One deal is a $4.2 billion development and commercialization partnership focused on ladiratuzumab vedotin, while the other would expand the reach of the breast cancer drug Tukysa.
Amid growing concern that the Trump administration is trying to get a vaccine rushed to market, nine biotech and pharma CEOs signed a letter pledging to uphold high scientific and ethical principles.
A new independent study from Phyx Primary Care’s Innovation Lab points to measurable improvements in physician burnout, documentation efficiency, and key VBC metrics among primary care practices.
Hanmi will retain options for the drug, efinopegdutide, in Korea under the deal, in which Merck is paying the Seoul-based company $10 million upfront and up to $860 for development, regulatory and commercialization milestones.
The FDA approved Keytruda as a single agent for patients with first-line metastatic or unresectable colorectal cancer that carries the biomarker MSI-H or dMMR. The drug was the first to win a biomarker-based, tumor-agnostic label, in 2017.
In three announcements, the drugmaker said it would acquire an Austrian vaccine developer and partner with a private biotech company and nonprofit organization on an antiviral drug and a vaccine.
The company, currently labeled only "NewCo," will focus on Merck's women's health, legacy products and biosimilars, while Merck itself focuses on oncology, vaccines, hospital drugs and animal health. The drugmaker's shares fell more than 4% when markets opened Wednesday.
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The companies said Monday that they would partner to develop small-molecule oncology drugs against several targets, including KRAS mutations, long thought "undruggable." Amgen and Mirati have already presented clinical data from their KRAS programs.
The FDA approved Lynparza for patients with pancreatic cancer after chemotherapy whose tumors harbor a certain genetic mutation.
The agency was expected to rule on whether or not to approve the vaccine, Ervebo, by March 2020. The vaccine protects against Zaire ebolavirus, but not other strains of the virus or the related Marburg virus.
ArQule's lead product candidate is a BTK inhibitor, ARQ-531, designed for heavily pretreated patients with leukemias and lymphomas, particularly those whose disease has become resistant to marketed BTK therapies. Phase I data on the drug were also presented Monday.
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The company said that the investment follows and extends the $60 million Series B investment that it announced in April. It plans to use the funding to bolster its clinical development capabilities.
The company said Imfinzi and chemotherapy, with or without tremelimumab, extended progression-free survival in first-line non-small cell lung cancer versus chemotherapy, setting up Imfinzi as a potential competitor to Merck's Keytruda. Overall survival data are expected next year.
Drug regulators in the U.S., Canada and Australia simultaneously approved Merck's Keytruda and Eisai's Lenvima for advanced endometrial carcinoma following a collaborative review under a program called Project Orbis.
The agency is expected to rule on the vaccine by March 14 of next year. The company has shipped nearly a quarter of 1 million doses of the vaccine to the WHO for countries facing outbreaks like the Democratic Republic of the Congo.
The study, by Personal Genome Diagnostics and academic researchers, was able to predict responses to checkpoint inhibitor therapy in patients with MSI-H and high tumor mutational burden.