Opportunities and Challenges for Advancing Non-Prescription Medicines

pharmtech | May 29, 2019

FDA officials are proposing new rules, beefing up regulatory resources, and promoting digital technologies to support the development and marketing of safe and innovative over-the-counter (OTC) therapies. The agency and manufacturers continue to hope that Congress will approve legislation authorizing new user fees to modernize the OTC monograph review program, a plan that has been high on the legislative agenda for several years. But even without final agreement on that reform initiative, officials at the Center for Drug Evaluation and Research (CDER) expect to establish an expanded review office for nonprescription drugs as part of a broader reorganization of the Office of New Drugs (OND). In addition, the revamped office will better manage new drug applications (NDAs) for non-prescription medicines, including the new Nonprescription Safe Use Regulatory Expansion (NSURE) initiative to facilitate switches of prescription therapies to nonprescription status. “OTC monograph reform remains a top priority for the agency,” stated FDA Chief of Staff Lauren Silvis at the recent meeting of the Consumer Health Products Association (CHPA). She described agency plans to facilitate prescription-to-OTC switches to increase consumer access to medicines that can be used safely without a prescription. Draft guidance issued in 2018 should encourage manufacturers to provide additional information on proper product use than what is found in the approved drug facts label (DFL). CDER also is working to finalize a proposed rule for developing and marketing OTC sunscreens, an issue that has raised a host of issues relevant to ensuring safe and proper use of these widely available products. FDA seeks additional data to document the safety of ingredients commonly used in sunscreens that can be absorbed in ways to possibly have systemic effects on the body.

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Geistlich Pharma is specialized in biomaterials for the regeneration of bone, cartilage and tissue and develops and manufactures medical devices and pharmaceuticals with the goal of giving patients a better quality of life.

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Geistlich Pharma is specialized in biomaterials for the regeneration of bone, cartilage and tissue and develops and manufactures medical devices and pharmaceuticals with the goal of giving patients a better quality of life.

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BUSINESS INSIGHTS

Quotient Sciences Acquires Arcinova

Quotient Sciences, Arcinova | February 09, 2021

Quotient Sciences, the drug development and manufacturing accelerator, reported that it has procured Arcinova, the U.K.- based multiservice contract development and manufacturing organization (CDMO). With more than 40 years of involvement and 160 representatives, Arcinova gives drug substance, drug item and bioanalysis administrations to more than 200 pharma and biotech clients around the world. The obtaining expands Quotient's administration portfolio and will empower the incorporation of drug substance, drug item and clinical testing abilities all under one organization broadening the year drug development course of events investment funds previously conveyed by Quotient's flagship platform Translational Pharmaceutics®. By slicing through storehouses and incorporating a scope of capacities, rethought development projects can be additionally improved and quickened, reliable with Quotient's conviction that particles need to become fixes, quick. “I’d like to congratulate the Arcinova team on building an exciting business, and I am thrilled to be joining forces. Both businesses are similar in culture and aspire to help customers accelerate molecules from candidate selection through development and on to commercial launch,” said Mark Egerton, Ph.D., CEO of Quotient Sciences. “I’d also like to take this moment to thank our private equity partner, Permira, for supporting our ambitious growth plans.” Professor Ian Shott, CBE, co-founder and executive chairman of Arcinova, said, “Since inception, we set out to build a unique organization that accelerates the development of new medicines for patients in need. We are delighted to move on to the next stage with Quotient as the perfect partner for Arcinova. Deep science, agility, flexibility and the drive for customer service excellence are the cornerstones of both businesses. I look forward to working with the Quotient team and Permira to deliver even greater value for our customers.” As part of the deal, Arcinova’s minority equity partner, BGF, will exit the business, having backed its growth since 2018. Mark Bryant, BGF, said, “It has been a privilege to support the expansion of Arcinova’s world-leading CDMO facility at such a critical part of its growth journey. We wish the team all the best as it moves to the next stage with Quotient Sciences.” RBC Capital Markets went about as selective monetary counselor to Quotient Sciences. PwC gave monetary and charge due industriousness administrations and Latham and Watkins gave legal counsel. BGF got legal counsel from Weightmans. KPMG filled in as corporate money guide for Arcinova, and Womble Bond Dickinson gave legal counsel. About Quotient Sciences Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. About Arcinova Arcinova is a multiservice contract development and manufacturing organization (CDMO) that serves pharmaceutical and biotechnology companies across the globe in developing their life changing medicines. The company, with decades of experience, combines agility with flexibility to provide an innovative approach to the development and manufacture of pharmaceutical products. Arcinova’s ambition is to save our clients valuable time, enabling them to rapidly bring life-changing medicines to market.

