NGK Spark Plug Co. Ltd., an automotive parts manufacturer based in Nagoya, Japan, has agreed to plead guilty and to pay a $52.1 million criminal fine for its role in a conspiracy to fix prices and rig bids for spark plugs, standard oxygen sensors, and air fuel ratio sensors installed in cars sold to automobile manufacturers in the United States and elsewhere, the Department of Justice announced today

The following statement is attributable to Justice Department spokesman Brian Fallon regarding Attorney General Eric Holder’s visit to Mexico City today to meet with his fellow attorneys general from across Central America to discuss the situation involving migrant children.

Nutrition 21, LLC has announced its Nitrosigine® is now featured in EVERTRAIN PRE, a recently launched pre-workout supplement designed to provide athletes with sustained energy, superior focus and increased endurance.

Outside influences have shown strong correlations with what lives inside our bodies, and researchers are just beginning to understand how these environmental factors may affect the makeup of the gut microbiome.

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]

The results of a 33-patient study conducted by a Burlington biotech suggest its long-acting steroid injection for osteoarthritis of the knee may be safer for the large percentage of those patients who also have type 2 diabetes. Flexion Therapeutics (Nasdaq: FLXN) has for years been developing its lead drug candidate, Zilretta (formerly called FX006), a reformulation of a common corticosteroid that’s used with osteoarthritis patients. Flexion’s version combines the drug with a employs proprietary…

Alexion agrees deal for Portola to gain access to its lead product, Andexxa, a treatment that counteracts anticoagulants.

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.

Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […]

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

Carson Meyer, daughter of an NBCUniversal executive and sister of jewelry designer Jennifer Meyer, is reaching parents-to-be virtually in the COVID-19 age.

Former CEO Achmad Zaky stepped down from his position, in a surprise move, in December 2019.

The post Indonesian unicorn Bukalapak’s co-founder & CTO Herucahyono exits appeared first on DealStreetAsia.

The pair announced their first investment on Tuesday into edtech startup Eduka System.

The post Bukalapak co-founders Zaky, Xinuc set up early-stage VC fund Init 6 appeared first on DealStreetAsia.

Scientists edited dogs' genes to correct a common form of muscle dystrophy

Mouse studies suggest inhibiting ferroptosis could help treat ischemia/reperfusion injury in the liver and kidney.

Guallar, Javier and Cornet, Anna Centros de documentación de diarios en el siglo XXI. Panorama después del tsunami. BiD, 2020, n. 44. [Journal article (Unpaginated)]

Verdugo-Sánchez, José-Alfredo La medición de la satisfacción de usuarios como indicador de calidad en los sistemas bibliotecarios: el caso de las universidades públicas de noroeste de México., 2015 PhD Thesis thesis, Universidad Complutense de Madrid. [Thesis]

Feb 3, 2020

The study of existential risk — the risk of human extinction or the collapse of human civilization — has only recently emerged as an integrated field of research, and yet an overwhelming volume of relevant research has already been published. To provide an evidence base for policy and risk analysis, this research should be systematically reviewed. In a systematic review, one of many time-consuming tasks is to read the titles and abstracts of research publications, to see if they meet the inclusion criteria. The authors show how this task can be shared between multiple people (using crowdsourcing) and partially automated (using machine learning), as methods of handling an overwhelming volume of research.

Apr 10, 2020

Unlike state sponsors, which value proxies primarily for their military utility, nonstate sponsors use proxies mainly for their perceived political value. An analysis of three case studies—al-Qaida in the Arabian Peninsula, the People’s Protection Units in Syria, and Hezbollah in Lebanon—illustrates this argument.

Apr 10, 2020

Unlike state sponsors, which value proxies primarily for their military utility, nonstate sponsors use proxies mainly for their perceived political value. An analysis of three case studies—al-Qaida in the Arabian Peninsula, the People’s Protection Units in Syria, and Hezbollah in Lebanon—illustrates this argument.

Feb 3, 2020

The study of existential risk — the risk of human extinction or the collapse of human civilization — has only recently emerged as an integrated field of research, and yet an overwhelming volume of relevant research has already been published. To provide an evidence base for policy and risk analysis, this research should be systematically reviewed. In a systematic review, one of many time-consuming tasks is to read the titles and abstracts of research publications, to see if they meet the inclusion criteria. The authors show how this task can be shared between multiple people (using crowdsourcing) and partially automated (using machine learning), as methods of handling an overwhelming volume of research.

Feb 3, 2020

The study of existential risk — the risk of human extinction or the collapse of human civilization — has only recently emerged as an integrated field of research, and yet an overwhelming volume of relevant research has already been published. To provide an evidence base for policy and risk analysis, this research should be systematically reviewed. In a systematic review, one of many time-consuming tasks is to read the titles and abstracts of research publications, to see if they meet the inclusion criteria. The authors show how this task can be shared between multiple people (using crowdsourcing) and partially automated (using machine learning), as methods of handling an overwhelming volume of research.