Search Results for “EC” – Page 61 – media

Roche exec says more pull incentives are needed to tackle AMR

“Pull incentives such as high cost of therapy and longer exclusivity periods, similar to those granted for orphan drugs, are needed to promote the development of new antimicrobials” says Severin Schwan, chairman of the board of directors of Roche. Schwan was speaking about the threat of antimicrobial resistance (AMR) at the World Economic Forum Annual Meeting taking place from 15–19 January 2024 in Davos, Switzerland. Shyam Bishen, head of the Centre for Health and Healthcare at the World Economic Forum, noted at the same discussion that AMR is the third leading cause of death globally and is forecasted to be responsible for 10 million deaths annually in 2050. Schwan said most companies have left the antimicrobial sector as they perceive that there is no sustainable business model. “The research and development subsidiaries offered by various governments to develop antimicrobials are a waste of money and are not worth it to ...
- Source: drugdu
- 157
- January 18, 2024
Shanghai Serum Bio-technology Co., Ltd. voluntarily discloses the announcement of obtaining the ethical review approval for Phase II clinical trial of Anti-Viper Venom Serum

Shanghai Serum Bio-technology Co., Ltd. (hereinafter referred to as the “Company”) has passed the approval of the Medical Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University, the lead organization of the Phase II Clinical Study of Anti-Viper Venom Serum Injection, and obtained the ethical review approval document. The relevant information is announced as follows: The results of the completed Phase I clinical trial study of Anti-Viper Venom Serum Injection (Registration No. CRT20202621) showed that good safety and tolerability were observed in healthy subjects given different dose groups of Anti-Viper Venom Serum. The results of drug dose, drug concentration, and correlation analysis with effect indicated that the efficacy of the anti-viper venom serum (ability to neutralize viper venom in vitro) was well correlated and dependent on the dose of the test drug administered, and the concentration of the drug in the blood. Based on the positive safety results ...
- Source: drugdu
- 129
- January 18, 2024
Announcement of Changchun Hi-Tech Industrial (Group) Co., Ltd. on the Acquisition of FDA Implied License for Clinical Trials of Drugs by its Controlling Subsidiary

According to the relevant rules of the U.S. Food and Drug Administration (hereinafter referred to as “FDA”), Changchun Hi-Tech Industrial (Group) Co. (hereinafter referred to as “GenSci”) will carry out Phase I clinical trials in the United States for GenSci125 for injection (IND No. 168162), and the relevant information is hereby announced as follows: The Company had issued the ”Announcement on the Approval of the Application for Clinical Trial of GenSci125 for Injection by the Controlling Subsidiary” (Announcement No. 2023-096) on December 15, 2023, obtaining the ”Notification of Approval for Clinical Trial of Drugs” by the State Drug Administration of the PRC in respect of the project of GenSci125 for injection and agreeing to carry out the clinical trial. On December 15, 2023, GenSci obtained the IND confirmation letter from FDA. According to the requirements of the letter, there is an implied license period of 30 days after the receipt ...
- Source: drugdu
- 179
- January 18, 2024
Cerebrospinal Fluid Testing of Alzheimer’s Patients to Help Identify Disease Molecular Subtype

Scientists have made a significant discovery by identifying five distinct biological variants of Alzheimer’s disease, each potentially requiring unique therapeutic approaches. This finding suggests that drugs previously tested for Alzheimer’s might have been wrongly deemed ineffective or only slightly beneficial due to these variants being unaccounted for. At the core of Alzheimer’s disease is the accumulation of amyloid and tau proteins in the brain. However, this aggregation is just one aspect of the disease’s complexity. Researchers, including those from Amsterdam UMC (Amsterdam, Netherlands), have employed innovative methods to analyze additional biological processes involved in Alzheimer’s. These processes, which include inflammation and the growth of nerve cells, were studied through the measurement of various biomarkers in the cerebrospinal fluid of patients exhibiting amyloid and tau accumulations. In their analysis of the cerebrospinal fluid of 419 individuals diagnosed with Alzheimer’s, the researchers assessed 1,058 proteins and identified five distinct biological subtypes within ...
- Source: drugdu
- 161
- January 17, 2024
Genetic Medicines Biotech Dyne Pulls In $345M for Clinical Tests of Muscle Drugs

Dyne Therapeutics recently reported encouraging Phase 1/2 clinical data in myotonic dystrophy type 1 and Duchenne muscular dystrophy. At the J.P. Morgan Healthcare Conference, CEO Joshua Brumm said Dyne’s existing cash combined with the new capital is expected to last through 2025—well beyond the next key milestones for both therapeutic candidates. By FRANK VINLUAN Dyne Therapeutics started the new year with proof-of-concept clinical data for experimental genetic medicines addressing two rare muscle diseases—one of which has no FDA-approved treatments. Now the biotech has $345 million as it looks toward key tests for both therapies. Ahead of the Martin Luther King Jr. holiday weekend, Dyne closed a stock offering of 19.7 million shares priced at $17.50 each. In the prospectus, Dyne said the net proceeds of the stock offering will be combined with its existing capital to fund ongoing clinical development of the two clinical-stage programs, DYNE-101 and DYNE-251. Dyne CEO ...
- Source: drugdu
- 136
- January 17, 2024
CanSinoBio voluntarily disclosed the announcement on the recombinant polio vaccine initiating Phase I clinical trial in Australia and completing the enrollment of the first subject.

