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FDA lijst 2009

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[verwijderd] 29 juni 2009 22:36

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

[verwijderd] 29 juni 2009 22:37

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

real life 28 augustus 2009 23:48

Staan wat fda data's in voor aankomende maand.

Spel en typefouten onder voorbehoud :-)

www.biotechticker.blogspot.com/

real life 28 augustus 2009 23:49

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

welshterrier 5 29 augustus 2009 09:20

stond hier, maar zie ik verder nergens meer staan... en maar wachten

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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

[verwijderd] 29 augustus 2009 09:57

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

welshterrier 5 29 augustus 2009 10:08

quote:
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

real life 3 september 2009 12:45

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

real life 12 september 2009 16:45

*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.

[verwijderd] 13 september 2009 23:46

Leuke lijst

IMILLIONAIR 15 september 2009 23:03

SUPERLIJST IK HEB VANDAAG MIJN BIOMEDREPORTS.COM VERLENGD, HOU JULLIE OP DE HOOGTE VAN MUSTHAVES

PS INVESTEER GESPREID MET GELD WAT JE KAN MISSEN

real life 1 oktober 2009 11:51

Gratis calendertje downloaden.
Ben benieuwd tot hoelang ze dat doen.

Zie www.profeticconsult.com/fdabiotechcal...

Demenkovets 13 november 2009 13:09

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)

real life 29 december 2009 23:46

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/

dimmer 29 december 2009 23:59

thanks!

[verwijderd] 7 januari 2010 17:51

quote:
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

dimmer 7 januari 2010 22:33

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.

[verwijderd] 7 januari 2010 22:36

quote:
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...

real life 7 januari 2010 22:42

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 ;)

[verwijderd] 7 januari 2010 22:46

quote:
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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