Tuesday, January 03, 2017

PROBLEM OVER PROMOTIONAL YOUTUBE VIDEO - US FDA Pulls Up Cadila Arm for Misbranding Drug

Told to stop violating legal provisions in US; co says it has taken action to respond to letter
Zydus Discovery DMCC, a research subsidiary of Cadila Healthcare, has been pulled up by the US Food and Drug Administration (US FDA) for misbranding Saroglitazar, its drug used in India to treat diabetic dyslipidemia and hypertriglyceridemia, in a promotional YouTube video.
In a December 21 letter to the company, the FDA has said the “broad statements“ made by the company as the “world's first“ is misleading. It directed the company to cease violating the legal provisions in the US and respond before January 6.
From a public health perspective, the FDA noted, the claims and presentations are concerning because they include representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA.
While the US drug regulatory agency acknowledged that the drug was approved in a particular country, it pointed out that it is not proven to be safe and effective within the meaning of the US FD&C Act and has not been approved as a drug under that authority for any use. Saroglitazar is branded as Lipaglyn and marketed in India since 2013.
The FDA note said “although we acknowledge that Saroglitazar is approved for use in another country, the claims and presentations, including the broad statements regarding the drug's approval as the `world's first', furthermore are misleading, suggesting that the drug is approved throughout the world, including in the United States, when that is not the case“.
“The video does not include any specific information regarding Saroglitazar's approval status in the world or any information to indicate that Saroglitazar is an investigational new drug that has not been approved for commercial distribution in the United States,“ it added.
Saroglitazar is a flagship research product of Zydus Cadila. The company has been researching on the drug to treat fatty liver disease or non-alcoholic steatohepatitis (NASH) apart from diabetic dyslipidemia. In November 2015, Zydus Cadila received approval from the US FDA to conduct phase two studies for dyslipidemia .
Cadila Healthcare clarified that the matter “very specifically relates to a Untitled Letter issued by the US FDA to Zydus Discovery DMCC and not a warning letter“.
It added that the letter is related to a product promotion of a drug, which is not marketed in the US and is marketed only in India. “We have already taken the necessary actions to respond to this letter,“ the company said.
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Source: DNA 29th Dec 2016

Zydus Buys Six Merck India Brands

Portfolio, which clocked Rs 84 cr in 2015, to sales of ` help strengthen Zydus' core therapeutic offerings
Ahmedabad-headquartered drug maker Zydus Cadila has acquired six brands from the Indian unit of US pharmaceutical giant Merck for an undisclosed amount.
Zydus, in a release late on Wednesday , said it has acquired Deca-Durabolin, Durabolin, Sustanon, Multiload, Sicastat and Axeten range from Merck Sharp and Dohme (MSD). The acquired portfolio . 84 crore in 2015, it said.clocked in sales of ` The brands fall in men's and women's health, wound management and cardiovascular therapy segments.
EThad reported in August that MSD was looking to sell a range of products as part of a rationalisation drive that would see sharper focus on select core brands.
Its deal with Zydus includes transfer of distribution and commercialisation rights as well as assignment of trademarks of all the six brands to Zydus Healthcare in India.
Organon (India), has also transferred the distribution and commercialisation rights for Deca-Durabolin and Durabolin for Nepal to Zydus.
The acquisition is expected to strengthen Zydus' portfolio in key therapeutic segments. “We look at this as a great opportunity to strengthen our core offerings to create value and growth,“ Zydus Healthcare chairman Sharvil Patel said. The drug maker's share prices closed 0.20% higher at . `350.45 on the Bombay Stock Exchange.
Recently, Zydus Cadila's research subsidiary Zydus Discovery DMCC was pulled up by the US Food and Drug Administration.


