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JUNE 2009 Currently under $10/per share HEB- 5/25 - DATE EXTENDED UFN (%$#@@!) N <2! Y Ampligen (Poly I: Poly C12U) experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug. BioMedReports ADLS.OB (ADLS Google) 6/2 7/31 Y <2 Ketek (Telithromycin) [STOCK]SNY[/STOCK] N Restanza (cethromycin) as a once-daily antibiotic for the treatment of adults with mild to moderate community acquired pneumonia. 5/19 OTC Investor ADLS UPDATE 6/2/09: Anti-Infective Drugs Advisory Committee of the FDA is scheduled to meet on 6/2/09 to discuss the NDA for cethromycin and provide a recommendation for the final FDA approval decision. Briefing documents for the panel meeting can be accessed here. ADLS UPDATE 6/2/09 AH - AP Newswire: FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP. ...Although it is not binding, the Committee's recommendation will be considered by the FDA as it completes its review of Restanza's NDA in CAP. VPHM 6/3 Y <2!N Cinryze (Human C1 Inhibitor): Treatment of acute attacks of hereditary angioedema.BDSI 6/12 (mid-June) Y 3+ Y Onsolis (Fentanyl Buccal Soluble Film)/Formerly BEMA Fentanyl: Breakthrough cancer pain in opioid tolerant patients. BioMedReports 6/2/09 UPDATE: Since the FDA has informed BDSI that all other aspects of the NDA review are complete, the prospects for Onsolis approval are excellent, with an approval decision possible by mid-June based on a Class II (six-month) review by the agency on the re-submission. SeekingAlpha ISTA FDA REVIEW 6/26/09: Bepreve (bepotastine ophthalmic solution) On 6/1/09, ISTA announced the Dermatologic and Ophthalmic Drugs Advisory Committee will review ISTA's NDA for Bepreve on June 26, 2009. SeekingAlpha ACUR 6/30 Y <2 Remoxy (Time-Release Oxycodone) PTIE Y Acurox (Abuse Resistant Oxycodone/Niacin )/Formerly OxyADF: Abuse resistant relief of moderate to severe pain KG 6/30 Y <2! N Acurox (Oxycodone/Niacin Abuse Resistant)/Formerly OxyADF: Abuse resistant relief of moderate to severe pain. JULY 2009 Currently under $10/per share SPPI 7/2 Y <2! N Zevalin (Ibritumomab Tiuxetan): First-line consolidation therapy in for previously untreated follicular indolent Non-Hodgkin's Lymphoma. BioMedReports TSPT REVISED DATE (cancel 7/3 - refer 10/31/09) Y <2 Zolpimist (Zolpidem Tartrate Oral Spray)NVD; Ambien (Zolpidem Tartrate)SNY Y Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed to treat insomnia from middle of the night awakenings. UPDATE (thumbs up for Ingew): Transcept Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet). The Intermezzo(R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009. PR NEWS WIRE 6/11/09 ARDM 7/15 (refer spinner) Sumavel (of privately-held company Zogenix). Zogenix have bought Aradigm's non-injection delivery system and ARDM stand to reap potential licensing rewards from this drug if approved. DDSS 7/18 Y 3+ Y Trazodone (DDS-04A) for the treatment of depression through the 505(b)(2) regulatory pathway for new formulations drugs that are already on the market. BioMedReport MEDX 7/30 Y <2 Genzyme Oncology CAMPATH (Alemtuzumab) GENZ Y Arzerra (Ofatumumab): B-Cell Chronic Lymphocytic Leukemia SVNT 7/30 Y <2! Y Krystexxa (Pegloticase): Elimination of excess uric acid (Hyperuricemia) in individuals with symptomatic gout that is unresponsive to conventional treatment. AUGUST 2009 Currently under $10/per share NRIFF.PK 8/5 (NRIFF.PK Google) Pennsaid, 8/5 expected decision date of PDUFA for company's NDA re-submission for topical NSAID for arthritis pain and inflammation. BioMedReport NGSX 8/16 Qutenza (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. BioMedReport