The latest global regulatory news, changes and updates affecting medical devices and technologies, including: BD offers little detail in reaction to advisory hearing; FDA invites stakeholders to user fee negotiations; MHRA wary of paclitaxel.
A U.S. FDA advisory committee voted 14 nays to three ayes that the benefits of the Lutonix 014 drug-coated balloon (DCB) do not outweigh the risks in a panel proceeding peppered by problems with missing data and a lack of operator blinding. The panel widely saw the use of paclitaxel-eluting technologies in other areas of the vasculature as a reassurance that this device might perform as promised, but the outcome nonetheless leaves the sponsor with a new round of negotiations with the FDA as to how to move forward.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA cites pivotal study failure for Lutonix 014; HHS adds to PREP Act immunity; Dermal fillers on tap at FDA advisory; GAO urges a pause in VA EHR deployment.
Becton, Dickinson and Co. (BD) reported revenue of $4.32 billion for the first quarter of fiscal year 2021, up 25.8% on a reported basis and 24.3% on a currency neutral basis. COVID-19 testing contributed 20.5% of that growth, totaling $867 million for the period, including $688 million in Veritor Plus system sales.
Becton, Dickinson and Co. (BD) reported good news Thursday, as it saw quarterly revenues of $4.784 billion for its fourth fiscal quarter, an increase of 4.4% over the prior-year period. Of note, the company’s life sciences segment saw worldwide revenues of $1.488 billion, representing an increase of 31.2% over the prior-year period as reported, or 31.4% on a currency-neutral basis.
Becton, Dickinson and Co. (BD) has received a green light for a premarket approval supplement from the U.S. FDA for an expanded version of its BD Onclarity HPV assay. It includes the expansion for genotype reporting beyond human papilloma virus (HPV) genotypes 16, 18, and 45.
Several companies have reported quarterly results over the past couple of days, and those offering testing for COVID-19 have seen impressive numbers. Standing out was San Diego-based Quidel Corp., whose numbers caught the attention of William Blair’s Brian Weinstein. Indeed, its $174.7 million in revenue far exceeded his organization’s estimate of $160 million, driven by influenza.
The COVID-19 pandemic has shaken the world – and the face of diagnostics. In a matter of weeks, a host of companies has worked to develop tests to find those patients who currently have the disease, as well as those who have developed antibodies.
The U.S. Patent Trial and Appeal Board (PTAB) determined it would not take an inter partes review petitioned by Advanced Bionics Inc., in a patent dispute with Med-El Elektromedizinische. The precedential PTAB decision notes that it had invoked a two-step process for declining to take the petition as seen in a patent dispute involving Becton Dickinson and Co., and affirming that this will be the standard for addressing prior art in such appeals going forward.
Making routine diagnostic blood tests less invasive, easier, cheaper and more accessible is a worthy goal. But achieving it has eluded many, including former unicorn startup Theranos that boasted it had achieved precisely that but then was later exposed as a fraud. Established med-tech player Becton, Dickinson and Co. (BD) and Babson Diagnostics Inc. have established a long-term strategic partnership to bring laboratory quality, small-volume blood collection into the retail pharmacy setting.
