PharmaFocus Today – Page 61 – media

SINOPHARM and University of Macao Joint Laboratory Project Signing Completed

On July 19, 2024, the Matchmaking Meeting and Signing Ceremony of Macao-Qin Science and Technology Industry, Academia and Research Capital was held in Hengqin Guangdong-Macao Deep Cooperation Zone (hereinafter referred to as the “Zone”). For the first time, the event brought together representatives from Macao’s universities, high-quality enterprises and industrial capital to build a high-level platform for matching and exchanges between industry, academia, research and capital. At the scene of the event, 4 Macao universities signed contracts with 16 well-known enterprises and organizations in the industry. Among them, the cooperation between SINOPHARM and the University of Macau Joint Laboratory Project completed the signing. Secretary for Economy and Finance of the Macao Special Administrative Region and Director of the Executive Committee of the Zone, Mr. Li Weinong attended the event and delivered a speech. Xu Jian, Vice President of the University of Macau, Chen Guokai, President of the Institute of Science ...
- Source: drugdu
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- July 31, 2024
FDA Approves Alpha Cognition’s Zunveyl as Oral Therapy for Mild-to-Moderate Alzheimer Disease

July 29, 2024 By Don Tracy, Associate Editor Approval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve tolerability and efficacy in treating Alzheimer disease, company says.The FDA has approved Alpha Cognition’s Zunveyl (benzgalantamine), an oral therapy for treating mild-to-moderate Alzheimer disease (AD). According to the company, the approval marks a significant advancement in the treatment of AD by offering a novel approach with a dual mechanism of action designed to improve tolerability and efficacy. Zunveyl is a prodrug of galantamine, an acetylcholinesterase inhibitor (AChEI), that works by preventing the breakdown of acetylcholine, a crucial neurotransmitter involved in memory and attention. Alpha Cognition stated that Zunveyl functions as an allosteric potentiator, enhancing the release of acetylcholine from presynaptic neurons.1 “I am very excited about the approval of Zunveyl, which we believe offers better tolerability for patients with Alzheimer’s disease. We have always believed in ...
- Source: drugdu
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- July 31, 2024
GSK, Flagship Pioneering Commit $150M to Start R&D Pact for Novel Drugs and Vaccines

Respiratory disease and immunology are the initial focus areas of GSK’s new drug discovery partnership with Flagship Pioneering. A similar Flagship alliance with Pfizer recently announced it is pursuing novel obesity treatments. By Frank VinluanGSK already has a strong presence in respiratory disease and immunology, two of its core therapeutic areas. The pharmaceutical giant is now teaming up with Flagship Pioneering in an alliance intended to discover novel medicines to bolster its pipelines in both disease categories. The deal announced Monday calls for the partners to fund up to $150 million up front for an exploration phase intended to identify concepts that can leverage the technologies of Flagship’s portfolio companies. Flagship forms and incubates startups, each one based on a platform technology that focuses on some aspect of biology. The research stemming from these platforms informs the discovery and development of novel medicines. The best known of these “bioplatform” companies ...
- Source: drugdu
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- July 31, 2024
Dexcom shares plunge on lower sales outlook

Dexcom lowered its sales forecast for 2024, surprising Wall Street as it lost market share among durable medical equipment (DME) providers and restructured its salesforce. Shares of the company were down 41% Friday morning. The diabetes device firm now expects 2024 revenue of $4 billion to $4.05 billion, a decrease from its previous forecast of $4.2 billion to $4.35 billion. “We have higher expectations for our business than what we experienced this quarter,” CEO Kevin Sayer told investors on Thursday, adding that he expects “more from myself and more from my team going forward.” Sayer attributed the lower sales outlook to three factors: a salesforce restructuring, lower revenue per customer due to rebates, and a loss of market share in the durable medical equipment channel. Those dynamics put Dexcom’s U.S. revenue about $40 million below the company’s internal estimates, CFO Jereme Sylvain said. The company also had about 70,000 fewer ...
- Source: drugdu
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- July 30, 2024
New study examines educational disruptions for children

Children with special health care needs (CSHCN) often face significant disruptions in their education due to extended hospitalizations. A recent study published online in Disability and Rehabilitation on July 1, 2024, by a multidisciplinary team of Kessler Foundation and Children Specialized Hospital researchers, highlights critical areas needing attention to ensure smoother school re-entries for CSHCN, ensuring they receive the necessary educational support post-hospitalization. Involving parents, former patients, and rehabilitation professionals, the study underscores the need for better coordination and communication to facilitate seamless transitions back to school for CSHCN. Titled Experiences of patients, parents, and healthcare professionals in the process of transitioning from hospital to community after inpatient pediatric rehabilitation among children with special health care needs (https://doi.org/10.1080/09638288.2024.2362951), the article offers insights into the challenges and solutions for improving school re-entry for CSHCN. Foundation authors are Yu-Lun Chen, PhD, OTR/L; Stephanie Jimenez; Alexa Bartalotta; John O’Neill, PhD; and Amanda L. ...
- Source: drugdu
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- July 30, 2024
Imfinzi with Neoadjuvant Chemotherapy Demonstrates Significant Benefit in Event-Free Survival Treating Resectable Non-Small Cell Lung Cancer

