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Pleased New Yr, biotech mates! We’re again with information, together with Merck’s choice to chop the value of its diabetes drug Januvia by 42% and Neumora’s readout on its experimental despair drug. Additionally, is one of the simplest ways to “save the FDA” to interrupt it aside?
Merck is a brand new yr outlier with its diabetes drug
From STAT’s Elaine Chen: The beginning of the brand new yr is historically a time when many drugmakers elevate the value of their therapies, and this yr, corporations did simply that with not less than 250 medicines. However Merck stood out by chopping the record worth of its diabetes drug Januvia by 42%.
Merck cited two causes: The primary, it mentioned, was that it needed to align the record worth extra carefully to the online worth to profit sufferers, corresponding to these paying coinsurance. The corporate additionally cited adjustments within the Medicaid rebate program in 2024. These adjustments allowed Medicaid to gather over 100% in rebates if corporations elevate drug costs by greater than inflation. Merck mentioned its Medicaid rebate charge for Januvia was over 100%, that means it was dropping cash on Januvia prescriptions.
This Medicaid change, specialists say, was additionally an element that had pushed makers of insulin merchandise — Eli Lilly, Novo Nordisk, and Sanofi — to chop record costs in 2023.
As was the case with the insulin pricing, although, chopping record costs could find yourself really hurting sufferers’ entry to the medicine. After Novo minimize the record worth of an insulin product referred to as Levemir, it seemingly wasn’t in a position to provide business pharmacy profit managers as excessive rebates because it used to. Novo mentioned it began dropping entry to business drug formularies and finally determined to discontinue the drug, leaving sufferers scrambling. There have additionally been shortages of different insulin merchandise produced by Novo, main sufferers to surprise if the corporate is de-prioritizing the manufacturing of insulin.
Neumora’s despair drug fails in Part 3 research
An experimental despair drug made by Neumora Therapeutics failed in a Part 3 research — a setback within the quest to search out much-needed options to SSRIs. The corporate’s inventory plummeted 83% on the information, STAT’s Allison DeAngelis writes. Though the drug confirmed a slight enchancment in girls, providing a 14-point discount in despair scores in comparison with placebo, it failed to satisfy the research’s endpoint and outcomes had been extra blended in males.
The failure underscores how tough it’s been to develop efficient new antidepressants, given how regularly late-stage trial have tanked on this house. Neumora launched in 2021 with greater than $600 million in funding, and has seven neuroscience medicine in improvement — in addition to the capability to remain operational till 2026.
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Bisect the FDA and reserve it
Splitting the FDA into two distinct entities — one for medicine and gadgets, the opposite for meals — might assist regulators rebuild public belief, opines Lee Cooper, a biotech investor who teaches moral bio-innovation at Tufts and Dartmouth. He says the FDA’s repute for drug security, which is supported by rigorous science and world management, is liable to being undermined by meals security controversies.
The company’s scope, Cooper writes, is simply too huge — overseeing meals, cosmetics, tobacco, medicine, and medical gadgets — which dilutes focus and accountability. A separate, drug-focused FDA might higher oversee cutting-edge biomedical advances whereas guaranteeing excessive requirements.
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Roche dives deeper into ADCs, Innovent
Roche is rising its footprint within the antibody-drug conjugate house: It’s inked a cope with China-based Innovent Biologics, to get entry to ICI3009, an ADC in Part 1 research for small cell lung most cancers. Innovent will get $80 million upfront, and the milestone funds might stretch as much as $1 billion.
This isn’t Roche’s first foray into ADCs, or with Innovent, as FierceBiotech factors out. Final yr, the Swiss drugmaker signed a $66 million pact with Moma Therapeutics for entry to its ADC platform. And in 2020, it entered a $2 billion cope with Innovent that allowed the Chinese language biotech to entry Roche’s cell therapies and bispecifics for each blood and strong tumor cancers.
Extra reads
Lilly asks to hitch lawsuit over compounded variations of its weight-loss medicine, Reuters
Pennsylvania Blue Cross insurer restricts protection of medicines granted FDA accelerated approval, Endpoints
Pfizer kills hemophilia gene remedy deal, imperiling Sangamo, STAT