Genentech
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FDA Approves Roche Lymphoma Drug, Bringing Competition to New AbbVie Med
The FDA approved Roche’s Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug will compete against Epkinly, AbbVie’s recently approved DLBCL drug.
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Healthcare Hires of Note
Read about executive hires across healthcare and life science companies and organizations such as ProofPilot, Genentech, MassBio, Virgin Pulse, and more.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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Project seeks to chart regulatory paths for digital products
The nonprofit Digital Medicine Society is partnering with the likes of Google and the FDA to develop a free resource designed to help digital health startups navigate the regulatory process.
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Roche bets $300M on Adaptimmune tech for off-the-shelf cell therapies for cancer
Roche is partnering with Adaptimmune Therapeutics to develop allogeneic cell therapies based on Adaptimmune’s technology. In addition to these “off-the-shelf” products, the partners will also develop a personalized allogeneic cell therapy designed specifically for a patient’s cancer.
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Artificial Intelligence, BioPharma
AI drug-discovery firm lands first partnership
The deal with Roche subsidiary Genentech is likely not the last for Genesis Therapeutics, which is based on AI research undertaken at Stanford. Such partnerships are potentially lucrative for drug-discovery startups.
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Artificial Intelligence, BioPharma
Roche, PicnicHealth start RWD partnership with multiple sclerosis focus
The companies will use a combination of more than seven years of medical record data with five years of prospective data on 5,000 MS patients, including real-world outcomes data and MRI images. Other disease areas to be explored include hematology and rare diseases.
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Improving the lives of children through wishes and medicine
The mission of Make-A-Wish is to create life-changing wishes for children with critical illnesses, so joining together with Genentech was a natural fit.
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Roche drug is third to win biomarker-driven cancer approval from FDA
On Thursday, Roche’s Rozlytrek won simultaneous FDA labels for NTRK fusion-positive solid tumors and ROS1-positive non-small cell lung cancer.
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Medicare Advantage startup Clover Health launches drug development arm
The company has signed an initial partnership with Genentech that will focus on understanding the genetic components that are related to a person’s risk of developing ocular diseases like macular degeneration.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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FDA draft guidance on bispecific antibodies still has some kinks
An expert pointed to the draft guidance’s lack of distinction between immune-activating bispecifics and those that do not activate the immune system, as well as potentially burdensome trials industry may have to conduct. The comment period ended Tuesday.
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Roche wins approval for new drug for heavily pretreated lymphoma
The drug, Polivy, was developed using antibody-drug conjugate technology in-licensed from Seattle Genetics. It received accelerated approval Monday for diffuse large B-cell patients relapsed or refractory after at least two prior therapies.
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Startups, Artificial Intelligence, Diagnostics
Bill Gates on 2019’s five breakthrough healthcare technologies
The Microsoft co-founder and billionaire philanthropist’s choices for the healthcare innovations that have the potential to change the world range from personalized cancer vaccines to voice assistants.
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Roche’s Tecentriq approved as first immunotherapy drug for breast cancer
The drug received accelerated approval for combination with Celgene’s Abraxane based on Phase III data. According to a study, PD-L1-positive patients account for 26 percent of TNBC patients overall.
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If FDA says ‘make it so,’ Loxo’s Vitrakvi could see competition from Roche’s entrectinib
The agency set an August PDUFA date for entrectinib, which it gave priority review. It did the same for another Roche drug, polatuzumab vedotin, for high-grade lymphoma.
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FDA approves Celltrion, Teva’s Rituxan biosimilar, but with a narrow label
The agency approved Truxima for three lymphoma indications, whereas European regulators approved it last year for all the same indications as the reference product, Roche’s Rituxan.
Promoted
Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
Promoted
Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
