Tag: Biotech

Blood Biotech Grifols Cuts Deep in the U.S. to Find €400M in Savings

Blood Biotech Grifols Cuts Deep in the U.S. to Find €400M in Savings

MedCity News

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…

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MD Anderson’s Tech Puts Replay on Fast Path to Clinic With TCR NK Cell Therapies

MD Anderson’s Tech Puts Replay on Fast Path to Clinic With TCR NK Cell Therapies

MedCity News

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…

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GSK’s Covid-19 Valentine to Vir Biotech: ‘You Can Go Your Own Way’

GSK’s Covid-19 Valentine to Vir Biotech: ‘You Can Go Your Own Way’

MedCity News

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…

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Adverse Survival Signal Leads G1 to Stop Pivotal Test in Colorectal Cancer

Adverse Survival Signal Leads G1 to Stop Pivotal Test in Colorectal Cancer

MedCity News

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…

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Episode 10: A Look at the Proposed HIPAA Changes

Episode 10: A Look at the Proposed HIPAA Changes

Health+Tech

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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Episode 9: Digital Health Trends and Issues for Life Sciences Companies

Episode 9: Digital Health Trends and Issues for Life Sciences Companies

Health+Tech

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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Episode 8: Telehealth Barriers During Covid-19

Episode 8: Telehealth Barriers During Covid-19

Health+Tech

In this episode of Health+Tech, McGuireWoods healthcare partner Janice Suchyta talks to Michele Satterlund, senior vice president in the state government relations practice of McGuireWoods Consulting and a partner with McGuireWoods, on the emergence of telehealth, particularly during the pandemic. They also look at how telehealth is evaluated state by state and discuss the need for uniform best practices….

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Episode 7: Houston Ready to Become the Third Coast for Biotechnology

Episode 7: Houston Ready to Become the Third Coast for Biotechnology

Health+Tech

In this episode of Health+Tech, McGuireWoods healthcare partner Janice M. Suchyta talks to Donna Chang, founder and CEO of Hope Biosciences. Donna discusses how Texas — particularly Houston — is making a name for itself in biotechnology by attracting research funding, supporting premier academic medical centers and welcoming investment by major pharmaceutical companies. Hope Biosciences, a stem cell biotechnology company that has flourished as part of the biotech cluster in the Houston area, is helping to make Texas the third coast for biotechnology….

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Episode 6: Health Information Exchange and Security

Episode 6: Health Information Exchange and Security

Health+Tech

In this episode of Health+Tech, McGuireWoods partners Jonathan Ishee and Andrea Lee Linna talk to George Gooch, CEO of the Texas Health Services Authority (THSA), about their cybersecurity, health information exchange and pandemic surveillance initiatives. They also discuss:Information blocking rule complianceRecent Texas legislation (now signed into law) affecting healthcare breach notificationThe role of health information exchange in public health surveillanceTHSA initiatives using open-source digital health tools to provide real-time situational awareness to healthcare providers during the pandemic…

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Episode 5: Venture Capital in Digital Health

Episode 5: Venture Capital in Digital Health

Health+Tech

For this episode of Health+Tech, please join Dr. Anwar Hussain, General Partner at RhythmVC, and McGuireWoods Chicago partner Andrea Lee Linna, as they discuss digital healthcare and the nuts and bolts needed to create better systems. Their discussion covers:What venture capital is looking for when investing in digital healthOpportunities for startups in healthcare business-to-business softwareHow healthcare regulations impact digital health investmentApplication of artificial intelligence, blockchain and the internet of things to healthcare data…

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