The ongoing controversy over the effectiveness of anti-amyloid drugs is about to get more heated, after a review of clinical trials showed statistically significant results do not read across to clinical benefit for patients with Alzheimer’s disease. The conclusion of the pooled analysis of 17 randomized controlled trials was that the impact of reduced levels of amyloid beta in the brain on cognitive decline, dementia severity and everyday functioning was “trivial,” and the effect of the seven different anti-amyloid antibodies tested was “well below” established thresholds for the minimum clinically important difference, where there is a perceived benefit.
Lilly reaffirms Foundayo safety with phase III data
Eli Lilly and Co. disclosed positive top-line results from the phase III Achieve-4 study to test the efficacy and safety of Foundayo (orforglipron) compared to insulin glargine in adults with type 2 diabetes (T2D) and obesity or overweight at increased cardiovascular (CV) risk. The largest and longest study of Foundayo in T2D so far, Achieve-4 enrolled more than 2,700 participants across 15 countries. The oral weight-loss glucagon-like peptide-1 (GLP-1) receptor agonist met the primary endpoint by showing a noninferior risk of major adverse CV events (MACE) including death, heart attack, stroke or hospitalization for unstable and sudden chest pain vs. insulin. Foundayo also turned up superior improvements in A1C and body weight at 52 weeks as compared to insulin, effects that held through 104 weeks of therapy. The risk of all-cause death was significantly lower for Foundayo vs. insulin, although the readout was not controlled for multiplicity, Lilly noted. Foundayo, the second oral GLP-1 to enter the U.S. market after December’s FDA nod for Novo Nordisk A/S’ Wegovy (semaglutide) pill, was approved at the start of this month. As part of the Foundayo go-ahead, the FDA asked Lilly for more info from a trial regarding the possible risk of MACE as well as drug-induced liver injury with Foundayo.
Abbott cuts 2026 profit forecast on Exact deal, shares fall
Abbott Laboratories saw its shares fall in early trading on Thursday after cutting its guidance for 2026 on the back of dilution related to its $21 billion acquisition of Exact Sciences Corp. The company revised its full-year adjusted earnings per share guidance to $5.38 to 5.58, down from $5.55 to $5.80 previously. The updated outlook includes 20 cents of dilution related to the Exact deal. Abbott also reported first-quarter profits of $1.08 billion, down 18.7% from a year ago.
Foundation Medicine buying Saga Dx and its MRD test for $595M
Nearly a year after the first U.S. commercial launch of the multicancer molecular residual disease (MRD) detection platform Pathlight, developer Saga Diagnostics entered a definitive merger agreement under which Roche Holding AG’s subsidiary Foundation Medicine Inc. will take over the firm in return for up to $595 million in payments. By gaining access to Roche’s commercial presence, Saga could potentially take a share of the $20 billion MRD market, alongside leading competitive products Signatera, from Natera Inc., and Guardant Reveal, from Guardant Health Inc. The $595 million includes commercial and regulatory milestone payments, and the transaction is expected to close in the third quarter. Saga launched its Pathlight test in May 2025 at the American Society for Clinical Oncology’s annual meeting in Chicago.
Storm raises $56M series C for phase II RNA inhibitor trial in sarcoma
RNA epigenetics specialist Storm Therapeutics Ltd. has closed a $56 million series C to fund phase II development of its lead RNA enzyme inhibitor, STC-15, in treating myo- and liposarcomas, and announced that the first patient has been treated in the trial. STC-15 is a first-in-class, oral small-molecule inhibitor of methyltransferase-like 3 (Mettl3), an enzyme that is involved in the regulation of stem cell differentiation. The inhibitor has been shown to reprogram malignant progenitor cells by modulating mRNA methylation, prompting cell cycle arrest and apoptosis.
Pointing to successes, Kennedy defends proposed HHS budget
U.S. Health and Human Services (HHS) Secretary Robert Kennedy made his first stop this morning on a congressional tour in support of the president’s proposed fiscal 2027 budget, which would reduce discretional spending for HHS and its agencies by about 12%. Kennedy opened his testimony before the House Ways and Means Committee saying, “We stand at a generational turning point” that requires challenging the status quo. He went on to tout what he sees as successes at HHS over the past year and for his Make America Healthy Again agenda. Noticeably missing from his remarks was any mention of vaccines. But some of the committee members wouldn’t let him escape that issue.
FDA grants priority review to Merck-Daiichi’s B7-H3 cancer ADC
The U.S. FDA has accepted and granted priority review of Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s BLA of ifinatamab deruxtecan (I-Dxd), a B7-H3-directed antibody drug conjugate (ADC) to treat patients with advanced extensive-stage small-cell lung cancer. If approved, I-Dxd will become the first B7-H3-directed ADC to be cleared by the FDA for any cancer. The agency set a PDUFA date of Oct. 10, 2026. B7‑H3 (CD276) is a type I transmembrane protein and a member of the B7 family of immune checkpoint molecules – a group that includes regulators of the CD28/PD‑1 pathway. B7‑H3 is overexpressed across a wide range of tumor types, including small-cell lung cancer, making it an increasingly attractive oncology target.
Med-tech financings steady at $8.8B in Q1, despite volume drop
Total med-tech financings reached $8.81 billion in the first quarter (Q1) 2026, a modest 6% decline from $9.33 billion in Q1 2025 but remaining well above the post-downturn lows of recent years. The 2026 total exceeds $6.45 billion in the same period in 2024 and $4.69 billion in 2023. Total med-tech financing volume reached 115 transactions in Q1, down 30% from 165 deals in the first quarter of 2025.
Kaleidoscope-like ‘engineered disorder’ expands imaging potential
A new metasurface design strategy that replaces rigid order with “engineered disorder” could significantly increase how many optical functions can be integrated into a single ultra-thin device without increasing size or complexity, according to a study published in Nature Communications. The study challenges a longstanding assumption in optical engineering that highly ordered, periodic structures are required to precisely control light.
Maryland 340B law likely pre-empted, appeals court rules
Given its decision earlier this month in a challenge to a West Virginia law, it’s no surprise that the U.S. Court of Appeals for the Fourth Circuit issued a 2-1 unpublished opinion Tuesday overturning a lower court that had refused a preliminary injunction to stall a similar Maryland law that would require drug manufacturers to offer 340B prescription drug discounts to unlimited contract pharmacies.
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