Search Results for “Clinical Trial” – Page 54 – media

Sinopharm’s Quadrivalent HPV Vaccine Marketing License Application Accepted

On July 4, 2024, Sinopharm’s application for marketing authorization of quadrivalent recombinant human papillomavirus vaccine (type 6, 11, 16, 18) (Hansenula polymorpha), which was jointly declared by Sinopharm’s Chengdu Institute of Biological Products of China Biological and China Academy of Biological Sciences (National Engineering Research Center for Novel Vaccines), was accepted by the State Drug Administration under acceptance No. CXSS2400063, the first domestic quadrivalent HPV vaccine in China. This is the first quadrivalent HPV vaccine in China, which mainly covers four subtypes of HPV virus, including 6, 11, 16 and 18, and is suitable for preventive vaccination for women aged 18-45. The vaccine was independently researched and developed by China Academy of Biological Sciences and industrialized and developed by Chengdu Institute of Biological Products, and the two sides jointly conducted clinical research and initiated Phase III clinical trial in May 2018, and obtained a positive recommendation from the interim analysis ...
- Source: drugdu
- 84
- July 10, 2024
Mission awarded $5.2m to advance potential Parkinson’s treatment

The progressive neurodegenerative condition affects around 153,000 people in the UK Mission Therapeutics has been awarded $5.2m in funding from Parkinson’s UK’s Virtual Biotech programme and the Michael J. Fox Foundation to advance a potential treatment for early-stage Parkinson’s disease (PD). The funding will help support the company’s ongoing phase 1 programme, which consists of a 28-day dosing of its small drug molecule, MTX325, to assess its safety, tolerability, pharmacokinetic profile and central nervous system penetration in patients living with the neurodegenerative condition. Affecting around 153,000 people in the UK, PD is a progressive neurological condition that damages parts of the brain over time, causing tremors, slow movement and stiff and inflexible muscles. Mission’s MTX325 is a potent, selective, small-molecule brain-penetrant USP30 inhibitor that works to protect dopamine-producing neurons by improving mitochondrial quality and function. Previous research has already shown evidence that a build-up of dysfunctional mitochondria in cells is ...
- Source: drugdu
- 78
- July 10, 2024
Michael J. Fox Foundation and Parkinson’s UK Award $5.2 Million to Mission Therapeutics for Research into Potential Parkinson’s Treatment

By Mike Hollan MTX325 is in Phase I trials and is believed to be able to modify the course of the disease. The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Parkinson’s UK award a multi-million dollar grant to Mission Therapeutics.1 The $5.2 million grant will be used to advance Mission Therapeutics MTX325, a potentially disease modifying treatment for Parkinson’s. In a press release, Mission Therapeutics’ CEO Anker Lundermose said, “This significant grant, from two of the world’s leading Parkinson’s disease organizations, underlines the huge potential of MTX325 as a disease-modifying treatment for this terrible neurodegenerative illness. It also represents a major endorsement of our mitophagy strategy in human diseases including PD.” The company’s chief scientific officer, Dr. Paul Thompson, PhD,, added, “We have already made excellent progress in healthy volunteers with preliminary data from the ongoing clinical trial showing that MTX325 has a good single dose safety profile, ...
- Source: drugdu
- 104
- July 9, 2024
Sanofi & Regeneron Drug Dupixent Gets EMA Approval as the First Biologic COPD Med

European Medicines Agency approval of Dupixent in chronic obstructive pulmonary disease makes the drug the first biologic therapy approved for treating the prevalent respiratory condition. In COPD, Dupixent addresses what’s called type 2 inflammation. By Frank Vinluan Inflammation that develops in chronic obstructive pulmonary disorder stems from different causes. A new regulatory decision in Europe makes Sanofi and Regeneron Pharmaceuticals drug Dupixent the first biologic therapy approved for COPD driven by one particular type of inflammation. The European Medicines Agency (EMA) has approved Dupixent for adults with uncontrolled COPD that is also characterized by raised blood levels of eosinophils, a type of white blood cell. COPD patients typically take multiple medications to manage the chronic condition. The new Dupixent approval, announced just prior to the Independence Day holiday in the U.S., covers use of the injectable drug as an add-on maintenance treatment for patients whose COPD is uncontrolled by available therapies. ...
- Source: drugdu
- 81
- July 9, 2024
New Labour government backs pharma reform in UK

“Change begins now,” said the UK’s new prime minister, Sir Keir Starmer, in his 5 July victory speech. Ending the 14-year Conservative party reign, the Labour Party has pledged to bolster the UK pharmaceutical sector through increased investment and regulatory action. Starmer’s government is expected to appoint cabinet members in the coming days while junior ministers will be announced today and early into next week. The new members of parliament (MPs) will soon be sworn in from 9 to 11 July. In his final speech as prime minister, Conservative Party leader Rishi Sunak hailed his party’s work to achieve a decreased inflation rate and implement the Windsor Framework for trade in and out of Northern Ireland. However, in a 5 July speech, Starmer said: “Our work is urgent – and we begin it today.” The Labour Party has already promised extensive change to the UK’s life sciences sector, setting forth ...
- Source: drugdu
- 73
- July 9, 2024
Hinova Pharmaceuticals receives FDA Fast Track Designation for HP518 for Treatment of AR+ Triple-Negative Breast Cancer (TNBC)

