In vitro diagnostic medical devices (IVD) are tests performed on human samples (such as blood, urine or tissues) to provide information on a person’s health. Until 2017 IVDs were regulated by the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). In May 2017 the new Regulation (EU) 2017/746 on in vitro diagnostic medical [...]
In view of the current pandemic, conducting a clinical trial on cough & cold seems challenging. If you are a manufacturer for a product with immunomodulatory activity and wish to generate data substantiating this, a&r’s Clinical Research team can be a partner for you even in these trying times. We have the ideas and [...]
Are you a manufacturer of infant formula? Do you plan to innovate your portfolio with new ingredients? If the logistics for obtaining a marketing authorization for your new ingredients are what’s holding you back, then a&r may be just the partner for you. Our Clinical Research team has extensive experience in clinical trials for [...]
Calls are open for consultation on the new EFSA guidance on nano-particles and the nutrient definition. EFSA's Scientific Committee has launched an open consultation on its draft EFSA Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles. This document sets out information requirements [...]
For nearly 15 years, trademarks and brand names that have existed in the EU before January 1, 2005 were granted a temporary exemption to the Nutrition and Health Claims Regulation (EC) No 1924/2006 (Article 27(2) NHCR). This means that names that imply a health claim, e.g. “Vital”, “Healthy” etc, were permitted to be used [...]
We dedicate this July issue to clinical research on infant nutrition and immune health, to the ending of the NHCR exemption for trademarks and brand names, and to EFSA’s open consultation on its technical draft for nanoparticles. Also, join us for our next webinar on the upcoming IVDR and prepare [...]
We dedicate this June issue to the on-going regulatory hurdles around CBD and the Commission evaluation regarding health claims on botanicals. […]
Recent regulatory news related to CBD worldwide. EU On June 8, 2020, two CBD novel food applications for synthetic Cannabidiol passed EFSA’s validity check. We look forward to more news. However, according to Vitafoods Insights and CBD-Intel, the progress on novel food authorizations for CBD-extracts (non-synthetic cannabinoids) will be paused until EU regulators decide [...]
Plants and their preparations are widely available on the EU market as foods or as herbal medicines, and their classification as “food” or medicine is of the responsibility of Member States. Thus, a plant substance classified as a “food” in one Member State, can be classified as “medicine” in another Member State. The European [...]
25 June 2020 – analyze & realize GmbH (a&r), the leading consulting and clinical research organization with specific focus on natural consumer health care products, is pleased to announce the appointment of Dr. Volker Schehlmann as new Managing Director. This appointment by the a&r shareholders is another step towards further strengthening the company with specific expertise [...]
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MeriCal, a contract manufacturer and packager of high quality probiotics and nutritional supplements, has recently signed a final commercial agreement to acquire Global Health Industries (GHI).
GHI is highly specialized in the manufacturing of probiotics. MeriCal’s acquisition of GHI will increase market competitiveness and will drive international expansion.
It has been reported by Bloomberg that Nestle is currently the top bidder for Merck KGaA’s, offering up to $5 billion. According to the sources, companies previously interested in this business have dropped out of the bidding, including Perrigo and Bain and Cinven, while Reckitt Benckiser and Mylan are still in the running. Nestle, frontrunner at the moment, has been strengthening its health business, and acquired Atrium Innovations for $2.3 billion last month.
Global ingredients company DSM has acquired Biocare Copenhagen, expanding their gut health portfolio for an undisclosed price. With this acquisition, DSM will increase its gut health portfolio with probiotics. The company has showed interest in gut health ingredients beyond the well-known indications for digestive and immune health.
Earlier this month, Nestlé announced that it agreed to acquire Atrium Innovations (transaction to be completed Q1 2018). Atrium is globally recognized for the development, production, and commercialization of innovative and scientifically-proven natural health products. Its strategy is complementary with Nestlé science-based natural solutions for consumers and health care professionals. With this acquisition, Nestlé will extend its consumer healthcare nutrition portfolio, and Atrium will compete more effectively in the global market place.
A clear evidence that silos between industries will be breaking down in the future.
Walgreens has announced that it will invest $416 million to acquire 40% stake in Sinopharm Holding GuoDa Drug Store Co., Ltd (GuoDa). Walgreens is the second-largest pharmacy store chain in the US behind CVS Health. GuoDa retails pharmaceutical and healthcare products across China.
Walgreens was already present in China through Alliance Boots. This new investment highlights the interest of Walgreens in the Chinese fast-paced retail pharmacy business.
Walgreens investment took place in the same week that CVS announced to spend $69 billion to buy Aetna, the third largest health insurer in the U.S. CVS also has international operations but has not revealed interest in China yet.
Frutarom licensed AB-FORTIS in 2012 and now is buying the patent. AB-Fortis is a micro-encapsulation system that allows delivering 100% of the recommended daily amount of iron in a single dose, with high bioavailability and no adverse effects in taste or during digestion. “AB-Fortis expands Frutarom’s diverse product portfolio in the growing field of specialty healthy ingredients,” says Dr Raimund C. Hoenes, General Manager of Frutarom Health. With this transaction, AB-BIOTICS will focus on its probiotics business, which represents 87% of its total sale. In addition, the sales of AB-FORTIS will support the great R&D investment that AB-BIOTICS has done to reinforce their current probiotics concepts.
Relevium has signed a non-binding agreement to acquire an American nutraceutical e-brand that sell their products mainly through Amazon.
Relevium is a publicly traded company focused on growth through the acquisition of businesses, products and/or technologies with a focus on e-commerce in the growing health and wellness market. The value of this transaction is currently estimated at 1,15 mill EUR and it is foreseen to be closed on the 30th of November this year.
Last summer, Relevium completed the acquisition of BioGanix, another e-commerce brand and they have plans to conclude more transactions with e-retail brands in the future.
In September, color-ingredients manufacturer Roha (India) completed the acquisition of New Foods Industry S.p.A., an Italian company.
Roha is a leader in the color-ingredients market worldwide, and New Foods Industry is specialized in dry ingredients for the food and beverage industries.
This is the third acquisition for Roha during this year, enabling its further consolidation in the color business.