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.
An analyst wrote Wednesday that the combination of Lilly's Olumiant and Gilead's Veklury, or remdesivir, could cost nearly $8,000, a high price tag that could potentially hamper uptake, especially given the availability of cheaper drugs like dexamethasone.
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 deal marks Gilead's latest big-ticket move into oncology this year, with Immunomedics' Trodelvy anticipated to reach $4 billion in peak sales. However, at least one analyst suggested Gilead may have overpaid.
The company said Friday that it had submitted for approval of Yescarta in follicular and marginal zone lymphoma, based on data from the ZUMA-5 study that were presented at the 2020 ASCO meeting in May.
The drug, JTX-1811, is designed to work by depleting certain T cells that suppress the immune system's response to tumors. A regulatory filing to begin clinical trials is expected in the first half of next year.
While there had been some risks to filgotinib's approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.
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 update to the partnership includes opt-in rights for Gilead on 15 drug targets, up from five under the original 2018 deal. Gilead will pay $125 million upfront and make a $20 million equity investment in Tango, which focuses on synthetic lethality.
UnitedHealthcare sent a notice to plan members stating that it would no longer cover Descovy to prevent HIV, while Truvada - after it goes generic next month - will be covered for free. Gilead reported that Descovy for PrEP had offset a second-quarter fall in product sales.
Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.
The agency approved Tecartus, previously developed under the name KTE-X19, as the first CAR-T therapy for mantle cell lymphoma. The company had previously won approval for another CAR-T, Yescarta. Tecartus is a similar product, but with a different manufacturing process.
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 study is enrolling 60 healthy volunteers aged 18-45, but the company hopes it will form the basis of trials of the drug as an outpatient treatment for patients who do not require hospitalization. Remdesivir is currently administered via IV.
Research on the drug's molecular target dates back to the 1950s. A spokesperson for Gilead noted that the company anticipates potentially investing more than $1 billion on the drug this year alone.
HHS said it had acquired all the supplies of the drug for July and 90% of supplies for August and September. Many developing countries have access to generic versions, but WTO rules could complicate the ability of wealthy nations to import them.
The company determined a price of $520 per vial for U.S. payers and $390 for government payers outside the U.S., the latter price being designed to avoid the need for country-by-country pricing negotiations, CEO Daniel O'Day wrote in an open letter.
The biotech company will have the exclusive option to buy the remainder of the company, while Pionyr's shareholders will be entitled to up to nearly $1.5 billion in option exercise fees and milestone payments.