PharmaFocus Today – Page 71 – media

MAXVAX’s recombinant herpes zoster vaccine (CHO cell) enrolled in Phase III clinical trials

On July 13, the Phase III clinical trial of recombinant herpes zoster vaccine (CHO cell) of Chengdu MAXVAX Biotechnology Co., Ltd (MAXVAX) completed the enrollment of the first subject in Liangyuan District, Shangqiu City, Henan Province, marking the successful start of the Phase III clinical trial of the recombinant herpes zoster vaccine of MAXVAX. The vaccine product adopts recombinant protein technology route and carries independently developed new adjuvant system MA105, which is the first innovative vaccine with composite adjuvant system with independent intellectual property rights to enter phase Ⅲ clinical trial in China. The results of Phase I and Phase II clinical trials show that it has good safety, tolerability and immunogenicity. Phase III clinical trials will further verify the safety, immunogenicity and protective efficacy of the vaccine in a large sample of people, providing key data for the product’s marketing application. About Herpes Zoster Vaccine Herpes zoster is a ...
- Source: drugdu
- 58
- July 16, 2024
How Leaders Can Empower Their People to be Their Best

By Spencer Gore If you wish for your team to be diligent, innovative, and collaborative, you must first exhibit these traits yourself Having the drive, desire, and ability to be the best starts with believing you can achieve something. As the saying goes, “If you think you can, you possibly will. If you think you can’t, you definitely won’t.” Since founding the European Medical Journal (EMJ) and most recently the American Medical Journal (AMJ), I’ve seen firsthand that the success of these organizations hinges on the strength and cohesion of their teams. As a leader, fostering a high-performing team goes beyond traditional management techniques. It requires continuous empowerment, instilling a growth mindset, and encouraging self-belief. A mindset for our future leaders that has been transformative is “be the leader you wish to follow.” This involves setting the standard for behavior, work ethic, and collaboration, encouraging team members to strive to ...
- Source: drugdu
- 84
- July 15, 2024
Merck Sharp & Dohme Animal Health Completes Acquisition of Leyland Animal Health Aquatic Business

Rowe, NJ, USA, July 9, 2024 – Merck Sharp & Dohme (Merck is the corporate trading name of Merck & Co. of Rowe, NJ, USA) announced today that its Animal Health division has completed the acquisition of the aquatic business of Gift Blue Animal Health. The acquisition strengthens Merck Sharp & Dohme Animal Health’s position in the aquaculture industry, enabling it to promote fish health, welfare and sustainability across all aspects of aquaculture, conservation and fisheries. Rick DeLuca, President of Mercer Animal Health, said: “With the completion of this acquisition, we are well positioned in the aquaculture industry with a strong and comprehensive portfolio of products covering warm water aquaculture, cold water aquaculture, vaccines, antiparasitic treatments, water conditioners and nutritional supplements. We are excited to welcome our new colleagues to Merck Sharp & Dohme Animal Health and look forward to working together towards our shared goal of ‘Science for Healthier ...
- Source: drugdu
- 85
- July 15, 2024
Publication in Journal of Translational Medicine Highlighting Henlius’ Dual HER2 Blockade Therapy Mechanism of Action

Recently, Journal of Translational Medicine, a prestigious medical journal, published a research article describing mechanism of action (MOA) of Henlius’ innovative anti-HER2 monoclonal antibody (mAb), HLX22, in dual HER2 blockade therapy. The research analysed the structure foundation and mechanisms of action associated with HLX22, further validating its potential in combination with trastuzumab in the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer to benefit more patients worldwide. Trastuzumab, the first HER2-targeted cancer therapy, was introduced in clinical practice and revolutionised the treatment of HER2-positive breast cancer and gastric cancer. Trastuzumab in combination with pertuzumab and docetaxel has also verified their synergistic effect in the treatment of HER2-positive metastatic breast cancer, and the combination regimen is now the standard of care in this indication. However, a phase 3 trial that assessed the efficacy of pertuzumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic gastric or G/GEJ cancer ...
- Source: drugdu
- 85
- July 15, 2024
Healey platform data to pave phase III path for Prilenia’s pridopidine

Developing disease-modifying treatments for amyotrophic lateral sclerosis (ALS), a rare and aggressive disease, has proven challenging. The high failure rate in ALS clinical trials is often attributed to the disease’s unclear etiology and complex pathophysiology. At the 10th Congress of the European Academy of Neurology (EAN) 2024, Prilenia Therapeutics presented promising results from the additional analyses of the Phase II Healey ALS Platform Trial evaluating pridopidine in ALS patients. The positive results will pave the way for the Phase III trial of pridopidine, says GlobalData. Erela Dana, Director of Neurology at GlobalData, comments, “The Healey ALS Platform Trial aims to accelerate the path to approval for ALS drugs by testing drugs simultaneously and adoptively. Given the challenges in developing treatments for this disease, the platform trial is anticipated to find an effective therapy more quickly, with fewer total participants and fewer participants on placebo.” GlobalData forecasts that the ALS market ...
- Source: drugdu
- 118
- July 15, 2024
Prioritised investments from pharma companies shaping competitive pipeline landscape of bronchiectasis

