Morning Briefing
Summaries of health policy coverage from major news organizations
Significant New Clinical Trial Begins For Roche Alzheimer's Drug
Partners Roche and Genentech are studying whether their investigational treatment for Alzheimer鈥檚 disease can prevent memory loss for patients who are yet to show symptoms, embarking on a four-year clinical trial without waiting for data from key ongoing studies. The new trial will test whether the partners鈥 treatment, gantenerumab, can prevent the development of Alzheimer鈥檚 for patients who have disease-related plaques called amyloid in their brains but no evidence of cognitive or functional decline. (Garde, 3/3)
In other pharmaceutical and biotech news 鈥
Flagship Pioneering, the Cambridge, Mass., life sciences investment firm that helped found Moderna over a decade ago, has unveiled a new company backed with $75 million to develop drugs for common conditions such as autoimmune disorders, diabetes, and Alzheimer鈥檚 disease. The startup, Vesalius Therapeutics, was founded at Flagship in 2019 on the premise that many common diseases remain underserved by drug companies. Biotech companies in particular often focus on developing therapies for rare genetic diseases, where a well-understood root cause of a condition provides a clear path for drug development. (Cross, 3/2)
KHN: HIV Preventive Care Is Supposed To Be Free In The US. So, Why Are Some Patients Still Paying?聽
Anthony Cantu, 31, counsels patients at a San Antonio health clinic about a daily pill shown to prevent HIV infection. Last summer, he started taking the medication himself, an approach called preexposure prophylaxis, better known as PrEP. The regimen requires laboratory tests every three months to ensure the powerful drug does not harm his kidneys and that he remains HIV-free. But after his insurance company, Blue Cross and Blue Shield of Texas, billed him hundreds of dollars for his PrEP lab test and a related doctor鈥檚 visit, Cantu panicked, fearing an avalanche of bills every few months for years to come. (Varney, 3/3)
On Monday, the U.S. Patent and Trademark Office ruled that CRISPR patents key to developing human therapies belong to the Broad Institute of Harvard and MIT, and not the home institutions of Jennifer Doudna and Emmanuelle Charpentier 鈥 the two scientists who won the Nobel Prize for creating the revolutionary genome-editing technology. After a bitter seven-year battle between the Broad and Doudna and Charpentier鈥檚 side, known as the CVC group, the patent judges finally issued a definitive opinion on who invented the 鈥済uide RNA鈥 molecule that allows the genome editor to work in eukaryotic cells. They determined that it was Feng Zhang, of the Broad, who first 鈥渞educed to practice鈥 this process, which is a critical step for developing medicines to treat human diseases, the most lucrative application of CRISPR technology. (Molteni, 3/2)
Chronic kidney disease is a serious medical problem that changes the lives of about 13% of the world鈥檚 population. Some kidney damage is reversible; kidney cells can marshal their repair mechanisms to heal harm caused by high blood pressure, diabetes, or harsh medications like chemotherapy. But some damage can become permanent, limiting people鈥檚 lives as their kidneys lose their ability to filter blood and remove the body鈥檚 waste products. Just where the tipping point sits between injury that is fixable and damage that鈥檚 beyond repair hasn鈥檛 been clear. (Cooney, 3/2)