The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.
The company also said that the Phase III study of the autoimmune disease drug Kevzara that it was running with Sanofi failed to meet either its primary or key secondary endpoints among critically ill Covid-19 patients.
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.
The U.S. district attorney for Massachusetts filed suit against the drugmaker this week, alleging that it paid tens of millions in kickbacks through a copay foundation for Eylea, a drug used to treat macular degeneration.
The company plans to test REGN-COV2 - consisting of the SARS-CoV-2-specific antibodies REGN10933 and REGN10987 - in four populations, including infected patients and uninfected people at high risk of infection.
The Phase III portion of the companies' trial of Kevzara will now only enroll critically ill patients and randomize them to receive the drug at 400mg or placebo, after the drug did not appear effective in severely ill patients.
Analyst reports over the past few weeks have looked into what effects the Covid-19 pandemic could have on drugmakers' sales, examining multiple factors. But virtual launches and telemedicine could mitigate some market challenges.
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.
While focus of potential Covid-19 treatment drugs has fallen on antivirals such as Gilead's remdesivir, there are anti-inflammatory drugs being tested to mitigate the huge overreaction of the immune system often seen in patients.
An official form Northwell Health said trials of Gilead and Regeneron drugs were able to get up and running in four days rather than taking months to start, in part because clinical trials in other disease areas have been put on hold.
More than 80,000 people worldwide have been infected with the SARS-CoV-2 virus. In response, the U.S. government has partnered with several companies to develop drugs to treat the infection and vaccines to prevent it.
The department and the drugmaker said they would leverage an existing partnership to develop monoclonal antibodies for 2019-nCoV. A drug made by Gilead Sciences for Ebola is also being tested as a treatment for the rapidly spreading virus.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
The decision was a loss for Amgen, which had claimed that Sanofi and Regeneron's drug Praluent infringed on its patents for the drug Repatha.
An analyst wrote that while the data are positive, the bigger question is how the drug will be priced, based on another drug already on the market for the same disease, HoFH, which affects about 1,300 people in the U.S.
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 deal will focus on discovery, development and commercialization of CNS and eye drugs and also includes development of two C5-targeting drugs in liver disease. The companies have an existing partnership centered on NASH drugs.
It seems there's no longer any tolerance for the 'how far can we push this' approach. The smart players are instead asking 'what is reasonable and sustainable in our current healthcare climate?'