The Medicare Part D rebate rule finalized by the Trump administration last November could be in limbo for a while. As it did with other so-called midnight rules issued in the waning days of the Trump presidency, the U.S. Department of Health and Human Services, under the Biden administration, is postponing the implementation of the rule, which was intended to simplify the U.S. drug pricing system by eliminating the rebates drug makers pay to pharmacy benefit managers for formulary placement or requiring plans to pass the discounts directly to patients.
The U.S. Centers for Medicare & Medicaid Services (CMS) had packaged a proposal to redefine the term “reasonable and necessary” along with the proposal to cover FDA-designated breakthrough devices, but ultimately punted on the definitional question until the end of this year. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that it may be just as well that the agency didn’t expeditiously push through the reasonable and necessary question because of the enormous complexity of the proposal.
Stryker Corp. reported Jan. 27 that per-share earnings for the fourth quarter of 2020 reached $2.81, but organic sales fell roughly 1%, largely an artifact of the COVID-19 pandemic. The company’s acquisition of Wright Medical Group NV, of Amsterdam, is part of a source of optimism for the company, however, as is the fact that the company’s sales in emerging markets continue to buoy Stryker’s outlook for 2021.
Swift Biosciences Inc. released an S gene panel for SARS-CoV-2 that covers 100% of the gene even with minimal viral titers. The S gene controls the spike protein, which enables the virus to bind to cells and affects transmissibility, and has accumulated multiple mutations in the concerning variants recently discovered in the U.K., South Africa, Brazil, Denmark and the U.S. The panel is expected to enable rapid scaling of surveillance efforts of the new strains and can be run by any lab using the Illumina system.
Hologic Inc. kicked off its fiscal year 2021 with gusto, reporting revenue of $1.61 billion – up 89.3% year over year, or 86.5% on a constant currency basis. Worldwide sales of molecular diagnostics exceeded expectations, jumping 457.6% to $995.3 million as the company ramped up production to meet growing demand for its two SARS-CoV-2 assays that run on the fully automated Panther and Panther Fusion systems.
For at least the past decade – under both the Obama and Trump administrations, and perhaps even in previous administrations – the U.S. Department of Health and Human Services has been using the “Bank of BARDA” to routinely cover millions of dollars of unrelated spending at the Office of Assistant Secretary for Preparedness and Response, the U.S. Office of Special Counsel said in letters yesterday to President Joe Biden and Congress.
The SARS-CoV-2 virus has now had ample time to mutate, as reports of the proliferation of multiple variants make clear, and the U.S. FDA’s Tim Stenzel said the agency is now focused on three variants, including one recently reported from Israel. Stenzel said on the latest COVID-19 testing town hall that one of the key concerns regarding existing authorized tests is the potential for loss of sensitivity, a problem the agency hopes to overcome without the use of live virus.
Abbott Laboratories reported 2020 fourth-quarter revenue up 29% year over year to $10.7 billion, outpacing the consensus estimate of $764 million. The positive growth was largely fueled by sales in diagnostics, which surged 111% to $4.35 billion, from $2.10 billion in the prior year period. Net earnings for the period totaled $2.16 billion, or $1.20 per share, up from $1.5 billion, or $.59 per share a year ago. Adjusted earnings per share (EPS) was $1.45, ahead of the Street target of $1.35.
The U.S. biosimilar market is coming of age under the BsUFA II agreement, but there are a few steps the FDA could take to help it develop more predictably. For starters, the agency should conduct pre-approval inspections earlier in the 12-month biosimilar review cycle to give sponsors time to address unexpected issues, industry representatives told the FDA Jan. 27 in response to an independent interim assessment of the enhanced transparency and communication processes included in the current user fee agreement.
When it comes to leveling the playing field for foreign-based biopharma and medical device companies, China has made a lot of promises, but delivering on those promises is what matters.
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