Johnson & Johnson (J&J) managed to beat analyst earnings estimates due to unexpectedly strong first-quarter results in its consumer health and pharmaceutical businesses. But while those saw revenues climb in the double digits, its medical devices business declined by almost 5% due to deferred procedures. Wall Street rewarded the New Brunswick, N.J.-based company by driving its shares (NYSE:JNJ) up more than 5%. That’s even though the company also lowered its 2020 guidance.
There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic.
The age of molecular testing for the COVID-19 pandemic is still with us, but the emphasis in the months ahead will be on serological testing as a quicker, more useful mass testing alternative. However, test developers have a number of hurdles to overcome in devising these serological tests, including that antibodies for the virus’s antigens emerge at different times in the disease cycle, just one of several challenges that have to be met in the effort to bring the SARS-CoV-2 virus to heel.
Physicians who perform a variety of device implant procedures face a difficult choice in determining whether a patient should be treated. A new article in the Journal of the American College of Cardiology (JACC) recommends that patients who ordinarily would be candidates for surgical aortic valve replacement (SAVR) might instead be referred for the transcatheter alternative.
During the first quarter of 2020, a total of 153 financings brought $13.2 billion into the med-tech industry, representing a 20% drop from the first quarter of 2019, but still significantly above all of the other quarters since 2017. The number of private financings appears to be climbing in comparison with recent years, and some large notes offerings have placed private raises of public companies on top. In contrast, IPOs and follow-on offerings are way down from previous quarters.
One simple four-letter word can make a world of difference in how quickly biosimilars and interchangeables bring full competition to the U.S. marketplace of biologics, a handful of companies and industry groups told the FDA in comments on a draft guidance concerning the labeling of follow-ons that are licensed for fewer indications than the reference biologic.
There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic. Carmen Wiley, president of the American Association of Clinical Chemistry, told BioWorld that the existing instrument types are up to the job, but that surge capacity is needed, and that it is not clear how the cost of that capacity will be handled.
Amid the COVID-19 pandemic, Genmark Diagnostics Inc., of Carlsbad, Calif., has offered a preliminary look at its first-quarter results. And it is forecasting hopeful news, increasing its full-year guidance to a range of $112 million to $122 million. That's up from a previous prediction of $100 million to $110 million.
Evercore ISI assembled a dozen internal specialists for a webinar to talk about COVID-19 from a variety of perspectives, with opinions aplenty on transmission route, up-and-coming treatment prospects, and problems in how testing procedures are understood – or not.
The U.S. FDA has granted several emergency use authorizations (EUAs) to address the COVID-19 pandemic, a series of actions designed to lower regulatory hurdles. Despite these developments, the agency is keeping a close eye on issues, such as product claims, and both federal and state agencies are in a position to prosecute for hoarding and price gouging.
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