UPDATE 5/21/09: NGSX announced that the European Commission has formally granted marketing authorization of Qutenza 179 mg cutaneous patch for the prescription-only treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. The centralized marketing authorization allows Qutenza to be marketed in all 27 countries of the European Union. SeekingAlpha 6/2/09 UPDATE 6/2/09: The Office of Orphan Product Development of FDA granted orphan drug designation for Qutenza. PR NewWire SEPTEMBER 2009 Currently under $10/per share ISTA 9/12/09: <2! Bepreve (bepotastine ophthalmic solution) Last November, ISTA announced it had filed its NDA with the FDA for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. STA continues to expect a standard review of ten months and has been given a PDUFA decision date of 9/12/09. SeekingAlpha OCTOBER 2009 Currently under $10/per share SPPI 10/8/09 Fusilev (levoleucovorin) for Injection to expand use of the drug in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. SeekingAlpha TSPT 10/31 Y <2 Zolpimist (Zolpidem Tartrate Oral Spray) NVD; Ambien (Zolpidem Tartrate) SNY Y Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed to treat insomnia from middle of the night awakenings. PR NEWSWIRE UPDATE: Transcept Pharmaceuticals, Inc. (NASDAQ: TSPT) announced today that the U.S. Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet). The Intermezzo(R) NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009. DECEMBER 2009 Currently under $10/per share SNTS FDA REVIEW 12/4/09 Google (No name) New tablet formulation to add to its Zegerid family of branded prescription pharmaceutical products. SeekingAlpha 6/2/09 VION.OB 12/12 Info not yet available Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia. BioMedReport NDA submissions – PDUFA dates pending Currently under $10/per share ACUS.PK - N/A (ACUS Google chart) Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. BioMedReport 5/24/09 BioMedReport (Article states, "There is no definitive timeline for a FDA decision on the NDA until further notice from the Comapany...) APPA - N/A Prod
in het kort ff : BDSI - June-July, 2009 (Nearly approved. Waiting for official FDA response) ACUR - June 30th, 2009 KG - June 30th, 2009 CTIC - July - October, 2009 SPPI - July 2nd, 2009 DDSS - July 18th, 2009 UTHR - July 30th, 2009 ADLS.OB – July 31th, 2009 SVNT - Aug 1st, 2009 NRI.TO - Aug 5th, 2009 NGSX - Aug 16th, 2009 AUXL - Aug 28th, 2009 ISTA - Sept 12th, 2009 ALTH – Sept 24th, 2009 SPPI - Oct, 8th, 2009 AMGN - Oct 19th, 2009 MEDX - Oct 21th, 2009 ACOR - Oct 22nd, 2009 GTXI - Oct 30th, 2009 TSPT - Oct 31th, 2009 DYAX - Dec 1st, 2009 SOMX - Dec 4th, 2009 MELA - Dec 4th, 2009 SNTS - Dec 4th, 2009 VION.OB – Dec 12th, 2009 OSUR - Dec 31, 2009 ILE - Jan 4th, 2010
Staan wat fda data's in voor aankomende maand. Spel en typefouten onder voorbehoud :-)www.biotechticker.blogspot.com/
Update: Small Cap Biotech Important FDA Action Dates for September Here are the FDA action dates for September, enjoy and now go play! Sept. 1 -FDA advisory Committee meets to review Vion Pharmaceuticals' (ticker: VION) Onrigin, drug for treatment of acute myeloid leukemia. Sept. 2 -FDA advisory Committee meets to review Allos Therapeutics' (ticker: ALTH) pralatrexate, drug for treatment of lymphoma. -FDA approval action date for Endo Pharmaceuticals' (ticker: ENDP) Nebido, a long-acting testosterone replacement therapy. Sept. 7 -FDA approval action date for Spectrum Pharmaceuticals' (ticker: SPPI) Zevalin, a drug for non-Hodgkin's lymphoma. Sept. 11 -FDA approval action date for Salix Pharmaceuticals’ (ticker: SLXP) Metozolv (Metoclopramide), a drug for treatment of gastroesophageal reflux who fail to respond to conventional therapy Sept. 12 -FDA approval action date for ISTA Pharmaceuticals’ (ticker: ISTA) Bepreve, a drug for ocular itching associated with allergic conjunctivitis. Sept. 16 -FDA Advisory Committee meets to review Auxilium Pharmaceutical's (ticker:AUXL) Xiaflex for advanced Dupuytren's disease. -FDA approval action date for Theravance's (ticker: THRX) antibiotic Telavancin. Sept. 24 -FDA approval action date for Eurand Pharmaceuticals' (ticker: EURX) Zenpep, a drug for pancreatic insufficiency. -FDA approval action date for Allos Therapeutics' (ticker: ALTH) Pralatrexate, a drug for peripheral T-cell lymphoma. Posted by U. Gia at 3:42 PM
stond hier, maar zie ik verder nergens meer staan... en maar wachten MIJN IEX / UITLOGGEN Voorpagina Opinie Laatste artikelen Columnisten DOSSIERS Beste Broker 2009 Interviews Kredietcrisis RUBRIEKEN Technische Analyse Beleggerssentiment Beleggingsfondsen Turbo's Speeders 10 van Tak Garantieproducten IEX InfoKeur Bedrijfsovernames Community Call CV-recensies PORTEFEUILLES Home Lage Landen Funds of Fonz Hypehopper De handelende TakNieuws Beursnieuws Videonieuws Vandaag in de kranten IEXProfsAgenda Beursagenda Dividend agendaKoersen Home Real-time koersen INDICES Europa Amerika Azie/Pacific Commodities Rentes Valuta Volatiliteit BELEGGINGSFONDSEN Genoteerd Niet genoteerd AMSTERDAM AEX realtime AEX vertraagd AMX AScX Lokale markt Preferent Overige Obligaties Special products Opties/Futures Certificaten Trackers Speeders Sprinters Turbo's BRUSSEL BEL 20 Brussel a - e Brussel f - n Brussel o - z Opties/Futures FRANKFURT DAX 30 MDAX TecDAX SDAX GEX Eurex - futures PARIJS CAC 40 Parijs a - e Parijs f - n Parijs o - z Alternext LISSABON PSI 20 Lissabon a - z LONDEN FTSE 100 FTSE 250 FTSE AIM FTSE Fledgling FTSE SmallCap FTSE techMARK NEW YORK Ned. fondsen in NY Dow Jones 30 Nasdaq 100 S&P 500 a - e S&P 500 f - n S&P 500 o - zTools Beurslinks Alerts IEX RSS IEXProfs ProductselectorForums Home Koffiekamer Forumreglement Beursspel Home Ranglijsten Uw portefeuilles Informatie Optiecompetitie.nl Turbotoernooi.nlNieuwsbrieven Magazine Abonnement IEX magazines 2009 IEX magazines 2008 IEX magazines 2007 IEX magazines 2006 IEX magazines 2005 AdverterenMijn IEX Mijn portefeuilles MIjn watchlist Nieuwsbrieven Alerts Instellingen wijzigenBeleggersshop Universiteit Inleiding Start cursus Woordenboek A-M Woordenboek N-ZContact Voer uw zoekwoorden in IEX Web Zoekformulier verzenden Nieuw op IEX: Interactieve grafieken Maak, bewaar, print of exporteer uw eigen technische analyses IEX Universiteit Leren beleggen? Ga nu naar de IEX Beleggersuniversiteit! IEX Ledenacties Doe mee aan de acties van IEX.nl en win mooie prijzen! Speedersectie De speedersectie op IEX is vernieuwd! Real-time koersen Geheel vernieuwd en tegen de laagste prijs van Nederland U bent hier | Forums | Amerikaanse aandelen | FDA lijst 2009 Amerikaanse aandelen - FDA lijst 2009 Posts 10 20 30 50 100 Zoeken Reageer kdik23 - 29 jun 09, 22:36 | Reageer | Quote | Dit is niet OK | Aanbevolen: 1 JUNE 2009 Currently under $10/per share HEB- 5/25 - DATE EXTENDED UFN (%$#@@!) N <2! Y Ampligen (Poly I: Poly C12U) experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug. BioMedReports
Welsh,misschien een rare vraag maar je hebt toch niet al wat alcoholische versnaperingen tot je genomen op deze vroege zaterdag-morgen? Want je posting is toch wat verwarrend..! gr,R
eikel1 schreef:
Welsh,misschien een rare vraag maar je hebt toch
niet al wat alcoholische versnaperingen tot je
genomen op deze vroege zaterdag-morgen?
