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PostPosted: 23 May 2010 19:59 
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Mahendra wrote:
The technology is prohibitively expensive and it is not likely that dumb country doctors will get their hands on it. Basic primary health care should be the main objective for dumb country doctors.
The rich will sooner or later find a way to have designer babies and it is more than likely that some Indian Whiz will pioneer the technology, but projecting from current trends it does not seem likely that designer babies will pass the ethical test. However like India is a hugely popular destination for firangis looking for a takeaway organ transplant centres, genetic engineering too will probably fall in the same category.

This moral dielmma of the west is pure eyewash, western companies fund clinical trials in developing countries with the aim of marketing the drug in the West first.



The technology will be improved until it becomes ridiculously easy to use - market forces will see to that. Nobody thought that computer chips would leave the mainframe environment and reach the home, but they certainly did, and sparked massive consumer demand.

Likewise, today we see Indian country doctors roving around the countryside offering ultrasound and amniocentesis tests for gender determination - and there are plenty of customers flocking to them.
Certainly, there is no shortage of people wanting to get a leg up on life through their children.

As long as the demand is there, then there will be a waiting market that calls for these products and services to be developed.
I don't know what kind of crazy world it will lead to, but genetic selection is itself a built-in human trait, as so many of our unconscious responses are built around it.

Here is the latest on Venter's "synthia":

http://news.bbc.co.uk/2/hi/science_and_ ... 140442.stm


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PostPosted: 24 May 2010 08:11 
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If anyone here has any interest or knowledge of manufacturing of tissue culture plasticware and serological pipettes, could someone kindly contact me at patentconsultatgmaildotcom. Also, I have started a group on linkedin called US-India Biotechnology Alliance. I'd love to see all of you there as well. My name is Anant there also and location is in Iowa. Moderator, if this is against the guidelines I humbly apologize. I look forward to interacting with all of you.


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PostPosted: 25 May 2010 02:37 
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Are stem cell related bio stocks worth investing in ?

Is this area likely to hold great promise ?


Thanks


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PostPosted: 25 May 2010 02:52 
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Neshant wrote:
Are stem cell related bio stocks worth investing in ?

Is this area likely to hold great promise ?


Thanks


It will have to be a very long term investment as there are no existing stem cell therapies (to earn from) in western countries now. Most of them are in development phase and some are in Phase I & II clinical trials. Upside being that share values of such companies is very less now and with Obama in power there is more hope for stem cell dependent therapies or developments towards that direction and you might have a good windfall profits if you hold on to them.


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PostPosted: 25 May 2010 03:13 
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James B wrote:
It will have to be a very long term investment as there are no existing stem cell therapies (to earn from) in western countries now. Most of them are in development phase and some are in Phase I & II clinical trials. Upside being that share values of such companies is very less now and with Obama in power there is more hope for stem cell dependent therapies or developments towards that direction and you might have a good windfall profits if you hold on to them.


That's what I'm asking for.

Are you in the industry and do you know what company might be following a promising angle to stem cell research ?


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PostPosted: 25 May 2010 03:34 
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Neshant wrote:
James B wrote:
It will have to be a very long term investment as there are no existing stem cell therapies (to earn from) in western countries now. Most of them are in development phase and some are in Phase I & II clinical trials. Upside being that share values of such companies is very less now and with Obama in power there is more hope for stem cell dependent therapies or developments towards that direction and you might have a good windfall profits if you hold on to them.


That's what I'm asking for.

Are you in the industry and do you know what company might be following a promising angle to stem cell research ?


I'm not exactly in stem cell field but in biotech field and I get to read about these in the journals as I have scientific interest in stem cells related stuff.

Regarding the leaders in the field of stem cell therapy, based on their clinical phase trials stage in launching therapies or products, I would look at these 3 companies in that order

Osiris therapeutics (http://www.osiristx.com/)
Aastrom Biotech (http://www.aastrom.com/)
Advanced Cell Technology (http://www.advancedcell.com/)

The products/therapies would come out from these companies in 2-5yrs time. You need to do your own diligence before you go for their stocks. I'm just priming you on this issue and standard disclaimers apply. Hopes this helps you.


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PostPosted: 25 May 2010 09:24 
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Hello Neshant,

I am a stem cell scientist. I'd stay away from these stocks like the plague for now. It's like the wild wild west. Yes there is great potential but at the moment, very little has moved from the bench to the clinic. I'd stay away for now. If you wish you can contact me offline. All the best.

Anant


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PostPosted: 25 May 2010 09:47 
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Anant, would you be able to shed some light on successes of stem cell treatment vs gene therapy?

broadly speaking stem cells seem to succeed when the right "ambiance" in terms of chemical signaling from surrounding cells exist while gene therapy is stuck on finding the exact and reliable marker probes to successfully switch the coding regions

while people are successful at gene arrays which involve same population of nucleotides per sample, gene therapy also acting on a population of similarly expressing cells is still not reliable even at the aggregate level?


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PostPosted: 25 May 2010 09:48 
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Thank you my brothers.

What are your opinions on the state of stem cell research and where its headed. Would you say its more hype than substance at this point or are we approaching some kind of critical mass?

My gut feeling is that this area holds great promise. Many have/are/will be rushing into stem cell/genetics related stocks and hardly anyone (myself included) will have a clue what we are buying into.

Any investor getting the timing wrong between now and then is liable to get his head handed to him as these stocks have an alarming tendency to trend towards zero I notice.

