Streetbeat News

Regulatory

AMZN

The Federal Trade Commission (FTC) is planning to prosecute Amazon.com Inc (NASDAQ:AMZN) over antitrust claims. The FTC has been investigating Amazon's practices for several years, focusing on preferential treatment to its products and treatment of third-party sellers. The impending lawsuit could target various aspects of Amazon's business, including its Fulfillment by Amazon logistics program and pricing practices. Amazon's stock has gained 60% YTD, and it reported Q2 revenue growth of 11% YoY to $134.4 billion.

Portfolio Pulse from Anusuya Lahiri

September 06, 2023 | 12:10 pm

TEVA

Teva Pharmaceuticals will present 16 data presentations at the Psych Congress 2023, including data for AUSTEDO, AUSTEDO XR, UZEDY, TV-44749, and AJOVY. The presentations will highlight real-world effectiveness and adherence of AUSTEDO, safety data for UZEDY, and results from the RISE and SHINE studies. Teva will also host a symposium to discuss the DECIDE study, which surveyed clinician perspectives on the use of long-acting injectable antipsychotics.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 12:10 pm

LSTA

Lisata Therapeutics announced that the interim futility analysis for the Phase 2b ASCEND trial of LSTA1 in metastatic pancreatic ductal adenocarcinoma will continue as planned without modification.

Portfolio Pulse from Benzinga Newsdesk

September 06, 2023 | 12:05 pm

AMRX

Amneal Pharmaceuticals has received approval for its first product, Sevelamer Carbonate, in China and expects to launch it soon. The company also plans to launch Oseltamivir Phosphate in China this year, pending approval. Amneal has six more products under review in China and plans to register more over time. Since 2019, Amneal has been collaborating with Fosun Pharmaceuticals to bring key therapies to market in China.

Portfolio Pulse from Benzinga Newsdesk

September 06, 2023 | 12:05 pm

AMRX

Amneal Pharmaceuticals has received approval from the FDA for its Abbreviated New Drug Application for Lisdexamfetamine Dimesylate Capsules in various dosages. This approval could potentially lead to increased revenues for the company.

Portfolio Pulse from Benzinga Newsdesk

September 06, 2023 | 12:04 pm

VBLT

VBL Therapeutics (NASDAQ:VBLT) has announced that its S-4 registration statement for the proposed merger with Notable Labs has been declared effective by the SEC. The merger, announced on February 23, 2023, is expected to close in mid-October 2023, subject to shareholder approval. The combined organization plans to apply Notable's Predictive Precision Medicines Platform to develop a pipeline of clinical-stage precision medicines in oncology.

Portfolio Pulse from Happy Mohamed

September 06, 2023 | 12:02 pm

RYTM

Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM) announced that a new International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code for Bardet-Biedl Syndrome (BBS) was approved by the Centers for Disease Control and Prevention (CDC). The new code, Q87.83 Bardet-Biedl syndrome (BBS), takes effect Oct. 1, 2023.

Portfolio Pulse from Benzinga Newsdesk

September 06, 2023 | 12:00 pm

AZN

The FDA has issued a complete response letter (CRL) to AstraZeneca regarding its supplemental Biologics License Application for Ultomiris therapy for neuromyelitis optica spectrum disorder (NMOSD). The FDA did not question the efficacy or safety data from the trial but requested modifications to enhance the Ultomiris Risk Evaluation and Mitigation Strategy (REMS). AstraZeneca's shares are down 0.78% in premarket trading.

Portfolio Pulse from Vandana Singh

September 06, 2023 | 11:51 am

AAPL

AMZN

FB

GOOG

MSFT

The European Commission has identified major tech companies including Alphabet Inc. (GOOG), Amazon.com Inc. (AMZN), Apple Inc. (AAPL), Meta Platforms Inc. (FB), and Microsoft Corporation (MSFT) as 'gatekeepers' to be regulated under the new Digital Markets Act (DMA). The DMA aims to limit the market dominance of these companies and requires them to compete based on the merits of their products and services. Companies failing to comply could face fines of up to 10% of their total worldwide turnover.

Portfolio Pulse from Benzinga Neuro

September 06, 2023 | 11:39 am

BBIO

The FDA and European Medicines Agency have indicated that a single, one-year, 2:1 randomized, placebo-controlled trial would be acceptable as a registrational study for BridgeBio Pharma's Infigratinib approval for children with Achondroplasia. The trial is expected to start by the end of 2023.

Portfolio Pulse from Benzinga Newsdesk

September 06, 2023 | 11:36 am