Indiviors former parent ponies up a whopping $1.4B to settle Suboxone marketing probe

fiercepharma | July 11, 2019

With the feds sniffing around Indiviors aggressive marketing of its opioid addiction treatment Suboxone, the forecast looked bleak for the drugmaker. The stink was bad enough that Indivior’s former parent company is paying a steep price to clear its name—to the tune of $1.4 billion. Reckitt Benckiser settled with the Justice Department and Federal Trade Commission for $1.4 billion Thursday to end multiple federal probes into an alleged scheme to push sales of the opioid addiction treatment Suboxone Film. The payout ranks as one of the largest in recent memory for pharma marketing, with only a handful of drugmakers ever having paid billion-dollar settlements. The single largest settlement on record was GlaxoSmithKline's criminal and civil payout of $3 billion in 2012, with the most recent seven-figure check signed by Teva in 2015 for $1.2 billion. Reckitt's settlement only covers allegations dating to the period before Indivior's 2014 spinoff, Indivior said in a statement. Reckitt was not directly named in the feds' criminal investigation, and prosecutors are still investigating Indivior’s own marketing of Suboxone. The company was indicted on criminal charges in April. “While RB has acted lawfully at all times and expressly denies all allegations that it engaged in any wrongful conduct, after careful consideration, the Board of RB determined that the agreement is in the best interests of the company and its shareholders,” the company said in a statement. While the settlement could represent a “high-water mark” for a possible payout from Indivior, the Suboxone maker will likely fight its case in court, which could take years, Jefferies analysts said in a note to investors Thursday.

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Spotlight

Side effects of asthma medications do not just stop taking your medication. Stopping your medication cause you more problems than any side effects, and could lead to an asthma attack here are some more compilation of topics and latest discussions relate to this video, which we found through the internet.

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CareRx Applauds Ontario Ministry of Health's Pause of Planned Fee Changes

CareRx | January 18, 2021

CareRx Corporation ("CareRx" or the "Company") (TSX: CRRX), Canada's leading provider of specialty pharmacy services to seniors, is pleased that the Ontario Ministry of Health has announced that it will pause for one year previously scheduled changes to long-term care pharmacy funding, which were scheduled to go into effect on April 1, 2021. Under certain amendments to the Ontario Drug Benefit Act that came into effect on January 1, 2020, the reimbursement model for long-term care pharmacies in Ontario was changed from a fee-for-service model to a fee-per-bed capitation model under which pharmacies receive a fixed professional fee for all pharmacy services provided to residents in long-term care homes. The fee for 2020, which was prescribed at $1,500, was scheduled to decline to $1,400 per bed serviced on April 1, 2021. The step-down in capitation has now been paused until April 1, 2022. "Long-term care homes and their staff have faced unprecedented challenges during COVID-19," said David Murphy, President and Chief Executive Officer of CareRx. "This pause will ensure that pharmacies like CareRx can continue to deliver the same exceptional partnership and service offering to long-term care homes and help alleviate the burden COVID-19 has placed on home staff. We want to thank Minister Elliott, Minister Fullerton and the Ontario Government for their ongoing dialogue and commitment to protecting the wellbeing of residents in long-term care." About CareRx Corporation CareRx is Canada's leading provider of specialty pharmacy services to seniors. We serve approximately 50,000 residents in over 900 seniors and other communities (long-term care homes, retirement homes, assisted living facilities, and group homes). We are a national organization with a large network of pharmacy fulfillment centres strategically located across the country. This allows us to deliver medications in a timely and cost-effective manner and quickly respond to routine changes in medication management. We use best-in-class technology that automates the preparation and verification of multi-dose compliance packaging of medication, providing the highest levels of safety and adherence for individuals with complex medication regimes. We take an active role in working with our home operator partners to promote resident health, staff education, and medication system quality and efficiency.

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BUSINESS INSIGHTS

With Veeva eConsent, Celerion is changing the consent experience for clinics and patients

