| Affordable, Expert IRB Solutions Our service-first IRB solutions, customer focused fee schedules and nationally recognized IRB committees with expertise in recombinant DNA, gene therapy, stem cell, rare diseases, oncology, digital health (and more) give you the assurance that the biggest IRB isn’t always your best option. Request a consultation. | CDC director overrides advisory panel, recommends Pfizer COVID boosters for front-line workers Cue Health kicks off $200M IPO to expand portable diagnostics: ‘We’re way more than a COVID-19 testing company’ Facing class action lawsuit over insulin pricing, Novo Nordisk inks $100M settlement with disgruntled investors Humana, Centene sue Merck over 'pay for delay' deal for cholesterol drugs Ransomware attacks impact patient care, including increased mortality rates, report finds If CytoDyn can't get leronlimab approved, these shareholders have a bold plan to tap Big Pharma FDA's ongoing review of accelerated cancer approvals targets 2 drugs from Secura and Aurobindo After stints at Kite and Amgen, Roivant's Sidhu heads to Brooklyn ImmunoTherapeutics as CMO Featured Story By Dave Muoio Industry groups have so far applauded the CDC's unusual move, saying the boosters give extra protection to the nation's healthcare workers at a time when it's needed most. read more |
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| | Webinar: Building a robust FIH biologics regulatory CMC package Thursday, October 7, 2021 | 2pm ET / 11am PT Join us to learn how to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules by integrating the following activities into your project plan: progressively developing knowledge of the molecule’s critical quality attributes to justify the manufacturing and control strategy, planning for continuing development, and identifying opportunities to enhance with scientific advice. Register Now. | Top Stories By Andrea Park Right on cue, another diagnostics-focused startup has made the transition to a public company. The latest to join the droves of medtechs flooding the stock market is Cue Health, which has so far found its greatest success in developing a portable COVID-19 test kit—but has big dreams of bringing the handheld system into every corner of healthcare. read more By Kevin Dunleavy Resolving a lawsuit that was in the courts for four years, Novo Nordisk has agreed to a $100 million settlement with investors who argued that the company made untrue statements about insulin pricing pressures. read more By Paige Minemyer Humana and Centene Corporation have filed suit against Merck, alleging that the drugmaker ran a "monopolistic scheme" to delay generic challengers to its cholesterol medications Zetia and Vytorin. read more By Anastassia Gliadkovskaya Besides nearly a quarter of respondents reporting increased patient mortality rates following an attack, they also report longer stays, delays in procedures that lead to poor outcomes, more patient transfers and increased complications from medical procedures. read more By Annalee Armstrong If CytoDyn’s management can’t get their lead treatment approved, a group of very optimistic investors want to give it a try. After weeks of very public infighting at the Vancouver, Washington-based biotech, a stockholder group has come forward with a strategic plan to get leronlimab approved in a cancer indication. read more By Angus Liu The FDA initially targeted immunotherapies in its industry-wide review of accelerated drug approvals in oncology that failed to deliver in confirmatory trials. But the agency isn’t stopping there. Blood cancer indications for Secura Bio’s Farydak and Aurobindo Pharma subsidiary Acrotech Biopharma’s Marqibo are now facing scrutiny. read more By Kyle LaHucik After about a year at Roivant Sciences, Roger Sidhu, M.D., is headed for the exit to take up the chief medical officer post at a smaller biotech, Brooklyn ImmunoTherapeutics. read more |