In your opinion, is there anything stem cell related worth investing in for the long haul ? If not, how far out would you say are we to a 'take off point'.


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PostPosted: 25 May 2010 11:24 
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vasu_ray wrote:
Anant, would you be able to shed some light on successes of stem cell treatment vs gene therapy?

broadly speaking stem cells seem to succeed when the right "ambiance" in terms of chemical signaling from surrounding cells exist while gene therapy is stuck on finding the exact and reliable marker probes to successfully switch the coding regions


Vasu ji, Gene therapy is a big failure as far as its applicability to treatment in considered. Its pushed into the background, no body even talks about it anymore.

Stem cell treatment holds great promise if one looks at the pre-clinical (mice) studies on their therapeutic value. Stem cells field was held back in the last decade due to ethical issues but that now seems to fading and there are more and more studies being done both in research institutes and companies. In India, some clinics are already treating terminally ill patients or patients with no other cure. The problem is that no body has done scientific study on these treatments as to the success rate, side effects, treatment related deaths etc, so it is difficult to say how stem cells will come into acceptance. The answer lies in success of the Phase III/IV clinical trials of some of these stem cell therapies in US. If they are successful without any side effects and good success rate, then it will give huge impetus to this area.

Quote:
while people are successful at gene arrays which involve same population of nucleotides per sample, gene therapy also acting on a population of similarly expressing cells is still not reliable even at the aggregate level?


Gene arrays has nothing to do with gene therapy. Gene arrays at the most will serve as diagnostic/prognostic tool in genetic and cancer diseases. Gene/cDNA arrays are extensively used in disease/cancer field to study the changes that occur in these diseases at gene level in the cells.

The practical problem with gene therapy so far has been in its ability to insert the correct form of the gene into all the disease cells. It is easy to do in the lab on mice and other animals but much difficult in patients without large side effects as there is a possibility of this gene incorporating at more than one site and thus leading to deleterious effects.


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PostPosted: 25 May 2010 11:30 
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Neshant wrote:
Thank you my brothers.

What are your opinions on the state of stem cell research and where its headed. Would you say its more hype than substance at this point or are we approaching some kind of critical mass?


At the research level it has already reached the critical mass, the only problem being getting it translated into treatments, which is happening at a slow pace and there is so far no FDA approved stem cell treatment available. Once that happens, I think sky is the limit for this field.

Quote:
My gut feeling is that this area holds great promise. Many have/are/will be rushing into stem cell/genetics related stocks and hardly anyone (myself included) will have a clue what we are buying into.


It does hold great promise and at the research level it showed very promising results. Its good to go for those stocks whose companies are in the last phase of clinical trials as in which are close to get approval if those trials go successfully. And these clinical trials usually take a lot of time (in years).

Quote:
Any investor getting the timing wrong between now and then is liable to get his head handed to him as these stocks have an alarming tendency to trend towards zero I notice.


If you look at the stocks of the stem cell companies that I listed in previous posts, they are in the 1-2 dollar range which are already at a very basal level. They will either stay at this level or go upwards depending on what is coming out of their pipelines into the market.

Quote:
In your opinion, is there anything stem cell related worth investing in for the long haul ? If not, how far out would you say are we to a 'take off point'.


Take off point is still few years away (2-5 years).


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PostPosted: 25 May 2010 17:43 
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Forgive my ignorance but I've got a few layman questions. I understand these stem cells are cultured and injected into the damaged tissue region and go about repairing it somehow. But what beyond that is involved in this research? Are the researchers involved in controlling how stem cells differentiate or are they just injecting away blindly ? Are they sure these cells don't form into cancerous tumors or is that a non-issue?

What other aspects are there to stem cell research? Are we on the cusp of coaxing stem cells to form into organs for body part replacement or is that lightyears away.

Thank you for the list of stocks. Ideally I'd like to pick up these things as penny stocks (under $5) as I understand its highly speculative as Anant pointed out. I'm only willing to part with a small amount of cash to buy these lottery tickets.

If you had to pick 2 of the 3 company you listed, which ones would you go for? Same question to Anant.


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PostPosted: 26 May 2010 09:11 
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Hi all,

I was pleasantly surprised that there is a biotech discussion on BR. I've been schleping on here for more than 10 years but apparently never visited the technology and economy forum. Now on to your questions.

Neshant, don't take it the wrong way but don't invest in stem cell stocks and biotech in general. It's a crap shoot and the market is undergoing consolidation or shrinkage. Many large companies like Pfizer etc are laying off lots of people (2500) or shutting plants. Even so called stem cell stalwarts like Osiris are not worth investing in. They had a stem cell therapeutic named Prochymal which performed equivalent to placebo and the stock tanked. They (Osiris) is backed by Genzyme but you can gild the lily all you want but that still doesn't enhance share holder value.

At this point in time, I'd stay away from the biotech sector period. I am. I am investing in ADR's but that's a discussion for another day.

As to your biotech questions, you can do the following. 1) inject stem cells in situ. Being done both in purified form or even just as a raw fractionate. 2) Creating progenitors from stem cells and injecting them in the right location. To address your issue about tumor formation, most therapies at the moment are autologous (from the patient) and are adult or somatic stem cells (like mesenchymal stem cells) which don't form tumors (teratomas) like ES or IPS cells, so largely not an issue. There are many many aspects to stem cells. Neshant, we are working on full organs at the moment so no not light years. I do it routinely on a daily basis. If you have further questions, please don't hesitate to ask but save your money and buy a nice single malt but don't invest in stem cell companies (yet). In a year or so, my answer will change.


