Search Results for “FDA” – Page 109 – media

ViiV Healthcare Reveals Positive Results from Phase I Trial for a Potential Longer-Acting HIV Treatment

Don Tracy, Associate Editor Novel formulation of cabotegravir (CAB-ULA) allows for dosing intervals of at least four months.Image Credit: Adobe Stock Images/alexskopjeViiV Healthcare has announced promising results from a Phase I study on a new formulation of cabotegravir (Apretude), known as cabotegravir ultra long-acting (CAB-ULA) for HIV pre-exposure prophylaxis (PrEP). Findings suggested that CAB-ULA is well-tolerated and has a pharmacokinetic profile supportive of extended dosing intervals. According to a company press release, the formulation allows dosing intervals of four months, resulting in a reduction of clinical visits for HIV patients.1 “The HIV community has told us of their desire for longer-acting medicines that can help alleviate the burden of daily treatment,” said Kimberly Smith, MD, MPH, head of research and development, ViiV Healthcare, in the press release. “ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the ...
- Source: drugdu
- 76
- March 8, 2024
Henlius’ Trastuzumab Plots Southeast Asia Expansion, to Enter Thailand and Philippines

Recently, Henlius’ self-developed and manufactured HANQUYOU (trastuzumab, trade names: Zercepac® in Europe, Tuzucip® and Trastucip® in Australia) has been approved for marketing in Thailand and the Philippines under the trade names of TRAZHER® and Hertumab®, respectively, for the treatment of HER2-positive breast cancer and gastric cancer. Up to now, HANQUYOU has been successfully approved in Southeast Asian countries, including Singapore and Cambodia, and in a total of more than 40 countries and regions. Breast cancer is the most prevalent malignancy in Southeast Asia, with nearly 170,000 new cases of breast cancer in the region in 2022. About 15% to 20% of breast tumours are HER2-positive breast cancers. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers, and has been included as a ...
- Source: drugdu
- 127
- March 8, 2024
Lundbeck Pharmaceuticals’ “Anti-Parkinson’s Category 1 Chemical Drug” Submits Clinical Application in China

March 4), according to the CDE official website, Lundbeck’s clinical trial application for Class 1 chemical drug Lu AF28996 capsules has been accepted. Currently, the drug is undergoing Phase I clinical trials overseas. Parkinson’s disease is a neurological dysfunction disease with complex symptoms and difficult early diagnosis. It is common in middle-aged and elderly people. At present, the main treatment for Parkinson’s disease is drug therapy, with the purpose of reducing symptoms, delaying the progression, and improving the patient’s quality of life. Lu AF28996 is a dopamine D1/D2 receptor agonist developed by Lundbeck Pharmaceuticals. It is a relatively new anti-Parkinson therapy and is currently undergoing Phase I clinical trials overseas. Among them, a study to evaluate the safety, tolerability, etc. of Lu AF28996 in Parkinson’s patients is expected to be completed in 2025. This time, the approval of Lu AF28996’s clinical trial application in China is expected to bring a ...
- Source: drugdu
- 153
- March 7, 2024
WHO issues guidance to improve access to hearing care in low- and middle-income settings

For World Hearing Day, marked on 3 March, the World Health Organization (WHO) has released new technical guidance on hearing aid service delivery approaches for low- and middle-income settings. This document is designed to provide practical guidance to countries in developing hearing aid services in areas that lack human resources for assessing hearing, as well as fitting and maintaining hearing aids. The guidance, developed with support from the ATScale Global Partnership for Assistive Technology, is based on the principle of task sharing among specialists and trained non-specialists. It includes two approaches, one targeting adults and the other for children 5 years and over, and is accompanied by resources with tips for healthy ear care practices, use of hearing aids and how to support people living with hearing loss. “Over 400 million people with hearing loss could benefit from using hearing devices. However, less than 20% of these needs are fulfilled,” ...
- Source: drugdu
- 66
- March 6, 2024
Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval. P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. Tumor regression was achieved in multiple cancer models covering various ...
- Source: drugdu
- 149
- March 5, 2024
Pfizer’s Bivalent Respiratory Syncytial Virus Vaccine Shows Promising Efficacy Across Two Seasons