Veeva Systems | October 07, 2021

Veeva Systems (NYSE: VEEV ) announced that Celerion has launched Veeva eConsent , a MyVeeva for Patients solution, to provide electronic consent for its Phase I clinical trials obtain. With Veeva eConsent, Celerion is moving from manual and paper-based consent forms to a fully digital process. The company uses Veeva eConsent for several studies and has already given their consent to more than 200 test subjects. Covid-19 limited the time we could spend with attendees. So we needed new and digital ways to advance our studies while meeting regulatory requirements for proper consent, - Staci McDonald , Executive Director, Scientific Clinical Operations at Celerion . An easy-to-use solution that can keep pace with our fast-paced environment and improves the participants' understanding of the study processes. The implementation of the solution went smoothly, and the feedback from the study teams, on-site staff and participants was positive. " Celerion, a leading global provider of early clinical research services, uses Veeva SiteVault to digitally create, manage and distribute informed consent (ICF). Patients can then securely access the eConsent document and complete the consent process via a mobile device. This simplifies the comparison of documents and reduces the administrative effort for the locations. Thanks to a seamless flow of information, Celerion has a complete overview of the status of consent and can thus improve study compliance and monitoring. Celerion is driving industry collaboration by leveraging digital solutions that enable patient-centric, paperless clinical trials, Veeva eConsent improves the process of informed consent for everyone Stakeholders by providing an intuitive and digital experience for patients and easy collaboration with locations and IRBs for sponsors. - Tim Davis , vice president, MyVeeva for Patients at Veeva Systems. About Veeva Systems Veeva is the world's leading provider of cloud software for the life science industry. Veeva is committed to innovation, product quality and customer success, serving more than 1,000 customers from the world's largest pharmaceutical companies to emerging biotech companies. As a not-for-profit, Veeva is committed to aligning the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.

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BUSINESS INSIGHTS

ARS Pharmaceuticals Expands Executive Leadership Team with Addition of Pharmaceutical Commercialization Veterans

ARS Pharmaceuticals, Inc. | February 10, 2022

ARS Pharmaceuticals, Inc., a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced the expansion of its executive leadership team with the appointments of Harris Kaplan as executive vice president, commercial strategy and Daniel Relovsky as senior vice president, sales and marketing. Mr. Kaplan and Mr. Relovsky, accomplished industry veterans with proven track records of commercial strategy and launch execution, will be responsible for preparing for and leading the commercialization of neffy™, once approved. neffy, a proprietary composition of epinephrine, is a small, reliable, easy-to-use option that allows for needle-free intranasal delivery of epinephrine, the only drug approved for the emergency treatment of Type I allergic reactions, including anaphylaxis. "The appointments of both Harris and Dan to the ARS team represent another building block in our ongoing commercialization preparations for neffy. We believe neffy's 'no needle, no pain' delivery, small size for convenient portability, and ease of use can provide a patient-friendly solution for individuals and caregivers to more easily and reliably administer epinephrine sooner, achieving more rapid symptom relief and preventing the allergic reaction from becoming severe or life-threatening. I'm excited to welcome Harris and Dan, both of whom bring decades of product launch and commercial leadership experience to our leadership team, and look forward to benefiting from their expertise as we progress toward our mission of being an innovative pharmaceutical leader in the treatment of severe allergy." Richard Lowenthal, founder, chief executive officer and president of ARS Harris Kaplan, MBA, executive vice president, commercial strategy, will join the ARS commercial team as lead for commercial strategy and oversee launch preparations for neffy. He brings more than 40 years of global experience across the pharmaceutical, biotechnology and healthcare consulting industries and most recently served as managing partner of Red Team Associates. Throughout his career, Mr. Kaplan has worked on the development, launch and commercialization of over 125 new products across more than 40 therapeutic categories, including LIPITOR®, Nexium, VIAGRA®, HUMIRA®, ALLEGRA®, HERCEPTIN® and Trikafta, and Yescarta. He has extensive experience in establishing and building new product planning initiatives, leadership and development programs and managing global strategic operations. Mr. Kaplan earned an MBA in marketing and operations research from Temple University where he also taught in the MBA program for several years. Daniel Relovsky, senior vice president, sales & marketing, will be responsible for leading the U.S. sales and marketing organization for neffy. He brings more than 30 years of commercial and operational experience, including product launch leadership in highly competitive markets and in establishing new standard-of-care therapies. Mr. Relovsky specializes in commercial planning and efficient team building to address complex executions, and brings a diverse background and success record in specialty, orphan, and major therapeutic markets. Prior to joining ARS, Mr. Relovsky held various senior commercial and operational leadership positions at MAIA Biotechnology, Inc., Clarity Global Solutions, LLC., Puma Biotechnology, Inc., Somaxon Pharmaceuticals, Inc., Cephalon, Inc. (now Teva Pharmaceuticals, Inc.), Salmedix, Inc., Maxim Pharmaceuticals, Inc., Agouron Pharmaceuticals, Inc. (now Pfizer, Inc.), Women First Healthcare, Inc., and IQVIA. Mr. Relovsky earned his B.S. in business administration, finance from Drexel University. About ARS Pharmaceuticals, Inc. ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The company is developing neffy™, an intranasal epinephrine spray with a unique absorption technology that could be easy-to-use, convenient, and more reliable for patients and loved ones at-risk of severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis.

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