By Don Tracy, Associate Editor FDA’s Oncologic Drugs Advisory Committee acknowledged that Imfinzi met its primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer. The FDA’s Oncologic Drugs Advisory Committee (ODAC) has found that AstraZeneca’s Imfinzi (durvalumab) achieved the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) in the Phase III AEGEAN trial. However, AstraZeneca noted that although the contribution by phase of neoadjuvant and adjuvant components of the perioperative regimen could not be clearly assigned based on the trial design, its potential should not be overlooked. Results of the trial were published in The New England Journal of Medicine. “The majority of patients with resectable lung cancer face recurrence of their disease even after surgery and neoadjuvant chemotherapy. The Committee acknowledged the potential to address this urgent unmet need with durvalumab both before and after surgery, ...
- Source: drugdu
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- July 30, 2024
FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year. By Frank Vinluan Hair loss caused by alopecia areata now has a new FDA-approved treatment, a third-in-class drug from Sun Pharmaceutical Industries that will compete against commercialized medicines from Eli Lilly and Pfizer. The regulatory decision announced Friday for the drug, deuruxolitinib, covers the treatment of adults with severe alopecia areata. Mumbai, India-based Sun Pharma, which has U.S. operations in Princeton, New Jersey, will market the twice-daily pill under the brand name Leqselvi. Alopecia areata is a condition in which the immune system attacks hair follicles, causing sudden hair loss. The disorder affects both males and females. While the hair loss mainly happens on the scalp, the condition can affect other parts of the body. Sun Pharma cites studies estimating that 700,000 ...
- Source: drugdu
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Study suggests targeting amyloid beta production could be promising in AD

A study led by the UK Dementia Research Institute (UK DRI) and University College London (UCL) has suggested targeting amyloid beta production in one cell type in the brain could improve early disease outcomes, with fewer side effects, in Alzheimer’s disease (AD). Published in the journal PLOS Biology, findings suggest that targeting the production of amyloid beta specifically from oligodendrocytes could be a promising therapeutic strategy for treating the neurodegenerative condition. Currently the most common cause of dementia, AD is a progressive, neurodegenerative disease that causes the brain to shrink and brain cells to die. Accumulation of misfolded amyloid beta is recognised as one of the hallmarks of AD, which is believed to be caused by neurons. Researchers aim to test whether oligodendrocytes, a neural cell that produces myelin, the insulating material that surrounds the projections that transfer impulses between neurons, called axons, could produce harmful amyloid beta and whether ...
- Source: drugdu
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KCL study finds cell ageing could reveal early signs of neurodegenerative disease

Researchers from King’s College London (KCL), along with other collaborators, have found that ageing cells could reveal early signs of neurodegenerative diseases, including Alzheimer’s disease or amyotrophic lateral sclerosis. Published in Aging Cell, the findings could provide a wider picture of a target area for drugs and could improve treatments for these types of conditions. Affecting more than one million people in the UK, neurodegenerative conditions, such as multiple sclerosis and Parkinson’s disease, occur when cells of the central nervous system stop working or die. Using fluorescence to measure the viscosity of neuronal cytoplasm, the fluid enclosed by the cell membrane of the neuron, in mice, researchers found that the viscosity of the cytoplasm in the neuron (soma) increased as the mice aged. However, it did not increase in the cytoplasm of the axon, a tail-like structure that transmits electrical and chemical signals to other cells. Researchers suggested that the ...
- Source: drugdu
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- July 30, 2024
Ractigen Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to RAG-18 for the treatment of Duchenne Muscular Dystrophy

SUZHOU, China, July 25, 2024 /PRNewswire/ — Ractigen Therapeutics, a pioneering developer of small activating RNA (saRNA) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to RAG-18, one of the company’s lead saRNA product candidates for the treatment of Duchenne Muscular Dystrophy (DMD). RAG-18 could represent a novel and translatable therapeutic strategy for DMD and Becker Muscular Dystrophy (BMD) caused by any mutation of the DMD gene. The RPDD is granted by the FDA to drugs that treat serious or life-threatening diseases primarily affecting children under 18 years of age with a prevalence of fewer than 200,000 in the United States. If a New Drug Application (NDA) for RAG-18 is approved, Ractigen may be eligible to receive a Priority Review Voucher (PRV), which can be used to expedite the review of a subsequent marketing application for a different product or ...
- Source: drugdu
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