Want je posting is toch wat verwarrend..!
gr,R
sorry heb niet gekeken wat er allemaal onnodig opkwam, normaal verwijder ik dat deel altijd gelijk hahaha, wat il wilde zeggen dat we nog steeds op de goedkeuring van HEB wachten en die reeds voor juni op de lijst staat. sorry
Copy from NEPH MB ISTA - September 12th approval date ARNA - phase iii data news in September CTIC - possible September 4th Priority Review GFGU - launching new stuff on September 9th EPCT - important presentation on September 9th ARIA - presentation September 9th; phase iii data anytime in September
*biomoda oktober (eerste longkankertest)+++ wel of niet goedkeuring clinical trial) *pharming group oktober 2009 *nuvo research oktober 2009 *aemd.ob november clinical clearance ++ *vral nda aanvraag dit jaar verwacht ++ Thx Imillionair.
SUPERLIJST IK HEB VANDAAG MIJN BIOMEDREPORTS.COM VERLENGD, HOU JULLIE OP DE HOOGTE VAN MUSTHAVES PS INVESTEER GESPREID MET GELD WAT JE KAN MISSEN
Gratis calendertje downloaden. Ben benieuwd tot hoelang ze dat doen. Zie www.profeticconsult.com/fdabiotechcal...
Dit zou tijd worden met de delays van afgelopen tijd: FDA head to speed reviews, visit China Thu Nov 12, 2009 5:58pm EST By Lisa Richwine and Susan Heavey NEW YORK (Reuters) - The U.S. Food and Drug Administration is working to increase the speed of drug reviews and clean up problems in the division that oversees medical devices, the agency's commissioner said on Thursday. Dr. Margaret Hamburg, speaking at the Reuters Health Summit in New York, also said visiting China to discuss the safety of imported products was a top priority for her in 2010. Hamburg in May took over an agency battered in recent years by a string of deadly food poisoning and drug safety issues. At the same time, companies complained the FDA had become too cautious and missed several drug review deadlines. "We are certainly working hard in terms of speeding up time frames" for drug reviews while assuring safety, said Hamburg, a Harvard-trained physician with experience on issues ranging from infectious disease to biological threats. She said the FDA was adding more staff and working to "leverage science to really improve the pathway to make it both more effective and efficient." Missing target dates for drug approval decisions is "a concern that we are trying to address," Hamburg added. Hamburg has pledged to restore confidence in the FDA, which oversees prescription and over-the-counter drugs, medical devices, most foods and other products that account for about one quarter of the U.S. economy. She said the agency's device unit was "clearly troubled" and it became immediately obvious to her that big changes were in order. "We are working on some important issues that will benefit industry and benefit the ultimate outcome of our regulatory procedures, including making sure we have a robust internal review process," she said. An internal review of the 510(K) process, an abbreviated pathway used for some medical devices, is under way in addition to a study by the Institute of Medicine, Hamburg said. On China, the FDA has grappled with tainted pet food, contaminated ingredients in the blood thinner heparin and other problems with products imported into the United States. Hamburg said she planned to visit the country next year to participate in ongoing discussions with officials there. Assuring the safety of imported products will involve "expansion of our international inspection capacity as well as working with regulatory authorities in those countries to ensure compliance with a certain level of standards," she said. An FDA deputy commissioner has visited China twice in recent weeks, she said, adding that challenges exist in India and other countries. "Moving into a globalized framework is going to be one of the greatest demands on my schedule and on the agency" she said. Hamburg also said she hoped for a "long and healthy" tenure as FDA commissioner. Industry groups have complained about high turnover in the FDA's top post in the past. "I didn't take on this job thinking it was going to be a short-term undertaking," she said. (Reporting by Lisa Richwine and Susan Heavey; Editing by Phil Berlowitz, Matthew Lewis)
Hier nog ff deze fda kalender extra onder de aandacht brengen. Hij loopt een aantal maanden vooruit. Tip: Print alvast per maand uit en leg ze naast je pc . Zelf zet ik nog de koers van dit moment er even handmatig bij. succes !www.profeticconsult.com/apps/calendar/
real life schreef:
Hier nog ff deze fda kalender extra onder de aandacht brengen.
