Venture capital is a long investment cycle business, and never before has that been so clear as now in the face of the ongoing COVID pandemic. Even with the unprecedented public equity market volatility, venture investing into private biopharma companies

The post Booming VC-Backed Biopharma: Strong Market Despite Pandemic appeared first on LifeSciVC.

This blog was written by Josh Brumm, CEO of Dyne Therapeutics, as part of the From The Trenches feature of LifeSciVC. I stood in front of 15 skeptical parents and prepared to sell them on an improbable mission. They had

The post Ordinary People Achieving The Extraordinary: Lessons In Leadership From The Court To The C-suite appeared first on LifeSciVC.

Rend Al-Mondhiry has joined the firm Amin Talati from the Council for Responsible Nutrition (CRN) as Senior Counsel, resident in the Washington, D.C. Office.

Valensa International announced today a joint venture agreement between Valensa’s parent company EID Parry and Synthite Industries Ltd., expanding plans to lead development and distribution of value-added microalgae extracts.

Baby Boomers, Gen X and Millennials are key consumer target groups for marketers, with three different sets of needs and buying propensities; it’s important that brands define their unique selling propositions.

Probi's largest clinical trial ever, focused on probiotic immune health, has recently been completed.

In the 8th edition of The Star Outstanding Business Awards (SOBA), ExcelVite has emerged as Gold winner for two award categories–Best Innovation and Best Global Market.

Selling directly to health care practitioners, supplement companies can foster open dialogue about their products; but, every regulation applies to products in this channel, too.

A study demonstrated Wellmune® may protect intestinal barrier function in adults when faced with stress.

In this SupplySide West edition of the Healthy INSIDER podcast, Rachel Adams, managing editor, and Scott Steinford, founder and CEO of Trust Transparency Consulting, discuss the role of transparency in establishing trust with supplements consumers.  

Valensa International announced Non-GMO Project has been awarded to Valensa’s Organic Spirulina, Chlorella and Microalgae products.

Emphasis on fat and protein intake, reduced carbohydrate intake and gut health for managing weight are trends affecting the global weight management category.

DSM today published the first part of a new report in its Global Insight Series, focused on breakfast habits and behavior in Europe and the US.

The Organic Trade Association and The Organic Center on Thursday applauded Senators Bob Casey (D-PA) and Susan Collins (R-ME) for introducing The Organic Agriculture Research Act of 2018.

The Council for Responsible Nutrition announced the launch of a consumer education initiative designed to raise awareness of Selective Androgen Receptor Modulators, a dangerous class of ingredients.

Natural product brands can boost trade show ROI by investing in PR to work with trade press via press releases and onsite interviews.

The chief executive of a supplement company under investigation by FDA could go to prison for allegedly violating the terms of his supervised release following a criminal conviction in 2014.

Potential brain health benefits of cannabidiol (CBD) can make it an attractive ingredient for supplement brands, but federal regulations and FDA action may hinder product success in the market.

Alkemist Labs is pleased to announce a move to a new facility with over four times more space to expand capacity and accommodate continued growth.

In this INSIDER Q&A, experts in contract manufacturing discuss aspects a brand owner should evaluate, what should be outlined in an agreement and what ongoing QA checks to conduct during the partnership.

A doctor, researcher and former chronic migraine sufferer, has launched her own biotech startup company named KetoSwiss selling supplements that she argues can help control migraine pain by tapping into our own biological mechanisms.

It is "inconceivable" that immunity will not remain high on the list of health priorities when this pandemic ends and now is the time to create more "convincing experiences" to ensure trial turns into adoption, according to food and drink research and branding experts.

NutraIngredients is pleased to announce the shortlisted finalists for the 2020 edition of the NutraIngredients Awards ... with the winners to be announced in the first online awards ceremony next week (May 13th).

Older adults who consumed large amounts of flavonoid-rich foods were two to four times less likely to develop Alzheimer's disease and related dementias over 20 years compared with people whose intake was low, in a study of 2,800 people.

French beauty supplement firm D+ For Care has launched a mouth spray to aid sleep and has a flurry of holistic wellbeing innovation primed for 2020 â the year nutricosmetics could really take off, its founder says.

A recent study conducted by researchers at Tufts University suggests that consuming 1.5 ounces of almonds per day, compared to no almond consumption, may help reduce CVD risk factors such as elevated LDL cholesterol levels, and as a result, reduce an individual's healthcare costs associated with treating such conditions.

In scenic Puerto Varas, APEC delegates engaged in constructive dialogue about how to adopt to a changing world.

APEC focuses on the progress the forum has made on the four priorities set by Chile this year.

Leaders from around the world gathered at the United Nations General Assembly in New York on 23 September for the first-ever United Nations High-Level Meeting (UNHLM) on Universal Health Coverage (UHC): Moving Together to Build a Healthier World.

A comprehensive study on the health needs of Filipino migrant workers has won the inaugural APEC Healthy Women Healthy Economies award.

