Streetbeat News

Regulatory

BCDA

BioCardia has announced the activation of the CardiAMP Heart Failure II Phase 3 pivotal study for its CardiAMP autologous cell therapy, aimed at treating patients with ischemic heart failure. This study, approved by the FDA in Q4 2023, is a double-blinded, randomized controlled multicenter interventional biotherapeutic study.

Portfolio Pulse from Benzinga Newsdesk

February 08, 2024 | 12:03 pm

FMS

The FDA has granted 510(k) clearance to Fresenius Medical Care's 5008X Hemodialysis System, allowing clinical evaluations and user studies in the US, with a broad commercial launch planned for 2025.

Portfolio Pulse from Benzinga Newsdesk

February 08, 2024 | 11:37 am

AUTL

BNTX

BioNTech SE (BNTX) and Autolus Therapeutics plc (AUTL) have announced a strategic collaboration to advance their autologous CAR-T cell therapy programs towards commercialization, subject to regulatory approvals. The collaboration includes a license and option agreement and a securities purchase agreement, aiming to enhance both companies' pipelines and expand their late-stage programs.

Portfolio Pulse from Benzinga Newsdesk

February 08, 2024 | 10:46 am

FXI

SPY

VGK

China's President Xi Jinping has urged Russia's President Vladimir Putin to strategically collaborate in defending their countries' sovereignty, security, and development interests. Xi emphasized the importance of opposing external interference in their internal affairs, as reported by Reuters citing state media.

Portfolio Pulse from Charles Gross

February 08, 2024 | 10:44 am

JOBY

Joby Aviation has been granted a Part 145 Maintenance Certificate by the FAA, enabling the company to conduct select maintenance activities on aircraft. This certification is a significant step for Joby as it progresses in the aviation industry, potentially impacting its operational capabilities and market position.

Portfolio Pulse from Benzinga Newsdesk

February 08, 2024 | 10:02 am

AAPL

AMZN

EWP

Spain's High Court has temporarily suspended the imposition of $209 million in fines on Apple and Amazon. This decision comes as the companies appeal against the fines, which were initially levied for alleged anti-competitive practices. The suspension of the fines is pending the outcome of the appeal process.

Portfolio Pulse from Charles Gross

February 08, 2024 | 9:49 am

DIS

GOOG

NFLX

The Walt Disney Co. (NYSE:DIS) announced plans to intensify its crackdown on Disney+ password sharing, following Netflix Inc.'s (NASDAQ:NFLX) lead. Disney CFO Hugh Johnston revealed during the Q1 earnings call that accounts suspected of password sharing will soon require users to create their own subscriptions. Additionally, Disney+ will offer the option to add users outside a household for an extra fee, similar to Netflix, though this feature will be introduced later in the year. The company does not expect significant benefits from these initiatives until the latter half of 2024. Alphabet Inc. (NASDAQ:GOOG) (NASDAQ:GOOGL) has also started enforcing similar restrictions on YouTube Premium family subscriptions.

Portfolio Pulse from Rounak Jain

February 08, 2024 | 8:56 am

NVDA

For the first time in over 20 years, Mexico has surpassed China as the top supplier of goods to the United States, with U.S. imports from Mexico exceeding $475 billion in 2023. This shift is attributed to the U.S.'s efforts to reduce dependency on Chinese goods amid escalating tensions and to source more from closer, allied nations. The U.S. has maintained tariffs on Chinese imports, and the Biden administration encourages 'friend-shoring' and 'reshoring' of manufacturing. Some Chinese manufacturers have moved to Mexico to benefit from the U.S.-Mexico-Canada Trade Agreement. Meanwhile, China is reducing its reliance on U.S. imports, especially in the tech sector, by increasing its chipmaking capabilities.

Portfolio Pulse from Benzinga Neuro

February 08, 2024 | 7:27 am

INDA

The Reserve Bank of India has decided to keep the interest rate unchanged at 6.50%. This decision was widely anticipated by market analysts.

Portfolio Pulse from Benzinga Newsdesk

February 08, 2024 | 6:05 am

BTCUSD

Rep. Maxine Waters announced that lawmakers are close to finalizing a stablecoin regulation bill, emphasizing the importance of Federal Reserve oversight. This development follows extensive discussions and is supported by Treasury Secretary Janet Yellen, who highlighted the need for regulatory action to protect investors and the financial system from cryptocurrency risks. Meanwhile, Bitcoin's price has seen a recent increase.

Portfolio Pulse from Mehab Qureshi

February 08, 2024 | 5:25 am