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PostPosted: 27 May 2010 07:32 
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Thanks for the tip Anant. I"ll take your word for it and not invest as I'm no expert in this field.

Speaking of Prochymal, I got a question for you. I had my eye on a company (Stem Cell Theraputics - http://www.stemcellthera.com) which is a penny stock (SSS.V). They had a drug for stroke under phase II testing. It was supposed to be administered after a stroke to stimulate production of stem cells in the brain to enable recovery of the damaged region. I participated in the stock run up hype but fortunately jumped out at the last minute just before they released their results (May 25th).

They had 96 stroke patients (all recruited guinea pigs in India) divided into 4 groups. One group given the med, the other three placebo. The result - all three placebo groups performed as well as the drugged group and hence no statistical significance. The stock bombed. Still the company claims it will re-examine the results in a variety of ways to see why the placebo group had such a high success rate and then try for phase III (?). My view is unless they go for a phase II re-trial, any alternative interpretation of the result will look like they are massaging the data. What do you think of these guys? Any sense in buying their stock now at the 9 cents sticker price currently ? How likely is it for a drug to make it to production after a bad Phase II trial result? For now, I'm just glad I jumped out ! Some guys were holding $125K of this stuff and they are probably standing on the ledge of a building now.

Had they succeeded, the stock would have soared as I know of no other company which has such a novel treatment for stroke which kills/disables millions. I imagine the potential application to other diseases involving cellular damage/repair would have been enormous. This is the kind of diamond in the rough I'm looking for but alas, they are far and few between.

Quote:
we are working on full organs at the moment so no not light years. I do it routinely on a daily basis.


But I take it you are not growing whole organs, just heart cells and skin cells..etc. How far are we from complete organ replacement (i.e. growing a new kidney or a new heart). I can see body organ replacement as being a trillion plus dollar industry.

Quote:
don't invest in stem cell companies (yet). In a year or so, my answer will change.


What do you anticipate happening in a year that would be of significance? I fear I may miss the bus. Would you sound the alarm when the time is near. :)


Last edited by Neshant on 27 May 2010 10:46, edited 1 time in total.

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PostPosted: 27 May 2010 09:38 
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Neshant,

Funny you mention Stem Cell Therapeutics. Yes, I know them and yes I've met them. First, if the stock is a penny stock, you shouldn't be hanging out in that neighborhood at all. Stocks like that are illiquid, pumped and dumped and often hard to get rid off. Be darn careful ok? You could lose your pants. All I can say about them is stay the h away. Get it? They are like a moving salesman selling stuff from the back of his truck. Not reputable with no therapy per se. There are good clinical trials being done in Germany for post stroke patients using hematopoietic stem cells, and these have shown efficacy, but they are being conducted by governmental entities not private companies. As far as your understanding of organogenesis is concerned, you are correct and wrong. Indeed, we are making organs like skin and cardiomyocytes but we are also creating full organs, e.g. bladders, livers on scaffolds, and even hearts. This is being done largely through external collaborations but check out Wake Forest University. They have a large and extensive program on this which was featured on 60 minutes in the US. I can get you that link. This is no pie in the sky dream. It is being done now. Why did I suggest a year? Its because IPS or induced pluripotent stem cells will revolutionize the field and we are rapidly in the process of moving these from viral based methodologies to patient matched non viral methods of generation. At any rate, glad to discuss these topics. I plan on setting up a stem cell presence in India and am gauging interest there at the moment. All the best folks.


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PostPosted: 27 May 2010 11:04 
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Anant wrote:
Funny you mention Stem Cell Therapeutics. Yes, I know them and yes I've met them. First, if the stock is a penny stock, you shouldn't be hanging out in that neighborhood at all. Stocks like that are illiquid, pumped and dumped and often hard to get rid off. Be darn careful ok?


Don't worry, I just rode the hype and jumped ship on their stock before their Phase II results. Interestingly some large investor dumped a ton of their stocks a few days before the results were out (after I sold fortunately) and sent their share price plunging. Speculation is rife that some insider must have tipped off the concerned party but as always, there is no proof. How did you meet Stem Cell Therapeutics and what was your impression of their drug and company?

Anant wrote:
As far as your understanding of organogenesis is concerned, you are correct and wrong. Indeed, we are making organs like skin and cardiomyocytes but we are also creating full organs, e.g. bladders, livers on scaffolds, and even hearts.


But do these cells grown on scaffolds function together as one cohesive organ. i.e. can you take a heart grown on a scaffold and transplant it into a human as yet? I think I've seen the documentary on 60 mins from 2 or 3 years ago. I even remember one Indian research assistant being in that clip. I think they showed a nose, an ear, heart muscles... and some other stuff growing in some kind of mixing vat filled with what I can only guess was stem cell soup. I didn't see a functioning organ however. Either that or I'm thinking of some other clip.

Anant wrote:
Why did I suggest a year? Its because IPS or induced pluripotent stem cells will revolutionize the field and we are rapidly in the process of moving these from viral based methodologies to patient matched non viral methods of generation.


Don't regular cells have those 4 magic genes introduced into them via a virus to transform them into pluripotent stem cells ? My knowledge here is sketchy.

Anant wrote:
At any rate, glad to discuss these topics. I plan on setting up a stem cell presence in India and am gauging interest there at the moment. All the best folks.


What will you be doing there if I may ask.

