Mallinckrodt's Synacthen Depot, or tetracosactide, has received fast-track status from the FDA as a treatment for Duchenne muscular dystrophy. The drug, a long-acting depot formulation of a synthetic 24 amino acid melanocortin receptor agonist, is being assessed in an early-stage trial.
NIH scientists and researchers from the Johns Hopkins Bloomberg School of Public Health are working together to develop a vaccine candidate that will protect people not only from Zika but also from dengue. The human challenge portion of the trial, to begin in December, aims to test the efficacy of a vaccine candidate that needs to be strong enough to evoke a protective antibody response while also being weak enough not to be transmitted sexually or through blood from mosquito bites.
The biofuel industry is criticizing a study partly funded by the American Petroleum Industry that says biofuels produce greater amounts of greenhouse gas emissions than gasoline. The Renewable Fuels Association and Growth Energy reiterated that objective research shows renewable fuels reduce greenhouse gas emissions and produce cleaner and more affordable gas.
F-star has agreed to collaborate with Denali Therapeutics on the development of antibodies designed to deliver drugs into the central nervous system across the blood–brain barrier using F-star's Modular Antibody Technology. Under the terms of the deal, Denali will pay $6 million upfront plus undisclosed milestone fees and research funding, and will gain the option to acquire F-star Gamma in exchange for as much as $450 million in aggregate milestone and exercise payments.
The Earlybird Health Tech Fund, with a target size of up to about $135 million, has been launched by venture capital firm Earlybird Venture Capital. The fund aims to invest in 12 to 15 medtech, diagnostics and digital health companies in the coming years, said Thom Rasche, a partner at Earlybird.
Biologist Jessica Whited studies salamanders' ability to regrow fully functional limbs, and she and her colleagues have identified genes in axolotl salamanders that are activated to grow new limbs. The scientists hope the research will eventually lead to treatments for severed digits and limbs in people.
A study in the journal Cell of sexual transmission of the Zika virus and its fetal effects in mice found that vaginal fluid could act as a reservoir for the virus, leading to fetal infection. The virus affected fetal development in normal mice and mice bred to be susceptible to the virus.
All blood donations should be tested for the Zika virus, the FDA has told blood centers in the US. Greater epidemiologic understanding of the virus makes it clear that increased precautions are needed, according to the agency's statement.
A 76-patient study in the New England Journal of Medicine showed positive results for InSightec's ExAblate Neuro focused ultrasound system in treating moderate to severe essential tremor. After three months, use of the system led to a 47% improvement in mean composite tremor score, compared with no change from use of a sham procedure.
Pfizer has agreed to acquire AstraZeneca's small molecule-antibiotics business, which includes the approved drugs Zavicefta, Merrem and Zinforo, as well as the investigational treatments ATM-AVI and CXL. Pfizer will provide a $550 million upfront payment, another $175 million unconditional payment in January 2019, milestone fees of $250 million, plus $600 million tied to royalties and future sales of Zavicefta and ATM-AVI.
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