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BioWorld - Friday, December 26, 2025
Home » Topics » North America » U.S.

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Pills, bottle atop $100 bill

FTC puts onus of PBM rebates on drug manufacturers

June 3, 2021
By Mari Serebrov
The U.S. Federal Trade Commission (FTC) is turning the biopharma industry’s claim about rebates on its ear, saying some rebates paid to pharmacy benefit managers and third-party payers are an anticompetitive tool drug companies use to maintain their U.S. market power.
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U.S. Capitol building

Abbvie the face of Senate tax probe

June 3, 2021
By Mari Serebrov
Two weeks ago, it was a grilling by the House Oversight Committee over the pricing of blockbuster drugs Humira and Imbruvica and a request for the FTC to launch an investigation into Abbvie Inc.’s patent settlements that delayed Humira biosimilar competition in the U.S. until 2023. This week, Abbvie became the face of a new investigation by the Senate Finance Committee over how multinational companies are shifting profits overseas as a way to avoid U.S. taxes.
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Sentinel system image

First deployable COVID-19 detection system targets school, workplace safety

June 2, 2021
By Ana Mulero
With the U.S. launch of the first deployable airborne COVID-19 detection system, Bioflyte Inc. is working to provide effective ways to sample the air and deliver results within an hour. The Sentinel integrated solution aims to prevent widespread infection in schools and workplaces.
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Avagen product packaging

Avellino offers insight into common cause of blindness with genetic test

June 2, 2021
By Annette Boyle
With the rollout of its Avagen test, Avellino Lab USA Inc. hopes to see a significant change in the diagnosis and management of keratoconus, a common cause of blindness. The test quantifies the risk of keratoconus and definitively diagnoses other corneal dystrophies, which are frequently misdiagnosed or undiagnosed until late in their development, when treatment is less effective and vision already impaired.
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U.S. intellectual property illustration

Alivecor takes patent dispute with Apple to ITC

June 2, 2021
By Mark McCarty
Alivecor Inc. has elevated its patent dispute with Apple Inc. to the U.S. International Trade Commission (ITC) in a move that could damage the latter’s foray into digital health. Alivecor is alleging that Apple, of Cupertino, Calif., has infringed on Alivecor patents for electrocardiogram monitoring technology, a development that may foreshadow a continuing legal struggle between the two companies for a large and rapidly growing market.
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Gold chain link engraved with "partnership"

With an eye on the future, BARDA enters VC partnership

June 2, 2021
By Mari Serebrov
Borrowing a chapter from venture capitalists, the U.S.’ Biomedical Advanced Research and Development Authority (BARDA) is partnering with the nonprofit Global Health Investment Corp. (GHIC) to accelerate the development and commercialization of medical technologies and products needed to respond to or prevent future pandemics and other public health emergencies.
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HHS: No harm yet, suit challenging importation premature

June 2, 2021
By Mari Serebrov
A lawsuit filed last year challenging a federal rule and certification allowing certain drugs to be imported from Canada should be dismissed because no drug companies have been harmed yet, nor are they likely to be any time soon, the Biden administration said in a motion seeking dismissal of the suit.
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Health professional reviewing digital health data

FDA’s Woodcock: RWE an evolutionary, not revolutionary transition in med tech

June 1, 2021
By Mark McCarty
Acting FDA commissioner Janet Woodcock appeared at the annual forum held by the Medical Device Innovation Consortium (MDIC) and noted that real-world evidence (RWE) has tremendous potential in regulatory decision making. However, she cautioned that while “the future is very bright” for RWE, “it’s going to take longer than some of the enthusiasts might have thought” to maximize this source of data in product reviews.
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Handshake with digital globe overlay

Veracyte bolsters diagnostic cancer offerings with $318M Haliodx buy

June 1, 2021
By Meg Bryant
Veracyte Inc. has agreed to acquire Haliodx SAS in a €260 million (US$318.1 million) deal to accelerate growth and strengthen its global footprint in cancer diagnostics. The cash and stock transaction will give Veracyte a manufacturing presence in Europe and expand its cancer diagnostics scope to eight of the 10 top cancers by U.S. incidence.
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Scientists in lab using BD's urine culture analysis imaging application

BD launches AI-powered urine culture analysis application

June 1, 2021
By Ana Mulero
Becton, Dickinson & Co. (BD) is looking to ease the burden on microbiology labs with the U.S. launch of its urine culture analysis imaging application by automating microbiology processes. Powered by artificial intelligence (AI), the app is intended for use on the device manufacturer’s Kiestra lab automation incubation and imaging system.
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