| | | |   | | | Guardant's colon cancer blood test good, not great New results from a 20,000-person study of liquid biopsy player Guardant Health's colon cancer diagnostic are a touch underwhelming. The blood test, called Shield, detected colon cancer 83% of the time that it was actually there, and correctly returned a negative result 90% of the time. That indicates the test is less sensitive than earlier studies had indicated.
The results are still good enough to warrant Medicare reimbursement, and Guardant still plans on applying for FDA approval of the test. But analysts note that the liquid biopsy test won't supplant other colon cancer screening methods, such as the stool-based Cologuard screen or colonoscopy.
"We see Medicare reimbursement risk addressed, but in our view [it's] likely to emerge as a multimodal market with colonoscopy in front, followed by Cologuard and then liquid biopsy," Puneet Souda of Silicon Valley Bank wrote in an analyst note.
Read more. | AbbVie is leaving BIO and PhRMA AbbVie is exiting the two biggest lobbying groups of the pharmaceutical industry — the Biotechnology Industry Organization and PhRMA. The company has been the target of much congressional scrutiny thanks largely to its efforts to fend off biosimilar competition for its blockbuster autoimmune drug, Humira. “We regularly evaluate our memberships with industry trade associations and our most recent assessment led us to decide not to renew our membership with select trade organizations,” an AbbVie spokesperson said. This year alone, AbbVie spent $7.2 million in lobbying — more than most of its peers. Only Pfizer, Roche, and Amgen have spent more. The company told STAT in May that “most of” the increase in lobbying spending in the first quarter this year was because of rising trade association dues. Read more. | Why do billionaires get booed? How does Facebook end up with sensitive health data? And does biotech have a dribbling problem? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Katie Palmer, STAT’s health tech correspondent, joins us to explain how the explosive popularity of telehealth is putting sensitive patient information into the hands of Facebook, TikTok, and other big tech firms. We also discuss the latest news in the life sciences, including highlights from a big hematology conference, a disastrous biotech IPO, and the downside of being a good quote. Listen here. | Pursuing a better future for people living with hematologic disorders Hematologic disorders, including non-Hodgkin’s lymphomas and others, significantly impact the lives of millions of Americans. Innovative immunotherapies and other novel medicines have the potential to offer hope to these individuals for a longer life and reduce burdens at various stages of their treatment journey.
Scientists at Genentech are pursuing therapeutic innovations to improve outcomes for people with hematologic disorders and rethinking what is possible when it comes to standards of care and the patient experience. Learn more about how research has made important strides in treating various types of blood diseases. | Alnylam will have an early Alzheimer’s readout soon Alnylam has been developing an RNAi therapy for early-onset Alzheimer’s disease and cerebral amyloid angiopathy, and just announced it’ll provide Phase 1 data in early 2023. This is the first time that an RNA-based therapy has been tested in humans for a CNS indication — to date, there hasn’t been much success in using RNA-based therapeutics outside of the liver. But Alnylam struck upon a new delivery method that could potentially deliver RNAi drugs to extrahepatic tissues. Lipid nanoparticles and GalNAc conjugates are the basis of approved Alnylam drugs that ferry siRNA to the liver. But to expand siRNA’s reach to other parts of the body, in this case the CNS, Alnylam conjugated 2’-O-hexadecyl to the molecules — improving their lipophilic ability, so they can be delivered intracellularly. Alnylam began testing RNAi drugs in these CNS indications earlier this year. | Inflation knocks down net drug prices After taking inflation into account, wholesale drug prices dropped by 3.1% in the third quarter this year. It’s a somewhat deceptive silver lining: The actual cost of brand-name drugs rose by 4.8%, up from 4.2% a year earlier. And inflationary pressures will likely push wholesale prices even higher. Meanwhile, the net prices that health plans paid for medicines, after subtracting rebates, discounts, and fees, dropped by 0.3%. And after considering inflation, net prices actually fell 8.2%.
The decline in net pricing is a key talking point in the contentious debate about the cost of medicines. The pharmaceutical industry argues that net prices are a more realistic way than wholesale prices to gauge actual changes in pricing, because they more accurately reflect actual revenues that are earned from a drug. Read more. | More reads - Bezos and Gates back Synchron in drive for brain implant breakthrough, Bloomberg
- 45 days later, BioCryst abandons another program, citing stiff competition, FierceBiotech
- For ALS patients, doctors, a new medicine reignites concerns about healthcare access, BioPharmaDive
- U.S. Commerce removes Wuxi Biologics from unverified list, Reuters
- Amid criticism over unaffordable insulin, Lilly strikes a manufacturing deal to supply Africa, STAT
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