Moderna’s ambitions in messenger RNA technology include therapies that do their editing work inside the patient. To that end, the biotech company is starting an R&D collaboration with a division of ElevateBio that brings…
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Clotting disorders can be treated by infusing patients with clotting proteins they lack, or with drugs that replace the function of these proteins. Gene therapies may soon become another option. Hemophilia A and B…
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Talaris Therapeutics aimed to transform solid organ transplants with a cell therapy that replaces anti-rejection drugs patients need for the rest of their lives. But after clinical trial setbacks, the biotech has decided to end two kidney transplant studies. Although a separate test of its experimental therapy is continuing in a rare autoimmune condition, Talaris has commenced a restructuring plan that it said could culminate in a merger or sale of the company.
The restructuring announced Thursday will lead to the layoff of about one-third of Talaris’s staff. As of the end of the third quarter of 2022, the Louisville, Kentucky-based biotech…
Indian biotech company Mylab Discovery Solutions is integrating Qure.ai’s AI technology into its upcoming x-ray device for screening tuberculosis.According to a press statement, MyBeam is a compact, lightweight device equipped with high-frequency technology for detecting TB. It will be powered by Qure.ai’s deep-learning software qXR to analyse chest x-ray images and identify TB within a minute.
WHY IT MATTERS
India is one of the biggest contributors to global TB cases, accounting for 26% of the total global count and 34% of all TB deaths.
By leveraging technological innovation, both Mylab and Qure.ai aim to support the Indian government’s goal of eliminating TB by 2025. Their integrated…
Grifols, a company that turns blood plasma into therapies for immunological disorders and other conditions, is laying off about 2,000 U.S. workers as part of a corporate restructuring projected to yield up to €400 million in annual cost savings, the biotech announced Wednesday.
The layoffs represent about 8% of the Barcelona-based company’s global workforce, but they will happen mainly in its U.S. plasma operations. That’s notable because as a company that relies on plasma, the U.S. is vital to its business. The starting point for Grifols’s therapies is blood plasma. Key to its drug-making process is fractionation, in which the protein components…
A slew of biotech companies are pursuing research that could overcome limitations of current cell therapies. Startup creator Replay has a new subsidiary pushing toward the front of the pack with a therapeutic candidate on track to start its first human test this summer—about one year after Replay emerged from stealth. It owes this rapid progress to a cell therapy pioneer’s technology that has already been de-risked by a big pharmaceutical company.
Replay calls itself a genome writing company. With operations split between San Diego and London, the private equity-backed business launched last July with $55 million and a suite of technologies…
Vir Biotechnology’s Covid-19 research may yield more drugs and perhaps a vaccine, but no longer with the financial support of GSK. The collaboration agreement the two companies struck up in the early days of the pandemic has been amended, leaving Vir to either find another partner or continue its coronavirus research on its own.
The alliance did successfully develop the Covid-19 drug sotrovimab. GSK and Vir will continue to share responsibilities for that drug, which is available under the brand name Xevudy in more than 40 countries. The U.S. is no longer one of them. Last April, the FDA withdrew emergency authorization…
G1 Therapeutics’ approach to cancer does not kill tumors. Instead, the biotech’s drug, trilaciclib, protects bone marrow from the damaging effects of chemotherapy, reducing the duration and severity of the problems that can limit the use of this cancer treatment. Since trilaciclib’s initial approval insmall cell lung cancer, G1 has pursued more clinical trials that could support expanding the drug to other cancers. Colorectal cancer will no longer be one of them.
On Monday, G1 reported preliminary data showing that the placebo group outperformed the trilaciclib arm in helping patients live longer. G1 said it has decided to stop the colorectal cancer…
In this episode of Health+Tech, Andrea Lee Linna and Jonathan Ishee are joined by fellow McGuireWoods digital health team member Michael Paluzzi to discuss proposed HIPAA changes that may require covered entities and business associates to overhaul their HIPAA policies and procedures in 2022.After providing a high-level overview of the proposed changes, the podcast turns to a live recording of Andrea and Jonathan’s recent webinar, “Preparing for Major HIPAA Changes in 2022,” offering in-depth details about the proposed changes and how to prepare for them in the new year….
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In this episode of Health+Tech, McGuireWoods healthcare attorneys Janice Suchyta, Kate Hardey, Kae Gruner and Royce DuBiner discuss the latest digital health updates from the Food and Drug Administration and Federal Trade Commission. Join the conversation as we wrap up Cybersecurity Awareness Month and discuss the following topics:• FDA draft guidance on electronic health records and medical claims data• FDA new resource for approved artificial intelligence/machine learning medical devices• FDA Digital Health Center of Excellence• FTC rules for health apps outside of HIPAA…
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