The Advantages of Flow Cytometry for Counting Bacteria in Probiotics

rapidmicrobiology | January 08, 2020

In 2001, a joint FAO/WHO working group defined probiotics as “live micro-organisms that, when administered in adequate amounts, confer a health benefit on the host.”  Each of the key terms, ‘live’, ‘adequate amounts’ and ‘health benefit’ are, in fact, much debated. Although the health effects of probiotics are implicit in the definition, there are no approved health claims in the EU and, as confirmed in 2018 by the Commission for Health and Food Safety , there is no intention to change this stance. The term ‘probiotic’ itself is forbidden on product labels as it is considered a health claim. ‘Live micro-organisms’ is not without problems either. Traditionally, that means cultivable cells whose amount is expressed in CFU. However, for Marco Pane, R&D manager of Probiotical, a manufacturer of probiotics located in the north-west of Italy, things are not so clear-cut:

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Will the Pharma R&D Annual Review 2018 from Citeline’s Pharmaprojects be music to your ears, or will it sound a sour note? Find out with the Pharma R&D Annual Review 2018 infographic

Spotlight

Will the Pharma R&D Annual Review 2018 from Citeline’s Pharmaprojects be music to your ears, or will it sound a sour note? Find out with the Pharma R&D Annual Review 2018 infographic

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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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PHARMA TECH

Silverback Therapeutics and ARS Pharmaceuticals Announce Merger

Silverback Therapeutics and ARS Pharmaceuticals | July 22, 2022

Silverback Therapeutics, Inc. and ARS Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which ARS will merge with Silverback in an all-stock transaction. The combined company will focus on the potential regulatory approval and commercialization of neffy, ARS’s investigational epinephrine nasal spray for the treatment of Type I allergic reactions including anaphylaxis. The combined company is expected to have approximately $265M in cash, cash equivalents and marketable securities at closing. Upon stockholder approval, the combined company is expected to operate under the name ARS Pharmaceuticals and trade on the Nasdaq Capital Market under the ticker symbol “SPRY.” The merger is currently expected to close in the fourth quarter of 2022. Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 25 million people in the United States who experience Type I severe allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency. ARS designed neffy to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapidly administered, and reliable nasal spray device. With its needle-free administration, neffy may help eliminate the anxiety and hesitation associated with using an autoinjector. “We are extremely pleased to announce this proposed merger with Silverback, which we believe enables ARS to maximize the paradigm-changing opportunity of neffy. neffy is on the cusp of achieving what has not been possible before – the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but with a simple to administer nasal spray. We have completed a comprehensive registration program with neffy and based on a favorable pre-NDA meeting with the U.S. Food and Drug Administration (“FDA”), we are preparing to submit our New Drug Application (“NDA”) in the third quarter of 2022. This merger positions ARS and our experienced team to execute on the potential launch of neffy in 2023 by providing the requisite capital needed for launch. ARS was founded with a mission of solving many of the issues that patients and caregivers express about their epinephrine autoinjectors. Today is an important step toward bringing this novel treatment to patients and caregivers to improve their treatment options for these serious and potentially life-threatening allergic reactions.” Richard Lowenthal, M.Sc., MSEL, co-founder and chief executive officer of ARS Data across three registration studies supports that neffy should meet all clinical endpoints recommended by regulators and that its pharmacokinetics are within the range of approved efficacious epinephrine injection products. In addition, neffy has been well-tolerated to date with more than 500 individuals having received at least one dose, and many with repeat administration. The majority of adverse events in clinical trials were mild in nature and comparable to injection products. Based on the totality of data, ARS is preparing to submit its NDA for neffy for use in adults and pediatric patients who are 30 kg or greater in the third quarter of 2022. If approved, ARS is planning to launch neffy in the United States in 2023. “This transaction represents the result of a thorough and thoughtful strategic review process by Silverback,” said Laura Shawver, Ph.D., chief executive officer of Silverback. “ARS is an exciting late-stage company with compelling clinical data demonstrated with neffy, a path to near-term commercialization in a large and dissatisfied market, and an expert team with proven experience in launching and commercializing market-leading nasal spray products, such as NARCAN. I believe we have found the optimal partner to provide value for our stockholders, and even more so, the potential to transform treatment for millions of people with or at-risk for Type I severe allergic reactions.” About the Proposed Merger Under the terms of the merger agreement, assuming that Silverback’s net cash at closing is $240 million, Silverback equity holders are expected to own approximately 37% of the combined company and pre-merger ARS equity holders are expected to own approximately 63% of the combined company on a fully-diluted basis on a treasury stock method. The percentage of the combined company that Silverback’s equity holders will own as of the close of the transaction is subject to certain adjustments as described in the merger agreement, including the amount of Silverback’s net cash at closing. Upon closing of the transaction, Silverback will be renamed ARS Pharmaceuticals, Inc. and will be headquartered in San Diego, California. Richard Lowenthal, M.S., MBA, will serve as chief executive officer and president of the combined company. The merger agreement provides that the Board of Directors of the combined company will be comprised of ten members, including seven from ARS and three from Silverback. The merger agreement has been approved by the Board of Directors of each company, and the transaction is expected to close in the fourth quarter of 2022, subject to approvals by the stockholders of each company and other customary closing conditions. About Silverback Therapeutics, Inc. Silverback Therapeutics, Inc. is a biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of chronic viral infections, cancer, and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Silverback Therapeutics is located in Seattle, Washington.

