Search Results for “EU” – Page 14 – media

【EXPERT Q&A】The requirement of an EU Representative for CE certification brings several benefits and impacts?

Drugdu.com expert’s response: The benefits and impacts of requiring an EU Representative for CE certification can be summarized as follows: Benefits : 1.Communication Bridge: An EU Representative serves as an intermediary between manufacturers and EU authorities, effectively communicating and handling technical, regulatory, and after-sales issues related to products. This bridging role significantly simplifies the communication process between manufacturers and EU authorities, improving the efficiency of problem-solving. 2.Compliance Assurance: Through an EU Representative, manufacturers can ensure their products meet EU regulatory requirements, mitigating the risk of compliance violations due to unfamiliarity with local regulations. The EU Representative’s familiarity and understanding of EU regulations can provide manufacturers with guidance and support in terms of compliance. 3.Clear Responsibility: In the event of product issues, EU authorities can directly contact the EU Representative to take prompt action, such as product recalls. This clear responsibility approach enhances the efficiency of problem resolution, reducing delays ...
- Source: drugdu
- 96
- June 14, 2024
LucyTx announces additional $12.5m research funding for neurological diseases

Lucy Therapeutics (LucyTx) has announced it has raised $12.5m in additional funding to develop potentially new drugs and advance the company’s research programmes for neurological diseases. The funding, provided by existing investors, Engine Ventures and Safar Partners, with recent participation from the Bill & Melinda Gates Foundation, the Michael J. Fox Foundation and £1.6m from Parkinson’s UK’s Biotech programme, brings the company’s total funding to $36m. The new project aims to develop novel therapies that are based on mitochondrial small-molecule treatments and diagnostic biomarkers for Alzheimer’s (AD) and Parkinson’s disease (PD), as well as continue the development of a novel drug target for Rett syndrome, a rare genetic neurological and developmental disorder that affects brain development. AD and PD are the two most common neurodegenerative diseases worldwide, affecting around 24 million and ten million people, respectively. Using LucyTx’s platform, the team will analyse a variety of disease drivers central to ...
- Source: drugdu
- 77
- June 14, 2024
Chiatai Tianqing and China Resources Pharmaceutical Commercial signed a strategic cooperation agreement

On June 7, Chiatai Tianqing Pharmaceutical Group and China Resources Pharmaceutical Commercial signed a strategic cooperation agreement in Tianjin. Based on the principle of resource sharing, complementary advantages and common development, the two parties will carry out in-depth cooperation in the fields of pharmaceutical research and development, production, sales and circulation, and jointly help the sustainable development of China’s pharmaceutical industry. Chiatai Tianqing’s commercial director Qi Tianze and CR Pharmaceuticals Commercial Deputy General Manager Dong Hao signed the agreement on behalf of the two parties. As one of the leading pharmaceutical companies in China, Chiatai Tianqing has always been committed to researching and developing innovative drugs, improving drug quality and meeting patients’ needs. With strong R&D strength and market competitiveness, the company has won wide recognition and trust. As an important pillar industry of China Resources Group, China Resources Pharmaceutical Commercial has a comprehensive pharmaceutical distribution network and market channels, ...
- Source: drugdu
- 93
- June 14, 2024
AbbVie’s Telisotuzumab Vedotin (Teliso-V) Included in CDE’s List of Breakthrough Therapeutic Varieties

Recently, the Center for Drug Evaluation (CDE) of the State Drug Administration formally included AbbVie’s clinically developed sterile lyophilized powder for infusion, Telisotuzumab Vedotin (Teliso-V), into the list of breakthrough therapeutic drug varieties for the treatment of advanced/late stage c-Met protein (OE) with high expression of c-Met protein (OE) with disease progression occurring during or after platinum-based drug therapy. metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq) non-small cell lung cancer (NSCLC) patients. About Telisotuzumab Vedotin (Teliso-V) Teliso-V is an investigational first-in-class antibody-coupled drug (ADC) targeting the c-MET protein in patients with tumors overexpressing c-Met, a receptor tyrosine kinase that is overexpressed in many solid tumors, including NSCLC. Its efficacy safety as monotherapy in previously treated patients with c-Met overexpressing NSCLC will be further evaluated in the randomized Phase 3 study TeliMET NSCLC-01 (Study M18-868) For more information on the Teliso-V clinical trial, please visit https://clinicaltrials.gov/. Currently, there ...
- Source: drugdu
- 120
- June 13, 2024
Qilu Pharmaceutical’s Three Clinical Studies on Cancer Immunotherapy Presented at ASCO 2024

JINAN, China, June 6, 2024 /PRNewswire/ — The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting convened from May 31 to June 4, 2024 in Chicago, USA, adopting a hybrid format. Among the presented works, three clinical studies from Qilu Pharmaceutical were selected for poster sessions. These studies introduced novel immunotherapeutic agents, specifically QLF31907, a bispecific antibody targeting PD-L1/4-1BB; iparomlimab and tuvonralimab, a MabPair product targeting PD-1/CTLA-4; and iparomlimab, a monoclonal antibody targeting PD-1. The research involved treatments for advanced solid tumors and lymphoma, nasopharyngeal carcinoma, as well as solid tumors characterized by either DNA mismatch repair (dMMR) deficiency or high microsatellite instability (MSI-H). QLF31907, developed by Qilu Pharmaceutical, combines two mechanisms: blockade of PD-L1 to restore T-cell receptor (TCR) signaling, while binding to 4-1BB to provide costimulatory signals essential for T-cell activation. This dual-action mechanism fosters T-cell proliferation and activation, enhancing the anti-tumor immune response. The study, led ...
- Source: drugdu
- 88
- June 12, 2024
Kangpu Biopharmaceuticals to Present Results from Phase 2a of KPG-818 in SLE at EULAR 2024

