After AdComm rejection, Correvio Pharma hit with FDA complete response letter

FierceBiotech | December 27, 2019

Correvio Pharma is not having a happy holiday. After being hit by an FDA AdComm rejection a few weeks back, its heart drug has now also been denied approval by the FDA.   In the AdComm, the Canadian company saw an overwhelmingly negative vote (11-2) against its drug to correct irregular rhythm in the upper chambers of the heart in adult patients. It was voted down over serious safety risks including low blood pressure and irregular rhythm in the lower heart chambers along with deaths during the trials. The drug, known as Brinavess (vernakalant IV), is approved outside the U.S. but needs U.S. sales to boost its share, which could swell to $150 million from the American market. The drug has a long record, as it tried and failed to gain FDA approval over the past 13 years and has also seen the regulator put the drug on a clinical hold.

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This video will cover 5 of the hardest pharmacy school interview questions and answers. Let our expert responses guide you in crafting your own answers for your pharmacy school interview.

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PHARMA TECH

COUR Pharmaceuticals Receives FDA Fast Track Designation for CNP-104 for the Treatment of Primary Biliary Cholangitis

COUR Pharmaceuticals | January 11, 2022

COUR Pharmaceuticals, a biotechnology company developing novel immune-modifying nanoparticles to treat immune disorders, today announced the U.S. Food and Drug Administration granted Fast Track Designation to the Company's investigational therapy CNP-104 for the treatment of Primary Biliary Cholangitis. CNP-104 aims to reprogram the immune system to address autoimmune causes of PBC. "We are pleased to have received Fast Track Designation for CNP-104, which demonstrates the FDA recognizes the importance of this potential treatment for PBC and the need for improved of clinical outcomes for patients with this degenerative autoimmune disease, which currently has no treatment to stop progression of disease. Based on data from another COUR autoimmune trial with a CNP platform product, our Phase 2 PBC trial is designed to show that we can stop progression of PBC disease with improved liver function. If successful in Phase 2, COUR would seek breakthrough therapy designation in PBC given that current therapies treat only symptoms." COUR CEO John Puisis Fast Track Designation is an FDA process designed to facilitate the development and review of potential therapies that seek to fill an unmet medical need. The FDA created this designation to help get new therapies to patients earlier. A therapy that receives this designation is eligible for more frequent communication with the FDA and may be eligible for Accelerated Approval and Priority review, if relevant criteria are met. The FDA accepted COUR's investigational new drug application for CNP-201 in October 2021 and COUR is currently opening the first human dosing in a proof-of-concept study for CNP-104 in early 2022 to evaluate the safety, tolerability, pharmacodynamics and efficacy of the therapy in PBC patients. CNP-104 uses COUR's proprietary nanoparticle platform, a novel system which combines disease specific pathogenic antigens with state-of-the-art pharmaceutical nanoparticles that mimic normal removal of dead or dying liver cells from the body. In November 2021, Ironwood Pharmaceuticals, Inc., a GI-focused healthcare company entered into a collaboration and license option agreement with COUR for the development and commercialization of CNP-104. This agreement gives Ironwood an option to acquire an exclusive license to develop and commercialize, in the U.S., COUR's investigational therapy CNP-104 for PBC. About COUR Pharmaceuticals COUR Pharmaceuticals is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. COUR's platform of immune-modifying nanoparticles is designed to treat the root cause of immune disease, unlike traditional approaches, which only minimize symptoms using toxic immune suppression. Data from clinical and preclinical settings demonstrate the opportunity for the COUR nanoparticle platform to address a wide range of immune and inflammatory conditions. The underlying technology was acquired from Northwestern University and draws from more than 30 years of research by the laboratory of Stephen D. Miller, Ph.D., the Judy E. Guggenheim Research Professor of Microbiology-Immunology.

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BUSINESS INSIGHTS

Ascential Digital Commerce and GSK Consumer Healthcare Announce Launch of Ascential Digital Commerce Connect at Cannes Lions

