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Regulatory

ALVO

Alvotech (NASDAQ:ALVO) announced positive top-line results from a pharmacokinetic study for AVT03, a proposed biosimilar for Prolia and Xgeva. The study met its primary endpoints, demonstrating pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia in healthy adults. Further studies, including a confirmatory efficacy study and a PK study comparing AVT03 to Xgeva, are in progress.

Portfolio Pulse from Benzinga Newsdesk

January 29, 2024 | 9:02 am

BABA

BIDU

XIACF

China has approved over 40 AI models for public use in the last six months, aiming to compete with U.S. AI development. The approval process, introduced in August, has seen companies like Xiaomi, 4Paradigm, and 01.AI benefit from the endorsement of 14 large language models. Baidu, Alibaba, and ByteDance were among the first to receive approval. Despite the AI push, there hasn't been a significant increase in cloud services spending in China. Concerns over AI misuse for espionage have been raised by the FBI. Baidu's Ernie Bot reached 100 million users in December.

Portfolio Pulse from Benzinga Neuro

January 29, 2024 | 8:41 am

TM

Toyota Motor Corp (NYSE:TM) is suspending shipments of 10 vehicle models due to certification irregularities with diesel engines supplied by Toyota Industries Corporation (TICO). The issue was identified during horsepower output testing for three diesel engine models, affecting global models such as Land Cruiser 300, Hilux, and Fortuner.

Portfolio Pulse from Anan Ashraf

January 29, 2024 | 7:40 am

TAK

The European Commission has approved Takeda's HYQVIA as a maintenance therapy for patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). HYQVIA is the only facilitated subcutaneous immunoglobulin therapy that offers a once-monthly treatment option, which can be administered at home or in-office. This approval enhances Takeda's portfolio of immunoglobulin therapies for neuroimmunological disorders.

Portfolio Pulse from Benzinga Newsdesk

January 29, 2024 | 7:21 am

AZN

DSNKY

The FDA has accepted and granted priority review for Daiichi Sankyo and AstraZeneca's supplemental Biologics License Application for ENHERTU to treat metastatic HER2 positive solid tumors. The application is supported by results from the DESTINY-PanTumor02 trial and additional ENHERTU data. The review will be conducted under the FDA's Real Time Oncology Review and Project Orbis, and if approved, ENHERTU could become the first HER2 directed treatment and antibody drug conjugate with a tumor agnostic indication.

Portfolio Pulse from Benzinga Newsdesk

January 29, 2024 | 7:19 am

BTCUSD

Robert F. Kennedy Jr., considering a presidential bid as a Libertarian, has joined Donald Trump in opposing central bank digital currencies (CBDCs). Kennedy Jr. has pledged to protect cryptocurrencies like Bitcoin and ensure transaction security, citing concerns over government surveillance and control. Trump, advised by Vivek Ramaswamy, has also promised to prevent federal control of finances through a CBDC. The Federal Reserve, however, has not made any concrete plans for a digital dollar, with a decision still years away.

Portfolio Pulse from Mehab Qureshi

January 29, 2024 | 5:21 am

AER

AL

BA

The aviation finance community is meeting in Dublin to discuss the impact of the Boeing 737 MAX 9 safety crisis on the $150 billion jet industry. This follows a recent in-flight incident with an Alaska Airlines 737 MAX 9, which led to an emergency landing due to a door plug blowout. The Federal Aviation Administration has halted any increase in 737 MAX production until Boeing addresses quality control issues. This could slow production, benefit leasing companies with increased returns, and raise lease rates for airlines. Key industry players like AerCap, SMBC Aviation Capital, Air Lease, and Avolon are in focus as the situation develops.

Portfolio Pulse from Benzinga Neuro

January 29, 2024 | 4:55 am

AMZN

GOOG

GOOGL

MSFT

The U.S. government has requested cloud service providers, including Amazon (AMZN), Alphabet (GOOG, GOOGL), and Microsoft (MSFT), to disclose foreign clients using their AI services, amid concerns over China's potential misuse of AI for espionage. This proposal could impact Chinese companies' access to AI resources and raises concerns about U.S. firms' competitiveness if allies don't implement similar measures. The industry has until April 29 to provide feedback before the rule is finalized.

Portfolio Pulse from Ananya Gairola

January 29, 2024 | 3:45 am

FBTC

IBIT

Bitcoin showed a steady upward trend over the weekend, with inflows into Bitcoin ETFs like BlackRock's iShares Bitcoin Trust (IBIT) surpassing $2 billion in AUM. Google is set to allow Bitcoin ETF ads, potentially increasing exposure. Analysts predict Bitcoin could reach $300,000-$500,000 in the future, while Ethereum may face a correction below $1,000. U.S. stock futures declined ahead of tech earnings reports and the Federal Reserve's rate policy decision.

Portfolio Pulse from Mehab Qureshi

January 29, 2024 | 3:03 am