Source:Economics Time 29th Dec2016

Ten Google hacks to ease your life

If you need to find websites on a given subject rather than those that include a specific phrase, add the “~” symbol to your search.
Use quotes to search for an exact phrase: These quotes will yield only pages with the same words in the same order as it is in the quotes.
You can search for images using images: You can save the image, and then search or it on Google Images (with the camera button). Similar images on the web will begin to pop up.
You can also use the minus sign to eliminate results containing certain words. Figure out the word, which you are not interested in, and rerun the search. For example, BMW –car.
Press the mic icon on Google's search bar, and say “flip a coin” or “heads or tails”. This move lets Google flip a coin for you when you do not have one on hand.
Searching within websites is easy too : To do this, type the address of the site, then a keyword or entire phrase from the article and it will show up in the top 5 results.
If you wish to find an article where all the terms you are searching for appear in the text of that page, type in allintext: followed by all those words or phrases.
Similarly, if you want to find pages with your search query mentioned in the URL, type allinurl: immediately followed by your search query.
If you have forgotten a word or two from a specific phrase, song, or a movie quote, you can use an asterisk sign as a wildcard to help you find the missing word. For example, Crazy * love.

If you wish to translate a word or phrase from one language to another, you can simply search Google for - translate [word] to [language].
Source: DNA-29th-December-2016
http://epaper2.dnaindia.com/index.php?pagedate=2016-12-29&edcode=820009&subcode=820009&mod=1&pgnum=2

Ten Google hacks to ease your life


   

   A list of the most effective methods for searching material on Google in just a couple of clicks
   If you need to find websites on a given subject rather than those that include a specific phrase, add the “~” symbol to your search.
  Use quotes to search for an exact phrase: These quotes will yield only pages with the same words in the same order as it is in the quotes.
You can search for images using images: You can save the image, and then search or it on Google Images (with the camera button). Similar
images on the web will begin to pop up.
You can also use the minus sign to eliminate results containing certain words. Figure out the word, which you are not interested in, and rerun the search. For example, BMW –car.
Press the mic icon on Google's search bar, and say “flip a coin” or “heads or tails”. This move lets Google flip a coin for you when you do not have one on hand.
Searching within websites is easy too : To do this, type the address of the site, then a keyword or entire phrase from the article and it will show up in the top 5 results.
If you wish to find an article where all the terms you are searching for appear in the text of that page, type in allintext: followed by all those words or phrases.
Similarly, if you want to find pages with your search query mentioned in the URL, type allinurl: immediately followed by your search query.
  If you have forgotten a word or two from a specific phrase, song, or a movie quote, you can use an asterisk sign as a wildcard to help you find the missing word. For example, Crazy * love.
If you wish to translate a word or phrase from one language to another, you can simply search Google for - translate [word] to [language].
India.com


Source: DNA-29th December, 2016.

HAPPY 2017!


