Tag: advisory-panel
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U.S. FDA panel narrowly backs Cempra’s antibiotic solithromycin
The effectiveness of Cempra Inc’s antibiotic to treat community-acquired pneumonia outweighs the risk of liver injury, an advisory panel to the U.S. Food and Drug Administration narrowly concluded on Friday. The panel voted 7-6 that the drug, solithromycin, should be approved to treat the kind of pneumonia that recently affected U.S. presidential candidate Hillary Clinton.…
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FDA highlights liver safety issues in Cempra drug review
(Reuters) – Cempra Inc’s experimental drug to treat community acquired pneumonia, the kind suffered by presidential candidate Hillary Clinton recently, causes a potentially concerning rise in liver enzymes, according to a preliminary review by the U.S. Food and Drug Administration. The review, posted on the FDA’s website on Wednesday, comes two days ahead of a…
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FDA highlights liver safety issues in Cempra drug review
(Reuters) – Cempra Inc’s experimental drug to treat community acquired pneumonia, the kind suffered by presidential candidate Hillary Clinton recently, causes a potentially concerning rise in liver enzymes, according to a preliminary review by the U.S. Food and Drug Administration. The review, posted on the FDA’s website on Wednesday, comes two days ahead of a…
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Tesla obliged to pay $1.7 billion to Panasonic for gigafactory cells
(Reuters) – Tesla Motors Inc had an obligation to pay a total of about $1.7 billion to Japan's Panasonic Corp as of Sept. 30 for electric vehicle battery cells made at Tesla's gigafactory in Nevada, the carmaker said in a regulatory filing. Panasonic, Tesla's longstanding battery partner, agreed in 2014 to invest in equipment, machinery…
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FDA panel supports Novartis version of Amgen arthritis drug
Novartis AG's cheaper version of Amgen Inc's arthritis drug Enbrel is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20-O that there is no clinically meaningful difference between Novartis's drug, a biologic made of…
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U.S. sends 47 troops to South Sudan to protect Americans
The White House said on Wednesday that it had deployed 47 troops to South Sudan to protect U.S. citizens and the U.S. embassy after an outbreak of deadly violence in the country. “These deployed personnel will remain in South Sudan until the security situation becomes such that their presence is no longer needed,” the White…