Nearly three years after being terminated as president and CEO of Cytodyn Inc., Nader Pourhassan was convicted June 9 by a U.S. federal jury for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab. The jury also convicted Kazem Kazempour, the CEO of Amarex Clinical Research LLC, a contract research organization hired by Cytodyn, for his part in the scheme.
Stereotaxis Inc. and Chinese partner Shanghai Microport EP Medtech Co. Ltd. gained the National Medical Products Administration’s approval of its Magbot magnetic navigation ablation catheter Dec. 9 for use with Stereotaxis’ robotic ablation system to treat drug-resistant cardiac arrhythmias in China.
Administrators at the U.S. Medicare program have proposed to cover the Cardiomems remote monitoring device for heart failure, but cardiologists are averse to several of the conditions spelled out in the draft coverage memo, including what they see as a somewhat futile demand for a comparator arm in the proposed coverage study.
The FDA’s new program for communicating the hazards of devices is in play and resulted in the posting of a notice of a problem seen with the Ivenix line of large volume infusion pumps by Fresenius Kabi USA, which will require some repair work by the manufacturer.
Astria Therapeutics Inc. has gained IND clearance from the FDA for STAR-0310, a monoclonal antibody OX40 antagonist being developed for atopic dermatitis.
Nextcure Inc. has reported IND clearance from the FDA enabling initiation of a phase I trial of LNCB-74, a B7-H4-targeting antibody-drug conjugate (ADC) being developed for various cancers.
The U.S. SEC filed charges against David Banister and The Market Analysts Group LLC, which Banister controls, alleging that they conducted a fraudulent scheme to promote long-term investment in Biovie Inc. without disclosing that Banister was actively selling his own shares in the biopharma company.
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
Bionomics is progressing BNC-210 to phase III trials in post-traumatic stress disorder (PTSD) following positive feedback from the U.S. FDA. Final data from the phase II Attune study showed that BNC-210 improved PTSD symptom severity at week 12 with efficacy observed as early as week four.
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