(“CanSinoBio” or the “Company”) has recently initiated a Phase I clinical trial of its recombinant polio vaccine in Australia and has completed the enrollment of the first subject. The Company has completed the clinical trial filing with the Therapeutic Goods Administration (TGA) under the Department of Health of Australia, and the vaccine has received ethical approval for the clinical trial from the Australian Human Research Ethics Committee prior to the filing of the clinical trial protocol. The Company’s virus-like particle (VLP)-based recombinant polio vaccine, which is based on the Company’s protein structure design and VLP assembly technology, is expected to contribute to the global control and eradication of polio. The recombinant polio vaccine is a non-infectious polio vaccine that does not rely on live viruses in the production process and is expected to have good safety and immunogenicity. Unlike the marketed attenuated and inactivated polio vaccines, the non-infectious VLP polio ...
- Source: drugdu
- 105
- January 17, 2024
CAR-T hype faces infrastructure reality check

Since the FDA approved the first CAR-T therapy back in August 2017, high prices, small patients pools and limited manufacturing capacity have at times hindered these cell-based treatments. As biopharma companies clear those hurdles, a larger, more systemic problem now threatens the drug class. Six CAR-T therapies targeting either CD19 or BCMA have reached the U.S. market to treat various blood cancers. Impressive efficacy data, wide reimbursement acceptance, earlier-line approvals and steady production expansions have fueled blockbuster revenue predictions. But drug developers and Wall Street may have underestimated the bottlenecks from the healthcare infrastructure needed to deliver a cell therapy, Leerink Partners analyst Daina Graybosch, Ph.D., warns. CAR-T therapies are indeed on a fast trajectory of growth. By 2027, when the drug class celebrates its first decennial anniversary, Johnson & Johnson expects its Legend Biotech-partnered Carvykti—the last of the six existing CAR-T products to hit the market—will have reached about ...
- Source: drugdu
- 295
- January 17, 2024
Pfizer’s eye for China ADC deals; Astellas’ gastric cancer rejection

Pfizer is still hungry for ADC opportunities, including in the Far East. Astellas’ impressive phase 3 data for its gastric cancer candidate couldn’t garner an approval because of manufacturing issues. Takeda’s 2022 TYK2 buy from Nimbus was highly competitive, an exec said. And more. 1. JPM24: Even after Seagen buyout, Pfizer oncology chief still eyes ADC deals As Pfizer continues its prowl for antibody-drug conjugate (ADCs) deals, the company is keeping an eye on opportunities around the globe. In an interview, Pfizer’s new oncology chief Chris Boshoff, Ph.D., said the company is looking for opportunities in China, which he said “is important in this whole area, especially ADC development.” The company is “not currently looking for big acquisitions,” Boshoff added. 2. Astellas’ gastric cancer candidate rejected by FDA because of manufacturing issues After running two phase 3 trials, Astellas’ near-term approval ambitions for its zolbetuximab have been dashed because of ...
- Source: drugdu
- 137
- January 17, 2024
Benchtop Analyzer Promises 1-Hour UTI Detection and Antibiotic Sensitivity Indication

More than 400 million cases of urinary tract infections (UTIs) are reported every year across the world. The gold standard for diagnosing UTIs and planning a treatment course depends on rapid dipstick tests and clinical diagnostic analysis. However, dipsticks have low specificity and can yield false positives, resulting in the overuse of antibiotics. Additionally, clinical tests have a lengthy turnaround time and offer 80% accuracy, resulting in physicians opting for the wrong course of treatment. Now, a benchtop analyzer with the ability to accurately identify the causative bug and the right antibiotic in under an hour could be a game changer for UTI diagnosis. Astek Diagnostics (Baltimore, MD, USA) is developing the JIDDU benchtop analyzer to improve UTI diagnosis through rapid, one-hour turnaround times and an unprecedented 96% accuracy. Leveraging a novel method for antibiotic susceptibility testing (AST), JIDDU rapidly detects bacterial infections in urine samples, assesses infection severity, and ...
- Source: drugdu
- 146
- January 16, 2024
3M Health receives grant to develop wound treatment solutions in US

3M Health Care’s Medical Solutions Division has received a $34.2m award to improve the treatment of traumatic wounds from point of injury to hospital. Provided by the US Army Medical Research Acquisition Activity, the funding will enable 3M to spearhead a programme that focuses on treatment strategies to be used in harsh settings, especially those related to delayed evacuation situations and mass casualties – the development of which is a Department of Defense Combat Casualty Care Capability Assessment objective. The programme’s scope includes developing solutions for infection prevention, wound management and healing. It will support the development of four product solutions, encompassing prototype creation, formulation development and the completion of two clinical studies for product registration. 3M’s collaboration involves partners such as the University of Minnesota Medical School, the 59th Medical Wing Science and Technology Office of the Chief Scientist, the Naval Medical Research Unit, San Antonio, and the University ...
- Source: drugdu
- 177
- January 15, 2024

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