RESEARCH

GenScript Receives FDA Emergency Use Authorization for World's First SARS-CoV-2 Neutralizing Antibody Detection Kit

GenScript | November 09, 2020

GenScript USA Inc., the world's leading research reagent provider, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first commercially available test to specifically detect neutralizing antibodies without the use of live virus. Neutralizing antibodies, a subset of antibodies that are specifically able to block the ability of the virus to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in any sample, from those from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2.

Spotlight

Initiated in 2009, Hunan Beyond Medical Technology Co., Ltd. (Beyond for short) , based in Yuelu District, Changsha with the registration capital of 30.48 million RMB, is dedicated to R&D, manufacturing, marketing and service of product solutions in medical healthcare industry.

Spotlight

Initiated in 2009, Hunan Beyond Medical Technology Co., Ltd. (Beyond for short) , based in Yuelu District, Changsha with the registration capital of 30.48 million RMB, is dedicated to R&D, manufacturing, marketing and service of product solutions in medical healthcare industry.

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PHARMACY MARKET, PHARMA TECH

Prescryptive Health Partners with Lilly on First-to-Market Value-Based Program to Stabilize Insulin Pricing

Prescryptive Health | December 16, 2022

Prescryptive Health, a healthcare technology company on a mission to rewrite the script for the U.S. pharmaceutical market, today announced a partnership with Eli Lilly and Company on a new and first-to-market subscription model to help lower costs for people who pay for their Lilly insulin through their employer-sponsored benefits. Through a flat, per-member, per-month subscription fee, employers can offer insulin to their employees with predictable, affordable, and transparent costs. This unique value-based program is designed to create price stability related to insulin utilization, with Lilly refunding a portion of the subscription fee if an employer's total medical spend increases over time for their employees who live with diabetes. "We are proud to partner with Lilly on this unique and first-to-market value-based program. This solution challenges the traditional drug pricing model and reduces the burden on employers who sponsor pharmacy benefits. The result is that it insulates employers against increased drug prices and aligns interests to focus on patient access and health outcomes." Chris Blackley, Prescryptive Health CEO This new program can help address controversial rebates in the pharmacy benefit manager pricing model and will be available through Prescryptive free of any margin or price mark-up, further reducing the cost to employers, health plans, and ultimately healthcare consumers. Additionally, the program offers opportunities for employers to supply insulin at lower costs, or at no cost, to their employees. Added benefits for employers participating in the program include the Prescryptive mobile experience that supports patient engagement and adherence for diabetes care. "In the U.S., more than 34 million people have diabetes, and some people who have employer-based insurance still need affordability solutions to ensure they don't pay too much out-of-pocket for their insulin," said Mike Mason, President, Lilly Diabetes. "At Lilly, we strive to provide new solutions to help lower costs at the pharmacy, including partnering with Prescryptive Health to ensure people with diabetes have access to affordable options to help them reach their treatment goals." According to the American Diabetes Association people with diagnosed diabetes spend about 2.3 times more on medical costs than those without diabetes, which impacts not only every individual patient and plan member, but also employers who sponsor their benefits coverage. Additionally, costs related to the condition include $3.3 billion in increased absenteeism. About Prescryptive Health Prescryptive Health is a healthcare technology company delivering solutions that empower consumers. Prescryptive's secure, mobile-first products connect consumers, pharmacists, and employers, ultimately providing people with the information they need to make informed decisions and take control of their health.

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BUSINESS INSIGHTS, PHARMACY MARKET

VERO Biotech Announces FDA Approval for Its Second-gen GENOSYL DS

VERO Biotech | February 03, 2023

On February 2, 2023, VERO Biotech Inc., a commercial-stage biotechnology company focused on neonatal intensive care and the acute care hospital community, announced that FDA has approved its innovative second-generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use in the operating room with rebreathing anesthesia. The second generation GENOSYL® DS is now the first and only iNO delivery device approved for use in both rebreathing and non-rebreathing anesthesia procedures, enhancing patient care, saving money for the hospital, and minimizing waste anesthetic gas pollution. GENOSYL® DS is the first tankless inhaled nitric oxide delivery system. Nitric oxide, when inhaled, dilates the pulmonary blood vessels and can improve oxygenation in neonates suffering from hypoxic respiratory failure and pulmonary hypertension. GENOSYL® DS, unlike tank-based systems, generates and delivers iNO at the bedside via a small disposable cassette. This helps eliminate the need for hospitals to manage large, cumbersome tanks while also aiding in the simplification of clinical workflow. The following are the expected advantages of the second generation GENOSYL® DS Ability to employ rebreathing anesthesia: Rebreathing allows reduced gas flows, resulting in less usage of expensive anesthetic drugs, thereby reducing hospital costs; enhanced patient comfort (by preserving patient body temperature and moisture). Smoother care process: seamless iNO delivery from the ICU to surgery and post-operative care leads to process and workflow enhancements for the healthcare organization, thus lowering the hospital's overall cost. Set and forget: It allows anesthesiologists to continue using rebreathing anesthesia, thereby preventing potentially dangerous, time-consuming and cumbersome workarounds. Reduced ecological consequences of anesthesia delivery: less anesthetic is released into the environment. It is important to note that FDA has only approved the second generation GENOSYL® DS for use with rebreathing anesthesia in the surgical suite. The third generation GENOSYL® DS, which was recently approved, has not been tested with rebreathing anesthesia. VERO Biotech is currently conducting similar validations and expects to have data available in the first quarter of 2023. About VERO Biotech Headquartered in Atlanta, GA, VERO Biotech is an emerging biotechnology firm that focuses on designing, developing, and commercializing next-generation inhaled nitric oxide (NO) delivery systems to tackle unmet medical needs in patients with cardiopulmonary conditions. The company's mission is to improve patients' lives by pioneering innovative technologies for inhaled NO delivery in acute care hospitals and beyond, wherever nitric oxide treatment is required. By focusing on the science, development, and commercialization of its innovations, it aims to exceed customer expectations regarding safety, efficacy, and growth.

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PHARMA TECH

Additional US$ 4 Million Received for Next Development Steps of MedinCell's 6-Month Active Injectable Bioresorbable Subcutaneous Contraceptive

MedinCell | December 01, 2022

MedinCell has received an additional US$ 4 million payment from the Bill & Melinda Gates Foundation This amount is intended to finance the next steps of MedinCell’s program mdc-WWM in readiness to initiate the first clinical trial end of 2023 It follows US$ 11,8 million already received as part of the two successive grants for a total of up to US$ 22,5 million from the Bill & Melinda Gates Foundation to finance the development of the program up to phase 1 completion The Gates Foundation has a non-exclusive license on the product for the purposes of achieving Global Access in the target low-and middle-income countries, whilst MedinCell owns all marketing rights worldwide About MedinCell MedinCell is a pharmaceutical company at premarketing stage that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.

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