Celldex drug barzolvolimab has mid-stage results in a chronic inflammatory skin disease that top those of an approved Genentech drug and two experimental Novartis therapies. The biotech is preparing to advance its drug to Phase 3 testing in 2024.
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Read about executive hires across healthcare and life science companies and organizations such as ProofPilot, Genentech, MassBio, Virgin Pulse, and more.
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.
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.
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.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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.
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.
On Thursday, Roche’s Rozlytrek won simultaneous FDA labels for NTRK fusion-positive solid tumors and ROS1-positive non-small cell lung cancer.
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.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
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.
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.
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.
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.
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.