  
 The New Year gives us a fantastic opportunity to reinvent ourselves. It's also a good time to start doing the things we've been
putting off for a long time... like read more books, learn something new ­ perhaps a new language or a musical instrument ­ take
up a new hobby, and just make lifestyle changes for a healthier life. Ashutosh Desai and Savio D'Souza tell you about some fantastic web resources for a...
READ MORE:
Many of us “book lovers“ can find hundreds of excuses for not reading as much as we'd like to. Well, the web is packed with communities that encourage this wonderful habit. A relatively new trend these days-and one which must be encouraged--is to read 52 books in a year, ie, one every week. Here, you can turn to websites such as...
http:www.read52booksin52weeks.com
52booksorbust.wordpress.com
oneyearfiftytwobooks.tumblr .com
http:www.reddit.comr52book for inspiration and groups of readers who've taken up the challenge in all earnestness.
Now, if you already hold a library membership, or have myriad unread books on your shelf, you're set. But if you don't fall in either
category , you could consider investing in a Kindle e-book reader...
Kindle (Wi-Fi: `5,999)
Kindle Paperwhite (Wi-Fi: `10,999), (Wi-Fi+3G: `13,999)
Kindle Voyage (Wi-Fi: `16,499), (Wi-Fi+3G: `20,499)
Kindle Oasis (Wi-Fi: `23,999), (Wi-Fi+3G: `27,999)
Except for the basic Kindle model, all the other devices come with a glare-free illuminated display that allows you to read in low light and dark environs. We suggest you read the complete specs of each of these models on http:www.amazon.in before you decide which one best fits your needs.
The Kindles come with an automatic bookmark feature that lets you immediately start from where you stopped; you get a built-in dictionary; and you can even annotate, highlight text passages. And if you link your Facebook and Twitter account to your Amazon Kindle ID, you can also share book excerpts with your friends and followers. Regardless of the model, these readers are backed by Amazon's online store where you can find e-books ­ paid and free ­ in each and every genre. Plus, there's Kindle Prime that lets you borrow books for a limited period of time at a highly discounted price.
For suggestions on which titles to read, you can try...
http:www.goodreads.com: After you create a free account on this website, you can see what your friends are reading; track the books you're reading, have read, and want to read; check out book recommendations that are based on your reading list, and also read reviews from other community members. The best part, GoodReads is also part of the Kindle ecosystem, so as you finish a book on your device, it is marked as complete on your online profile, and you are provided with suggestions on what you could read next.
Also consider http:www.librarything.com
LEARN SOMETHING NEW
Sign up for an online education to expand your skill set. You can enrol for short-term courses that you can pursue at your convenience, gain proficiency in a foreign language and even increase your general knowledge.
gohighbrow.com: This website lets you sign up for bite-sized programmes in subjects such as art, business, health, history , languages, literature, logic, nature, philosophy , productivity, psychology , science and technology . All the courses are free, about 10-days long and are broken into text-based 5-minute lessons that are delivered to your inbox every day .
The lessons come with suggestions for further reading and include links to other related resources, wherever applicable.For instance, you can learn about the history of cinema, understand the secrets of body language, do a quick course in HTML and CSS basics, complete a programme on how to be a better leader, and more.http:www.duolingo.com: This is, by far, the best resource to learn a new language for free. Here, as an English speaker, you can learn Spanish, French, German, Italian, Vietnamese, Hindi and more. Lessons comprise multiple choice questions that require you to listen, translate and even say the answer out aloud (provided you have a mic). Duolingo grades your responses, awards you with badges for being regular and even encourages you to revisit lessons that require practise. You can compete and interact with other members to clarify doubts, use its mobile app to complete lessons while on the move and even join a Duolingo “club“ for motivation. Now i know.com: Did you know that the orange carrot is a mutant? That polar bears are invisible to infrared night vision cameras? That Google hired 200 goats in 2009 to mow and re-fertilise the fields at their Mountain Valley headquarters? No? Head to Now I Know ­ a trivia website created and maintained by Dan Lewis since 2010. Sign up with your email address and you will receive newsletters with something new and interesting that you can share with your friends every day .
FIND A NEW HOBBY
In 2017, you could try and carve out some time, away from work, for yourself and a new hobby perhaps, consider photography . You could, , drawing and sketching, or even learn to play a new musical instrument...photographycourse.net: It doesn't matter if you own a point-and-shoot camera, a digital SLR or a smartphone, you can still fine tune your photography skills with online tips and tutorials. In Photography Course, you will find suggestions to help you improve the way you frame a shot, focus on a subject, use effects and even photo editing software to enhance your pictures. Depending on your proficiency , you can opt for courses that are tailor-made for beginners, intermediates or advanced users. The website also comprises tips and articles on specific topics like how to photograph landscapes, the use of perspective, when to (or not to) use your camera's flash and more.
