Regeneron to go to regulators with Covid-19 drug on results in outpatients
The company said that those who received the two-antibody cocktail REGN-COV2 showed a lower viral loads and faster alleviation of symptoms than those who received placebo.
AI-centered drug discovery startup XtalPi raises nearly $319M in Series C round
The six-year-old Google-backed company was founded by three MIT physicists and hopes to use its technology to make drug discovery faster and less cumbersome by combining physics, AI and cloud computing.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
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.
Policy makers should ‘set their sights higher’ on U.S. drug pricing regulations, researchers say
A review published in JAMA found that bills introduced into the House and Senate don't go nearly as far as existing drug pricing regulations other countries. The researchers listed eight key lessons from six nations.
Inovio shares sink after FDA places partial hold on Phase II/III Covid-19 vaccine study
The company emphasized that the partial hold was due to "additional questions" about the study, including the delivery device being used, and was not related to any adverse events. As such, the Phase I study of the vaccine, INO-4800, is proceeding.
Gilead, Galapagos arthritis drug rejected by FDA gets go-ahead from Japanese, European regulators
The European Commission and Japan's Ministry of Health, Labor and Welfare approved filgotinib, marketed under the name Jyseleca, for rheumatoid arthritis. The drug is partnered in Japan with Eisai. The FDA rejected the drug last month.
Combating the Covid-19 loneliness epidemic takes the courage to talk about it
At the MedCity INVEST Digital Health virtual conference, panelists talked about ways to deal with loneliness stemming from months of lockdowns and stay-at-home orders.
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A Personalized Approach to Medication Nonadherence
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.
Novavax starts Phase III Covid-19 vaccine trial in U.K.
The company, which also published Phase I data from its Phase I/II study earlier this month, is enrolling 10,000 volunteers aged 18 to 84 for the placebo-controlled trial of the vaccine against SARS-CoV-2, NVX-COV2373.
Monte Rosa raises $96M Series B for drug development platform technology
The Boston-based company plans to develop small-molecule therapeutics that go after historically "undruggable" targets using a process known as protein degradation.
J&J launches Phase III trial of single-shot Covid-19 vaccine
The placebo-controlled trial, ENSEMBLE, will enroll up to 60,000 healthy volunteers on three continents. The trial will test the vaccine JNJ-78436735, also known as Ad26.COV2.S.
Decentralized clinical trials won’t slow down after Covid-19 pandemic ends
In a interview, an executive from Medable said patients will likely demand to have the choice of whether to show up at trial sites or participate in studies remotely. The Covid-19 pandemic has accelerated a trend toward decentralized trials that was already underway before it began.
Maximize Revenue and Patient Care with Strategic Weight Loss Management
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Blueprint to take cancer drug back to FDA after positive results in rare blood disease
The drug, Ayvakit, showed a high overall response rate in patients with advanced systemic mastocytosis, a rare type of blood cancer with limited treatment options. Novartis' Rydapt has been approved for advanced SM for several years.
BMS, bluebird get sped-up review for multiple myeloma CAR-T cell therapy
The companies said Tuesday that the FDA had accepted their application for idecabtagene vicleucel, which they resubmitted in July after the agency initially refused to file it in May. The action date is in March of next year.
Illumina to acquire early cancer detection startup Grail for $8B
Illumina originally spun off Grail in early 2017. Grail plans to launch its test for early detection of cancers, Galleri, next year. Illumina already owns 14.5% of the company, which it started in 2016.
La FDA, c’est moi: In memo, HHS’ Azar asserts power to sign new rules, traditionally purview of agencies’ lawyers
The New York Times reported that in a memo, Alex Azar stated that the power to sign new rules is "reserved" for him, a move that one expert called a "power grab." It is unclear how it will affect authorizations of vaccines against the coronavirus.
Amgen publishes, presents data on therapy with ‘undruggable’ target
Sotorasib, a KRAS G12C inhibitor, showed an overall response rate and duration of response that analysts called approvable, but they noted the results have waned over time, and combinations may be the way forward.