Covectra Announces VRS For Pharmaceutical Manufacturers To Enhance Drug Supply Chain Security

Covectra | June 22, 2020

Covectra, a leader in track and trace solutions, today announced the Covectra Verification Router Service (VRS), a complete API solution enabling pharmaceutical brands to validate the status of a returned product to ascertain its resell ability and ensure regulatory compliance with the upcoming Drug Supply Chain and Security Act (DSCSA) saleable returns requirement.

In November 2020, the FDA enforcement will begin as pharmaceutical distributors of regulated medicines will need to be compliant - or at least on a path to compliance - for the DSCSA saleable returns verification requirement. Implementation of these requirements is intended to enable the U.S. Food and Drug Administration (FDA) to better protect consumers from counterfeit, contaminated, or stolen drugs, and better detect and remove such drugs from the U.S. pharmaceutical supply chain. Wholesalers and distributors will need to verify the unique identifier of returned products before these can be placed into inventory for resale.

Spotlight

Welcome to Pharmaprojects’ 2023 review of trends in pharmaceutical R&D. For over 30 years now, I’ve been taking an annual look at the evolution of pharma R&D, and in this article, I’llexamine the state of play at the start of 2023.

Spotlight

Welcome to Pharmaprojects’ 2023 review of trends in pharmaceutical R&D. For over 30 years now, I’ve been taking an annual look at the evolution of pharma R&D, and in this article, I’llexamine the state of play at the start of 2023.

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PHARMACY MARKET

Mednow Announces Partnership With Medcan Health Management Inc. to Deliver Collaborative, Interdisciplinary Healthcare

businesswire | May 18, 2023

Mednow Inc Canada’s on-demand virtual pharmacy has been named the preferred virtual pharmacy partner for Medcan Health Management Inc. and its valued clients. Mednow is focused on improving the delivery of pharmacy services in Canada through digitization to provide better patient access to pharmacists, doctors and other healthcare professionals. Mednow offers instant access to pharmacists in the Mednow app or on the phone and offers fast, free delivery of prescription medication. “At Medcan, we’re always striving to bring our valued clients the highest level of service and incredible level of care through integrated, comprehensive and convenient health and wellness services, including ensuring they have easy access to a premium pharmacy experience,” said Shaun Francis, CEO and Chair of Medcan. “By partnering with Mednow, our Medcan clients will not only have a new option to get their prescription medications, over the counter products or supplements, but also the added benefit of always-on access to knowledgeable pharmacists who can help ensure they’re taking medications correctly,” said Francis. “Mednow is proud to partner with Medcan, a pioneer in high quality healthcare in Canada and an ideal partner to work with to reduce care fragmentation and enhance collaboration between our two healthcare professions,” said Ali Reyhany, CEO and Co-Founder of Mednow. “Our proprietary technology provides seamless access to our pharmacy team, which deploys the latest health technologies and best practices in pharmacy to optimize patient care. Texting your pharmacist, automatic refill reminders and the availability of Pillsmart™ medication packs are just some of the ways Mednow can help Medcan’s mutual patients,” said Reyhany. About Mednow Mednow is a healthcare technology company offering virtual access with a high-standard of care. Designed with accessibility and quality of care in mind, Mednow provides virtual pharmacy and telemedicine services as well as doctor home visits through an interdisciplinary approach to healthcare that is focused on the patient experience. Mednow’s services include free at-home delivery of medications, doctor consultations, a user- friendly interface for easy upload, transfer, and refill of prescriptions, access to healthcare professionals through an intuitive chat experience and the specialized PillSmart™ system that packages prescriptions in easy-to-use daily dose packs, each labelled with the date and time of the next dose.

