News

Shenzhen Salubris commits additional funding to continue research and development of novel, complex biologics

First patient enrolled in RENEU-HF, the Phase 2 clinical trial of JK07 in heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF)

Clinical trial application filed for JK06, SalubrisBio’s first-in-class biparatopic ADC

April 22, 2024 07:00 AM Eastern Daylight Time
GAITHERSBURG, Md.–(BUSINESS WIRE)–Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced a new capital infusion of $35 million to fund continued research and development of clinical and pre-clinical programs. SalubrisBio also provided progress updates for JK07, the first investigational antibody fusion protein for heart failure, JK08, the first investigational IL15-CTLA4 antibody fusion for solid tumors and JK06, a first-in-class biparatopic antibody-drug conjugate (ADC) targeting a known tumor antigen.

Pioneering Move Unites Medical and Pharmacy Benefits, Enhancing Access, Affordability, and Adherence for Specialty Medications and Procedures

ROCKVILLE, Md., April 18, 2024 /PRNewswire/ — Healthcare technology pioneer DrFirst today announced it has acquired substantially all assets of Myndshft Technologies, Inc., a leader of end-to-end real-time medical benefits and automated prior authorization (PA) software-as-a-service (SaaS). This strategic acquisition aims to improve the patient experience and expedite access to vital specialty medications, such as infusions and in-office injectables primarily covered by medical benefits. Combined with DrFirst’s platform and scale, the technology will also lighten the substantial administrative load on healthcare providers and their staff.

Founded in 2018, Myndshft is the only unified platform that streamlines prior authorization and related services for both medical and pharmacy benefits. This innovative technology uses AI, machine learning, and robotic process automation (RPA) to automate and streamline complex benefits, pricing, and PA processes across various payers and therapeutic classes into one seamless, intuitive workflow. The Myndshft platform also supports labs, imaging, and other procedures covered under medical benefits, which are often prerequisites for patients prescribed specialty medications.

April 18, 2024
For Global Investor Audience Only

Novavax’s Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) is now available to pharmacies across the United Kingdom (U.K.) for private healthcare providers to offer an updated protein-based non-mRNA option as part of the 2024 vaccination season.

Today is an important milestone for our organization. It demonstrates our commitment to deliver an updated protein-based COVID-19 vaccine as we evolve into an endemic market. It also underscores our place as a long-term partner to public health. We believe a diverse vaccine portfolio and broader access can play vital roles in protecting communities in the U.K. and elsewhere.

Multi-institute clinical trial demonstrates therapy can be safely used in pediatric regional centers

WASHINGTON, April 18, 2024 (GLOBE NEWSWIRE) — In a first-of-its-kind clinical trial, researchers found that intravenous therapies made from virus-specific T-cells (VST) can effectively treat immunocompromised pediatric patients, far surpassing the current standard of care, according to new research published in Nature Communications.

More than 60% of patients in the phase 2 clinical trial led by investigators from Children’s National Hospital and Huntsman Cancer Institute responded to the innovative VST therapy. This new treatment uses blood from healthy donors to manufacture a highly specialized immune therapy that, when given to immune-compromised patients, prompts their immune system to fight off potentially life-threatening viruses, including cytomegalovirus, Epstein-Barr and adenovirus. Without this therapy, estimates suggest that less than 30% of patients would recover, using standard protocols.

OXFORD, United Kingdom, April 18, 2024 (GLOBE NEWSWIRE) — Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer, today announced topline final data from the APOLLO trial (also known as HPV001), a completed randomized, placebo-controlled Phase 1b/2 dose-ranging trial of VTP-200 in women with low-grade cervical lesions associated with persistent hrHPV infection.

“This was our first in-human, dose-ranging trial of VTP-200 in women with hrHPV-associated low-grade cervical lesions, who currently don’t have any treatment option until progression to high-grade lesions,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “While we didn’t observe a significant improvement from VTP-200 in the overall pooled results, we did observe positive trends in the highest dose cohorts.”

By Rebekka Spiller – For inventor and CEO Sue Carr, tenacity and determination drive success. The founder of CarrTech Corp. says that challenges helped her envision a revolutionary innovation in health care: the FROG ® needle.

FROG ® stands for Filter Removal of Glass and is the only all-in-one needle designed to filter out glass shards from ampoules prior to administering medication to patients. It offers three main purposes: to ensure that practitioners do not bypass the filtering process, to reduce needle prick injuries and to save time in emergency situations.

Carr’s journey was initiated after deciding to transition from her longtime role as hometown pharmacist to clinical pharmacist for hospitals. After spending time working alongside various doctors and nurses, she noticed a concerning trend.

BY ERIC SCHMIDTAPRIL 16, 2024 4:20 PM EDT
Schmidt, Commissioner, National Security Commission on Emerging Biotechnology; Co-founder with his wife Wendy, Schmidt Sciences; Former CEO & Chairman, Google

Imagine a world where everything from plastics to concrete is produced from biomass. Personalized cell and gene therapies prevent pandemics and treat previously incurable genetic diseases. Meat is lab-grown; enhanced nutrient grains are climate-resistant. This is what the future could look like in the years ahead.

The next big game-changing revolution is in biology. It will allow us to more effectively fight disease, feed the planet, generate energy, and capture carbon. Already we’re on the cusp of these opportunities. Last year saw some important milestones: the U.S. approved the production and sale of lab-grown meat for the first time; Google DeepMind’s AI predicted structures of over 2 million new materials, which can potentially be used for chips and batteries; Casgevy became the first approved commercial gene-editing treatment using CRISPR. If I were a young person today, biology would truly be one of the most fascinating things to study.

Joel Marcus, the longtime head of Alexandria Real Estate Equities, sees few near-term challengers to the established biotech hubs of Boston, San Diego and San Francisco.

Joel Marcus built a real estate empire on the life sciences industry’s steady growth. Over three decades, his company Alexandria Real Estate Equities has amassed tens of millions of square feet of office and laboratory space in drug development hubs like Boston, San Diego and the San Francisco Bay Area.

Those holdings have given Alexandria a front row seat to biotech’s boom over much of the past decade through to the sector’s pandemic highs and more recent downturn.

[4/15/2024] Today, FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.

“CDER’s long-standing efforts to embed innovation in clinical trial design and conduct into our regulatory work have been crucial in bringing new therapies to areas of unmet medical need,” said Patrizia Cavazzoni, M.D., director of CDER. “We are eager to build on this foundation by launching C3TI to further spur the adoption of clinical trial innovation across industry and within CDER.”

2024 may well become the year of the bootstrapped founder.

The startup “mass extinction event” that doomsayers have predicted for two years is likely to ramp up in 2024. New founders facing a brutal funding environment may instead opt to bootstrap their growth.

Over 55,000 VC-backed companies are operating in the US right now, according to the latest PitchBook-NVCA Venture Monitor. Many of them are aggressively competing for funding in a slow dealmaking landscape.

At the same time, over 2,000 VC firms effectively halted making new investments in startups in the first nine months of 2023. Approximately 3,200 startups failed in 2023, and there’s even a burgeoning industry dedicated to helping founders wind down their companies.