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

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.

From : Communities>>Regulatory Open Forum
Hello,  I can see many unapproved combinations of Minoxidil as topical solution like minoxidil+ Azelaic Acid; Minoxidil + Finasteride; Minoxdil+ niacin+retinol+caffeine that are available online for sale in US but these drug products are not approved by FDA as visble from USFDA website.  Can anyone explain that is there any mechanism or guideline to allows to sell such unapproved drug products online in US and also in EU? Or is this totally illegal practice?  Thanks Ankur RAC

From : Communities>>Regulatory Open Forum
Hi, Ankur - Some may be "legal," others not. It's a big industry, and it is fair to be cynical. Combination products for sale that have not been approved-as the combination-by FDA are just that, unapproved drugs. I assume you checked for the approval status in FDA's "Orange Book" (https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm). Even if both active pharmaceutical ingredients in a 2-drug mixture were approved separately on their own, it does not mean the combined product is approved for [More]

From : Communities>>Regulatory Open Forum
These are all unapproved new drugs. Many people who have very limited knowledge of our OTC drug system, assume that if it is sold OTC, it is a monographed drug and they can change the formulation. They do not know that there are two types of OTC drugs allowed-compliance with a monograph or NDA. Minoxidil is one and chlorhexidine antiseptic wash is another. ------------------------------ David Steinberg,FRAPS President Steinberg & Associates, Inc. Pompton Plains NJ USA 609-902-8860 -------------- [More]

From : Communities>>Regulatory Open Forum
The only  possible way I can see any of these products being legally marketed in the US without going the OTC NDA route would be if the ingredients  other than Minoxidil are considered "inactive" and have some purpose (other than their active ingredient purposes) in the formulation.  That said, this might work for the last combination in your listing because all of these can and are often used in OTC products as inactive ingredients with understood and current reasons for existing in a formulation [More]

From : Communities>>Regulatory Open Forum
These types of products and combinations you mention are all unapproved drugs and unapproved combinations.  Unless the specific combination is approved or listed in an OTC monograph, it is a new drug and requires a NDA to market it.  Minoxidil is a Rx to OTC switch product so it requires a NDA or ANDA to market this drug in the US, even as a OTC drug.  Thus any combination with minoxidil is a new drug. In the past the FDA has also specifically stated that combining different types of products (drug [More]

Third Rock Ventures, the Boston-based venture capital firm behind some of the Bay State’s most prominent biotechs, has reclaimed its title as the biggest life science-focused VC firm in the state with a new $616 million round, and has also named its first female partner in eight years. With the announcement of its Fund IV today — its largest ever — the firm now has raised $1.9 billion in the nine years since it was formed. That eclipses its rival across the Charles River, Flagship Ventures,…

The company receives approval for MenQuadfi to prevent meningococcal disease.

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April saw the company add new CEO, receive approval for lead ADC drug, and launch a public offering of stock.

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Wholesalers have “almost completely run out” of the personal protective equipment supplied by Public Health England for distribution to community pharmacies during the COVID-19 pandemic, the wholesaler trade body has warned.

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Just a few months after Alexion snapped up complement inhibitor biotech Achillion, Gemini Therapeutics has nabbed one of its key R&D execs as its new chief medical officer.

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The centre issued the order restricting the sale and distribution of Hydroxychloroquine to prevent its misuse. 

The virus seems to have accelerated and amplified an ongoing trend of belt-tightening at startups.

The post Startup giants’ laid-off talents shaken, but undeterred appeared first on DealStreetAsia.

IBPS RRB Provisional Allotment List & Final Result 2019-2020 out @ ibps.in. Check your result on direct link provided here. IBPS conducted the RRB Office Assistant & Officer Scale I, II & III recruitment exam in August 2019.

IBPS Exam Calendar 2020-21 released @ ibps.in in PDF Download format. Check here exam dates and schedule of IBPS Recruitment 2020 of IBPS PO, IBPS Clerk, IBPS RRB and IBPS SO 2020 in banks. Download IBPS Calendar 2020 here. 

Shandong First Medical University (Shandong Academy of Medical Sciences) has been actively promoting the strategy of “invigorating the university through talents” and therefore has formulated a series of high-level talent introduction programs, and welcome talents at home and abroad to join us.

1. Qualifications for Different Levels of Applicants:

(1) Strategic Talents

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Changes to the layout of Valencia's street circuit could be made prior to F1's return next year