J&J eyes Darzalex convenience, safety boost with subcutaneous win

fiercepharma | June 03, 2019

J&J eyes Darzalex convenience, safety boost with subcutaneous win
Right now, the first infusion of Johnson & Johnson multiple myeloma fighter Darzalex can take between seven and eight hours. But data on a new formulation could be a game changer. At the American Society of Clinical Oncology annual meeting, the New Jersey drugmaker trumpeted results from a phase 3 study showing that a subcutaneous form of Darzalex could measure up to the original and with an average injection time of just five minutes. At a median 7.5 months of follow-up, 41% of patients in the head-to-head study which enrolled relapsed or refractory patients had seen benefits after receiving the subcutaneous drug, while 37% of those taking the infused drug could say the same. And without skimping on efficacy, subcutaneous Darzalex recorded a big win, too. Only 12.7% of patients receiving the subcutaneous drug experienced infusion-related side effects a big drop from the 34.5% of patients in the control group who reported them. Majorly cutting down on the time it takes to administer Darzalex could help not just patients, but healthcare providers, too, Tendler said. There are “a lot of nursing staff and personnel that are watching the patient closely with the first infusion,” he said. And if that first dose can wrap up in three to five minutes, “you could free up resources in the office for other things.”As Credit Suisse analyst Vamil Divan pointed out in a note to clients, though, post-administration reactions took longer to show up in subcutaneous patients, with average onset times of 3.6 hours versus 1.5 hours meaning additional monitoring may still be required. “The [new formula] should help address the prolonged infusion time that is needed for the IV formulation, although it was noted in the discussion that for the first subcutaneous dose an observation time of about 3-4 hours may still be needed,” he wrote.

Spotlight

Over the past two years, the pharmacy industry has seen unprecedented increases in the prices of generic drugs, causing unexpected cost increases for payers and consumers, and spurring an investigation by the United States Congress. High generic drug prices have had an adverse effect on almost everyone in the pharmaceutical supply chain. Consumers face higher co-pays and prices and health plans are dealing with higher drug spend. Physicians are finding the need to prescribe alternative drug therapies while dealing with angry patients.

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Karo Pharma acquires OTC brand portfolio from Teva Pharmaceuticals

Karo Pharma, Teva Pharmaceuticals | February 04, 2021

Karo Pharma Aktiebolag ("Karo") today reports the securing of an OTC brand portfolio containing Flux®, Decubal®, Lactocare®, Apobase®, Dailycare® and Fludent® from Teva Pharmaceuticals (Teva) for an absolute thought of EUR 84m. The exchange moves responsibility for brand portfolio, included Flux®, Decubal®, Lactocare®, Apobase®, Dailycare® and Fludent® from Teva to Karo. The brands created deals barely shy of EUR 35m in 2020 on a worldwide premise. The greater part is created in the Nordic business sectors, including Scandinavia, where the brands as of now are dispersed and showcased by Karo under a 7-year permit arrangement that was endorsed in the spring of 2019. The exchange adds around EUR 4m in net deals from new business sectors outside of Scandinavia of which approx. 80% is in Finland. The exchange disentangles the business set-up and gives Karo control of the resources, in this way preparing for long haul advancement of the brands and the worth chain. As far as monetary effect Karo will acknowledge direct investment funds in year 1 of simply under EUR 5m as expenses to Teva are disposed of. Karo as of now popularizes the items in Scandinavia and has dynamic associations with the agreement manufacturers that supply the brands. Subsequently, restricted added expenses and faculty are needed as an immediate aftereffect of the exchange. "The transaction is in full alignment with our strategy of owning and commercializing strong OTC brands within everyday healthcare. It gives us full global control of a very exciting brand portfolio that we will develop and optimize over the next years. It strengthens our position in the Nordic markets and notably it expands our business in Finland where we did not previously control these brands. Over the next years we shall expand life cycle management opportunities, drive activation across more channels and explore geographical market expansion", says Christoffer Lorenzen, CEO of Karo Pharma. The obtaining is an unadulterated resource bargain. No staff or assembling locales are incorporated, which limits business just as the innovation move chances. The exchange, which is financed with existing money and requires no extra credit facilities, is relied upon to close on April 1. About Karo Pharma Karo Pharma delivers smart choices for everyday healthcare. We own and commercialize branded, original over-the-counter products and prescription medicines. Our products are available in more than 60 countries, with Europe and the Nordic region as our core markets. Karo Pharma is headquartered in Stockholm, Sweden and listed on Nasdaq Stockholm Mid Cap.

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IQVIA and NRx Pharmaceuticals Collaborate on Potential Medical Support for Novel COVID-19 Treatment

IQVIA™ | September 14, 2021

IQVIA™ , a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry, today announced a transformative collaboration with NRx Pharmaceuticals (NRx). NRx is a company dedicated to creating innovative, life-saving treatments and bringing hope to those facing life-altering conditions with no approved disease-modifying therapies or cures. IQVIA is excited to collaborate with NRx as its designated partner, to provide pharmacovigilance services and medical information in preparation for potential regulatory actions. "As the world suffers yet another surge of COVID-19, thousands of patients require intensive care and too many succumb to this virus. New medicines with new mechanisms of action are urgently needed," said Robert Besthof, chief commercial officer and head of Operations of NRx. "As a small biopharma company preparing to launch a lifesaving medicine across multiple countries, we deeply appreciate the global reach that IQVIA is able to offer in support of patients, families, and those who care for them.” This collaboration will allow NRx to access IQVIA’s domain experience with COVID-19, our unparalleled data assets, and analytics to support potential emergency use authorization (EUA) of ZYESAMI. IQVIA will work closely with NRx to support key activities required for EUA activation, including the pharmacovigilance and medical information programs. “We are honored by the opportunity to join with NRx on the EUA activation and compliance for ZYESAMI in treating some of the sickest patients suffering from COVID-19,” said Susan Kitlas, vice president, Precommercial Business Unit, IQVIA. “IQVIA’s experience and expertise within the COVID-19 market will be a valuable component in helping make this treatment more widely available.” About NRx NRx Pharmaceuticals draws upon more than 300 combined years of scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. About IQVIA IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 74,000 employees, IQVIA conducts operations in more than 100 countries. IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures.

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CEM Corporation and AmbioPharm enter into US partnership for GMP peptide production

CEM Corporation | September 16, 2021

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Spotlight

Over the past two years, the pharmacy industry has seen unprecedented increases in the prices of generic drugs, causing unexpected cost increases for payers and consumers, and spurring an investigation by the United States Congress. High generic drug prices have had an adverse effect on almost everyone in the pharmaceutical supply chain. Consumers face higher co-pays and prices and health plans are dealing with higher drug spend. Physicians are finding the need to prescribe alternative drug therapies while dealing with angry patients.