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

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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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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BUSINESS INSIGHTS, PHARMA TECH

Koneksa Starts Trial Comparing At-home Mobile Spirometry to In-clinic Spirometry

Koneksa | January 18, 2023

On January 17, 2023, Koneksa, a healthcare technology company that develops evidence-based validated digital biomarkers, announced the beginning of a clinical study that will compare the treatment effect of at-home mobile spirometry using digital biomarkers versus in-clinic spirometry in patients who have moderate asthma and are receiving long-acting beta-agonist (LABA) treatment. The LEARN study is a single-arm interventional trial that compares the identification of treatment effects in people with moderate asthma using at-home mobile spirometry by utilizing an ultrasonic spirometer and a smartphone compared to in-clinic spirometry. Up to 60 people with mild, uncontrolled asthma who already use inhaled corticosteroids (ICS) will take part in the study. Besides, it will also cover those who need to take LABA medication for a six-week treatment period. In-clinic spirometry can be performed at home with the same or higher accuracy compared to in-clinic and potentially less strain on the patient. The study will analyze the LABA treatment impact in clinic and mobile spirometry along with assessing the association between different readouts of mobile spirometry, in addition to evaluating asthma control as determined by the ACQ-6, a patient-reported outcome questionnaire. Other goals include assessing patient and site-specific satisfaction with mobile spirometry technology. Chris Benko, CEO & Founder, Koneksa, stated, “This study builds on Koneksa's prior work demonstrating that mobile spirometry has the potential to detect clinically meaningful changes in very small cohorts of asthma patients on standard of care.” He further added, “The LEARN study will evaluate whether at-home mobile spirometry can detect treatment effects of a known positive control (LABA) in a significantly smaller population than would traditionally be assumed for an in-clinic proof-of-concept study.” (Source – Business Wire) About Koneksa Based out of New York, Koneksa is a patient-centric digital biomarker firm that develops end-to-end solutions for remotely obtained clinical data to expedite clinical research and guide decision-making in drug development and market strategy for the pharmaceutical and biotechnology industries. It seeks to revolutionize effect detection in clinical research by providing integrated solutions for efficient trial designs that yield more meaningful data. Its evidence-based biomarker solutions allow for more efficient clinical trial designs, allowing novel medicines to reach patients sooner.

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Citius Pharmaceuticals, Inc. Secures $3.6 million through New Jersey Economic Development Program

Citius Pharmaceuticals, Inc. | November 22, 2022

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