Just weeks after seeing one late-stage candidate hit a wall in a subtype of non-small-cell lung cancer (NSCLC), Merck KGaA's EMD Serono has won accelerated approval from the FDA for another important NSCLC therapy, Tepmetko (tepotinib).
The numbers are staggering when it comes to the potential drug risks pregnant and breastfeeding women, as well as their babies, are exposed to and the treatments they may be denied because of the lack of data.
BEIJING – Beigene Ltd. out-licensed its anti-PD-1 monoclonal antibody tislelizumab to Novartis AG in a deal worth up to $2.2 billion, including $650 million up front. Novartis gains rights to develop and commercialize tislelizumab in the U.S., Canada, Mexico, the EU, the U.K., Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan.
PARIS – Tilak Healthcare SAS is signing an ophthalmology partnership agreement with Novartis AG from Basel, Switzerland, to expand international distribution of its vision monitoring technology, Odysight.
By acquiring privately held Cadent Therapeutics Inc., Novartis AG gains full rights to Cadent’s allosteric modulator program, part of which the two companies began collaborating on in 2015, and all the company’s outstanding stock. Cambridge, Mass.-based Cadent will receive as much as $770 million, $210 million of it up front, plus $560 million in milestones.
LONDON – Retinai Medicine AG reported a three-year master agreement with Novartis AG to apply its artificial intelligence (AI) tools in ophthalmology clinical trials. The first project will look at how machine learning can be used to speed up and improve the interpretation of optical coherence tomography (OCT) images of patients with neovascular age-related macular degeneration (AMD).
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
The casual observer may think that physician speaker programs sponsored by makers of drugs and medical devices have drawn less attention from U.S. federal attorneys, but reality has failed to meet that expectation. Mark Gardner, managing attorney of Gardner Law of Stillwater, Minn., said on a Nov. 19 webinar that “there’s a lot coming through right now in terms of settlements,” including a settlement with a drug maker that sent the company into bankruptcy.
If the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services has its way, one of the casualties of the COVID-19 pandemic would be the in-person speaker programs many drug and device companies sponsor. The OIG issued a special fraud alert Nov. 16 questioning the need for such events in which health care professionals are often paid a hefty honorarium or fee to provide colleagues with information that’s readily available online and in the labeling of a drug or device.
