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HuidaGene Announces Rare Pediatric Drug Designation Granted to HG302, A Novel CRISPR DNA-editing Therapy, for the Treatment of Duchenne Muscular Dystrophy

SHANGHAI and CLINTON (NJ), December 19, 2023 – HuidaGene Therapeutics (辉大基因“HuidaGene”) today announced the U.S. FDA granted Rare Pediatric Drug Designation (RPDD) to HG302, a novel CRISPR-Cas12 DNA-editing therapy, to treat Duchenne muscular dystrophy (DMD), affecting 1 in ~5,000 newborn boys. Unlike the in-vivo use of Cas9 system with limited genome-editing efficiency, high occurrence of off-targeting modifications, viral delivery packaging limitations, and complicated CRISPR-Cas9 patent dispute, HuidaGene identified novel Cas12i proteins using AI and deep machine-learning of DNA sequencing through the proprietary HG-PRECISE® platform to develop high-fidelity Cas12i variant (hfCas12Max®). This hfCas12Max® is smaller in size than Cas9, thereby packaging it using one viral vector with the lowest off-targeting activity and highest editing efficiency in mammalian cells when compared to SpCas9 and LbCas12a. Furthermore, Cas12i was granted a patent by USPTO with a cleaner commercial landscape. “This is Company’s third program receiving RPDD, suggesting the recognition of the importance of ...
- Source: drugdu
- 148
- December 26, 2023
Anke Biotechnology’s Joint Venture Company, Yuan Song Biotechnology, Receives FDA Approval for the First Oncolytic Virus National Class I New Drug IND Application

According to the announcement from Anke Biotechnology’s joint venture company, Yuan Song Biotechnology: Shanghai Yuan Song Biotechnology Co., Ltd. (hereinafter referred to as “Yuan Song Biotech”) announced that its independently developed oncolytic virus anticancer drug, “Recombinant L-IFN Adenovirus Injection,” obtained the Investigational New Drug (IND) approval from the United States Food and Drug Administration (FDA) on December 21, 2023. Dr. Zhang Kangjian, Co-founder and General Manager of Yuan Song Biotech, stated that the successful completion of the IND in the United States is a significant milestone for Yuan Song Biotech, a company dedicated to the development of oncolytic virus anticancer clinical drugs. This achievement not only validates our research and development strategy and technological platform for industrialization but also demonstrates Yuan Song Biotech’s clinical development capabilities in the field of targeted gene-virus therapy. This includes oncolytic adenovirus process development, quality method research, high-quality preclinical studies, and clinical research. With the ...
- Source: drugdu
- 175
- December 26, 2023
Henlius Passes Its Second EU GMP Inspection

Shanghai, China, December 22, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that the company has received the European Union (EU) GMP Certificates (Certificates of GMP Compliance of a Manufacturer) for the production lines of anti-PD-1 mAb HANSIZHUANG (serplulimab) from Netherlands’ health supervision agency Health and Youth Care Inspectorate, marking that the company’s Xuhui Facility and Songjiang First Plant have successfully passed the EU GMP on-site inspection for HANSIZHUANG and meet the EU GMP standards. The inspection success, as well as the previous certification by the EU GMP for Henlius’ self-developed trastuzumab HANQUYOU in 2020, confirms the company’s longstanding reputation in maintaining quality systems fully compliant with the highest international standards. The inspection-related product HANSIZHUANG is the first anti-PD-1 therapy approved for first-line treatment of small-cell lung cancer (SCLC). At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), ...
- Source: drugdu
- 97
- December 26, 2023
The AI Tool that Matters Most for Clinical Care Isn’t ChatGPT

The excitement for artificial intelligence (AI) use cases in healthcare—especially those involving generative AI and ChatGPT—is palpable, with experts predicting generative AI could help unlock $1 trillion in healthcare savings. However the AI solution that holds the strongest potential to strengthen care outcomes and health equity isn’t the one healthcare leaders think of first. Instead, right-now value could come from extractive AI. It’s a tool that gives organizations the power to put even handwritten text sent via images or PDF by digital fax into a structured data play. It’s also a practical solution for advancing data interoperability without a heavy technology lift to include healthcare’s “digital have-nots,” like post-acute care facilities and health clinics. A powerful lever for improving health equity A healthcare organization’s ability to support total care, especially for our nation’s most vulnerable patient populations, depends on access to data that enables a 360-degree view of the patient’s ...
- Source: drugdu
- 112
- December 25, 2023
Previously unrecognized class of antibodies can broadly neutralize multiple virus strains

