First quarter earnings reports from Johnson & Johnson and Abbott Laboratories provided some surprising insights into the likely hit med-tech companies will sustain with current tariffs. The main takeaway? The impact of the trade war with China is far greater than expected by most analysts.
The U.S. Centers for Medicare & Medicaid Services decided to peel back a series of local coverage determinations for skin substitute grafts that provoked a vigorous response from stakeholders.
The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS.
Days after Pfizer Inc. pulled the plug on its oral GLP-1 candidate danuglipron, Eli Lilly and Co. aired positive top-line data from the phase III trial called Achieve-1 testing orforglipron vs. placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone.
Glycomine Inc. secured $115 million in a series C financing round to support the advancement of GLM-101 into a phase IIb study in patients with phosphomannomutase-2 congenital disorder of glycosylation (PMM2-CDG).
South Korea’s Ministry of Food and Drug Safety on April 8 cleared Barythrax injection (GC-1109) as the world’s first recombinant anthrax vaccine. The product was codeveloped by GC Biopharma Corp. and Korea Disease Control and Prevention Agency.
The recent staff cuts at the U.S. FDA’s device center caught the attention of outsiders but also caught the attention of those who work on premarket applications for 510(k) and PMA filings.
Radnet Inc. expanded its commitment to the use of AI in improving diagnosis of breast cancer with an all-stock purchase of Icad Inc. for approximately $103 million. The transaction is expected to close in the second or third quarter of 2025.
The American Medical Association’s CPT editorial panel will meet May 1-3 to consider codes for several devices and services, but the most important of these might be the code for cardiac contractility modulation.
In a blast from the past, U.S. President Donald Trump signed an executive order April 15 to deliver on his 2016 campaign promises and strengthen or reinstate efforts of his first administration to drive down prescription drug prices. “My first term included numerous significant actions, including some of the most aggressive in recent history, to deliver lower prescription drug prices to American patients,” Trump noted in the order, which builds on many of those actions, including increased competition, re-importation, price transparency and a mandate to pass discounts through to patients.
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