Year: 2021

Endpoint in Line with FDA Guidance on Key Outcomes in High-Risk Patients and with Pharma Industry Drugs Approved for Cardiovascular Risk Reduction in Diabetes Key points:Analysis of pre-specified high-risk groups in the DREAM-HF Phase 3 trial of rexlemestrocel-L in patients with chronic heart failure and low ejection fraction (HFrEF) showed greatest treatment benefit in major adverse cardiovascular events (MACE) of cardiovascular mortality or irreversible morbidity (non-fatal heart attack or stroke) in patients with diabetes and/or myocardial ischemia (72% of total treated population)   This target population is at very high risk for mortality and irreversible morbidity due to micro- and macro-vascular disease despite receiving optimal standard of care therapies 1 Rexlemestrocel-L, added to optimal standard of care therapies, reduced...

— Recruitment of 687 patients globally completed in fifteen months, ahead of schedule — — FRESCO-2 primary objective is to confirm overall clinical benefit seen in the China FRESCO pivotal study1, and to support global registrations — HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Dec. 06, 2021 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that it has completed patient enrollment of FRESCO-2, a Phase III registration study of fruquintinib, an investigational treatment for the treatment of patients with metastatic colorectal cancer (“CRC”) in the U.S., Europe, Japan and Australia. The enrollment goal was reached on December 2, 2021. FRESCO-2 is a randomized, double-blind, placebo-controlled, multicenter trial being conducted in patients with metastatic CRC. The primary...

First and only neutralizing antibody therapy for this age group SHANGHAI, China, Dec. 06, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the United States Food and Drug Administration (the “FDA”) has expanded the emergency use authorization (“EUA”) for etesevimab (JS016/LY-CoV016) and bamlanivimab (LY-CoV555) administered together (the “Therapy”) to include certain high-risk pediatric patients from birth to under 12 years old for the treatment of mild to moderate COVID-19 as well as post-exposure prophylaxis, according to Eli Lilly and Company (“Lilly”), the company’s global partner. The Therapy has been the first and only authorized neutralizing antibody...

A representative of novel MPro inhibitor series, MPI8, dually inhibits MPro and cathepsin L, a key viral entry enzyme, with high potency and selectivity. Other analogs of the series have been evaluated by Sorrento to develop an oral antiviral drug for treatment of patients infected with existing and emerging SARS-CoV-2 variants of concern, including Omicron. A promising candidate of the series with unique features distinguished from SARS-CoV-2 MPro inhibitors published by others has been systematically evaluated and advanced to late stage of pre-clinical phase.SAN DIEGO, Dec. 05, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced the peer-reviewed publication of a series of novel SARS-CoV-2 MPro inhibitors with potent activities for both MPro and cathepsin L, a key host enzyme for...

Bavarian Nordic’s non-adjuvanted COVID-19 vaccine candidate, ABNCoV2 (100μg), demonstrated a strong boosting effect, increasing the existing levels of SARS-CoV-2 neutralizing antibodies against the Wuhan variant by 2-40-fold depending on the initial levels of antibodies The large boosting effect of ABNCoV2 elevated the neutralizing antibodies to levels reported to be highly efficacious (>90%) against SARS-CoV-21 A similar fold increase was observed for all SARS-CoV-2 variants tested (Wuhan, Alpha, Beta and Delta) following the booster vaccination with ABNCoV2 The vaccine was well-tolerated, with no serious adverse events reported These initial results confirm the potential of ABNCoV2 to function as a universal COVID-19 booster vaccine The Company’s management will host a conference call tomorrow at 2 pm CET (8 am EST) to discuss the resultsCOPENHAGEN,...

San Francisco, California, USA., November 30, 2021 – Following its rapid expansion over the past 24 months, US Capital Global now operates from 13 offices in 10 countries. The group’s global presence allows it to provide the best customized financial and investment solutions for its clients, often by breaking through international barriers that have traditionally hampered the industry. The upshot of this expansion across four continents is, of course, increased diversity in its investment officers, support staff, clients, and partners. As a global group serving global clients, US Capital Global prides itself on its diversity. Each of its office locations is driven by a strong team sharing different ethnicities, nationalities, genders, religions, education, and political outlooks, and yet united by a deep-rooted company culture of...

PALM BEACH, Fla., Dec. 04, 2021 (GLOBE NEWSWIRE) — Trump Media & Technology Group Corp. (“TMTG”) and Digital World Acquisition Corp. (Nasdaq: DWAC), today announced that Digital World Acquisition Corp. (“DWAC”) has entered into subscription agreements for $1 billion in committed capital to be received upon consummation of their business combination (the “PIPE”) from a diverse group of institutional investors. President Donald J. Trump, Chairman of TMTG, stated, “$1 billion sends an important message to Big Tech that censorship and political discrimination must end. America is ready for TRUTH Social, a platform that will not discriminate on the basis of political ideology. As our balance sheet expands, TMTG will be in a stronger position to fight back against the tyranny of Big Tech.” Patrick Orlando, Chairman and CEO of Digital...

Steve Muehler, the Managing Member of the Private Placement Markets stated, “given the opportunities being presented to us today in the California Real Estate Market, we formed the ‘SJM Credit and Alternative Mortgage Investment Fund” that focuses on the emerging distressed debt and equity markets, as well as structured credit ventures that include mortgage backed, asset backed, collateralized loan obligations, collateralized debt obligations, mezzanine debt and non-performing real estate loan pools. The ‘SJM Credit and Alternative Mortgage Fund’ is a hybrid model fund which allows us to a creative structure in dealing with both tax and liquidity issues generally associated with a short-term credit investing.”The funds investment objectives are available at www.PPMDebt.com and www.PPMEquity.com.The portfolio of Private Placement Companies...

Credgenics, a first-of-its kind debt resolution platform, has recently expanded its leadership team, soon after its $25Mn Series-A fundraise. Sandeep Dinodiya, a 11-year veteran in technology and product, having built global systems for unicorns and MNCs like OYO, Lenskart and Cisco, has joined as Head of Engineering. Sanchit Dayal, an ex-Investment analyst with WestBridge Capital, has joined as the new Chief of Staff. Yash Dabriwal, a former management consultant at McKinsey is onboard as Head of Growth and Strategic Initiatives to drive overall company strategy and steer global expansion. Ramashis Biswas, having previously scaled HR teams at 91springboard & Shuttl is the new Head of HR & Admin. Ashish Mittal, with deep experience in customer lifecycle journey through his stints with Adobe, Sprinklr and Moser Baer is onboard...