The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 112 entries through 4/6/09. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
The Clinical Trial Calendar includes 127 entries through 4/6/09 and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
1.) Theravance (THRX). The FDA accepted Theravance's NDA today for Telavancin as a once-daily injectable antibiotic in the treatment of hospital-acquired pneumonia (HAP), including MRSA strains of antibiotic-resistant and other Gram-positive bacteria. The FDA has established a goal of a standard 10-month review of the telavancin NDA, resulting in PDUFA decision date deadline of 11/26/09 and triggering a milestone payment of $10M from THRX partner, Astellas Pharma (ALPMF.PK).
This is the second telavancin NDA filed with the FDA, which is currently reviewing telavancin for the treatment of complicated skin and skin structure infections (cSSSI), for which a Complete Response Letter (CRL) was received on 2/26/09. The CRL requires a Risk Evaluation and Mitigation Strategy (REMS), data on patients with certain renal risk factors from the cSSSI and HAP studies, revisions to the draft label, and a safety update.
2.) Gilead Sciences (GILD) and Teva Pharma (TEVA): GILD recieved notice today of a Paragraph IV challenge by Teva as part of an Abbreviated New Drug Application (ANDA) filing to the FDA requesting permission to manufacture and market a generic version of HIV drug Atripla (a three-drug combination in a single tablet).
Gilead is currently reviewing the notice letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva’s ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Atripla is currently protected by 15 patents, which are listed in the FDA’s Approved Drugs Products List and all 15 patents would need to be invalidated or expired before a generic version of Atripla could be marketed.
3.) Alnylam Pharma (ALNY), a leading RNA interference (RNAi) therapeutics company, today announced that it has initiated a Phase 1 human clinical trial of ALN-VSP to evaluate its safety and pharmacological parameters in patients with advanced liver cancers, including hepatocellular carcinoma and other solid tumors with liver involvement.
ALN-VSP is an RNAi therapeutic comprised of two small interfering RNAs (or siRNAs, the molecules that mediate RNAi) formulated in a lipid nanoparticle and designed to target two genes which are crucial to the growth and development of cancer cells. Pre-clinical data in mice tumor models have demonstrated robust efficacy of ALN-VSP, including suppression of targeted genes, demonstration of an RNAi mechanism of action, tumor reduction, and extension of survival.
4.) ReNeuron Group PLC (UK: RENE.L) (US: RNUGF.PK) announced positive preclinical data today for its CTX stem cell line in the treatment of peripheral artery disease (PAD), which is a chronic and progressive condition that restricts the flow of blood in the limbs.
The Company's CTX stem cell line was injected IM into mice with restricted blood supply in their limbs and the cells resulted in a significant recovery of blood flow and tissue perfusion. The results of this study will be presented later this week at the UK National Stem Cell Network Conference.
ReNeuron plans to continue gathering preclinical data in an effort to begin clinical studies within the next two years. The Company will also begin a clinical trial for disabled stroke patients using the same CTX stem cell line as the basis for ReN001 therapy for this indication since receiving UK regulatory approval to conduct the trial earlier this year in January.
ReNeuron is one of the 40 companies included in the ETF Innovators Global Stem Cell and Regenerative Medicine index, featured along with other healthcare stock indexes at BioMedReports.com at http://biomedreports.com/health-indexes.html .
This winter the brand of Canada goose, the same as usual, is highly praised by consumers all over the world. In details, Canada goose Company is one of the leadership manufacturers in textile industry in Europe and North America, which is best known for producing high-performance canada goose clothing. Since the brand of Canada goose coming into people's sight, Canada goose products, including Canada goose down jackets, Canada goose down coats and Canada goose down parkas, have been well received by men, women and kids around the world. Of course, this winter is no exception. Moreover, this winter's sales of Canada goose clothes achieve a new height and more and more people have faith for the brand of Canada goose. That is just because Canada goose down coats is made of high-quality materials and has 625 fills power white goose down, which can make Canada goose clothes much warmer and softer. Furthermore, Canada goose down jackets and Canada goose down parkas can make the wearers fashionable and outstanding in a crowd. If you want to follow fashion and stand out in public in winter, Canada goose is your first choice. .12.27
Nowadays, there is a trend of getting a website designed and developed every other day, however, most of them do not provide the returns, which they could. Yes, you have read it right, a website can provide you immense potential customers on a daily basis if it is a business web portal, and countless visitors,
Coach Handbags has a rich history Africian myths and legends, from Coach Outlet Factory heroism and victory over adversity story. The hero has to use cunning plastic Coach Outlet Online, hidden in their clothes, to do their ladies to win the hearts of their mission impossible! My favorite was a young man, the king's daughter with the wave of love story. He told reporters that he might have this as his wife, the lovely woman, but only if he can use his sweat villages submerged rocks. He hid Coach Shoulder Bags full of water in his clothes, and to complete his task. Other Nike Air Max involve our hero is placed in a bag, from sub-Saharan Africa, in particular Michael Jordan Shoes. Fortunately, all parties concerned Gucci Handbags, our young people are smart, but placed in a Gucci Shoes, he can still hear and talk his way out of a situation. Coach Factory Outlet played an important role in human history, and will continue to be intregal part of both the myth and our everyday life in Coach Outlet Store, both in this country and around the Coach Factory.
