The alleged activities of two Chinese hackers outlined in a federal indictment unsealed Tuesday offer “concrete examples of two concerning trends,” U.S. Assistant Attorney General John Demers said, as U.S.-China relations further soured with the news of the charges.
The FDA has approved Xywav (calcium, magnesium, potassium and sodium oxybates; JZP-258), an oxybate product for treating both cataplexy and excessive daytime sleepiness in narcolepsy patients ages 7 and older, from Jazz Pharmaceuticals plc.
With the green light for a phase II trial to test a new drug to tackle some of the impacts of COVID-19, clinical-stage antibody developer Sorrento Therapeutics Inc. is going all in on the COVID-19 business. The company is now developing three therapeutic products, one diagnostic and a vaccine.
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I. The phase I trials testing the in-house antiviral antibody treatment CT-P59 began on July 17, the same day the company received approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its investigational new drug application on the back of positive preclinical results.
With the green light for a phase II trial to test a new drug to tackle some of the impacts of COVID-19, clinical-stage antibody developer Sorrento Therapeutics Inc. is going all in on the COVID-19 business.
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I.
In its first fully virtual markup session, the House Energy and Commerce Committee Wednesday set aside politics to approve a bill that would make the U.S. Strategic National Stockpile (SNS) a better emergency resource – at least for the next few years.
While members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee all recognized the severity of hepatorenal syndrome type 1 (HRS-1) and the significant unmet need in the space, they were divided on whether the FDA should follow the decades-old lead of regulators in 60 other countries in approving Mallinckrodt plc’s terlipressin as an HRS-1 treatment.
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