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IOBT

MRK

IO Biotech has reached a significant milestone by randomizing 225 patients in its global Phase 3 clinical trial for IO102-IO103, in combination with Merck's pembrolizumab, for advanced melanoma patients. The trial protocol calls for an interim analysis of overall response rate one year after 225 patients have been enrolled. If positive, this could lead to accelerated approval in the US.

Portfolio Pulse from Happy Mohamed

June 14, 2023 | 12:01 pm

AMRX

Amneal Pharmaceuticals has secured FDA approval for PEMRYDI RTU, a ready-to-use oncology injectable. The product is the first of its kind and does not require reconstitution, dilution, or refrigeration. It will be available in three vial sizes and is expected to launch in Q1 2024.

Portfolio Pulse from Benzinga Newsdesk

June 14, 2023 | 12:01 pm

AAPL

AMZN

Apple's Watch Series 8 is now available at a $70 discount on Amazon, with prices starting at $329. The discount applies to both 41mm and 45mm models across all four colors.

Portfolio Pulse from Rounak Jain

June 14, 2023 | 12:00 pm

V

Visa has launched the Visa Africa Fintech Accelerator Program to support the growing start-up community in Africa. The program aims to provide resources, mentorship, and access to Visa's global network for fintech start-ups in the region.

Portfolio Pulse from Benzinga Newsdesk

June 14, 2023 | 11:38 am

BWV

Blue Water Biotech acquires six FDA-approved drugs from WraSer and Xspire Pharma for $8.5 million, expanding its product portfolio across various treatments.

Portfolio Pulse from Benzinga Newsdesk

June 14, 2023 | 11:35 am

NLSP

NLS Pharmaceutics announced positive safety data from in vitro CYP450 and transporter-mediated drug-drug interaction studies of Mazindol, showing a low risk for drug-drug interaction.

Portfolio Pulse from Benzinga Newsdesk

June 14, 2023 | 11:34 am

SRDX

The FDA has granted 510(k) clearance to Surmodics' Pounce Low Profile Thrombectomy System for non-surgical removal of thrombi and emboli from peripheral arterial vasculature in vessels 2mm-4mm in diameter, typically found below the knee.

Portfolio Pulse from Benzinga Newsdesk

June 14, 2023 | 11:33 am

HCWB

HCW Biologics has been granted a patent containing methods of use claims for administering HCW9218 to treat cancer. This development could potentially lead to new cancer treatment options.

Portfolio Pulse from Benzinga Newsdesk

June 14, 2023 | 11:33 am

APYX

Apyx Medical Corporation has received FDA 510(k) clearance for its Renuvion Micro Handpiece, a device used in minimally invasive cosmetic procedures. This approval will allow the company to expand its product offerings in the aesthetics market.

Portfolio Pulse from Benzinga Newsdesk

June 14, 2023 | 11:32 am

IVA

Inventiva SA (NASDAQ:IVA) announced positive topline results of a Phase 2 clinical study evaluating lanifibranor in patients with NAFLD and type 2 diabetes mellitus. The study achieved the primary efficacy endpoint with a 44% reduction of Intra Hepatic Triglycerides and met multiple secondary metabolic endpoints. IVA shares are up 26.40% at $4.64 during the premarket session.

Portfolio Pulse from Vandana Singh

June 14, 2023 | 11:30 am