OK I looked up ADRs - American Depository Recepits - ownership of non-US companies which trade in US market. What ADRs are you invested in? I'm guessing Indian biotech companies listed on the NASDAQ. I'd like to get in on this sector earlier rather than later so in your professional opinion, about a year or two from now - what kind of companies should I be looking at ? I won't be putting much in, just a little. Please suggest a few names to keep on my radar.


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PostPosted: 28 May 2010 10:01 
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wow, what amazing little machines these viruses are.

working at the sub-microscopic level with such precision and purpose.

----------

Animation of how the HIV virus replicates

http://www.youtube.com/watch?v=RO8MP3wMvqg


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PostPosted: 29 May 2010 22:30 
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Thanks James, sorry got tied up so far

to all biotech gurus,

are there any stem cell therapies for diabetes? can insulin generating cells be rejuvenated/replaced without the need for whole organ replacement?

how are stem cells used to fix problems that are fundamentally genetics based? if a stem cell population is injected at a particular site in the human body, can the generation of working alleles by this stem cell population overcome the genetically defective alleles being generated by the original tissue

lets assume this particular gene is being expressed only in this tissue, it can become complex when the deletion/duplication overlaps multiple genes and each gene is expressed in different tissue not necessarily co-located

then the problem is prioritizing the genes as targets, that's the theory where does research stand in practice?


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PostPosted: 29 May 2010 22:45 
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Anant/James,

where are you heading with stem cell initiative in India? research and/or therapies. I know China has number of hospitals that are doing stem cell treatments without proven studies

Lot of Brain injury patients are being treated and currently its not predictive without knowing the science behind. It either works or not but treatments are very expensive.

Brain tissue replacement is not an option since while the tissue responsible for a particular region of the body is known such as eyes/vision, the neural connections within that occipital region tend to be unique for every person, where is the research in this area heading?


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PostPosted: 02 Jun 2010 22:08 
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India's BT sector to become $5 bn industry by this yr

http://www.business-standard.com/india/ ... r/96553/on


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PostPosted: 28 Sep 2010 22:55 
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Holy cow! Gir gai goes global via Brazil.

Given that the Gir cow is indigenous to Gujarat, local business should have been milking it to earn foreign exchange. But it seems far away Brazil is doing a better of this.

The South American country today has around 50 lakh heads of this unique breed known for high milk production. Gujarat is estimated to have only around 3,000 pure breed Gir cows left, according to Satyajit Khachar, scion of the erstwhile princely state of Jasdan and a known breeder of the cow.

And now, the Gir breed is set to go global. As Khachar puts it, "Brazil has emerged as the world's biggest supplier of improved cattle embryos and semen of Indian origin, now rated among the best dairy breeds in the world. The demand is particularly high from African and Southeast Asian countries. The Indian 'holy cow' has turned out to be a great money-spinner for Brazil."

According to Khachar, the focus of the dairy industry in Gujarat was on buffalo milk because of its fat content. So the Gir breed was neglected, resulting in the dwindling of both its numbers and pedigree.

Only recently, two containers with embryos of the breed were flown to Brazil to improve the stock of cows there :shock: . The embryos were developed in a laboratory in Bhavnagar which has been funded at a cost of Rs 2 crore by cattle breeders of Brazil.

"The last major export of the breed to Brazil took place in 1960, after which laws made import and export of animals difficult. The South American country has taken very good care of the breed, but they need fresh blood every three to four generations because of which the embryos were flown there," says Khachar.

The Bhavnagar laboratory was set up in 2001. Khachar is exporting the embryos in partnership with a Brazilian firm. In Brazil, the Indian cows are known as the Zebu breed. Brazilian farmers first shipped three cattle breeds from India - Gir and Kankrej from Gujarat and Ongole from Andhra Pradesh, in 1850. These breeds were essentially for use in agriculture and for beef. But they soon found out that Gir cow gave large quantities of milk. Interestingly, pedigreed Gir cows in Brazil get the Pure Origin India (POI) tag. Each animal's pedigree and DNA is registered with Association of Brazilin Zebu Breeders, an apex body.


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PostPosted: 01 Feb 2011 11:31 
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Bump.

Marine Biotechnology Park at Mamallapuram soon

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A Marine Bio-Technology Park will be set up at Mamallapuram and the State government has already identified 300 acres for the purpose.

encouraged by the success of TICEL Biotechnology Park-I, the State government was establishing TICEL Biotechnology Park-II at the cost of Rs.150 crore.

Mr Stalin said Park-II would be completed in 2011 and would provide employment opportunities for 1,500 scientists.

Dr. P M Murali, Convenor, CII Tamil Nadu Biotechnology Panel, said the Rs 14,000-crore biotech industry in India was expected to expand 5 times by 2015.


Instead of having many science & technology related threads, maybe we can merge a few and keep one for new developments in s&t in India.


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PostPosted: 02 Feb 2011 07:13 
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this is the future of meat production
-----
South Carolina scientist works to grow meat in lab

http://www.science20.com/run_and_tumble ... wn_chicken


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PostPosted: 21 Mar 2011 13:10 
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US body recognizes Guj genome initiative

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GANDHINAGAR: In a major boost to the state's biotech mission, the National Centre of Biotechnology Information (NCBI), US, which is the global repository for genomic sequence information of humans, animals, plants and micro-organisms, has recognized Gujarat Genomics Initiative's (GGI's) whole genome sequencing of aciditiohbacillus sp as the only standalone work done anywhere in India.

