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Devices & Diagnostics, Health Tech
Limbix digital therapeutic for adolescent mental health finds niche amid Covid-19 pandemic
The Silicon Valley startup plans to start its registration-directed study of Limbix Spark in the earlier part of next year and – if successful – would anticipate FDA clearance in early 2022.
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Seattle Genetics rebrands as Seagen as it expands business globally
The company has received FDA approvals for two cancer drugs in less than 12 months and announced partnerships with Merck last month for a Phase II antibody-drug conjugate and a marketed drug.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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Takeda strikes $1B RNAi deal with Arrowhead Pharmaceuticals
The companies will partner on development and commercialization of ARO-AAT, Arrowhead’s Phase II RNA-interference drug for alpha-1 antitrypsin-associated liver disease, a rare genetic disorder. An analyst wrote that the deal makes sense given Takeda’s position in the AAT-augmentation therapy market.
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CRISPR gene-editing discoverers awarded Nobel Prize in chemistry
The prize went to Jennifer Doudna of the University of California Berkeley and Emmanuelle Charpentier of the Max Planck Institute. Charpentier published her research on the biology behind the technology in 2011 and collaborated with Doudna. The two discovered it was possible to control the mechanism.
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Lilly seeks emergency clearance for Covid-19 monoclonal antibodies on Phase II data
The company announced data on the combination of two antibodies against the SARS-CoV-2 virus, showing significant reductions in viral load compared with placebo. The company has applied for an EUA for LY-CoV555 and will seek an authorization for the combination of that drug with LY-CoV016 next month.
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FDA issues Covid-19 vaccine guidance as White House reportedly relents
The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.
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Amgen announces ‘positive’ Phase II lung cancer results for cancer drug with hard-to-reach target
The company did not provide data, but said results for patients who received sotorasib at the 960mg dose were consistent with those seen in the Phase I portion of the Phase I/II study, which showed an overall response rate of 35.3%. ……
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BMS acquires MyoKardia, maker of drugs for cardiovascular disease, for $13.1B
The companies expect the deal to close in the fourth quarter. MyoKardia’s lead drug candidate is mavacamten, which it is developing for hypertrophic cardiomyopathy and plans to submit to the FDA in the first quarter of next year.
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MD Anderson researchers find mechanisms behind CAR-T cells’ efficacy, toxicity
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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Amid mixed messages about his Covid-19 diagnosis, Trump looks like a one-man clinical trial
While the White House and doctors at Walter Reed have sought to reassure the public that Trump’s condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.
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Gilead takes over distribution of Covid-19 antiviral drug from federal government
The company said it was meeting real-time supply demands for Veklury (remdesivir) in the U.S. and anticipated meeting global demands for the drug worldwide. AmerisourceBergen will continue acting as sole U.S. distributor.
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Ovid drug reduces seizure frequency in two rare forms of epilepsy, according to early Phase II data
The data from a Phase II pilot and an extension study of soticlestat, also known as OV935 or TAK-935, showed short- and long-term reductions of seizure frequency in patients with CDKL5 deficiency disorder and Dup15q syndrome.
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Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.
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Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data
The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.