Ascential Digital Commerce and GSK Consumer Healthcare | June 15, 2022

Ascential Digital Commerce, whose technology driven products power brands to win in digital commerce, and GSK Consumer Healthcare, a science-led healthcare company, will join forces on June 20th during the Cannes Lions International Festival of Creativity to launch Ascential Digital Commerce Connect, a first-of-its-kind, data-rich, digital commerce platform that provides C-suite executives with visibility of brand sales and performance from multiple data sources. Ascential Digital Commerce Connect improves reaction time to market dynamics, increasing a brand's performance in the rapidly growing eCommerce retail market. Ascential Digital Commerce and GSK Consumer Healthcare partnered together to develop Ascential Digital Commerce Connect to provide visibility and clarity of GSK Consumer Healthcare's eCommerce brands performance, improve reaction time to market dynamics and position the brand for further growth. GSK Consumer Healthcare anticipates eCommerce growth to reach the mid-teens percentage of the business by 2025, thereby making eCommerce a priority channel to drive overall sales. According to Nasdaq research, 95% of all purchases by 2040 will be conducted via eCommerce and a 2021 IDC study revealed that the digital commerce applications market will see double-digit growth through 2025. “Visibility of data is becoming increasingly vital to businesses every day. Especially as eCommerce has become a core business capability for businesses around the globe, managing data streams for those businesses has become increasingly challenging.” Filippo Battaini, Research Manager at IDC Retail Insights The Ascential Digital Commerce Connect web-based platform captures, analyzes, visualizes, and displays critical marketing data about each brand and competitor to monitor key activities and answer marketers' key questions when it comes to Understanding the current brand/sales performance in the eCommerce marketplace – standalone vs. key competitors and owned channels vs. major online retailers like Amazon and Alibaba Dissecting what brand health looks like regionally throughout EMEA, US/North America, Asia-Pacific, and Latin America Navigating potential challenges and outages around supply chain, research and development, disruptive markets, and other key metrics. More accurately calculating marketing spending as a percentage of gross revenue During Cannes Lions 2022, Ascential Digital Commerce and GSK Consumer Healthcare will host a panel discussion to discuss the catalyst for developing Ascential Digital Commerce Connect and how GSK Consumer Healthcare currently leverages the platform for brand success. Product demos will also be available to showcase the platform. "The next five years represent a tipping point in the retailing industry," says Duncan Painter, CEO at Ascential. "Retailers and brands with the deepest, most recent insights into the digital performance of their products and services will gain an informed, competitive edge. The Connect platform turns data into actionable insights, and GSK Consumer Healthcare is on a strong path to further realize eCommerce growth." "Healthcare today is driven by the digital economy, whether consumers and patients are searching for healthcare information and services online, logging into exercise classes, ordering health and beauty products from their favorite online retailers, or managing prescription medications online," says Taryn Marella, Global Head of Digital Commerce, GSK Consumer Healthcare. "Ascential Digital Commerce Connect delivers actionable insights that help us monitor the health of our business and identify growth opportunities, update messaging and enhance creativity in the digital environment." About Ascential Digital Commerce Ascential Digital Commerce powers the global eCommerce ecosystem. Our platform allows brands, businesses and their agency partners to connect to consumers in every touchpoint of their journey to purchase goods and products. We transform data into actionable insights, allowing brands to build their competitive edge and drive growth with better, faster decisions. We solve the most complex challenges that global brands and businesses face in the digital commerce landscape with technology and human expertise to drive sales growth on the leading digital eCommerce marketplaces globally. About Ascential Ascential delivers specialist information, analytics, and eCommerce optimization platforms to the world's leading consumer brands and their ecosystems. Our world-class businesses improve performance and solve problems for our customers by delivering immediately actionable information combined with visionary longer-term thinking across Digital Commerce, Product Design, and Marketing. We also serve customers across Retail & Financial Services. With over 2,800 employees across five continents, we combine local expertise with a global footprint for clients in over 120 countries. Ascential is listed on the London Stock Exchange. About GSK Consumer Healthcare GSK’s Consumer Healthcare business is on track to become an independent company through a proposed demerger from GSK, expected in July 2022. The new business, to be named Haleon, is expected to be a world-leader in consumer healthcare. Led by its purpose to deliver better everyday health with humanity, it will be strongly positioned to play a vital role in a growing sector that is more relevant than ever. Haleon will have a world-class portfolio of category-leading global brands, including Sensodyne, Voltaren, Panadol and Centrum, brands that are trusted by healthcare professionals, customers and people worldwide to improve the health and wellbeing of individuals and their communities.

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PHARMACY MARKET

Fusion Pharmaceuticals has Signed an Agreement to Build a Radiopharmaceutical Manufacturing Facility

Fusion Pharmaceuticals | June 03, 2021

Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines; today announced it entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University, to build a 27,000 square foot Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be made by McMaster and equipped and validated by Fusion, will be designed to support the manufacturing of the Company's growing pipeline of targeted alpha therapies (TATs). Fusion expects the manufacturing facility will be operational by early 2024. "Manufacturing and supply chain are critical components of radiopharmaceutical development and commercialization, and with Fusion's expertise, we believe we are well-positioned to create a facility to scale production in support of our growing pipeline and development collaborations," said Fusion Chief executive officer John Valliant, Ph.D. "We will continue to prioritize manufacturing and supply chain infrastructure in our long-term plans, and this facility is an important milestone in executing those plans. The location of the facility, adjacent to our internal research organization and a world-class University that specializes in medical isotope research and training, enables us to efficiently advance new TATs and hire top-tier talent to support our leading portfolio of radiopharmaceuticals." In conjunction with the execution of the lease agreement, Fusion has entered into a services agreement with its long-time partner, the Centre for Probe Development and Commercialization (CPDC), to provide services relating to certain aspects of the validation of this new manufacturing facility. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, Fusion connects alpha particle emitting isotopes to various targeting molecules to deliver the alpha-emitting payloads to tumors selectively.

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