Search Results for “EU” – Page 30 – media

Henlius Passes Its Second EU GMP Inspection

Shanghai, China, December 22, 2023 – Shanghai Henlius Biotech, Inc. (2696.HK) announces that the company has received the European Union (EU) GMP Certificates (Certificates of GMP Compliance of a Manufacturer) for the production lines of anti-PD-1 mAb HANSIZHUANG (serplulimab) from Netherlands’ health supervision agency Health and Youth Care Inspectorate, marking that the company’s Xuhui Facility and Songjiang First Plant have successfully passed the EU GMP on-site inspection for HANSIZHUANG and meet the EU GMP standards. The inspection success, as well as the previous certification by the EU GMP for Henlius’ self-developed trastuzumab HANQUYOU in 2020, confirms the company’s longstanding reputation in maintaining quality systems fully compliant with the highest international standards. The inspection-related product HANSIZHUANG is the first anti-PD-1 therapy approved for first-line treatment of small-cell lung cancer (SCLC). At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), ...
- Source: drugdu
- 100
- December 26, 2023
Previously unrecognized class of antibodies can broadly neutralize multiple virus strains

Researchers have identified a previously unrecognized class of antibodies-;immune system proteins that protect against disease-;that appear capable of neutralizing multiple forms of flu virus. These findings, which could contribute to development of more broadly protective flu vaccines, will publish December 21st by Holly Simmons of the University of Pittsburgh School of Medicine, US, and colleagues in the open access journal PLOS Biology. A flu vaccine prompts the immune system to make antibodies that can bind to a viral protein called hemagglutinin on the outside of an invading flu virus, blocking it from entering a person’s cells. Different antibodies bind to different parts of hemagglutinin in different ways, and hemagglutinin itself evolves over time, resulting in the emergence of new flu strains that can evade old antibodies. New flu vaccines are offered each year based on predictions of whatever the most dominant strains will be. Extensive research efforts are paving the ...
- Source: drugdu
- 215
- December 25, 2023
Merck’s 21-Valent Pneumococcal Conjugate Vaccine Granted FDA Priority Review

Pharmaceutical Executive Editorial Staff Merck’s Biologics License Application for V116, a novel 21-valent pneumococcal conjugate vaccine has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. The FDA has granted priority review to Merck’s Biologics License Application (BLA) for V116, a novel 21-valent pneumococcal conjugate vaccine developed as a single dose for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. The BLA has been given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024. “Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a press release. “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed ...
- Source: drugdu
- 135
- December 25, 2023
Kunming Plasma Products, a subsidiary of China National Pharmaceutical Group (Sinopharm), has been selected for the list of Intelligent Manufacturing Demonstration Factories in 2023.

The announcement, jointly released by the Ministry of Industry and Information Technology, the National Development and Reform Commission, the Ministry of Finance, the State-owned Assets Supervision and Administration Commission of the State Council, and the State Administration for Market Regulation, highlights Kunming Plasma Products’ achievement in intelligent manufacturing by making it to the ‘2023 Intelligent Manufacturing Demonstration Factories’ list. This recognition marks a new milestone in Kunming Plasma Products’ efforts towards intelligent manufacturing and digital factory construction. As a crucial component of China’s ’14th Five-Year Plan’ Intelligent Manufacturing Pilot Demonstration Action, the national-level Intelligent Manufacturing Demonstration Factories and Outstanding Scenes are part of a major national project led jointly by the Ministry of Industry and Information Technology, the National Development and Reform Commission, the State-owned Assets Supervision and Administration Commission of the State Council, the Ministry of Finance, and the State Administration for Market Regulation. The initiative aims to select ...
- Source: drugdu
- 210
- December 22, 2023
The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™, have been published in The Lancet Rheumatology.

The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™ (BAT1806/BIIB800), have been published in the prestigious international rheumatology journal, The Lancet Rheumatology (impact factor IF = 25.4). This research, derived from a global multicenter, randomized, double-blind, active-controlled Phase III clinical study (ClinicalTrials.gov, NCT03830203; EudraCT, 2018-002202-31), reveals outcomes from the initial treatment phase (TP1). The study, conducted in 54 centers across five countries (China, Ukraine, Poland, Georgia, Bulgaria), included a 24-week initial treatment phase (TP1) followed by a subsequent 24-week secondary treatment phase (TP2). A total of 621 patients with moderate to severe rheumatoid arthritis, unresponsive to methotrexate, were enrolled. During the trial, participants received investigational drug therapy with an initial dose of 8mg/kg, administered intravenously every four weeks, either BAT1806/BIIB800 or the reference Tocilizumab. The study consisted of two treatment stages (TP1 and TP2), with 50% of the control group transitioning to BAT1806/BIIB800 treatment in TP2 until ...
- Source: drugdu
- 118
- December 22, 2023
CPhI Worldwide Europe

