| | | |   | Hi, it's Meghana! Let's talk ICER, let's talk capsid inhibitors, and then let's pause: We won't be publishing The Readout next week, but will recommence in the new year. Happy holidays! | | | ICER evaluates cost of experimental Alzheimer’s drug Lecanemab, the promising new Alzheimer’s drug from Eisai and Biogen, needs to be less than $20,000 a year to be cost effective, according to a draft analysis from the Institute for Clinical and Economic Review. Based on evidence for the drug’s modest but statistically significant ability to delay the advance of the neurodegenerative disease, it should cost somewhere between $8,500 and $20,600 per year, ICER said. Lecanemab follows the disastrous footsteps of its predecessor, Aduhelm, which was given a list price of $56,000 a year. Biogen cut that price in half after a backlash from physicians and payers about both the drug's cost and its efficacy. But the damage had been done, with Medicare imposing new restrictions on reimbursement for Alzheimer's drugs that work by targeting toxic plaques in the brain. For lecanemab to succeed where Aduhelm failed, Eisai will need to persuade regulators it's a worthwhile medicine — and set a price that doesn’t make that argument untenable. Read more. | FDA approves Gilead’s new capsid inhibitor for HIV The FDA just approved lenacapavir, a new HIV antiretroviral drug from Gilead Sciences that’s meant for patients with infections that have been difficult to treat due to resistance, intolerance, or safety concerns. The drug, which will be sold as Sunleca, belongs to a new class of antiretroviral drugs called capsid inhibitors. It works by blocking the HIV-1 virus’s outer protein shell, interfering with its viral life cycle. The drug is meant to be injected subcutaneously once every six months. This past May, the FDA released a clinical hold on injectable lenacapavir, after the drug’s manufacturing process was called into question. The agency had previously halted 10 lenacapavir studies a year back, saying it was concerned that the vials holding the drugs were shedding “sub-visible” glass particles. | How can we make strides toward 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 are pursuing therapeutic innovations to improve outcomes for people with hematologic disorders and rethinking what is possible. Learn more. | When does optimism become criminal? Why can’t biotech find its way back? And what’s going to happen in 2023? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We look back on the biggest biotech stories of 2022 and how, despite some meaningful advances in Alzheimer’s disease and gene therapy, the industry seems stuck in a sentiment rut. We also discuss the latest news in the life sciences, including a pair of indicted CEOs and the debate over how much an oft-debated new medicine should cost. Listen here. | Parker Institute expanding to two new centers Tech mogul Sean Parker is expanding his immunotherapy research empire, the Parker Institute of Cancer Immunotherapy, adding two more centers to its roster. The institute, or PICI, has already funneled hundreds of millions of dollars into six research centers around the country — bringing top researchers like CAR-T pioneer Carl June and Nobel winner Jim Allison into the fold. Now, it’s adding centers at San Francisco’s Gladstone Institutes and Boston’s Dana-Farber Cancer Institute. Researchers at the new PICI centers will have access to funds that could be spent on just about anything — from building new labs to running clinical trials or hiring more scientists. That’s not easy to come by in academic funding. “If you give some money without strings attached, that’s huge. That’s a big deal for an investigator,” one top cancer researcher who isn’t affiliated with PICI told STAT. Read more. | PDUFA date approaches for MS drug On Wednesday next week, the FDA will evaluate whether ublituximab, made by TG Therapeutics, is worthy of approval for multiple sclerosis. The antibody drug was once a component of a combination blood cancer treatment along with TG's Ukoniq, Endpoints writes, but Ukoniq was ultimately pulled from the market over safety concerns. A recent ICER report indicated that ublituximab would not be worth a $55,081 price tag — the cost of competitor ocrelizumab, which is made by Roche. The report said there isn’t enough evidence to compare ublituximab’s benefit against other monoclonal antibodies for multiple sclerosis like Roche’s drug, Novartis’s ofatumumab, or Biogen’s natalizumab. | More reads - A TikTok trend sold out Ozempic, leaving people with diabetes dizzy, scared, Bloomberg
- BioNTech ships COVID shots to China for use by Germans, Reuters
- Merck expands ADC footprint with $9.3B Kelun licensing deal, BioSpace
| Thanks for reading! Enjoy your holidays,  | | | |
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