Recent studies have allowed the unexplored field of bronchiectasis to be further investigated by shedding light on the mechanisms behind the disease’s pathophysiology. In recent years, bronchiectasis has garnered a significant amount of attention, with pharmaceutical companies prioritising their investments in the development of promising pipeline agents to treat the disease through various mechanisms of action (MOAs). Pharmaceutical companies involved in the field of bronchiectasis include Insmed, Boehringer Ingelheim, Sanofi, Renovion, Armata Pharmaceuticals, Chiesi, CSL, BioAegis Therapeutics, and Reistone Biopharma, all of which are shaping the competitive landscape of the field, according to GlobalData. Current research focuses on disease mechanisms, such as inflammation, further uncovering potential targets for pharmaceutical companies. Such targets include neutrophil-mediated inflammation components but also general inflammation components, such as interleukins and bacteriophages. Interestingly, the pipeline landscape is filled with Phase I and Phase II agents, with only Insmed’s brensocatib in Phase III. These pipeline agents have ...
- Source: drugdu
- 88
- July 15, 2024
Aspect wins $72.75m from Canadian government for bioprinted pipeline

Canadian biotech Aspect Biosystems has received a $72.75m government investment to advance its proprietary bioprinting technology. The funding, from the governments of Canada and British Columbia (BC), is set to support a $200m multi-year project to advance Aspect’s clinical biomanufacturing capabilities, full-stack tissue therapeutic platform, and bio-printed tissue therapeutic portfolio. Aspect develops bioprinted tissue therapeutics designed to replace or support specific biological functions. According to the company, these implantable, allogeneic cell-based therapies offer solutions such as retrievable implants, and integrated tissues. Aspect’s tissue therapeutic platform is said to combine the company’s bioprinting technology, therapeutic cells, biomaterials, and computational design. In April 2023, Aspect announced a partnership with Novo Nordisk to produce tissue therapeutics for diabetes. Aspect received $75m from Novo in initial payments, with Novo potentially giving Aspect up to $650m in future payments for each of the four potential products arising from the partnership. The collaboration has so far ...
- Source: drugdu
- 94
- July 13, 2024
After AdCom rejection, FDA rebuffs Novo Nordisk’s once-weekly insulin

The US Food and Drug Administration (FDA) has rejected the biologics licence application (BLA) for Novo Nordisk’s once-weekly insulin icodec for the treatment of diabetes mellitus. The company did not disclose the details of the complete response letter (CRL) issued by the FDA. But did share that the CRL outlined concerns related to the “manufacturing process and the type 1 diabetes (T1D) indication”. Novo Nordisk also added that the company did not expect to fulfil the requests detailed in the CRL by the end of this year, and consequently will not be refiling the BLA for insulin icodec until next year, at the earliest. The BLA rejection news comes two months after the FDA Endocrinologic and Metabolic Drugs Advisory Committee (AdCom) voted against the approval of insulin icodec for T1D. In a 7-4 vote, the panel found that insulin icodec’s benefits do not outweigh its risks, especially the elevated risk ...
- Source: drugdu
- 91
- July 13, 2024
Indegene collaborates with Microsoft to promote use of GenAI in global life sciences companies

Indegene announced a strategic collaboration with Microsoft to empower global life sciences companies to scale up the adoption of purpose-built, enterprise-grade Generative AI services, thereby driving faster innovation at scale. Indegene and Microsoft have aimed to develop resources in highly specialised and skilled medical and technology tools to co-innovate generative AI services and workflows across commercial, medical, regulatory, and clinical functions. Some of the key use cases the strategic collaboration focuses on in the first phase, include: Content Super App: Using Azure OpenAI Service, the modular content value chain simplifies content creation and tagging for life sciences companies. This integrated approach offers a holistic view of the content value chain, enabling greater velocity, personalized content, and adoption of new conversation form factors. It also streamlines creative and video transformation while effectively engaging healthcare professionals (HCPs), patients and payers Future-ready medical content value chain: Generative AI capabilities are revolutionising the medical ...
- Source: drugdu
- 82
- July 13, 2024
The growing threat of antibiotic resistance

The alarming rise of multi-drug-resistant (MDR) superbugs is a significant threat to global health, with traditional antibiotics losing their efficacy at an unprecedented rate. Antibiotic resistance is one of our time’s most pressing public health issues. It occurs when microbes evolve mechanisms to withstand the drugs designed to kill them, rendering standard treatments ineffective and leading to persistent infections and increased risk of spread. This phenomenon poses a significant threat to global health, development, and sustainability. Microorganisms can become resistant to antibiotics through genetic mutation, horizontal gene transfer, Efflux pumps and enzymatic degradation. Several factors contribute to the rise of antibiotic resistance. Amongst them, overuse and misuse of antibiotics is the most distressing. Prescribing antibiotics when they are not needed such as for viral infections and patients not completing their prescribed courses of antibiotics also contribute to the resistance. The use of antibiotics in livestock for growth promotion and disease ...
- Source: drugdu
- 65
- July 13, 2024

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