the bar on cancer med R&D? Not exactly, say experts
China’s drug reviewers released a new draft guideline, noting that oncology drug development should focus on creating “clinical value” for patients. It states that late-stage trials should use best standard of care as a control. The requirement stirred up fear of a chilling effect on R&D. As two industry experts view it, though, it won’t affect industry front-runners but may deter drugmakers that are piling on to develop drugs against the same targets.
4. Lupin's Novel Laboratories knocked by FDA for cleanliness, quality issues at New Jersey plant
The FDA slapped a warning letter on a Lupin plant in Somerset, New Jersey. During an inspection late last year, investigators found the company’s labs failed to properly clean nondedicated equipment. They also identified manufacturing process problems for sleep med temazepam as well as deficiencies in its quality control unit.
Chicago biotech Sparx Therapeutics unveiled a plan to build a 1,200,000-square-foot commercial manufacturing facility in Yangzhou, China. It will have bioreactor capacity of 80,000 liters that will be able to simultaneously make five commercial products and support at least 12 clinical programs, the company said. It expects the stie to come online by the end of 2022.
6. Takeda promotes empathy for IBD patients with immersive 'In Their Shoes' experience
Takeda is expanding the reach of its award-winning program “In Their Shoes.” It includes a downloadable app and related equipment that offers immersive experience for inflammatory bowel disease. The two-day program aims to mimic the disease’s disruptive and painful nature.