HEFEI, China, June 10, 2024 /PRNewswire/ — Kangpu Biopharmaceuticals today announced that a poster tour presentation highlighting the Phase 2a clinical data of KPG-818 in patients with Systemic Lupus Erythematosus (SLE) will be presented at the upcoming Annual European Congress of Rheumatology EULAR 2024, taking place in Vienna, Austria, June 12-15, 2024. Poster tour presentation details: Abstract Title: KPG-818, a Novel Cereblon Modulator in Patients with Systemic Lupus Erythematosus: Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study Abstract number: POS0057 Abstract authors: Robert Levin, et al. Poster tour title: Clinical Poster Tours: Systemic lupus – Of old and new therapies Poster tour date and time: Wednesday, June 12, 2024, 15:30 – 16:30 CEST Poster tour location: Hall C The Phase 2a trial is a multicenter, randomized, double-blind, placebo-controlled study, to assess the safety and tolerability, pharmacokinetics, and preliminary efficacy of KPG-818 in patients with SLE, and to select dosing ...
- Source: drugdu
- 92
- June 12, 2024
FDA Committee Votes Against Approval of Lykos Therapeutics’ MDMA Treatment for PTSD

Don Tracy, Associate Editor In a majority vote, the Psychopharmacologic Drugs Advisory Committee cited concerns regarding the data presented for MDMA as a treatment for post-traumatic stress disorder. The FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) has voted against recommending Lykos Therapeutics’ New Drug Application (NDA) for midomafetamine (MDMA) capsules for use in combination with psychological intervention for the treatment of post-traumatic stress disorder (PTSD) in adults. The committee voted 2-to-9 against the efficacy of the treatment, and voted 1-to-10 against the benefits outweighing the risks, stating its doubts that MDMA-assisted therapy is effective in treating PTSD.1 “We are disappointed in today’s vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” said Amy Emerson, CEO, Lykos Therapeutics, in a press release. As a basis of their ...
- Source: drugdu
- 76
- June 11, 2024
ITM gains $204.6m investment for radiopharmaceutical pipeline

ITM Isotope Technologies Munich (ITM) has secured an investment of €188m ($204.6m) aimed at bolstering its radiopharmaceutical pipeline. Global investment company Temasek spearheaded the funding round with contributions from entities managed by BlackRock, the Qatar Investment Authority (QIA), ATHOS and Carbyne. The funding will be channelled towards advancing and broadening ITM’s radiopharmaceutical pipeline, supporting the development platform and commercially launching its Phase III lead candidate, ITM-11 (n.c.a.177Lu-edotreotide). The asset is currently under evaluation in two Phase III trials, COMPETE and COMPOSE, for the treatment of gastroenteropancreatic neuroendocrine tumours. The investment will enable ITM to bolster its manufacturing capabilities for Lutetium-177 (177Lu) and expand its production to include other high-value medical radioisotopes such as Actinium-225 (225Ac). As part of the expansion, the company will also supply the in-demand medical radioisotopes to its extensive global network and utilise them to diversify its radiopharmaceutical therapy pipeline. This strategy is designed to address a ...
- Source: drugdu
- 115
- June 11, 2024
GSK acquires Elsie to unlock oligonucleotide therapeutics

GSK has acquired Elsie Biotechnologies for $50m to unlock the potential of oligonucleotide therapeutics. Elsie Biotechnologies has been at the forefront of oligonucleotide therapeutic development, focusing on increasing potency, reducing toxicity, and optimising delivery to harness the potential of the modality fully. The acquisition is set to enhance GSK’s research and development (R&D) in gene modulation. Elsie Biotechnologies offers technologies that can modulate gene expression. This feature is particularly valuable for targeting therapeutic areas that are not responsive to traditional small-molecule drugs or biologics. The integration of Elsie’s technologies for the discovery, synthesis and delivery of oligonucleotide into GSK’s R&D framework is expected to advance the company’s platform capabilities significantly. The move follows a successful initial partnership between the two companies which began in July 2023 and allowed GSK to assess and validate Elsie’s technology. GSK’s use of AI and machine learning, combined with data from Elsie’s platform, aims to ...
- Source: drugdu
- 87
- June 11, 2024
FDA fast tracks Quince Therapeutics’ rare ataxia drug EryDex

California-based biotech Quince Therapeutics has won fast track designation from the US Food and Drug Administration (FDA) for its ataxia-telangiectasia (A-T) drug EryDex. According to the 3 June announcement, fast track designation was awarded to address a high unmet medical need for patients with A-T. The status allows for earlier interactions with the FDA as Quince seeks accelerated approval, and also the possibility to undergo rolling reviews. A-T is a rare disease of the nervous and immune systems, affecting motor movement and speech. EryDex utilises autologous intracellular drug encapsulation (AIDE) technology to administer dexamethasone sodium phosphate (DSP) into a patient’s red blood cells. Red blood cells filled with DSP are then reinfused into the patient, allowing for the slow release of steroids over several weeks, without the long-term toxicity commonly associated with chronic administration. The FDA lifted a partial clinical hold that was on the drug in October 2023, advancing ...
- Source: drugdu
- 71
- June 6, 2024

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