Hij loopt een aantal maanden vooruit.
Tip: Print alvast per maand uit en leg ze naast je pc . Zelf zet ik nog de koers van dit moment er even handmatig bij.
succes !
www.profeticconsult.com/apps/calendar/ real life, ik probeer de FDA kalender te lezen, maar ik moet inloggen wat me niet lukt. Kun je nogmaals de link plaatsen zodat ik die kan printen? Marco
Zelfde probleem, sinds 2 jan moet je er ineens voor betalen...(was misschien een foutje dat de pagina toegankelijk was) had helaas nog niets uitgeprint (stom) Misschien kunnen we gezamelijk iets beginnen op dat gebied.
dimmer schreef:
Zelfde probleem, sinds 2 jan moet je er ineens voor betalen...(was misschien een foutje dat de pagina toegankelijk was)
had helaas nog niets uitgeprint (stom)
Misschien kunnen we gezamelijk iets beginnen op dat gebied.
ach ja effe drie euro storten op mijn rekening en ik log wel effe in ;-))) ehh na 100 aanmeldingen... lijkt me niet echt haalbaar om zoiets gezamelijk te doen alhoewel...
Haha, dat klopt. Ik had er voor betaald. 10 Dollar voor 1 maand met Paypal. Vandaar zij ik printen. ( had er ff bij moeten vermelden dat het tijdelijk was ) Nu is de maand afgelopen vandaar. Eerste rondje was van mij ;)
real life schreef:
Haha, dat klopt.
Ik had er voor betaald.
10 Dollar voor 1 maand met Paypal.
Vandaar zij ik printen. ( had er ff bij moeten vermelden dat het tijdelijk was )
Nu is de maand afgelopen vandaar.
Eerste rondje was van mij ;)
tweede rondje van mij... allemaal effe drie euro en klaar... ;-)) en ehh heb het toen wel even bekeken, maar ook niet opgeslagen haha maarja hoe serieus is het? zag heel veel over anx staan eind december en begin januari... maar ehh nog niks!
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Smartphoto Group
Smit Internationale
Snowworld
SNS Fundcoach Beleggingsfondsen Competitie
SNS Reaal
SNS Small & Midcap Competitie
Sofina
Softimat
Solocal Group
Solvac
Solvay
Sopheon
Spadel
Sparen voor later
Spectra7 Microsystems
Spotify
Spyker N.V.
Stellantis
Stellantis
Stern
Stork
Sucraf A en B
Sunrun
Super de Boer
SVK (Scheerders van Kerchove)
Syensqo
Systeem Trading
Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
Tele Atlas
Telegraaf Media
Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
Tessenderlo Group
Tetragon Financial Group
Teva Pharmaceutical Industries
Texaf
Theon International
TherapeuticsMD
Thunderbird Resorts
TIE
Tigenix
Tikkurila
TINC
TITAN CEMENT INTERNATIONAL
TKH Group
TMC
TNT Express
TomTom
Transocean
Trigano
Tubize
Turbo's
Twilio
UCB
Umicore
Unibail-Rodamco
Unifiedpost
Unilever
Unilever
uniQure
Unit 4 Agresso
Univar
Universal Music Group
USG People
Vallourec
Value8
Value8 Cum Pref
Van de Velde
Van Lanschot
Vastned
Vastned Retail Belgium
Vedior
VendexKBB
VEON
Vermogensbeheer
Versatel
VESTAS WIND SYSTEMS
VGP
Via Net.Works
Viohalco
Vivendi
Vivoryon Therapeutics
VNU
VolkerWessels
Volkswagen
Volta Finance
Vonovia
Vopak
Warehouses
Wave Life Sciences Ltd
Wavin
WDP
Wegener
Weibo Corp
Wereldhave
Wereldhave Belgium
Wessanen
What's Cooking
Wolters Kluwer
X-FAB
Xebec
Xeikon
Xior
Yatra Capital Limited
Zalando
Zenitel
Zénobe Gramme
Ziggo
Zilver - Silver World Spot (USD)
Indices
AEX
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FTSE 100
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Germany40^
18.004,30
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Gold spot
2.332,68
0,00%
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17.688,88
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Stijgers
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