Daiichi waits on FDA as AML drug quizartinib approved in Japan

Pharmaphorum | June 20, 2019

The Japanese regulator has approved Daiichi Sankyo’s quizartinib for certain patients with acute myeloid leukaemia (AML), amid doubts over the outcome of a regulatory review in the US. Japan’s Ministry of Health, Labor and Welfare (MHLW) approved quizartinib, newly branded as Vanflyta, for adults with relapsed/refractory FLT3-ITD AML, if confirmed by a test. It’s not uncommon for Japan’s regulator to approve drugs ahead of the US, but in this case quizartinib has run into some issues with the FDA during its review. Daiichi has been developing quizartinib, a potential rival to Astellas’ Xospata and Novartis’ Rydapt, after acquiring it via a $410 million acquisition of Ambit Biosciences in 2014. Although the FDA had initially granted a faster six-month review for quizartinib, tagging it as a Breakthrough Therapy, things began to unravel in April when the regulator extended the review by a further three months, pushing back a decision date to the end of August. Then came the crucial review by experts on the FDA’s Oncology Drugs Advisory Committee (ODAC) last month – and things did not go well. Although the FDA is not bound to follow the advice of its advisory committees, it usually does, and in this case the US regulator will be considering an 8-3 vote against approval for quizartinib. The ODAC raised concerns that although the crucial phase 3 QuANTUM-R hit its target of a statistically significant improvement in overall survival, its design may have biased the results.

Spotlight

At its core, the pharmaceutical industry is about improving the quality of people’s lives. But today’s life-saving drugs are often small, high-value items which are easily stolen or diverted. Nearly impossible to authenticate by the end user, they have become an attractive target for counterfeiters and incidents of counterfeit drugs are on the rise. But counterfeit drugs are only one visible symptom of a deeper issue.


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PHARMACY MARKET

DrFirst Pharmacy Solution Earns Edison Award for Excellence in Commercial Technology, Consumer Safety

DrFirst | April 26, 2022

DrFirst's SmartSuite for Pharmacy has earned a prestigious Bronze Edison Award in the Commercial Technology, Consumer Safety Category, honoring the solution's innovative use of artificial intelligence to improve safety for patients and efficiency for pharmacies. The Edison Awards is a global leader in recognizing and honoring the best in innovation and excellence in the development of new products and services to create a positive impact on the world. "Being recognized with an Edison Award is one of the highest accolades a company can receive for innovation in product development and business. We deeply appreciate this recognition for SmartSuite for Pharmacy, which also highlights the dangers posed by medication errors and the need to provide more accurate, efficient technology solutions to hard-working pharmacists." G. Cameron Deemer, president at DrFirs SmartSuite for Pharmacy cleans and accurately translates medication data between incompatible systems, which saves time and can help reduce adverse drug events—the cause of more than 100,000 deaths per year. "The Edison Awards is delighted to recognize DrFirst for its innovation and positive impact on patients and health systems throughout the U.S. with SmartSuite for Pharmacy," said Frank Bonafila, executive director of Edison Awards. This year's Edison Awards finalists were chosen by senior business executives and academics from across the globe, whose votes acknowledge excellence in meeting the award criteria. The awards are named for Thomas Alva Edison, whose extraordinary contributions garnered 1,093 U.S. patents, pioneered multiple industries, and made him a household name worldwide. The 2022 Edison Awards were celebrated April 20 to 22, 2022, in Fort Myers, Florida, at an event hosted by award-winning science and technology journalist Miles O'Brien of PBS NewsHour. SmartSuite for Pharmacy is an AI-powered solution that cross-links an electronic prescription from a provider's EHR to an actual product on the shelf at the receiving pharmacy. It also translates abbreviated medication directions from the electronic prescription into the specific "short codes" used by the receiving pharmacy. Finally, SmartSuite for Pharmacy codifies allergy data for safety checks within the pharmacy workflow. About The Edison Awards The Edison Awards is an annual competition designed to honor excellence in new product and service development, marketing, human-centered design and innovation. Winners represent "game changing" products, services and excellence and leadership in innovation around four criteria: Concept, Value, Delivery and Impact. Started in 1987, The Awards are named after inventor Thomas A. Edison and symbolize the persistence and excellence in innovation personified by him. About DrFirst Since 2000, DrFirst has pioneered healthcare technology solutions and consulting services that securely connect people at touchpoints of care to improve patient outcomes. We create unconventional solutions that solve care collaboration, medication management, price transparency, and adherence challenges faced in healthcare. We unite the Healthiverse—the interconnected healthcare universe—by providing our clients with real-time access to the information they need, exactly when and how they need it, so patients get the best care possible. DrFirst solutions are used by nearly 325,000 healthcare professionals, including more than 120,000 prescribers, 70,000 pharmacies, 280 HIS/EHRs, and 1,500 hospitals in the U.S. and Canada.

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BUSINESS INSIGHTS

Teva Reaches Agreement With Texas to Settle the State’s Opioid-Related Claims

Teva Pharmaceuticals | February 08, 2022

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and its affiliates, has reached an agreement with the Attorney General (AG) of Texas that settles the state’s and its subdivisions opioid-related claims. Under the terms of the settlement, Teva will pay Texas $150 million over a 15-year time period and will provide the recently launched, lifesaving medicine generic Narcan®, valued at $75 million over 10 years. “Expanding access to lifesaving medicines is at the core of Teva’s mission. The Texas Attorney General is taking steps to address the opioid epidemic in the State by negotiating a settlement that includes critical medicines as part of their solution. While the settlement includes no admission of wrongdoing by Teva or its affiliates, it remains in the best interest of Teva to put these cases behind us and continue to focus on the patients we serve every day.” Kåre Schultz, Teva’s President and CEO Naloxone is a life-saving medication that can reverse an overdose from opioids.1 As of December 2021, Teva has made available the first generic version of this critical medicine and has included this product in the Company’s ongoing pursuit of a national or narrower settlement with individual states such as the deal announced today. The Company will continue to defend itself in court in states where we have not reached terms of a settlement agreement. Teva believes that today’s settlement with the state of Texas is a critical step forward in getting life-saving treatments to people suffering from opioid addiction. About Teva Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products.