Also consider http:www.geofflawrence.com and 
http:www.exposureguide.com365project.org: Also, register with 365 Project, a website that encourages members to post one photograph a day . You will not only create a bank of memories through the course of the year, but also improve your photography skills while interacting with other members.
http:www.drawinghowtodraw.com: Here, you can follow step-by-step tutorials on how to draw cartoons with basic shapes and letters from the alphabet. For instance, you can draw elephants from the letter `P', use the letters `b' and `d' to draw a bunny or try your hand at drawing popular characters like an Angry Bird and Pikachu from Pokemon. As you gain confidence after completing basic sketches, you can move on to advanced tutorials on how to draw expressions, hands, eyes, etc. How to Draw also lets you download free drawing ebooks for kids.
http:www.drawingnow.com: For access to tutorials on how to draw people, places, manga and more, try Drawing Now. The site has contests where you can share your drawings and connect with other website members. You can also use its app ­ for Android and iOS devices ­ to practise while you are away from your computer.
http:www.justinguitar .com: The guitar, besides the keyboardpiano, is one of the most popular instruments, which you can teach yourself fairly well. Simply log onto Justin Guitar and you will find courses for beginners, as well as intermediates (in case you have played a bit in the past), along with music theory and songs that you can use to hone your skills.
Lessons are accompanied with videos, so you can learn and play along with Justin.
Here you will also find step-by-step practise tips, and even simplified versions of popular songs.
pianolessons.com, piano-keyboard-guide.com: If you want to learn the piano then you should check out the lessons on Piano Lessons and the Piano Keyboard Guide. Between these two, you will have access to over a hundred video lessons on how to play from scratch, read sheet music and learn about different playing styles.
http:www.youcanplayit.com: Besides piano, You Can Play It also shows you how to play tunes on a recorder (a type of flute used in western classical). The tutorials are labelled as very easy , easy and advanced, depending on their complexity . The videos are played slowly so that you can play along to get a hang of finger placement.
learntheharmonica.com: The harmonica or mouth organ, which has been featured in many popular Bollywood songs, is another instrument you can learn with a little bit of practise. Learn the Harmonica is an excellent resource comprising over a hundred video tutorials that will teach you the basics, with tips and tutorials on how to play popular English songs.
discoverahobby.com: In case you need some inspiration on what activity to take on, then visit Discovery a Hobby and browse through its list of 200+ hobbies. They are organised under catego ries such as collecting, arts and crafts, board games, sports, performing arts, music and much more. Click on an activity of interest and the website provides detailed how-to articles, along with videos and useful web links to help you get started. If you regis ter or sign in with your GoogleFacebook account, you can click on “I want to do this“ and keep a track of the hobbies you are passionate about. Later, you can revisit these and click “I've done this“ for the ones you have mastered.
GET FIT
You don't need the gym to get healthy All you have to do is follow these web sites regularly , at your own pace, for a healthier 2017.
darebee.com: Think of Darebee as a complete fitness how-to website.
Here you will find downloadable PDF files, with exercises neatly illustrated to make routines easy for beginners to follow. Users can then print these for reference. In its `Workout' section, you will find 794 exercises, which can be filtered by type (strength, cardio, stretchingflexibility...), focus area (upper body , lower body , abs...), equipment (none, dumb bells, bar...), and difficulty (easy, normal, hard...). `Programs' includes 30-day exer cise routines that prep you for strength building, boxing, endurance and more. `Chal lenges' are similar to 30-day programmes, only here you are pushed to meet goals like 1,000 crunches in a month, no sugar challenge, eight glasses of water a day , sustained ab workouts, et al.
`Running' helps prepare you for 5km, 10km and marathon runs, while `Fitness' comprises exercises to lose weight, build muscle, get rid of the belly... ­ and finally, `Nutrition', `Meal Plans' and `Recipes' help you plan your diets with detailed eating advise for a more holistic approach to all-round health and wellness.
Darebee has a section that helps beginners pick an exercise programme and it has a video library that demonstrates the right way to perform over 200 exercises.The best part? It is completely free to use.
http:www.doyogawithme.com: If you want to start this year with yoga lessons, visit Do Yoga with Me. It comprises over 150 free high-definition videos that teach students different asanas ­ and these can be browsed by difficulty (beginner, intermediate, advanced), class length (0-20 minutes, 20-40, 40-60, more than an hour), style (Hatha, Power, Vinyasa Yoga...) and even choice of teacher (with over 15 instructors to choose from).
Do Yoga with Me also has a section on yoga poses, meditation, breathing exercises, and complete programmes spanning 6 to 8 weeks, including a `beginner's studio' with simple routines.
Source:TIMES OF INDIA-31st December,2016