PharmaFocus Today – Page 159 – media

Regeneron’s Linvoseltamab Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma

Davy James The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024. Image credit: ibreakstock | stock.adobe.com The FDA has granted Priority Review to Regeneron Pharmaceuticals’ biologics license application (BLA) for linvoseltamab to treat adults with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies. The bispecific antibody was developed to bridge B-cell maturation antigen on multiple myeloma cells that have CD3-expressing T cells, which subsequently activates T cells to prompt the elimination of cancer cells. The FDA assigned the BLA with a Prescription Drug User Fee Act of August 22, 2024. An estimated 35,000 US residents will be diagnosed with multiple myeloma on an annual basis. Although research efforts have achieved significant progress in treating multiple myeloma, the disease is not yet curable. Current treatments have been able ...
- Source: drugdu
- 132
- February 23, 2024
Bavarian Nordic Hones Infectious Disease Focus by Dropping Cancer Vaccine R&D

Bavarian Nordic will concentrate on its portfolio and pipeline of infectious diseases vaccines, including top seller Jynneos, approved for mpox and smallpox. The company only had one clinical-stage cancer vaccine program. By FRANK VINLUAN The mpox outbreak is a memory, but Bavarian Nordic, maker of the only FDA-approved vaccine for the pathogen behind this viral infection, turned skyrocketing demand for its product into record revenue. With that growth comes a need to focus, and the pure-play vaccines company is getting out of the business of developing vaccines for cancer. Bavarian Nordic’s lone cancer vaccine candidate, TAEK-VAC, had reached Phase 1 testing as a potential treatment for chordoma or HER2-positive breast cancer. But this program had also reached the point where further investment is needed, and Bavarian Nordic decided it needs to focus its R&D efforts on infectious disease, the Denmark-based company said Wednesday in its announcement of preliminary 2023 financial ...
- Source: drugdu
- 154
- February 23, 2024
Innovent Announces Primary Endpoint Met in the Phase 3 Clinical Trial (RESTORE-1) of IBI311 (Anti-IGF-1R Antibody) in Treating Thyroid Eye Disease and Plans to Submit NDA to the NMPA

ROCKVILLIE, MD. and SUZHOU, China, February 20, 2024— Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the primary endpoint has been achieved in the Phase 3 registrational study (RESTORE-1) of IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody in Chinese subjects with Thyroid Eye Disease (TED). Innovent plans to submit the new drug application (NDA) for IBI311 in the treatment of TED to the Center for Drug Evaluation (CDE) of the National Drug Administration (NMPA). RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled Phase 2/3 clinical trial to evaluate the efficacy and safety of IBI311 in subjects with TED. The Phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye ...
- Source: drugdu
- 177
- February 23, 2024
Multi-agency report highlights importance of reducing antibiotic use

Taking a One Health approach, which recognises the connection between the health of people and animals, the report presents data primarily collected between 2019 and 2021 on antibiotic consumption and AMR in Europe. For the first time as part of this project, the three agencies analysed trends of antimicrobial consumption and AMR in Escherichia coli (E. coli) from both humans and food-producing animals. They also looked into how these trends were changing in humans and food-producing animals during 2014 – 2021. For example, during this timeframe, antibiotic consumption in food-producing animals decreased by 44%. The analysis performed by the three Agencies found that E. coli bacteria in both animals and humans are becoming less resistant to antibiotics as the overall antibiotic consumption is reduced. This shows that the concerning trends in antibiotic resistance can be reversed with the right actions and policies. The report also shows that, in humans, the ...
- Source: drugdu
- 81
- February 23, 2024
Pfizer’s Velsipity granted EC approval for ulcerative colitis in patients aged from 16 years

Pfizer’s S1P receptor modulator Velsipity (etrasimod) has been approved by the European Commission (EC) to treat moderately-to-severely active ulcerative colitis (UC) in patients aged 16 years and older. Those eligible for the drug, which is now the first and only oral advanced UC therapy approved in the EU for this patient population, will have had an inadequate response, lost response or been intolerant to conventional therapy or a biological agent. Affecting approximately 2.6 million people in Europe, UC is a chronic, immune-mediated condition where the colon and rectum become inflamed, causing symptoms such as frequent diarrhoea, bowel urgency, rectal bleeding, abdominal pain, fatigue, fever and anaemia. The EC’s decision on Velsipity follows a recommendation from the European Medicines Agency’s human medicines committee in December and was supported by positive results from the late-stage ELEVATE UC registrational programme. The ELEVATE UC 52 and ELEVATE UC 12 studies, which evaluated Velsipity 2mg ...
- Source: drugdu
- 106
- February 23, 2024
Olymvax’s Quadrivalent Influenza Virus Vaccine (Split Virion) Clinical Trials Accepted

