PHARMA TECH

Pfizer, BioNTech COVID-19 vaccine works in more contagious coronavirus variants

Pfizer | January 11, 2021

Newly emerged variants of the novel coronavirus have sparked a key question: Will existing COVID-19 vaccines be less effective against them? But scientists have preliminary data showing that may not be the case, at least for Pfizer and BioNTech’s shot.

Researchers from the University of Texas and Pfizer found that, in lab dishes, the vaccine was able to neutralize an engineered version of a variant, which bears an N501Y mutation in its spike protein. The finding was published in bioRxiv and hasn’t been peer-reviewed.

Variants of coronavirus with this mutation were first discovered in the U.K. and South Africa and immediately grabbed global attention because they are more contagious.
Currently available COVID vaccines—including Pfizer and BioNTech’s Comirnaty, or BNT162b2—target the spike protein of SARS-CoV-2, the coronavirus behind COVID-19. The N501Y mutation improves the ability of the virus’ spike protein to bind to its receptor on human cells, making it easier to gain entry for infection.

To test whether Comirnaty worked against the mutation, the scientists collected antibodies from 20 vaccinated trial participants and compared their ability to kill off the engineered virus with the N501Y mutation to their ability to neutralize the strain on which Pfizer and BioNTech based Comirnaty.

Spotlight

In pharmaceutical, biotech, and medical device industries, validation activities confirm that a system or process consistently achieves its objective.

Spotlight

In pharmaceutical, biotech, and medical device industries, validation activities confirm that a system or process consistently achieves its objective.

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PHARMA TECH

Eyenovia Announces $15 Million Credit Facility with Avenue Venture Debt Fund

Eyenovia, Inc. | November 30, 2022

Eyenovia, Inc. a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, announced that the company has entered into a $15 million credit facility with the Avenue Venture Opportunities Fund, L.P. The financing is intended to support manufacturing in anticipation of a MydCombi launch and clinical supply for ongoing programs. Per the terms of the agreement, Eyenovia received $10 million of gross proceeds at closing. The additional $5 million will be available, at the company’s option, should MydCombi™ be approved for marketing in the U.S. by the Food and Drug Administration by August 2023. The Avenue facility replaces the company’s Silicon Valley Bank facility, which was recently paid off. “We are pleased to have the support of Avenue through this credit facility at terms which create minimal dilution as compared to a traditional equity capital raise. Together with our existing cash on-hand, we expect the additional capital provided by this facility to fund our operations through at least late 2023 or early 2024, or through value creating milestones, including the potential approval of MydCombi™ and preparations for the possible submission of a New Drug Application for our novel presbyopia treatment, MicroLine™.” Michael Rowe, chief executive officer of Eyenovia “We are pleased to provide this financing to Eyenovia as we believe its Optejet dispensing technology truly differentiates the company from its peers and offers great potential across a broad range of high value ophthalmic indications,” stated Chad Norman, Senior Portfolio Manager of the Avenue Venture Debt Fund. Eyenovia’s current pro-forma unrestricted cash balance, including approximately $9.5 million of net proceeds from this facility, is approximately $25.5 million. About Eyenovia, Inc. Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression. About Avenue Venture Opportunities The Avenue Venture Debt Fund seeks to provide creative financing solutions to high-growth, venture capital-backed technology and life science companies. The Avenue Venture Debt Opportunities Fund focuses generally on companies within the underserved segment of the market created by the widening financing gap between commercial banks and larger debt funds. The Avenue Venture Debt fund is part of the larger group of funds of Avenue Capital Group. For additional information on Avenue Capital Group, which is a global investment firm with assets estimated to be approximately $12.3 billion as of October 31, 2022.

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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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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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