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BUSINESS INSIGHTS

FSD Pharma Announces Launch of New Corporate Website

FSD Pharma Inc. | January 24, 2022

FSD Pharma Inc. a life sciences holding company dedicated to building a portfolio of assets and biotech solutions, announced today the launch of its newly designed website. The new site conveys the Company’s emerging position within the biopharmaceutical industry and its ongoing commitment to bring novel treatment solutions for brain and inflammatory disorders to millions of patients in need. “We have strategically assembled a team of scientists to help develop our powerful pipeline of next-generation therapeutics. With some of the greatest minds in neurology and inflammation working together to advance our promising therapeutic compounds, and supported by a strong balance sheet, we believe that we are very well positioned to continue the advancement of our three leading drug candidates: Lucid-MS, Lucid-PSYCH and FSD-PEA. The new look and user-friendly experience of FSD Pharma’s website reflects that, while also serving to educate clinicians, researchers, patients, and investors about our unique approach to delivering 'Total Brain Health'.” Anthony Durkacz, Interim CEO of FSD Pharma About FSD Pharma FSD Pharma Inc. is a biotechnology company with three drug candidates in different stages of development. FSD BioSciences, Inc. a wholly owned subsidiary, is focused on pharmaceutical research and development of its lead compound, ultra-micronized palmitoyl ethylamine or FSD-PEA Lucid Psycheceuticals Inc. a wholly owned subsidiary, is focused on the research and development of its lead compounds, Lucid-PSYCH and Lucid-MS. Lucid PSYCH is a molecular compound identified for the potential treatment of mental health disorders. Lucid-MS is a molecular compound identified for the potential treatment of neurodegenerative disorders.

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BUSINESS INSIGHTS

OPTEL ACQUIRES PHARMA TRACK-AND-TRACE UNIT OF KÖRBER

OPTEL Group | January 12, 2022

OPTEL GROUP, already a world leader in supply chain traceability, is expanding its expertise and global reach with the recent acquisition of the track-and-trace unit of the Körber Business Area Pharma, formerly known as Traxeed, based in Germany. Körber is a leading international technology group. The acquisition, announced today, will allow OPTEL to leverage the unit's expertise in pharmaceutical and agrochemical track-and-trace technologies, provide the company with a second foothold in the European marketplace and contribute to its diversification plans. "Creating a strong presence in the German market is key to the success of our strategic objectives because Germany is a well-established manufacturing hub, with a strong history of developing innovative manufacturing efficiency solutions and Industry 4.0 technologies," Louis Roy, founder and president of OPTEL "We are pleased that we have found a solid and future-oriented new owner with a broad international market access, from whose global network and years of experience in the highly specialized track-and-trace sector customers will clearly benefit. We are furthermore convinced that the new strategic owner can open up attractive development opportunities for the team," said Dr. Jürgen Krebs, Chief Technology Officer and Chief Operating Officer in the Körber Business Area Pharma. The acquisition allows OPTEL to welcome highly skilled pharma track-and-trace experts from Körber, complementing OPTEL's existing strengths in traceability, vision technologies, software and hardware. Furthermore, it will solidify and expand the company's presence in the European market by providing a second base of operations after Limerick, Ireland. In addition to the acquisition, a close collaboration between OPTEL and Körber's Business Area Pharma is planned in the future. The two companies plan to sign a partnership agreement whereby OPTEL becomes Körber's preferred partner for track-and-trace solutions for the pharmaceutical industry. Since its founding in 1989, OPTEL has become the world's foremost provider of track-and-trace solutions to the pharmaceutical industry. Its acquisitions in recent years have positioned it as the only company with the ability to provide complete, full-stack supply chain traceability. The Canadian multinational has since diversified into other industries, including consumer-packaged goods, metals and minerals, and agrochemicals. The acquisition of the track-and-trace unit of the Körber Business Area Pharma is expected to accelerate further expansion. ABOUT OPTEL OPTEL is a leading global provider of traceability systems whose goal is to use its innovative technologies to build a sustainable world through the Intelligent Supply Chain. OPTEL is the only company with the ability to offer complete end-to-end traceability, providing granular data at every step of the supply chain – from raw materials to the consumer and beyond. Founded in 1989, OPTEL is a Certified B Corporation headquartered in Canada, with facilities in Ireland, India and Brazil, as well as employees worldwide. ABOUT KÖRBER We are Körber – an international technology group with about 10,000 employees, more than 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, Tissue and Tobacco, we offer products, solutions and services that inspire. We act fast to customer needs, we execute ideas seamlessly, and with our innovations we create added value for our customers. In doing so, we are increasingly building on ecosystems that solve the challenges of today and tomorrow. Körber AG is the holding company of the Körber Group.

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Spotlight

At its core, the pharmaceutical industry is about improving the quality of people’s lives. But today’s life-saving drugs are often small, high-value items which are easily stolen or diverted. Nearly impossible to authenticate by the end user, they have become an attractive target for counterfeiters and incidents of counterfeit drugs are on the rise. But counterfeit drugs are only one visible symptom of a deeper issue.

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