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.
The FDA has extended the deadline for the submission of unique device identifier data into the Global Unique Device Identification Database by manufacturers of biologic-device or drug-device combination products that go through the Center for Drug Evaluation and Research to Sept. 24, 2019. The agency said more time is needed to update the database system, although these products still have to adopt UDI on their labeling by Sept. 24. of this year.
Researchers in Switzerland and the UK found that type 2 diabetes patients who used an artificial pancreas had significantly better blood glucose levels, 8.6 mmol/L on average, compared with 10.4 mmol/L among those in the control group. The findings in The New England Journal of Medicine, based on 136 adult diabetes patients, revealed no severe hypoglycemia episodes and no significant differences for hypoglycemia between the two groups.
FDA Commissioner Scott Gottlieb said on Twitter the agency will release more detailed information on the meaning of food packaging terms to help consumers better understand them. A recent op-ed article in The Wall Street Journal discussed the roughly $47 billion-a-year organic industry, claiming the FDA purportedly allows "blatantly false and deceptive advertising claims."
The FDA approved Mumbai, India-based 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.
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.
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.
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.
Insulet CEO Patrick Sullivan says he plans to make Insulet a billion-dollar company focused on making lives of patients with type 1 diabetes easier. Growth plans center around its Omnipod tubeless insulin delivery technology, its new Dash configuration for wireless insulin management and its Horizon artificial pancreas system, expected to hit markets in late 2019 or early 2020.
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