A bipartisan bill aimed at limiting patent thickets on biologics moved a step closer to law July 11 when the Senate passed it with unanimous consent in an unexpected vote that came more than one-and-a-half years after the Judiciary Committee reported it favorably to the Senate floor. The Affordable Prescriptions for Patients Act, S. 150, which would limit the type and number of patents that can be litigated under the Biologics Price Competition and Innovation Act (BPCIA), now awaits House action.
The U.S. Medicare outpatient draft for 2025 is rich with applications for pass-through payment, but the draft also would boost payment for radiopharmaceuticals, a proposal that drew the applause of industry and physicians alike. The outpatient draft for CY 2025 tackles the implications of some new technologies for the pass-through payment program, but nestled in the draft rule is a proposal to pay separately for diagnostic radiopharmaceuticals.
Edwards Lifesciences Corp. said it has exercised its option to buy Innovalve Bio Medical Ltd., an early stage transcatheter mitral valve replacemen company, for $300 million in cash following its initial investment in 2017. Since that time, Edwards said Innovalve has demonstrated progress in its program with promising early clinical experience.
A committee of the U.S. House of Representatives proposed an FDA discretionary spending bill of less than $26 billion in appropriated taxpayer dollars for fiscal year 2025.
Lunglife AI Inc. is looking for a strategic partner to help get Lunglb — its non-invasive test for the early detection of lung cancer — into the market and to the patients who need it. The company’s artificial intelligence-supported blood-based test, which identifies indeterminate lung nodules, will be game changing for early lung cancer diagnosis, Paul Pagano, Lunglife CEO, told BioWorld.
The U.S. FDA’s final guidance for device-based treatments for opioid use disorder breaks little new ground relative to the 2023 draft, including a call for the use of a randomized, controlled clinical trial that retains blinding of not just enrollees, but also of the clinicians taking part in these studies.
Two weeks after reporting positive top-line results in first-line head and neck cancer with its lead candidate, eftilagimod alfa, in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab), Immutep Ltd. presented updated data indicating the treatment could offer a non-chemotherapy option for patients with negative PD-L1 expression. Data from cohort B of the Tacti-003 (Keynote-PNC-34) phase IIb trial, which included 31 evaluable patients with PD-L1 expression of less than 1, as measured by Combined Proportion Score, showed a 35.5% objective response rate per RECIST 1.1 assessment.
AI-focused medical diagnostics company Spectral AI Inc. is collaborating with burn wound therapy company Polynovo Ltd. to test limited deployment of Spectral’s Deepview system for predicting burn healing in Australia.
Just a day after the U.S. FTC released an interim report on harmful pharmacy benefit manager (PBM) practices and appeared before a House subcommittee that encouraged the commissioners to take enforcement action, the agency reportedly was preparing to file suit against the country’s three largest PBMs over their practices in negotiating insulin and other drug prices.
Following an advisory committee’s recommendation in May against approval, the U.S. FDA issued a complete response letter (CRL) to Novo Nordisk A/S for its once-weekly insulin icodec injection for diabetes, which is on the market as Awiqli in several other countries.
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