The FDA has approved Alnylam Pharmaceuticals' Onpattro, or patisiran, for the treatment of polyneuropathy in patients with hereditary ATTR amyloidosis, making it the first gene-silencing drug to win US approval. Onpattro will carry an annual list price of $450,000 for the average patient, and several insurers, including Harvard Pilgrim Health Care, agreed to cover the drug through value-based deals with Alnylam.
Youths with sleep-disordered breathing who underwent adenotonsillectomy had a significantly greater median decline in the number of oxygen desaturation episodes per hour of at least 3% by nocturnal oximetry from baseline to three months' follow-up, and were significantly more likely to achieve normal ODI3 at follow-up, compared with those in the control group, Greek researchers reported in Pediatrics. The findings also found the adenotonsillectomy group had significantly greater improvements in disease-specific quality-of-life scores at three months than the control group.
An international group of researchers from the Viral Hemorrhagic Fever Immunotherapeutic Consortium is working to determine which Ebola-fighting antibodies are best and why to create a combined therapeutic cocktail that could disable the infection machinery of the Ebola virus and trigger the patient's immune system to combat the virus. The research was published in Cell.
The FDA approved Cipla's abbreviated new drug application for atazanavir capsules in 100 mg, 150 mg, 200 mg and 300 mg, the AB-rated generic therapeutic equivalent version of Bristol-Myers Squibb's Reyataz. The drug, in combination with antiretroviral agents, is indicated to treat patients age 6 and older with HIV-1 infection who weigh at least 15 kg.
The first patient was dosed in a late-stage trial of BeiGene's tislelizumab in combination with chemotherapy, being assessed in China as a treatment of stage IIIB or stage IV squamous non-small cell lung cancer. The study will evaluate progression-free survival as assessed by the Independent Review Committee.
Ophthalmic gene therapy company Quethera was purchased by Astellas Pharma in a deal that gives Quethera upfront and contingent payments of up to $110.3 million. Quethera's lead program is an undisclosed gene therapy in preclinical testing for patients with glaucoma.
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Startups such as Calyxt are leading the way as companies apply gene-editing techniques to soybeans and other crops. Proponents say these techniques allow for more-precise DNA modification, but it remains to be seen how regulators and the public will react.
By using the CRISPR gene-editing tool to alter two of the more than 12 million nucleotides in the yeast genome, scientists from the University of Wisconsin-Madison and the Department of Energy were able to protect yeast from damage caused by pretreatment chemicals in biofuel production. The ionic liquids used in biofuel production can render yeast up to 70 percent less effective at converting sugar to biofuel.
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It's bad policy to speculate on what you'll do if a plan fails, when you're trying to make a plan work.
Condoleezza Rice, diplomat and political scientist
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