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PHARMA TECH

Quantum Leap and SignalPath to Integrate Clinical Trial Software Infrastructure Across I-SPY Platform Trials

Quantum Leap, SignalPath | February 24, 2021

Quantum Leap Healthcare Cooperative (Quantum Leap) and SignalPath reported a partnership today that will further enable the I-SPY platform trials with vigorous, streamlined technology infrastructure to drive the straightforwardness and efficiency of trial execution. SignalPath will integrate existing work process instruments being utilized to control the I-SPY trials into SignalPath's research operations and financial platform. In view of the public health emergency surrounding the COVID-19 pandemic, this advanced technology infrastructure will initially be conveyed for I-SPY COVID-19 with subsequent expansion to I-SPY2. “As we continue to grow our platform trials with a focus on I-SPY COVID-19, and the growing complexity of processing drug candidates through our platform trials, we need sophisticated infrastructure to ensure we can maintain our efficiency and agility. SignalPath provides the missing link for a comprehensive, tech-enabled trial technology platform to unlock the full potential of adaptive trial designs. This further empowers us to address urgent health needs that can only be solved through exceptional, technology-enabled clinical research,” observed James Palazzolo, CEO of Quantum Health. The I-SPY platform has had incredible accomplishment in working with leading academic medical centers around the United States. SignalPath is helping to extend that footprint across the a-list community health systems on the SignalPath platform. The objective is to continue to draw in community health systems with hearty research programs in cutting edge research to help their patients. “We founded SignalPath to re-imagine clinical trial execution through technology,” stated Brad Hirsch, MD, CEO and Co-Founder, SignalPath. “The Quantum Leap team has already accomplished an amazing amount in the fight against breast cancer and is now applying their full force to drive insights into COVID-19. It is an incredible opportunity for us to collaboratively support trial execution through our powerful technology infrastructure to meaningfully reduce the complexity for both the Quantum Leap team and the sites involved in the I-SPY trials. Everyone’s goal is the same - to bring life-saving medicines to patients that need them most.” About SignalPath SignalPath is the premier clinical trial technology partner for research sites and sponsors, focused on improving the ease and efficiency of trial execution and management. Supporting over 5,000 trials across more than 300 sites and thousands of active users, SignalPath is the industry standard that addresses key pain points in the conduct of trials. About Quantum Leap Healthcare Collaborative Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate care and research, and to foster high-impact trials with embedded clinical processes and systems technology and improved data management, greater access to clinical trial matching, and greater benefit to patients, providers, and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. About the I-SPY TRIALs The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations.

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Allied Expands Pharmaceutical Pipeline By Filing US Provisional Patent for Psilocybin Based Therapeutics

Allied Corp | October 21, 2020

Allied Corp, an international medical cannabis company focused on creating and providing targeted cannabinoid health solutions to address today’s medical issues is pleased to announce the filing of a new United States provisional patent application entitled “PSILOCYBIN COMPOSITIONS AND FORMULATIONS AND THEIR USE IN TREATING MENTAL HEALTH DISORDERS AND IMPROVING MENTAL HEALTH”. The provisional patent application covers a novel combination of psilocybin and proprietary mushroom formulation, as well as a novel treatment regimen targeting Post Traumatic Stress (PTSD), Depression and General Anxiety. Psilocybin is the active pharmaceutical ingredient contained in the Golden Teacher psychedelic mushroom. Along with the novel treatment regimen, Allied’s formulation consists of novel micro-dose ratios of several medical mushroom compounds combined with additional natural health molecules.

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