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BUSINESS INSIGHTS, PHARMACY MARKET

Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-323, its Oral, L-Protein Inhibitor in Development

Businesswire | April 10, 2023

Enanta Pharmaceuticals, Inc. a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-323, Enanta’s L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV). "Receiving Fast Track designation from the FDA underscores EDP-323’s potential as a once-daily, oral therapeutic for the treatment of this deadly virus and reflects the pressing need for a highly potent, direct antiviral to treat RSV, particularly for high-risk populations,” said Scott T. Rottinghaus, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. “Given that EDP-323 has shown sub-nanomolar potency against several RSV-A and RSV-B strains in vitro and is not expected to have cross-resistance to other classes of inhibitors, we believe it could be used as a monotherapy or in combination with other RSV mechanisms to potentially broaden the addressable RSV patient populations or the treatment window. We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.” The Fast Track program is designed to accelerate the development and review of products such as EDP-323, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation enables more frequent communication with the FDA and eligibility for FDA programs such as priority review and rolling review, if relevant criteria are met. EDP-323 is being evaluated in a Phase 1 double-blind, placebo-controlled study designed to assess its safety, tolerability, and pharmacokinetics (PK). Enanta plans to present new preclinical PK data at the European Congress of Clinical Microbiology and Infectious Diseases in April and expects to report topline data from the Phase 1 study this quarter. EDP-323 is supported by in vitro data demonstrating a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B, with consistent potency across a range of RSV clinical isolates in various cell types. In a mouse model of RSV infection, EDP-323 treatment was associated with dose-dependent decreases in viral load in the lung, reduced lung immunopathology and decreases in pro-inflammatory cytokines, including IFNγ, TNFα, and IL1β. Additionally, EDP-323 has favorable oral bioavailability with good plasma exposures across preclinical species and pharmacokinetic properties supporting once-daily, oral dosing in humans. These data indicate that EDP-323 is a potent inhibitor of RSV replication and has the potential to be a best-in-class, once daily, oral antiviral treatment for RSV. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections. Enanta’s research and development programs include clinical candidates for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 and hepatitis B virus. Enanta is also conducting research on a single agent targeting both RSV and human metapneumovirus.

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BUSINESS INSIGHTS, PHARMACY MARKET

Aquestive Therapeutics Expands License and Supply Agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film to Additional Global Markets

Globenewswire | March 30, 2023

Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced it has expanded its exclusive license and supply agreement with Atnahs Pharma UK Limited (“Pharmanovia”), a global pharmaceutical company that revitalizes, extends and expands the lifecycle of established medicines, for Libervant™ Buccal Film to cover the rest of the world, excluding the United States, Canada, and China. The original licensing agreement with Pharmanovia announced in September 2022 covered the European Union, United Kingdom, Sweden, Switzerland, and Norway, as well as countries in the Middle East and North Africa (MENA). “We are pleased to announce the expansion of our collaboration with Pharmanovia,” said Daniel Barber, Chief Executive Officer of Aquestive. “We believe Pharmanovia’s experience and geographic footprint align well with our goal of providing patients throughout the world with access to Libervant. This announcement also aligns with our mission to put the patient at the center of everything we do. We will continue to advocate for patient access, patient choice, and patient empowerment on a global basis.” Pharmanovia CEO, James Burt, commented, “Following a strong start to our collaboration with Aquestive Therapeutics, we’ve expanded our agreement to include many more territories. Our experience with diazepam marketed under an established brand in Valium®, combined with Aquestive Therapeutics’ unique PharmFilm® technology, provides a potentially significant delivery option to caregivers and patients in times of critical need and enables us to optimize an existing medicine to better meet the needs of patients, healthcare professionals and payors.” Pursuant to the expanded agreement, Aquestive Therapeutics will serve as the exclusive sole manufacturer and supplier for the product and Pharmanovia will be responsible for all regulatory and commercialization activities. Aquestive will receive an undisclosed upfront payment and, if approved for market access, milestone payments, and double-digit royalties on net sales of the diazepam buccal film in the licensed territories. About Aquestive Therapeutics Aquestive Therapeutics, Inc. is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

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