Streetbeat News

Regulatory

CGTX

Cognition Therapeutics has announced the activation of the first clinical trial site for the Phase 2 START study of CT1812 in adults with early Alzheimer's disease. The site can now begin recruiting participants for the 540-patient study.

Portfolio Pulse from Benzinga Newsdesk

July 05, 2023 | 11:33 am

DXCM

DexCom, Inc.'s (NASDAQ:DXCM) Dexcom G7 Continuous Glucose Monitoring System has been approved by Health Canada. The device can warn of high or low glucose levels and help avoid hypoglycemic events. The approval gives Canadians access to a technology that reduces hospitalizations and emergency room visits due to hypoglycemia by up to 42%. The product is expected to be launched in Canada by the end of 2023.

Portfolio Pulse from Nabaparna Bhattacharya

July 05, 2023 | 11:16 am

AMZN

MSFT

NVDA

The Biden administration is planning to limit the access of Chinese companies to U.S. cloud-computing services, which would require U.S. cloud-service providers like Amazon and Microsoft to obtain government approval before offering cloud-computing services that utilize advanced AI chips to Chinese customers. This move is seen as a strategy to close a loophole that allows Chinese AI companies to circumvent current export controls by using cloud services.

Portfolio Pulse from Benzinga Newsbot

July 05, 2023 | 11:12 am

CCCC

The FDA has cleared C4 Therapeutics' Investigational New Drug Application for CFT8919, a treatment for non-small cell lung cancer. C4T plans to initiate trials outside Greater China after Betta Pharmaceuticals concludes its Phase 1 dose escalation study in the region.

Portfolio Pulse from Benzinga Newsdesk

July 05, 2023 | 11:03 am

MRNA

Moderna, Inc. (NASDAQ:MRNA) has announced regulatory submissions for its Respiratory Syncytial Virus (RSV) vaccine, mRNA-1345, aimed at preventing RSV-associated lower respiratory tract disease and acute respiratory disease in adults aged 60 years or older. The company has submitted marketing authorization applications to the European Medicines Agency, Swissmedic, and the Therapeutic Goods Administration in Australia, and initiated the rolling submission process for a Biologics License Application to the U.S. FDA.

Portfolio Pulse from Benzinga Newsdesk

July 05, 2023 | 11:02 am

INCY

The Medicines and Healthcare Products Regulatory Agency has approved Incyte Biosciences' Opzelura (Ruxolitinib) cream for non-segmental vitiligo with facial involvement in patients aged 12 years and above.

Portfolio Pulse from Benzinga Newsdesk

July 05, 2023 | 10:16 am

FXI

MRNA

Moderna has signed a Memorandum of Understanding (MoU) and a collaboration agreement to research, develop, and manufacture mRNA medicines in China. The medicines produced under this agreement will be exclusively for the Chinese people and will not be exported.

Portfolio Pulse from Charles Gross

July 05, 2023 | 10:09 am

IMPL

Impel Pharmaceuticals has received a US patent for respiratory tract delivery of levodopa and DOPA decarboxylase inhibitor for Parkinson's disease, leading to a rise in its share prices.

Portfolio Pulse from Benzinga Newsdesk

July 05, 2023 | 9:54 am

AXTI

FXI

AXT's subsidiary in China, Tongmei, plans to immediately seek permits from Chinese authorities to export gallium and germanium substrate products. This news has led to a 7.7% premarket increase in AXT shares.

Portfolio Pulse from Charles Gross

July 05, 2023 | 9:52 am

AMRX

Amneal Pharmaceuticals has received a Complete Response Letter from the FDA regarding its New Drug Application for IPX203, a treatment for Parkinson's disease.

Portfolio Pulse from Benzinga Newsdesk

July 05, 2023 | 9:52 am