Biden to sign executive order formalizing reproductive care, privacy protections Ex-Theranos President Balwani found guilty on all 12 fraud charges FDA is letting pharmacists prescribe Pfizer's Paxlovid but won't do the same for Merck's Lagevrio Sponsored: Decentralized clinical trials, patient experience and the role of supply chain management Schrödinger eyes 'hundreds' of programs over a decade amid clinical-stage evolution SEC charges ex-Mazor exec with insider trading over $1.6B Medtronic buyout More than 600 providers impacted by ransomware attack on payment vendor AstraZeneca escapes one Seroquel pay-for-delay claim but loses bid to scrap another Provention snags $60M in private placement as future of diabetes therapy hangs in the balance Horizon's Krystexxa wins FDA combo nod to fight drug resistance AbbVie dumps Alector's Alzheimer's immunotherapy after phase 1 review Medical billing startup Cedar cuts 24% of workforce as market constricts Roche, EarlySign expand partnership to include AI-powered lung cancer diagnosis Featured Story | By Dave Muoio Measures outlined in the Friday executive order generally fall in line with the administration's recent promises, which may not be enough for Democrats calling upon the White House to flex its emergency powers. read more |
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Top Stories By Andrea Park Another chapter in the saga of disgraced blood testing company Theranos has drawn to a close after a California jury on Thursday delivered its verdict in the criminal fraud trial of Ramesh “Sunny” Balwani, the startup’s former president and chief operating officer. read more By Kevin Dunleavy After authorizing Pfizer’s COVID-19 oral antiviral Paxlovid to be prescribed by pharmacists, the FDA said it will not extend the same privilege to Merck and Ridgeback’s antiviral pill Lagevrio. The regulator cited Lagevrio’s side effect profile as reason to leave the decision in the hands of physicians. read more Sponsored By: Parexel The rise of clinical trial complexity has been well-documented but the impact on logistics is not well understood. Here, we look at decentralized trials, patient experience and the role of logistics. read more By Max Bayer Led by former top Merck scientist Karen Akinsanya, Schrödinger is expanding its horizons, developing wholly-owned, clinical-stage assets for the first time. But even as phase 1 nears, the company is realistic about its commercial-stage ambitions. read more By Andrea Park The SEC filed charges against a former Mazor Robotics executive and two associates, alleging that they made more than $500,000 in profits through an insider trading scheme related to Mazor's 2018 acquisition by Medtronic. read more By Heather Landi A payment vendor was hit with a ransomware attack back in February that may have exposed patient data from more than 600 healthcare providers and organizations. Also this week, federal officials issued a warning that hackers sponsored by North Korea's government have been using the Maui ransomware to target healthcare and public health services providers since last May. read more By Angus Liu Apparently, a $107 million deal value isn't large enough to be considered anticompetitive when viewed in the context of delaying generics to a blockbuster brand. A Delaware federal judge reached that conclusion in throwing out an antitrust claim targeting a pay-for-delay deal involving AstraZeneca's antipsychotic Seroquel XR. read more By Gabrielle Masson Provention Bio may be waiting a bit longer for the FDA's decision on its diabetes prevention drug teplizumab, but at least the biotech has $60 million cash in the meantime to work through launch preparations. read more By Zoey Becker Krystexxa, approved in 2010, is getting a new partner medicine in the chemotherapy and immunosuppressive drug methotrexate. The combo won FDA approval based on a trial in which 71% of patients with uncontrolled gout met the threshold of serum uric acid reduction for the primary endpoint. read more By Nick Paul Taylor Alector’s new approach to amyloid beta has ended the way of many of the old ideas for how to tackle the troublesome peptide. After going over data including phase 1 results, AbbVie has severed its ties to the potential Alzheimer’s disease immunotherapy—and the asset has vanished from Alector’s pipeline. read more By Heather Landi As health tech companies try to navigate a market downturn, Cedar joins other digital health startups in cutting its workforce with an eye on its bottom line. read more By Andrea Park Less than a year after entering into a collaboration focused on using artificial intelligence tools to improve the early detection of cancer, Roche and Medial EarlySign are taking their relationship to the next level. read more | | On Demand Webinar: Automating Cell Therapy Product Now Available on Demand The major key cost drivers of the autologous CAR T-cell therapy are generally QC analytics and biocharacterization of viral vector and supporting starting biomaterials, all of which could be developed and managed in-house. The cost and impacts revealed through the decision-making process emphasize the need for automation. Watch now to learn more. |
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