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PHARMA TECH

Vivera Receives 3rd U.S. Patent Allowance for ZICOH Drug Delivery Device

Vivera Pharmaceuticals, Inc. | May 26, 2022

Vivera is pleased to announce the allowance of its third U.S. patent for ZICOH™, the Company's high-tech, electronic dose-controlled portfolio of drug delivery devices. The patent allowance from the U.S. Patent and Trademark Office secures ZICOH's rights as a smart dosing system with automated delivery, measurement, and management for oral format medications, including pills, capsules, and tablets. ZICOH is an electronic dose-controlled delivery device and technology designed to enable real-time communication through the drug supply chain, from drug manufacturers, distributors, and wholesalers to pharmacists, providers, physicians, caregivers, and patients. The device can be programmed to dispense the medication dosage type, amount, and frequency according to the health care provider's orders to ensure compliance with dispensed prescriptions while also implementing controls to help prevent medication misuse and abuse. Later versions of the device will also implement user authentication features, such as fingerprint authorization and facial recognition, to help prevent prescription drugs from being diverted. Medication reminders are another core feature of ZICOH. These reminders can be programmed into the device by the pharmacist per the physician's orders to alert the patient when it's time to take their medication. This feature can be particularly beneficial for patients who forget to take medications on time or for patients and caregivers who manage multiple medications. "ZICOH is a major innovation in the medical device and technology sectors. This device is going to make it easier than ever for patients to comply with their medication regimens, regardless of how complex they are." Mehdi Hatamian, Ph.D., Chief Scientific Advisor for Vivera This third patent differs from the device's two previously issued patents in that it specifically pertains to the dispensing of tablets, capsules, and pills. The device has already secured its patent rights as a secure, smart liquid and inhaler delivery device with automated dose delivery, measurement, and management. "We are proud of the progress we have made on the development of ZICOH's multiplatform uses and technology," said Paul Edalat, CEO and Chairman of Vivera. "The way that Tesla revolutionized the automotive industry, and the way Apple created a category for smart devices, is what Vivera is doing to the prescription dispensing industry. ZICOH will forever change the way that medications are prescribed and dispensed, and Vivera is reaching the milestones to get there in a fraction of the time projected." Vivera is looking forward to bringing ZICOH to market. The Company has already initiated the device's design and is looking forward to having a working prototype by late summer 2022. About Vivera Pharmaceuticals Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH™, a smart dose-controlled medical device. It also has patents pending on its telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.

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