Bristol Myers scores new FDA nod for Opdivo/Yervoy combo; US Army wants Gilead's potential Covid-19 drug for infected troops
→ Bristol Myers Squibb has added one more type of cancer that its Opdivo/Yervoy combo is approved to treat, scoring an accelerated OK for second-line cases of hepatocellular carcinoma. While the PD-1 and CTLA-4 dual immunotherapy failed to beat Nexavar in the frontline setting, regulators were satisfied by the overall response rate of 33% among patients who were previously treated by the Bayer drug. Bristol will be competing with Bayer’s multi-kinase inhibitor Stivarga and Eli Lilly’s VEGFR2 inhibitor Cyramza in this liver cancer niche.
→ The US Army Medical Research and Development Command has reportedly signed a deal with Gilead, which will allow for the use of the drugmaker’s experimental coronavirus therapy, remdesivir, in US troops with confirmed infections. The NIH is already working with Gilead to test the drug — which failed to pass muster as an Ebola therapeutic — in humans as a treatment for Covid-19.
→ In an effort to tackle one of the most discussed drug pricing issues in the US, the Centers for Medicare & Medicaid said it’s rolling out a voluntary senior savings model that caps copay for insulin at $35 for a 30-day supply. Beneficiaries would have to pay a slightly higher premium for these enhanced plans, but it ensures that they have predictable out-of-pocket costs, the CMS said.
→ San Francisco-based AI drug discovery company Atomwise, which in September inked its first deal in China (with Hansoh Pharmaceuticals), now has its first partnership in Korea. The research alliance, with Bridge Biotherapeutics, is expected to span the launch of up to 13 small molecule programs across multiple therapeutic areas. Atomwise said it estimates that it could receive up to $1.08 billion (including royalties) with success in all research programs — but did not disclose any specifics.
→ Dermatology biotech Verrica Pharmaceuticals, which in 2018 made its Nasdaq debut with a $75 million IPO, has secured a $55 million injection via loans from Silicon Valley Bank and WestRiver Innovation Lending Fund VIII as it preps for the potential launch of its molluscum contagiosum therapy. The FDA is expected to make its decision on the drug by July 13.
→ Israel-based cancer drug developer Biosight — whose lead experimental drug BST-236 is in a mid-stage acute myeloid leukemia study — has secured $19 million in a Series C round of financing, led by Israel Biotech Fund with participation by SBI JI Innovation Fund and Arkin Bio Ventures, among others.