The NCBI came into existence as a result of the human genome project, launched in 1990 in collaboration with the US department of energy, US' National Institute of Health, UK's Welcome Trust and 20 various other world organizations. The project was completed in 13 years, after which NCBI as the global repository of all genetic research came into existence.

An internal note of the state science and technology department calls aciditiohbacillus sp"an important bacteria studied widely for bioleaching – or extraction of metals". It adds, "It offers exceptional opportunity to probe life in extremely acidic environments, offering insights into ancient ways of life in Archaean, acidic seas. It also suggests potential biomarkers to be used when searching for evidence of extra-terrestrial life."

GGI is a state government project — which with two other proje-cts, Gujarat Biodiversity Gene Ba-nk and Virtual Institute of Bioinfo-rmatics — seeks to create an integrated platform for the whole geno-me sequencing. The whole set of ge-nes of an organism is called geno-me and process of sequencing and analysis of whole DNA of a cell of the organism is called whole genome sequencing


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PostPosted: 15 Feb 2012 20:49 
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C-DAC develops Biochrome.

Giving new dimensions to the sequencing of hundreds of genomes or biological data of human beings, the Centre for Development of Advanced Computing (C-DAC) has developed a supercomputing cluster called as Biochrome. It is an advanced blade server-based high performance computing (HPC) facility that has a computing capacity of 5 teraflop, said director general of C-DAC Rajat Moona.

He was speaking to media persons on the eve of launch of the machine on Tuesday at Accelerating Biology 2012, the three-day symposium at a hotel in city.

He said, “The computing facility is one of the technology enablers that can accelerate the process of analysing, data mining and simulation of biological data. The advent of next generation sequencing technology has brought in a new dimension to understanding the molecular basis for the occurrence of diseases.’’

The pace of sequencing is leading to data overload and the ability to analyse is much beyond the existing computing capabilities. In order to gear up to tackle these challenges, most biologists are adopting the use of cyber infrastructure. Bioinformatics Resources and Applications Facility (BRAF) at C-DAC is an effort towards providing high-end supercomputing facility to researchers working in the area of life sciences.

The project is funded by the department of information technology, ministry of communications and information technology.
C-DAC is collaborating with organisations like National Cancer Institute (NCI) of USA, Tata Memorial Centre (Mumbai), Roslin Institute (UK), University of Edinburgh (UK), University of Surrey (UK), Oregon Health and Science University (USA), Sanger Institute (UK), National Centre for Cell Science (Pune) and University of Pune (Pune).


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PostPosted: 01 Apr 2013 19:31 
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SC rejects Novartis' patent plea for cancer drug Glivec

Novartis India case: Campaigners hail patent rejection

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There were celebrations outside the Supreme Court as the landmark decision was read out. One charity, Medecins Sans Frontieres, called it a victory for poor patients not just in India but across the world.


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Experts say Monday's court order will set a precedent for the so-called "patent cliff" - a phrase used to describe the expiry of pharmaceutical patents across a range of blockbuster drugs.

It is estimated that drugs with combined annual sales of $150bn will go off-patent by 2015 and that could help companies here earn millions of dollars in profits.


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PostPosted: 01 Apr 2013 19:42 
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^ Thanks Gerard ji. I remember posting an article on the impact of this judgement on indigenous drug mfgrs and possible boycott by firangi companies and possible WTO law suits... need to dig in.


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PostPosted: 01 Apr 2013 19:55 
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Will not invest on R&D in India: Novartis
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Swiss pharma major Novartis on Monday said it will not invest on research and development in India and move R&D to favourable destinations following the Supreme Court order rejecting its patent plea on cancer drug Glivec.

The company will continue to introduce products in the country, but not invest in R&D here, Novartis India Ltd Vice-Chairman and Managing Director Ranjit Shahani said at a press conference in Mumbai.


IIRC there were threats that Novartis would not allow its products to be sold in India.

Novartis loses landmark India patent case on Glivec
Quote:
"The multinational companies will have to find new ways of doing business in India," said Deepak Malik, healthcare analyst at brokerage Emkay Global, suggesting they may consider licensing agreements with local firms to offer cheap versions of branded drugs like Glivec.

Ranjit Shahani, managing director of Novartis India Ltd, the firm's locally listed unit, said it will still file patents and carry on investing in the country, but with caution, and will continue to refrain from research and development activities there.

"The intellectual property ecosystem in India is not very encouraging," Shahani told reporters in Mumbai after the ruling.

Quote:
The ruling may dampen that enthusiasm in the short term, said S. Majumdar, head of law firm S. Majumdar & Co based in the eastern city of Kolkata.

"But they (foreign pharmaceutical firms) will have to get used to it and learn to live with the law," he said.

Pfizer's cancer drug Sutent and Roche's hepatitis C treatment Pegasys lost their patented status in India last year, decisions the companies are fighting to have reversed. The Supreme Court's latest ruling will make it tougher for them to win back patent protection.

"Henceforth, multinational pharma companies are likely to want that their patents are first recognized in India before launch of a patented product," said Ameet Hariani, managing partner at Mumbai-based law firm Hariani & Co.


