AbbVie had alleged Alvotech had recruited a former employee who then transferred data about its best-selling Humira treatment. In other news, the Food and Drug Administration halted trials by Allogene Therapeutics for its CAR-T cell therapy after a blood cancer patient had chromosome issues.
Stat: AbbVie Loses A Lawsuit Over Humira Trade Secrets It Claimed Were Stolen
In a setback to AbbVie (ABBV), a U.S. federal court judge dismissed a lawsuit in which the drug maker claimed a would-be rival hired one of its employees, who then allegedly transferred a boatload of confidential information about its best-selling Humira treatment. AbbVie had contended that Alvotech recruited Rongzan Ho in its quest to jumpstart its entry into the market for biosimilar versions of Humira. The biologic treatment is widely prescribed to combat rheumatoid arthritis, among other ailments, and racked up $19.8 billion in worldwide sales last year, including $16.1 billion in the U.S. The medicine accounted for 43% of its revenue. (Silverman, 10/7)
In other pharmaceutical news —
Stat: FDA Halts Allogene Blood Cancer Trials After Abnormality Seen In Patient
Allogene Therapeutics said Thursday that the Food and Drug Administration had placed a hold on its clinical trials after a patient with blood cancer treated with its off-the-shelf CAR-T cell therapy was found to have a “chromosomal abnormality.” An investigation is underway to determine what might have caused the unexpected changes to the engineered T cells that make up the Allogene treatment, the company said. At this time, the clinical significance to the patient remains unclear. (Feuerstein, 10/7)
Stat: Amgen’s Lumakras Disappoints In Combination With Other Drugs
Combining Amgen’s KRAS-blocking cancer drug Lumakras with other targeted medicines led to higher rates of side effects without improving tumor responses, according to preliminary results from two clinical trials released Thursday. Amgen secured U.S. approval of Lumakras in May to treat patients with lung cancer caused by a genetic mutation to the KRAS protein. In the future, combining Lumakras with other targeted drugs may lead to more effective treatments for patients with cancer, but the data revealed Thursday show that goal not yet within reach. (Feuerstein, 10/7)
CIDRAP: Study Highlights Impact Of Antibiotic Resistance On Older Americans
New research shows that roughly 40% of the deaths caused by the most common antibiotic-resistant infections occur in American 65 years and older. In a study published today in Clinical Infectious Diseases, researchers estimated that in 2017, more than 11,000 Americans 65 and over died from community- and hospital-onset invasive infections caused by six resistant bacterial pathogens. According to the most recent report from the Centers for Disease Control and Prevention (CDC), those same pathogens killed an estimated 30,000 Americans in 2017. (Dall, 10/7)
Stat: Backed With $500M, A Startup Aims To Rethink Psychiatric Drug Development
For more than a decade, psychiatry has been a graveyard for new medicines. While in the 1990s and 2000s the pharmaceutical industry became rich off of the profits from big-name drugs like Prozac and Abilify, in recent years many firms have exited the neuroscience business entirely. Recent attempts to re-enter it have been underwhelming. On Thursday, ARCH Venture Partners, one of the biotechnology industry’s top venture capital firms, revealed new details about a company it has started to try to re-ignite the development of medicines for diseases such as depression, schizophrenia, and Alzheimer’s. Neumora, a roll-up of assets from several biotech firms and from the drug giant Amgen, is backed with $500 million in funding from ARCH and at least 12 other investors. (Herper, 10/7)
Stat: Europe’s Largest Clinical Trial Sponsors Are Getting Better At Reporting Results
More than two dozen of the largest universities and hospitals in Europe have shown a “dramatic improvement” in reporting clinical trial results and most are actively working to clear their backlogs of missing results to a European Union database, according to a new analysis. The 26 research institutions have run nearly 4,600 trials testing medicines and, so far, 641 sets of results have been made available. Of the 2,300 of those studies with results due to be reported to the EU Clinical Trials Register, 28% have now been submitted. Only five trial sponsors have not shown any sign of progress, and all of these are located in Italy and the Netherlands. (Silverman, 10/7)
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