The accident on the second Mulberry Bags day, 24 (at 4 o 'clock,) in the D3115 Mulberry Handbags crane crashed train carriage number 16 before hanging, we once again in the search. Mulberry Alexa This is the third time that I had to carriage number 16.......
Cars have been Mulberry Sale squashed flat, like paper. We know, two car tracing cauda, behind the move to a previous car hits a moving car, dropped three carriages pressure after 16 Mulberry Factory Shop is carriage number and then fell off the Mulberry Outlet bridge, and Mulberry Bag that day the bridge in the hanging in the car is the carriage number 16 pressure slide down.
When you see some women wearing moncler jackets 2011 always give people a sense unbridled. But it is this feeling that reflects the new phase of women in this new age.In, if properly dressed, the cheap moncler jackets in the fashion show is a kind of treason not only unique, but also show wise and elegant dress . In wardrobe people, it must be light moncler jackets sale inside. Seemingly ordinary winter wild fabric are the base models, not charming, not spicy, but the simpler and more to win a great reputation. After other clothing accessories for the collision, Moncler vest on sale is also casual, may be innocent, can bring a certain elegance. Clothing of Europe and the United States by the star to see the moncler women vest with her wisdom. In such a cold winter, people get a life portable and always keep you warm with moncler women jackets, it's really a smart choice for you. Choose your love moncler jackets from http://www.topjacketsmarket.com/ to improve your impression.
Nike released http://www.lebron8cheap.com/ because young people can fully grasp the need of sports and leisure lebron james shoes, understand the realities of life style and ideal development a unique and innovative new nike lebron 9, sales promotion activity dissemination appeal, from start to finish all create consumer Pai ceramic trends. nike lebron james shoes of the world's first a good for nothing. While still a week left the United States sell, but the nike air max 2011 infrared red bull market black restore ancient ways has quietly. But the more nike lebron 8 surprisingly, exposure of the samples before a version, pearlescent leather with nba shoes considerable changes.
Some of you may not know,or sale uggs boots even hear the snow boots.Snow boots is an internationally recognized style, everyone must be like to wear boots.For some reason, the popular snow boots.To know all about the characteristics of snow boots,which introduced the definition of these cheap ugg boots boots are necessary.Authentic UGG style boots and other footwear,not only to fulfill the requirements to guide the foot from toe to ankle complete coverage,but also made?from sheepskin. Boots, or boots are also acknowledged as authentic,there are two important features. First of all, that these shoes are from the sheep, this ugg boots sale is the Ugg Boots Online Store most important function of boots. Secondly, this double sided sheepskin boots. Double-sided or double-faced sheepskin boots, Ugg Boots OnLine authentic boots is mandatory conditions, mean temperature for the ugg boots outlet material and the outer surface of the wool tanned,sheepskin inner surface behavior.This constant nature of the sheep,so that your feet cool in summer,warm in winter.
In order to avoid being a victim of fraud,some of the following tips should be useful to determine the originality of the boots.Identification is the first real snow boots Cheap Ugg Boots boots the only well-known brand logo.Then, you should also check to cheap ugg boots sale complete the stitch and the only flexibility.With the original snow boots,fake boots and not look fluffy sheepskin "warm ugg boots outlet real UGG robot is round and the longer front part of this fake brand not usually used,which can be identified admit it or not snow boots boots are real - you can see this trademark,which is like the original brand.Finally, the price is the ultimate,different from the false,the real snow boots.
Female outdoor sports lovers can wear the North Face Jackets For Women to cope with the bad conditions.
Cheap North Face Jackets For WomenThe jackets are
specially designed for women and selling hot in our site now. Purchasing in our site, and you get great
discount, best quality, Cheap North Face Jackets delicately packing, no sale tax, and fast delivery to your door
Cheap North Face JacketsThe North Face Jackets
For Women come in more vibrant colorways cater to ladies.
Data powered by FinancialContent.
All Rights Reserved.
Quotes delayed at least 20 minutes unless otherwise indicated.
None of the information contained on SocialPicks.com constitutes a recommendation by SocialPicks or its users that any particular security, portfolio of securities, transaction, or investment strategy is suitable for any specific person. SocialPicks is not responsible for the posts, discussions, and recommendations of the users on the Site. SocialPicks does not provide investment advice. You must make your own independent decisions regarding any security, portfolio of securities, transaction, or investment strategy mentioned on the website. SocialPicks' users' past results are not necessarily indicative of future performance. Neither SocialPicks nor any of its users guarantees any specific outcome or profit, and you should be aware of the real risk of loss in following any strategy or investments discussed on the website. You understand and agree that you use the Site and Services at your own discretion and risk and that you will be solely responsible for any damages that arise from such use. Before acting on any information contained on the website, you should consider whether it is suitable for your particular circumstances and strongly consider seeking advice from your own financial or investment adviser.