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PostPosted: 02 Apr 2013 09:42 
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http://www.forbes.com/sites/greatspecul ... ig-pharma/
India Court Ruling Against Novartis Is Dark Omen For Big Pharma
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It is official: India is siding with poor cancer patients over profits for multinational drug giants.The Supreme Court of India has rejected a plea by Swiss pharma giant Novartis that ends the seven-year legal battle to restrict Indian companies from copying blood cancer drug Glivec. Novartis had filed a plea with the Supreme Court after the Intellectual Property Appellate Board had rejected a patent claim for Glivec. Glivec is marketed as Gleevec in the United States. In 2001, Time magazine called it the magic bullet for cancer patients. The drug was originally developed as Imatinib using rational drug design after Philadelphia chromosome mutation was discovered.In India, Glivec costs about 120,000 rupees for a one month dose. In contrast, generic copies by Indian companies cost about 8,000 rupees, or about $148 at current exchange rates.The decision is being hailed by activists and has major implications for multinational pharmaceutical firms. The decision opens the door for Indian companies to continue to make generics of a large number of drugs that are under patent in the developed world.The decision is also a big setback for the ever-greening strategy employed by big pharma. In this strategy, big pharma makes minor changes to extend patents.Lately, American investors have shown irrational exuberance about pharmaceutical stocks. Pharmaceutical stocks have been one of the best performing groups.Bulls on pharmaceutical stocks cite two reasons behind their analysis. First, they deem pharmaceuticals as safe at a time of uncertainty in Europe and slowing growth in China. The thinking goes that people will always need drugs. Second, pharmaceutical stocks typically pay high dividends and buying dividend stocks is in fashion because there are not many other places to get yield.Bulls miss two key points. The fastest growing markets are not the developed markets, but the developing markets such as India. Now India has thrown down the gauntlet against big profits on branded drugs. My expectation is that most emerging markets will follow. In the long run, this is a very negative development for big pharma.The second point is that it is easy to forget $15 trillion in debt at a time when the stock market is in party mode. The debt situation is partly exasperated by ever increasing spending on Medicare and Medicaid. In the long run, the growth of Medicare and Medicaid at present rates is unsustainable. At present Medicare and Medicaid do not obtain competitive pricing for drugs; this situation cannot last forever. Typically, branded drugs in the U. S. tend to cost more than many other places in the world.
Bulls are right that the drug lobby is strong and politicians prefer to kick the can down the road. However, sooner or later the pricing of branded drugs in the U. S. is bound to come under pressure and herein lies a valuable insight for the long-term investors. Investors may want to exercise caution in stocks of firms such as Pfizer, Merck, Lilly, and Bristol-Myers. Aggressive investors can also take advantage of the present irrational exuberance to start slowly and cautiously building short positions in pharmaceuticals.


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PostPosted: 02 Apr 2013 13:16 
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Novartis underestimated the task before them, by submitting a poorly exemplified application. Had they demonstrated therapeutic effectiveness or selectivity with the evergreen molecule, the courts would have favoured them. This was the wrong battle to fight, and it sounds like sour grapes to suggest that you will shut down non-existent R and D facilitities in India. Woldwide, large Pharma have been scaling back research and closing facilities whilst shedding huge amounts of highly qualified staff, so, it doesn't make a great deal of difference to Indian pharma companies to be scare-mongering.
The entire TRIIPS regulation has been imposed on the rest of the wold by the USPatent office and is an empourer without any clothes.

Where companies in India stand to benefit in the future is if they could repurpose compounds from the large collection of molecules that have passed phase 3 testing. Existing drugs could also be reprofiled and I'd be happy to discuss the mechanics of this with anyone who is interested.


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PostPosted: 04 Apr 2013 03:40 
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The Novaritis boast to not invest in R&D in India is a Kalidasa move as India is the future of pharma. BTW its the Indian CEO that said it and not the Swiss Hqs!
Besides if Medicare and Medical are to remain solvent they need Indian pharma.

Also speaks voulmes of the USPTO low level of acceptance of reformulation!!!


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PostPosted: 04 Apr 2013 03:52 
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Novartis' predecessors - Ciba Geigy and Sandoz, were both in India during the several decades when we did not even recognize drug product patents at all, just process patents. Talk about them leaving sounds like just hot air.

rgosain: please feel free to elaborate on your second paragraph in this thread.


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PostPosted: 05 Apr 2013 01:46 
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The med-chem R and D in the UK and Europe is the last bastion of institutional racism - very rare to see Indians above the bench grade levels, and this is reflected in the comments seen in the feedback to the Novartis patent issue. The industry or what's left of it is filled with the same faces, promoting the same ideas and group think. Many are saying that this is politics because Indian judges cannot be expected to understand the science, and it's actually funny to tell them that Western patents are more likely to be protected in India, if Indian companies try to evergreen molecules, rather than in the West where the bar is lower.
Actually many Americans find it hard to believe that Indira Gandhi's response to US sanctions in 1974, was to disregard US patents.
Suraj regarding reprofiling please contact me at
mitsykatze@outlook.com

If anyone knows of Indian Companies out there who are interested in reprofiling or retooling drugs please get in touch with me at the email address above.


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PostPosted: 08 Apr 2013 11:25 
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The temporary monopoly that a nation gives in recognizing the patent claim is the price it pays for the innovation in the hope of continued innovation.

There is nothing wrong with that.

However, the patent regime is broken - trivial ideas are being patented. Even Indian employees at MNCs are forced to apply for patents for bull$hit ideas because it is a factor in annual review (not joking). Just look at the smartphone wars happening. It is very difficult for startups to innovate because they will challenge a giant organization which is incumbent and which has more lawyers than the number of employees.

Amidst all this, nobody knows the value of the IP because anybody can sue and claim outlandish amounts.