Researchers have identified a previously unrecognized class of antibodies-;immune system proteins that protect against disease-;that appear capable of neutralizing multiple forms of flu virus. These findings, which could contribute to development of more broadly protective flu vaccines, will publish December 21st by Holly Simmons of the University of Pittsburgh School of Medicine, US, and colleagues in the open access journal PLOS Biology. A flu vaccine prompts the immune system to make antibodies that can bind to a viral protein called hemagglutinin on the outside of an invading flu virus, blocking it from entering a person’s cells. Different antibodies bind to different parts of hemagglutinin in different ways, and hemagglutinin itself evolves over time, resulting in the emergence of new flu strains that can evade old antibodies. New flu vaccines are offered each year based on predictions of whatever the most dominant strains will be. Extensive research efforts are paving the ...
- Source: drugdu
- 211
- December 25, 2023
FDA Approves Expanded Indication for LEO Pharma’s Adbry for Pediatric Patients With Atopic Dermatitis

Pharmaceutical Executive Editorial Staff Indication of Adbry (tralokinumab-ldrm) expanded to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable. The FDA has approved an expanded indication for LEO Pharma’s Adbry (tralokinumab-ldrm) for patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable. Adbry is a human immunoglobulin G4 monoclonal antibody that specifically binds to human interleukin (IL)-13 and inhibits its interaction with the IL-13 receptor α1 and α2 subunits. Adbry is the first and only biologic FDA-approved for this indication. “This is an important milestone on our path towards making a fundamental difference for those who need it most. This critical patient group now has access to a much-needed ...
- Source: drugdu
- 146
- December 25, 2023
Merck’s 21-Valent Pneumococcal Conjugate Vaccine Granted FDA Priority Review

Pharmaceutical Executive Editorial Staff Merck’s Biologics License Application for V116, a novel 21-valent pneumococcal conjugate vaccine has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. The FDA has granted priority review to Merck’s Biologics License Application (BLA) for V116, a novel 21-valent pneumococcal conjugate vaccine developed as a single dose for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. The BLA has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. “Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a press release. “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed ...
- Source: drugdu
- 130
- December 25, 2023
Glass specialist Schott Pharma touts 2023 sales growth, Serbia expansion and hiring plans

Following an IPO and ahead of its fiscal 2023 earnings release next month, German drug containment and delivery specialist Schott Pharma is trumpeting its recent momentum. Over the course of its 2023 fiscal year, Schott Pharma charted a 9% year-over-year revenue boost to €899 million (about $986 million), the company said Tuesday. For comparison, the company pulled down €821 million in fiscal year 2022. Schott credited the gains to the expansion of its production capabilities, especially as they pertain to drug delivery systems and new production lines for prefillable polymer syringes in Germany. Schott partners with a range of drugmakers in the biopharma industry. The company and its products are involved in several significant trends, such as the GLP-1 treatments from Novo Nordisk and Eli Lilly, plus mRNA vaccines from Moderna. Schott’s revenue win comes more than a year after the company set out on its own. Back in August ...
- Source: drugdu
- 128
- December 25, 2023
Deerfield Agency names Sam Cannizzaro as first chief creative officer

Deerfield Agency has named its first chief creative officer. Sam Cannizzaro has ended a two-year stint at Elevate Healthcare Marketing to take up the position at a fast-growing agency that is carving out a niche serving small to midsize pharmaceutical companies. Pennsylvania-based Deerfield is a full-service agency specializing in healthcare. Last year, the acquisition of Verge Scientific, a company that supports brand strategy and public relations, helped the agency to grow its sales by 40% and increase its headcount from 88 to 141. Deerfield has navigated its rise without a chief creative officer. Now, Deerfield is filling that gap by hiring Cannizzaro, a person whose CV features highlights related to the initiation of omnichannel campaigns, work on telehealth solutions and immersive technologies, use of voice-based health assistants and launch of AstraZeneca’s first digital detailing solutions. In a statement, Frank Burrell, managing partner at Deerfield, said Cannizzaro will “lead creative visioning ...
- Source: drugdu
- 145
- December 25, 2023
Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F

Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in rSLE, aiming for deeper and wider depletion of disease-causing antibody secreting cells and B-cells FasTCAR-T GC012F has demonstrated a favorable safety profile in clinical investigator-initiated trials in 60 patients with multiple myeloma and B-cell non-Hodgkin lymphoma SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 21, 2023 (GLOBE NEWSWIRE) — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has cleared Gracell’s Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus (rSLE). Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate ...
- Source: drugdu
- 82
- December 25, 2023

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