Davy James Abrysvo was found to produce durable efficacy against respiratory syncytial virus across two seasons in adults 60 years of age and older. Top-line data from the ongoing, pivotal Phase III RENOIR clinical trial (NCT05035212) demonstrated that Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo produces durable efficacy against respiratory syncytial virus (RSV) across two seasons in adults 60 years of age and older. Efficacy against RSV-associated lower respiratory tract disease (LRTD), defined as three or more symptoms, was 88.9% after the first season, whereas efficacy was 77.8% after the second season.1 “We are encouraged by the level of protection that we observed after two full RSV seasons for Abrysvo,” Annaliesa Anderson, PhD, Pfizer senior vice president and chief scientific officer, Vaccine Research and Development, said in a press release. “This new data indicate that broad and durable protection against both types of RSV that cause ...
- Source: drugdu
- 151
- March 4, 2024
AstraZeneca’s “CD19/CD3 dual antibody” receives clinical approval in China

According to the CDE official website, AstraZeneca’s Class 1 therapeutic biological product AZD0486 has obtained implicit approval for clinical trials and is intended to be used to treat relapsed or refractory B-cell acute lymphoblastic leukemia. AZD0486 (TNB-486) is a new, fully human CD19xCD3 IgG4 bispecific antibody, originally developed by TeneoTwo. In 2022, AstraZeneca acquired TeneoTwo for US$1.265 billion and also obtained its clinical-stage drug TNB-486. According to public information, AZD0486 can bind to CD19 on the surface of B lymphocytes and CD3 receptors on the surface of T lymphocytes, thereby initiating the immune response of T lymphocytes. A Phase I clinical study (NCT04594642) published in the journal “OncLive” in August 2023 showed that AZD0486 has a durable tumor inhibitory effect on relapsed/refractory follicular lymphoma, regardless of the expression level of CD20, and it is also independent of the type and dosage of existing drugs. Currently, AZD0486 has entered the Phase ...
- Source: drugdu
- 92
- March 2, 2024
【EXPERT Q&A】How to apply for Biologics License Application (BLA)?

Drugdu.com expert’s response: The Biologics License Application (BLA) is a licensing application for biologic products, typically managed and approved by the United States Food and Drug Administration (FDA). BLA submission is required to obtain approval for the sale of biologic products in the U.S. market. The following are the key aspects to consider and the required documents for BLA submission: 1.Clinical Trial Data: Detailed clinical trial data must be provided in the BLA submission, including study design, trial results, safety, and efficacy data. These data should adhere to FDA’s requirements for clinical trial design and reporting. 2.Product Quality Control: Information on product quality control, including manufacturing processes, quality control methods, stability data, etc., needs to be provided. These data ensure that the manufacturing process and quality of the product comply with FDA requirements. 3.Nonclinical Data: Relevant nonclinical data, such as animal model studies, toxicology data, etc., should be provided to assess ...
- Source: drugdu
- 143
- February 29, 2024
Alzheimer’s Blood Test Could Soon Replace Invasive Spinal Taps and Brain Scans

Historically, Alzheimer’s disease was primarily diagnosed based on observable symptoms, particularly when individuals started exhibiting memory and cognitive difficulties. However, it’s been revealed through research that up to a third of individuals diagnosed with Alzheimer’s based solely on cognitive symptoms have been incorrectly diagnosed, with their symptoms stemming from other causes. The accurate identification of Alzheimer’s disease has become increasingly crucial, especially since the introduction of the first treatments that can slow the disease’s progression, along with other promising drugs currently in development. These treatments are potentially more effective when administered early, highlighting the need for early detection of the disease. Therefore, to qualify for Alzheimer’s therapies, patients must show cognitive impairment and test positive for amyloid plaques, which are distinctive to Alzheimer’s. Techniques like amyloid positron emission tomography (PET) brain scans, cerebrospinal fluid analyses, and blood tests are used to detect brain amyloid plaques. However, these are only employed ...
- Source: drugdu
- 156
- February 28, 2024
Teva, Jiangsu Nhwa Ink Strategic Partnership Deal Focused on Patient Access to Austedo in China

Don Tracy, Associate Editor Collaboration aims to leverage Nhwa’s expertise in the country’s neuro-psychiatric health sector. Today, Teva announced that it has entered into a collaboration with Nhwa Pharmaceutical Co., Ltd with the goal of providing easier access to Teva’s drug Austedo in China. Austedo focuses on the treatment of neurodegenerative and movement disorders, particularly chorea associated with Huntington disease (HD) and tardive dyskinesia (TD) in adults. According to Teva, the partnership is a part of its goal of expanding the medication as a global brand, as it earned approximately over $1.2 billion in profits last year. Further, Teva reported that Austedo is the first deuterated drug to be approved in China. Deuteration involves replacing hydrogen atoms with deuterium, which can slow down the drug’s metabolism, allowing for less frequent dosing and potentially improving patient compliance.1 “We are committed to addressing the pressing needs of patients in China with more ...
- Source: drugdu
- 116
- February 28, 2024

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