Streetbeat News

Regulatory

DARE

Daré Bioscience has received FDA clearance for its Investigational New Drug (IND) application for DARE-VVA1, a product aimed at treating vulvar and vaginal atrophy (VVA). This regulatory milestone allows Daré Bioscience to proceed with clinical trials, which is a critical step in the development and potential commercialization of DARE-VVA1. The FDA's clearance is a positive sign for the company's pipeline and could potentially lead to future revenue streams if the product successfully passes clinical trials and receives market approval.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 1:02 pm

AAPL

GOOG

GOOGL

Apple Inc. (AAPL) has updated its Legal Process Guidelines to include data from push notifications in response to law enforcement requests. This change was prompted by concerns raised by Senator Ron Wyden about governments using notification data for surveillance. The guidelines now outline how Apple must provide Apple ID information associated with its notification service when legally ordered. Alphabet Inc. (GOOG, GOOGL) was also mentioned as having received similar requests from governments.

Portfolio Pulse from Benzinga Neuro

December 07, 2023 | 12:39 pm

AZN

BMY

The Biden administration is considering using 'march-in rights' to seize patents for high-cost medications developed with federal funding. A new framework by the Commerce Department will outline criteria for such actions, focusing on drug pricing and public accessibility. Pharmaceutical companies oppose this, claiming it's illegal and could hinder new drug development. AstraZeneca, Bristol Myers Squibb, and Boehringer Ingelheim, despite lawsuits against the administration's drug pricing policies, are open to Medicare price negotiations.

Portfolio Pulse from Vandana Singh

December 07, 2023 | 12:33 pm

SYBX

Synlogic has announced that an abstract detailing their SYNB1353 program, aimed at treating Homocystinuria, has been accepted for presentation at the International Conference on Microbiome Engineering 2023 in Berkeley.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 12:26 pm

ALTR

Altair, in collaboration with Jaguar Land Rover (JLR) and battery manufacturer Danecca, announced receiving funding from the UK government to develop a new design process for electric vehicles. This initiative is part of a broader effort to advance the EV sector in the UK and could potentially lead to innovations in vehicle design and battery technology.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 12:10 pm

BDX

Becton, Dickinson and Company (BDX) has obtained FDA 510(k) clearances for a new blood collection device designed for fingerstick blood samples that can deliver lab-quality results for commonly ordered blood tests.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 11:52 am

ESMT

EngageSmart announced that the waiting period under the HSR Act for its merger with Icefall expired on December 6, 2023, at 11:59 PM Eastern Time, as per an 8-K filing. This expiration is a step forward in the merger process, indicating that the deal has cleared a significant regulatory hurdle.

Portfolio Pulse from Charles Gross

December 07, 2023 | 11:44 am

GOOGL

The European Union is nearing a deal to regulate AI technologies, including those like ChatGPT and Google Bard. The agreement, involving the European Commission, Parliament, and member states, will establish a control framework for AI tools. The AI Act will require developers to document training models, summarize copyrighted material, and label AI-generated content. Systems posing systemic risks will need to follow an industry code of conduct and report incidents. Google (NASDAQ:GOOGL) is directly mentioned as one of the companies developing such AI technologies.

Portfolio Pulse from Benzinga Neuro

December 07, 2023 | 11:37 am

AAPL

AMZN

GOOG

GOOGL

META

MSFT

Beeper Mini, a messaging app, is planning to integrate iMessage, SMS, RCS, WhatsApp, and Signal, aligning with the EU's Digital Markets Act for interoperability between messaging services. Meta Platforms Inc. (META), Microsoft Corp. (MSFT), Amazon.com Inc. (AMZN), Apple Inc. (AAPL), and Alphabet Inc. (GOOG, GOOGL) are mentioned as major players in the messaging space, with Apple recently announcing RCS support for iPhones under pressure from Google and the EU.

Portfolio Pulse from Rounak Jain

December 07, 2023 | 11:34 am

LEV

The Lion Electric Company announced that its LionBattery MD, designed for medium-duty trucks and school buses, has received final certification. This milestone could enhance the company's product offerings and market competitiveness.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 11:32 am