CHENGDU, China, July 5, 2024 /PRNewswire/ — Hinova Pharmaceuticals Inc. (688302.SH), a leading biopharmaceutical company dedicated to developing innovative cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HP518, an investigational drug for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC). This designation is intended to expedite the development and review process for drugs that address serious conditions and fill an unmet medical need. About HP518 HP518 is a potent PROTAC AR degrader showing efficacy in AR+ TNBC. In preclinical IND-enabling studies, HP518 has demonstrated promising antitumor activity in AR+ TNBC animal models, showcasing significant tumor reduction and a favorable safety profile. The molecular subforms of TNBC are particularly aggressive forms of breast cancer that lack targeted treatment options, accounting for approximately 15-20% of all breast cancer cases, and are characterized by the absence of estrogen and progesterone receptors ...
- Source: drugdu
- 66
- July 9, 2024
EMA approval of Sanofi/Regeneron’s Dupixent fills biologic gap in COPD

Following the European Medicines Agency (EMA) approval of Sanofi/Regeneron’s Dupixent (Dupilumab) on July, 03 2024, Asiyah Nawab, Pharma Analyst at GlobalData, offers her view: “Dupixent, a monoclonal antibody (mAb) targeting interleukin-4 (IL4) and interleukin-13 (IL13) pathways, has been approved by the EMA as the first biologic for uncontrolled chronic obstructive pulmonary disease (COPD) patients. It is to be used specifically as an add-on maintenance treatment, given alongside the standard of care (SoC), with a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA. The approval is set to improve the treatment landscape for COPD and offer patients a treatment option with potential to improve quality of life,” states Nawab “After reviewing the data published from Sanofi/Regeneron’s two landmark phase 3 studies (BOREAS and NOTUS), Dupixent (dupilumab) was able to significantly reduce moderate or ...
- Source: drugdu
- 101
- July 6, 2024
Beacon secures $170m to advance ophthalmic gene therapies

Beacon Therapeutics has raised $170m in a Series B funding round to accelerate the development of its lead asset AGTC-501, for X-linked retinitis pigmentosa (XLRP). The financing round was led by life sciences venture capital firm Forbion, alongside existing investors Syncona Limited, Oxford Science Enterprises and the University of Oxford, and also featured initial investments from TCGX and Advent Life Sciences. The British investment trust Syncona previously acquired Applied Genetic Technologies Corporation (AGTC) for $23.5m in October 2023. AGTC inherited a portfolio of ophthalmic pipeline candidates, including AFTC-501, an adeno-associated virus (AAV) gene therapy. XLRP is a genetic disorder that causes progressive vision loss, primarily in males, due to retinal degeneration. AFTC-501, now transferred to Beacon, has been investigated in several clinical trials for XLRP. Promising interim data from the Phase II SKYLINE trial (NCT03316560) was announced in February 2024, showing that 63% of eyes treated with high-dose AGTC-501 experienced ...
- Source: drugdu
- 86
- July 5, 2024
Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy. By Frank VinluanEli Lilly Alzheimer’s disease drug has received its long-awaited FDA approval, bringing patients a treatment that works similarly to an Eisai medication for the neurodegenerative disorder but with dosing advantages that patients might prefer. The Tuesday regulatory decision comes less than a month after an FDA advisory committee voted unanimously that the benefits of the Lilly drug in slowing cognitive decline outweigh its safety risks. The approval covers the treatment of Alzheimer’s patients with mild cognitive impairment or mild dementia, the same population that was evaluated in clinical trials. Known in development as donanemab, Lilly will market its new Alzheimer’s ...
- Source: drugdu
- 109
- July 4, 2024
Henlius Receives Approval in Japan for Phase 3 MRCT of Anti-PD-1 mAb Serplulimab Combo on First-Line mCRC

Shanghai, China, July 2, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the clinical trial notification (CTN) for phase 3 international multicenter clinical study (ASTRUM-015) of Henlius’ self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency. The study has previously completed dosing of the first subject in China, and the regulatory registration and clinical development is advancing efficiently in more countries and regions around the world. Colorectal cancer (CRC) is one of the most common malignant cancers globally. Over 1.9 million newly diagnosed cases and more than 900,000 deaths were estimated in 2022, and the incidence rates were highest in Europe and Oceania [1]. It is estimated that, by 2040, the burden of CRC will increase to 3.2 million new cases per year (an increase of 63%) and ...
- Source: drugdu
- 71
- July 4, 2024

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