Recently, the State Drug Administration announced on its website that it agreed to accept Olymvax’s application to conduct clinical trials of quadrivalent influenza virus cracking vaccine, marking new progress in Olymvax’s first product pipeline of virus-based vaccines. Influenza (also known as influenza) is an acute respiratory infection caused by influenza viruses, spread by respiratory droplets and contact, and the population is generally susceptible. Influenza poses a significant burden on global public health, and vaccination is the most effective way to reduce this burden. Vaccination with quadrivalent influenza virus lysate vaccine can stimulate the body to produce anti-influenza virus immunity, and is used to prevent influenza caused by vaccine-associated types of influenza viruses. Currently, most of the influenza vaccines available in China are based on chicken embryos. The influenza vaccine developed by Olymvax is based on MDCK cell mass culture technology, which can realize higher production yield, more stable product quality ...
- Source: drugdu
- 77
- February 23, 2024
Kangpu Biopharmaceuticals to Present Preclinical Efficacy Data of KPG-818 in Crohn’s Disease at the 19th Congress of ECCO (IND Application for Phase II in Progress)

HEFEI, China, Feb. 20, 2024 /PRNewswire/ — Kangpu Biopharmaceuticals, a clinical-stage company dedicated to the discovery and development of novel therapeutics for the treatment of cancer, autoimmune diseases, and inflammation, through targeted protein degradation technology, today announced that a poster on preclinical efficacy data of KPG-818 in Crohn’s disease will be presented at the upcoming 19th Congress of European Crohn’s and Colitis Organisation (ECCO), taking place in Stockholm, Sweden, February 21-24, 2024. Poster Title: Therapeutic Effects of KPG-818 in a Trinitrobenzene Sulfonic Acid-Induced Mouse Crohn’s/Ulcerative Colitis Model Abstract Number: EC24-0844 Exhibition Zone: Poster Exhibition, Hall A Presentation Number: P131 Crohn’s disease is a chronic and difficult-to-treat autoimmune disorder. The current available therapeutic options for this condition are very limited, and there remain significant unmet medical needs. In preclinical studies, KPG-818 demonstrated potent therapeutic efficacy in mouse model of Crohn’s disease. KPG-818 significantly improved clinical symptoms, colorectitis, ulcers, and local immune ...
- Source: drugdu
- 119
- February 23, 2024
WuXi Biologics Recognized as Both Industry and Regional ESG Top-Rated Company by Morningstar Sustainalytics

SHANGHAI, Feb. 21, 2024 /PRNewswire/ — WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced it has been recognized as a 2024 Industry Top-Rated and Regional Top-Rated Company by Morningstar Sustainalytics’ Environmental, Social and Governance (ESG) Ratings, marking the fourth consecutive year the company has achieved this honor. Sustainalytics is a leading ESG data, research, and ratings firm that supports global investors with the development and implementation of responsible investment strategies. Its 2024 ESG Ratings cover more than 14,000 companies across 42 industries worldwide, with Top-Rated Badges given to those companies with the strongest ESG achievements. WuXi Biologics ranks in the top 2% of the nearly 1,000 companies assessed in the pharmaceutical sector. Dr. Chris Chen, WuXi Biologics CEO and Chairman of the ESG Committee, commented, “We are very pleased to once again receive this honor from Morningstar Sustainalytics, which is a strong ...
- Source: drugdu
- 129
- February 23, 2024
Pain-Free, Low-Cost, Sensitive, Radiation-Free Device Detects Breast Cancer in Urine

Currently, mammography is the standard method for breast cancer diagnosis, but it has several limitations. The primary concern with mammograms is their lack of infallibility. False negatives can occur when normal breast tissue conceals cancer, and false positives may arise from anomalies that resemble cancer but are benign, causing unnecessary anxiety for patients. Additionally, the radiation involved in these tests could potentially contribute to the development of cancer over time. Now, a pain-free, low-cost, sensitive, radiation-free device that can detect breast cancer in urine with a sensitivity of 88.33% could bring about a shift in the diagnostic approach toward this disease. The Blue Box Biomedical Solutions (Barcelona, Spain) has developed an affordable, user-friendly, and portable device that can detect breast cancer using a urine sample. This device, known as the Blue Box, employs an innovative eNose (electronic nose) to detect the smell of urine. It features a chemical sensor array ...
- Source: drugdu
- 144
- February 22, 2024
Wireless Hepatitis B Test Kit Completes Screening and Data Collection in One Step

Hepatitis B, a significant global health concern, is responsible for chronic liver diseases like cirrhosis and liver cancer which is one of the most common cancers worldwide. The challenge with hepatitis B is that most carriers are asymptomatic, remaining unaware of their infection, which can lead to its unintentional spread. Thus, early diagnosis is vital to halt the spread, initiate timely treatment, and reduce the risk of liver complications primarily caused by the hepatitis B virus. However, conventional tests for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) are complex, requiring specialized skills and large, expensive machine-based assays typically found in major hospitals. To overcome the problem of inadequate access to screening for Hepatitis B, researchers have developed a wireless, point-of-care test for the Hepatitis B Virus that can make diagnosis simpler and faster. Researchers from Chulalongkorn University (Bangkok, Thailand) have developed a testing kit that enables ...
- Source: drugdu
- 94
- February 22, 2024

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.