Streetbeat News

Regulatory

MDAI

Spectral AI plans to submit a De Novo request for its DeepView AI-Burn device to be classified as a Class II medical device by Q2 2025.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 12:05 pm

GLMD

INTC

SES

Intel shares rise 11% following a strategic collaboration with AWS to boost US chip manufacturing. SES AI shares surge 57% after announcing a collaboration with NVIDIA, Crusoe, and Supermicro on AI for scientific initiatives. Galmed Pharmaceuticals regains Nasdaq compliance.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 12:04 pm

BGNE

BeiGene announced that the Israeli Ministry of Health has approved TEVIMBRA (Tislelizumab) for use as a monotherapy in adult patients with unresectable or metastatic OESCC who have undergone prior systemic chemotherapy.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:46 am

BBIO

BridgeBio Pharma has received Breakthrough Therapy Designation from the FDA for its oral drug Infigratinib, which is under development for treating children with achondroplasia. This designation is intended to expedite the drug's development and regulatory review.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:32 am

CI

Express Scripts, a subsidiary of Cigna, has filed a lawsuit against the Federal Trade Commission (FTC) demanding the withdrawal of a report on pharmacy benefit managers (PBMs). This legal action could impact Cigna's operations and regulatory environment.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:22 am

GSK

Japan's Ministry of Health, Labour and Welfare has accepted GSK's new drug application for Blenrep in combination with other drugs for treating relapsed or refractory multiple myeloma.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:18 am

GRMN

Garmin has received certification for its G5000 integrated flight deck for the Cessna Citation XLS+ and XLS Gen2 aircraft. This certification marks a significant milestone for Garmin in expanding its aviation product offerings.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:16 am

SENS

The FDA has cleared Senseonics' Eversense 365, a next-generation continuous glucose monitoring system for people with diabetes. This system is the first of its kind to offer a one-year duration for continuous monitoring.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:15 am

BCRX

BioCryst Pharmaceuticals has successfully completed negotiations with the Pan-Canadian Pharmaceutical Alliance for Orladeyo, a drug approved in Canada for preventing hereditary angioedema attacks in patients aged 12 and older.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:12 am

ACIU

AC Immune SA (NASDAQ:ACIU) has received a CHF 24.6 million milestone payment from Janssen Pharmaceuticals for its Alzheimer's immunotherapy candidate, JNJ-2056. This payment highlights the progress in the Phase 2b ReTain trial and strengthens AC Immune's financial position.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:11 am