APEC officials announced this year’s winners for the annual APEC Business Efficiency and Success Target Awards, or BEST Awards - a collection of some of the best women-led businesses in the Asia-Pacific region.

Ministers in charge of women’s economic participation in the APEC region issued a joint statement following their meeting in La Serena, Chile, on 4 October 2019.

President Sebastián Piñera, Chair of APEC Chile 2019, announced that APEC Leaders’ Week will not be held in Chile this year.

Media Registration is Open for the APEC Informal Senior Officials’ Meeting

The winner of the APEC Photo Contest 2019 has also won the most votes for the Popular Choice Award, announced the APEC Secretariat.

Malaysia, incoming host of APEC, will rally the forum to ensure that the ‘”benefits from trade, investment, and economic cooperation are felt and enjoyed by our people,” said Prime Minister Dr Mahathir Mohamad as he launched APEC Malaysia 2020.

A duo of innovative programmers from Malaysia are the winners of the 2019 APEC Digital Prosperity Award, announced on the sidelines of the APEC Informal Senior Officials’ Meeting in Langkawi.

Media registration is open for the First APEC Senior Officials’ Meeting (SOM1) and related meetings in Putrajaya, Malaysia from 3 February to 22 February 2020.

An APEC Business Travel Card mobile application will make travel easier and more secure

The first Senior Officials Meeting for APEC Malaysia 2020 begins

The challenge: Innovative mobile apps and platforms that empower the aging society

From : Communities>>Regulatory Open Forum
Hello Anon, In the version, I usually put the last year or the year generally recognised, e.g. ISO 14971 being 2007.  Then for the publication date, I do put the latest version when published so would be April 2010.  Because of the way standards are amended and revised, it can be quite difficult to determine what to put on the cover sheet.  I would also rely a bit on the Recognized Standards list the FDA publishes:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  to list [More]

From : Communities>>Regulatory Open Forum
Wondering if anyone has seen FDA guidance for timelines or procedures for all these Emergency Use Authorizations to transition to cleared IVD or Devices? Beverly Whitaker Indigo Consulting Group, LLC --------------------------------- Beverly Whitaker Beaufort SC United States ---------------------------------

From : Communities>>Regulatory Open Forum
Hi everyone, I just finished it, and it is a really simple task! Go ahead! Thanks Anna --------------------------------- Anna Alonzi MD Sr. Regulatory Associate Newtown PA United States ---------------------------------

From : Communities>>Regulatory Open Forum
Hi Beverly, To find out details on EUAs go to the FDA website central for EUAs at  https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019.    They are pumping out lots of them pretty quickly.  Each type of EUA has different requirements and FDA is flexible depending on the EUA you are looking for.  Timelines are not specific I just asked that question of one of my connections at the FDA today.  They are giving priority to more technically [More]

From : Communities>>Regulatory Open Forum
I have not seen anything, but during the interactive EUA process FDA were very clear that we need to continue with 510[k] preparation and offered supportive and constructive comments of where additional information would be needed. Although the EUA team are very busy, they see it as mutually beneficial, well actually in everybody's interests, to help us to a cleared status as soon as possible and the level of interactive engagement has been great. I am not convinced any general guidance would have [More]

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Dear RAPS members, I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few. 62304-  ANSI AAMI IEC   62304:2006/A1:2016 62366-1:2015-  Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices 14971- Medical Devices - Applications Of Risk Management To Medical Devices I am trying to see what approach will be good. Should I prepare a DOC or [More]

From : Communities>>Regulatory Open Forum
Hi All, Always appreciate and respect the great advice that comes through this forum: The scope of my question is CE Mark of a Class IIa medical device system under the MDD (and then eventually MDR): We have Class I devices which will be CE Marked through self-certification. These devices can be used with other CE marked products (not owned by us). One of which is not CE Marked as a medical device (conformity to machinery and low voltage directives). In terms of what we consider this vendor, what [More]

From : Communities>>Regulatory Open Forum
Thank you all for participating in our Tagging Project! We're glad to hear you enjoyed it. All volunteers were entered into a drawing for a $50 Amazon gift card. See a video of the drawing attached.  I'm happy to announce that the winner is ...  @Jonathan Amaya-Hodges ! Thanks again to all who participated. If you're interested in more volunteer opportunities, see our full list here .​​ ------------------------------ Danielle Fezell Manager, Chapter & Volunteer Relations, RAPS Rockville MD United [More]

Files Attached Document
RE: Sort It Out by participating in the RAPS Tagging Project

From : Communities>>Regulatory Open Forum
Thank you RAPS, what a pleasant surprise! I appreciate the opportunity to contribute to the project! Now, if only Amazon had any toilet paper in stock... ------------------------------ Jonathan Amaya-Hodges Associate Director, Regulatory Affairs CMC Combination Products and Medical Devices Cambridge MA United States ------------------------------