FDA Found Quality-Control Issues In California Neuralink Lab
The brain implant company was cited for problems with record-keeping and quality controls for animal experiments, Reuters says. The company's Texas facility was found problem-free. Also in the news, biotech companies worry about government oversight of biosecurity as it pertains to China.
Reuters:
Exclusive: Musk's Neuralink Brain Implant Company Cited By FDA Over Animal Lab Issues
U.S. Food and Drug Administration inspectors found problems with record keeping and quality controls for animal experiments at Elon Musk's Neuralink, less than a month after the startup said it was cleared to test its brain implants in humans, according to an agency report reviewed by Reuters. The inspectors identified quality control lapses at the company's California animal research facility. A similar inspection at Neuralink's Texas facility did not find problems, according to agency records. (Taylor, 3/1)
In other biotech and pharma news —
Stat:
Biotech Companies Concerned About China Biosecurity Crackdown
The federal government increasingly is scrutinizing Chinese businesses and their interactions with American companies, including in the biotech sector. Chinese biotechnology companies, the thinking goes, could threaten national security by giving the Chinese government access to the genetic and health information of Americans. (Wilkerson, 2/29)
Stat:
Medical Device Lobby: We're Tired Of Waiting On Medicare Coverage
Medical technology lobby AdvaMed is fed up with the Centers for Medicare and Medicaid Services. In a letter sent to the agency and shared with STAT, the group urged CMS to act on finalizing a pathway that would make reimbursement for breakthrough devices easier. (Lawrence, 3/1)
Reuters:
Pharma Companies Ask Court Not To Break Up US States’ Price-Fixing Lawsuits
A group of major pharmaceutical companies want an appeals court to force Connecticut and other states to remain in a coordinated legal proceeding over generic drug pricing, arguing that allowing them to pursue their claims separately would upend years of legal work and cause delays. Drug companies Upshur-Smith, Teva, Glenmark and more than a dozen others in a petition urged the Philadelphia-based 3rd U.S. Circuit Court of Appeals to keep Connecticut and 45 other states a part of the antitrust litigation in Pennsylvania. (Scarcella, 2/29)
Stat:
Pfizer Highlights Cancer Drugs It Thinks Could Reignite Investor Interest
Pfizer spent more than four hours Thursday laying out its oncology program to investors. But the company also spent some time talking about the effects of the Inflation Reduction Act on its pipeline. (Herper, 2/29)
The Philadelphia Inquirer:
Every Cure, Led By Penn's David Fajgenbaum, Will Use AI To Find New Treatments For Rare Diseases
Every Cure, a Philadelphia-based disease research nonprofit, has received a $48.3 million federal contract to develop an artificial intelligence-powered matchmaking program to help doctors find new uses for already approved medications. Algorithms will scan tens of thousands of approved medications and rare diseases to find potential matches. The approach would automate and expedite a process that is currently done on a case-by-case basis, when a medical team needs to find a new treatment for a patient’s rare disease. (Gantz, 2/29)
Also —
Bloomberg:
Trudeau Introduces Bill On National Drug Coverage Program
Prime Minister Justin Trudeau’s government has introduced a bill in Parliament that moves Canada closer to a national drug coverage program. The legislation sets up “foundational principles” for a national drug program. As a first step, the bill establishes that the government will start negotiations with provinces to provide universal, single-payer coverage for a number of contraception and diabetes medications, Health Minister Mark Holland said Thursday at a press conference in Ottawa. (Platt and Dhillon Kane, 2/29)