You know, there is a simpler solution to it - property and capital gain tax on Intellectual property, like we have tax on any other property. If an organization acquires IP, then it has to pay the govt a tax which is in proportion to the value it assigns. That means the claim amounts are self-limiting. Also, trivial patents go out of window. This will also cause them to hesitate to patent an idea "just in case" ...


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PostPosted: 19 Apr 2013 12:28 
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India should develop and expand this technology of phage therapy against bacterial infections.

The west does not pursue. I wonder if its because there's nothing to patent or if anti-biotics are just so much more effective & convenient.

Anyone have any informed opinions on phage therapy? Does it work, is India pursuing it ?

Phage therapy



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PostPosted: 19 Apr 2013 18:23 
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Very high mutation rate.. I imagine maintaining the genotypical purity is difficult of probiotic phage is difficult. It indeed is a good option, if one is sure that the infection is by single strain of bacterium. If the infecting bacterium mutates slightly in the genes whose proteins phage targets to bind, enter and lyse its bacterial host, it become a moot point..

The question of administration too becomes a problem. How to administer and make sure that phage reaches infecting host, without eliciting immune response from human body? If it is for intestinal infections, how to make sure that virus reaches intestine without being digested in stomach? Same goes for lungs. It is out of question to administer a phage (bacteria specific virus) intra-venously.. the repercussions are too hideous to contemplate.

its a good idea for topical infections, upper respiratory infections (usually Streptococcus and Staphylococcus spp) and skin infections. rest, eh... worth a try though, I am not surprised at lack of interest by pharma giants..

One can patent modified organisms, so that is not the issue..


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PostPosted: 20 Apr 2013 07:38 
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Herbal plant Tulsi to help in detoxifying fluoridated water – A new study

Quote:
This article deals with the news of a new research about the herbal plant Tulsi. A new study has revealed the natural property of Tulsi plant leaves and stems which can help detoxifying fluoridated water. The cost-effective and environmental friendly process involves keeping the leaves or stems of Tulsi plant immersed in a glass of water for about 20 minutes to effectively detoxify fluoridated water. The water so treated satisfies fluoride content limits prescribed by the Bureau of Indian Standards.

Tulasi the wonder medicinal plant

• Most of the people in India know Tulsi plant to be deity which is worshipped by many Hindu women along with other Hindu gods and goddesses. Tulsi plant is therefore grown in the courtyard of the house either on a sort of raised round or square structure made for this purpose or is planted in the earthen pots. It is considered as holy herb. A Hindu house appears to be incomplete without a Tulsi plant. Tulsi plant is also known as Basil plant. The scientific name of Tulsi is ocimum sanctum. The herbal plant is used in many Ayruvedic medicines.

• Tulsi leaves and stems are said to contained properties of great medicinal value. Tulsi leaves have proven to a good nerve tonic. The leaves of Tulsi plant when boiled along with tea leaves act as preventive cure for certain type of fevers and common colds. The common ailments like cough and sore throat are well treated by doing gargling with Tulsi leaves boiled in water. Honey and ginger with decoction of Tulsi leaves provide relief for bronchitis, influenza, cough and cold. Influenza can also be cured with the decoction of Tulsi leaves, cloves and common salt. One can simply chew Tulsi leaves to get relief from cold and flu. There are reports of the effectiveness of the Tulsi leaves juice mixed with honey to help remove kidney stones. But this must be taken for a minimum period of 6 months on a regular basis.

• Tulsi also helps in the reduction of blood cholesterol. Tulsi leaves are said to act as anti-stress agents. These help in purifying the blood. The Tulsi leaves if chewed regularly also help in curing the infections of the mouth. The researchers have found several used of the Tulsi plant in curing disorders of skin, teeth and eyes. Decoction of leaves of Tulsi plant also relieves headache in certain cases. A little juice of the Tulsi leaves applied repeatedly on insect bites and stings helps in relief from them.

Tulsi has properties to detoxify the fluorides found in water.

• There are several places in India where there is a lot fluoride content in the water. The high fluoride content in water. Excess fluoride content is widely found in many states in India. It is reported that over 10 lakh of population spread over in 500 villages in Nalgonda district of Andhra Pradesh are affected by high fluoride content in the ground water. The ground water content in water in this area ranges between 0.4 ppm and 20 ppm. The maximum permissible content of fluoride permitted in drinking water in India is 1.2 mg/L. The government of India is therefore under obligation to start water treatment projects to bring down the fluoride content in the water.

• A report published in the Deccan Chronicle from Secunderabad on January 21, 2012 has revealed a very astonishing study carried out by the scientists of the Department of Environmental Sciences of Sardar Patel Mahavidyalaya, Chandrapur. The team of this institute has very successfully found out that the leaves and stems of the Tulsi (Basil) herbal plant have a wonderful property of detoxifying the fluoridated water. The team members of the institute demonstrated their experiment by using both the dried and fresh leaves and stems of the Tulsi plant to prove their research.

• One of the members of the team, Mr Kamble said while reporting the experiment, "With initial fluoride concentration of 5 ppm, it was observed that maximum 94 per cent of fluoride can be removed with a dose of 75 mg of fresh basil leaves for a sample of 100 ml for a contract period of 20 minutes.". The study revealed that fresh basil stems with a dose of 100 mg / 100 ml had a removal efficiency of 75 per cent. When the dry leaves and dry stems of the Tulsi plant were used with a dose of 250 mg / 100 ml, the removal efficiency came down to 78 per cent in case of dry leaves and 74 per cent in the case of dried stems.