Time: Oct 8-10, 2024 sponsor: Informa Markets Venue:Milan International Exhibition Center City: Milan / Italy Product categories: Bulk drug: Vitamins, hormones, sulfonamides, antipyretic and analgesic drugs, tetracycline, amino acids and their derivatives, chloramphenicol, digestive system drugs, other anti-infective drugs, penicillins, aminoglycosides, lincomycin, cardiovascular system drugs, anti-parasitic diseases drugs, cephalosporins, macroliones, respiratory system drugs, central nervous system drugs, and other Western medicine raw materials. Excipients and dosage forms: excipients, flux-aids, enteric-soluble materials, antioxidants, sweeteners, permeability enhancers, preservatives, disintegrators, coating materials, surfactants, sunblocks, fragrances, filter AIDS, stabilizers, lubricants, plasticizers, solvents, flavor straighteners, colorants, clarifying agents, PH regulators. Other natural extracts: Plant extract, animal extract, traditional Chinese medicine raw materials, functional food raw materials, health products raw materials, nutrition and health products raw materials, supplements, dietary fiber, beauty cosmetics raw materials, biological product reagents: antibody, nucleic acid/protein synthesis, carrier and construction, cell biological detection, animal/plant protein/antigen/polypeptide, nucleic acid analysis, library and construction, biochemistry, standard Product/reference product, ...
- Source: drugdu
- 867
- December 20, 2023
AI-Enabled Prescription Digital Therapeutics Should Be An Investment Priority

To identify true growth opportunities, investors must consider how companies are using AI to revolutionize the treatment journey. Some companies are doing just that via Software as a Medical Device (SaMD), particularly by developing prescription digital therapeutics (PDTs). By DAVID B. KLEIN The excitement around artificial intelligence has been palpable for some time, dominating industry discussions and mobilizing capital for investment opportunities, but as of late, there’s been a change in the air. The optimism that reached a fever pitch in the first half of the year has dissipated. Now begins the hard work of sorting through what it all means. As the healthcare industry responds to the burgeoning opportunities AI presents, especially in developing new, more effective therapeutics and enabling access to treatment, it’s critical that investors prioritize proof over positivity. They must determine if a company’s AI strategy will lead to a high return on investment, or if ...
- Source: drugdu
- 94
- December 19, 2023
Imperative Care begins first-in-human study of neurovascular stent

BY SEAN WHOOLEY Imperative Care announced today that it initiated a first-in-human clinical study for its novel neurovascular stent system. Campbell, California-based Imperative Care designed the system to only require single antiplatelet therapy for patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms. Dr. Nobuyuki Sakai successfully treated the first three patients enrolled in the study. Sakai serves as director of neurosurgery at the Kobe City Medical Center General Hospital in Kobe City, Hyogo, Japan. All three patients underwent planned procedures for stent-assisted coiling of unruptured aneurysms. Imperative Care reported all three patient discharges from the hospital within 48 hours on an aspirin-only antiplatelet regimen. The company reported no device- or procedure-related complications, including clot formation. “The ability for neurovascular implants to avoid dual antiplatelet drug therapy, which carries the risk of serious bleeding complications, will be an important step forward,” said Sakai said in a news release. “I am encouraged ...
- Source: drugdu
- 126
- December 18, 2023
【EXPERT Q&A】How should one start a business in pharmaceutical intermediates?

Drugdu.com expert’s response: Entering the business of pharmaceutical intermediates involves several key steps and considerations: 1.Industry Understanding Comprehensive Research: Understand the pharmaceutical industry, focusing on the role and demand for intermediates in drug production. Market Trends and Needs: Identify current trends, future projections, and specific needs within the market for pharmaceutical intermediates. 2.Regulatory Compliance Regulatory Knowledge: Familiarize yourself with the regulatory environment, including quality standards and certifications like Good Manufacturing Practice (GMP). Licensing and Permits: Obtain necessary licenses and permits required for manufacturing and trading pharmaceutical intermediates. 3.Business Plan and Strategy Business Model Development: Develop a clear business model, including target market, business scale (local, national, international), and value proposition. Financial Planning: Prepare a detailed financial plan covering startup costs, operational expenses, and revenue projections. 4.Supply Chain and Manufacturing Manufacturing Setup: Decide whether to manufacture in-house or outsource. If manufacturing, ensure the setup meets industry standards. Supplier and Customer ...
- Source: drugdu
- 177
- December 18, 2023
Abbisko Therapeutics Announces that U.S. FDA Has Granted Fast Track Designation for Its CSF-1R Inhibitor Pimicotinib(ABSK021)

Abbisko Therapeutics Co., Ltd.(Abbisko Therapeutics) today announced that its CSF-1R inhibitor pimicotinib(ABSK021) has been granted the fast track designation (FTD) by the U.S. FDA for the treatment of tenosynovial giant cell tumor (TGCT) patients that are not amenable to surgery. Previously, pimicotinib was granted the breakthrough therapy designation (BTD) by the U.S. FDAfor TGCT in January, 2023.The grant of FTD and BTD will accelerate the global development and commercialization of pimicotinib. Fast Track is a policy designed to facilitate the development and expedite the review of drugs in order to treat serious conditions and fulfill unmet medical needs. Its purpose is to get important new drugs to patients earlier. Moreover, the FTD enables companies to maintain more frequent communications and meetings with the U.S.FDA. The drug also becomes eligible for accelerated approval and priority review by the U.S.FDA. In early December, Abbisko entered into an agreement with Merck KGaA, Darmstadt, ...
- Source: drugdu
- 104
- December 17, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.