Biology Digest

  Jessica Richman and Zachary Apte, the cofounders of the now shuttered microbiome company uBiome, are facing criminal and civil charges stemming from their efforts to build uBiome into a poop-testing powerhouse. The Securities and Exchange Commission alleged that Richman and Apte defrauded investors out of $60 million by giving a false impression of how well the company was doing. The married cofounders are also facing criminal charges in federal court in California. They were indicted on Thursday on charges including healthcare fraud and wire fraud, as well as related conspiracy charges. The SEC complaint alleged Richman, 46, and Apte, 36, portrayed uBiome as receiving health-insurance reimbursements for its tests, which tested poop samples for different conditions related to gut health. The complaint alleged the cofounders made millions as uBiome raised money from investors. "We allege that Richman and Apte touted uBiome as a successful and fast-growing biotech pioneer while hi

 

  (Reuters) - On a chilly spring morning in 2019, Amrit Mula arrived in her office at pharmaceutical giant Eli Lilly and Co’s factory in Branchburg, New Jersey, to find a desk drawer open that she had kept locked. Her files were missing. Mula was a top human resources officer at what was one of America’s largest biotech plants. Over the years, she had been investigating employee complaints about manufacturing problems related to multiple drugs, including the company’s blockbuster diabetes medication, Trulicity, according to internal company documents and email correspondence reviewed by Reuters. Among the most serious allegations: Records had been falsified or destroyed in the wake of manufacturing mistakes. In one case, according to 2018 emails among executives, company-mandated quality assurance documents were missing for Trulicity, which security filings show garnered more than $4 billion in sales in 2019. Shortly after Mula discovered her files missing that day, her boss told her t

  The clock is ticking on an FDA commissioner nomination, with public pressure on President Joe Biden to pick up the pace. Six former FDA commissioners wrote the White House this week urging Biden to make a choice, according to several media reports. The letter, signed by Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, Mark McClellan and Andrew von Eschenbach, pushed Biden to act in the face of the ongoing coronavirus pandemic. They noted vaccine, drug and testing issues related to the pandemic, as well as the need to implement new tobacco regulations,  according  to The Washington Post. Some prominent voices on social media are asking for the same clarification as the former FDA heads, while others guessed that Biden will name a candidate after his nominee for Health and Human Services, Xavier Becerra, is confirmed. Science journalist and author Laurie Garrett  wrote  recently on Twitter that it’s not a good time for the FDA to be “leaderless,” adding that Biden “despera

 

  As Biogen awaits an FDA decision on its controversial Alzheimer's disease hopeful aducanumab, the company is setting the stage for an entry into the hot gene therapy field.  Biogen has drawn up plans for a new gene therapy manufacturing facility at its Research Triangle Park campus in North Carolina. The 175,000-square-foot facility will be designed to scale up the manufacturing of the products that are in Biogen's growing gene therapy pipeline. Biogen expects the facility to be up and running by 2023.  The company will  invest  some $200 million in the new site, with plans to add about 90 new jobs to its current Research Triangle Park workforce of 1,900. The expansion comes as Biogen searches for revenue sources to pick up the slack from declining sales of its spinal muscular atrophy blockbuster Spinraza and multiple sclerosis drug Tecfidera. The company is expecting the FDA to rule on aducanumab in June, but it will most definitely need more blockbuster prospects. Biogen do