• The process of detoxifying the fluoridated water with Tulsi plant is very simple and easy for anyone to do. One has to keep the leaves of stems of the Tulsi plant immersed in a glass of water for about 20 minutes for the detoxification to take place. Afterward this period, one has to simply remove the leaves and stems from the water and drink the same. The water so treated is just at par with the norms laid down by the Bureau of Indian Standards (BIS). The fluoride content within the permissible limit of Indian standard for drinking water is (IS 10500:1991, Fluoride 1.0 – 1.5 ppm).

Conclusion

• The natural bio-absorbent properties of Tulsi plant leaves and stems create a 20 minute wonder when immersed in water for this period. This is going to give a great relief to the millions of Indians who live in the fluoride hit areas. This cost-effective and environmental friendly simple technique can prove to a boon of health to the people which can help improve the health of the people who might otherwise been afflicted by the ailments caused by the high fluoride content in the water. Thanks to the spirited work of the team of the department of environmental sciences of the Sardar Patel Mahavidyalaya, Chandrapur.



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PostPosted: 20 Apr 2013 12:47 
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Atri wrote:
Very high mutation rate.. I imagine maintaining the genotypical purity is difficult of probiotic phage is difficult. It indeed is a good option, if one is sure that the infection is by single strain of bacterium. If the infecting bacterium mutates slightly in the genes whose proteins phage targets to bind, enter and lyse its bacterial host, it become a moot point..


From what I understand, it does not take long to find a phage that takes out a strain of bacterium. A mutated bacterium would not be a problem as a phage capable of dealing with it would be found just as quickly. In that documentary, they literally dip a glass jar into a river that runs near by to select a phage from that murky water. It means there must be quite a few phages that can deal with bacteria of a certain kind - some perhaps more effectively than others.

From what I've seen, its administered through the mouth - even to children in those countries. I think some of the phages migrate into the blood stream and mount an attack against the bacteria to keep its numbers down. The immune system delivers the crushing blow both to the bacteria and the phages. That's just my guess.

Quote:
If it is for intestinal infections, how to make sure that virus reaches intestine without being digested in stomach?


Time release capsule?

Anyway, the profit agenda of big pharma is surely not aligned with popularizing a method that can to be done by any microbiology lab. What about the issue of anti-biotic resistance?


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PostPosted: 22 Apr 2013 22:29 
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Clinical trials of drugs in India plummet
http://newindianexpress.com/nation/Clin ... 554980.ece

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Clinical trials of drugs in India have seen a drastic fall this year after toughened norms were introduced following Supreme Court directives.Not only have the number of trial approvals in the country reduced, there has also been a significant reduction in the number of sponsoring pharma firms applying for such approvals.Official Health Ministry data shows that until January 31 this year, only six trials had been approved. Even these pertained to older applications where the Drug Controller General of India had asked the applying firms to make some amendments.Sources say until April, only around 12 approvals have been granted by the DCGI for trials of drugs in India. Pending applications for trials as of today are just 70.This is in sharp contrast to the past when the number of Global Clinical Trials (GCTs) approved for conduct in India was in hundredsThough in 2008 the DCGI had granted just 65 approvals for trials, the number in 2009 rose sharply to 391.The trend continued with a whopping 500 GCTs being allowed in 2010 and 325 in 2011 followed by 262 approvals in 2012.Admitting that there has been a drastic fall in fresh applications for conduct of global clinical trials of drugs in the country, DCGI GN Singh told PTI, "The safety and well being of Indian subjects participating in clinical trials is the foremost in our minds."This is why the Government has tightened the norms putting the onus of safety of participants on firms conducting the trials. It is for the first time that such norms have been put in place."As many as 2,262 people died in these trials during the past five years, leading to a public outcry and Supreme Court intervention for stricter norms for holding drug trials. The apex court had rapped the Health Ministry for allowing Indians to be used as "guinea pigs" in the conduct of drug trials.


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PostPosted: 28 Sep 2013 03:37 
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Urine Spills Staining Image of Wockhardt’s Generic Drugs

http://www.bloomberg.com/news/2013-09-27/urine-spills-staining-image-of-wockhardt-s-generic-drugs.html
Quote:
The Indian factory that makes copies of a popular heart pill sold in the U.S. turns out to be a jumble of dilapidated buildings with blighted windows connected by flaking pipes and capped by a rusty roof.

When U.S. Food and Drug Administration inspectors visited the Wockhardt Ltd. (WPL) plant that produces generic copies of the heart tablet Toprol-XL in July, they found urine spilling over open drains, soiled uniforms and mold growing in a raw-material storage area. They summarized their findings in a filing obtained by Bloomberg via a Freedom of Information Act request.

The document, known as an FDA Form 483, listed 16 so-called observations about Wockhardt’s factory in Chikalthana, 200 miles east of Mumbai, including concerns about quality control. While the FDA isn’t commenting on the possibility of enforcement action, such forms can be a prelude to export restrictions. A typical one contains only four to eight entries, said John Avellanet, managing director of Cerulean Associates LLC, an FDA compliance consultancy in Williamsburg, Virginia.

“This is very serious,” Avellanet said in an e-mail after reviewing the document. “Think of it as a giant vote of ‘no confidence’ from the FDA.”

Shares Fall

Wockhardt fell 5 percent to 551.05 rupees at 10:00 a.m. in Mumbai, the most since Sept. 17. That compares with a 0.4 percent drop in India’s benchmark S&P BSE Sensex index.



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