NASDAQ instructs AFFY to delist. DEPO CRL. ONTY trial failure. VNDA files NDA. MNKD data due this summer + CLSN OMER AEGR news

Jun 01, 2013 No Comments by

Affymax (NASDAQ: AFFY) was notified by NASDAQ that it has determined the company is operating as a public shell and no longer has an operating business. As a result, NASDAQ have requested that the company delist from NASDAQ before trading on June 6, 2013. The  company intends to list on the OTC Bulletin Board. Vanda […]

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DEPO gets hit with negative Adcom vote. BIIB NDA accepted. ACRX releases Phase 3 data.

Mar 05, 2013 No Comments by

Depomed, Inc.(Nasdaq: DEPO) announced that the Reproductive Health Drugs Advisory Committee (RHDAC) of the FDA voted 2-12 against approval for SEFELSA. Biogen Idec (NASDAQ: BIIB) announced today that the FDA has accepted its Biologics License Application (BLA) for rFIXFc for the treatment of hemophilia B and granted the company a standard review timeline. The company issued a press […]

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30 Upcoming Catalysts – PDUFA dates, FDA Advisory meetings and Clinical data releases

Dec 01, 2012 10 Comments by

30 short and long term potential catalysts as of December 1, 2012. See the links in the FDA Calendar for more details about each catalyst. Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA):  PDUFA date December 21 2012 for the Class 2 resubmssion of Staccato loxapine (ADASUVE). CHMP (EMA) decision due December 14, 2012. A.P. Pharma, Inc. (OTCBB: APPA): PDUFA Mar 27, 2013 […]

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MDVN forward split. DVAX Adcom meeting. CPRX raises cash + AEZS DEPO RVX news

Aug 29, 2012 No Comments

Medivation, Inc. (NASDAQ: MDVN) announced a 2-for-1 forward split of its common stock with a Record Date of September 7, 2012. The forward split will take effect on September 21, 2012. Dynavax Technologies Corporation (NASDAQ: DVAX)  announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to discuss HEPLISAV at its meeting on November 14-15, 2012, pursuing […]

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GENT expects CHMP decision 3Q 2012. STEM initiates Phase 1/2 AMD trial. DEPO acquires Zipsor

Jun 21, 2012 No Comments

Gentium S.p.A. (Nasdaq:GENT)  announced today that it has submitted its responses to the Day 180 List of Outstanding Issues received from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) with respect to its Marketing Authorization Application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic […]

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DCTH NDA expected August. Pipeline updates and news for GTXI SVNT AIS CRIS DCTH MDVN DEPO ACAD ACRX CLVS SGEN

May 09, 2012 No Comments

Delcath Systems (NASDAQ: DCTH) said that it intends to submit its NDA for its Hepatic CHEMOSAT delivery system in mid-August, 2012. GTx, Inc. (Nasdaq: GTXI) said that the clinical hold placed on Capesaris (GTx-758),for secondary hormonal therapy of advanced prostate cancer, has been lifted by the FDA. The Phase 2 trial will test three lower doses of Capesaris (125 mg, […]

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DEPO plans Serada NDA filing 2H 2012. IDRA pipeline update. PBMD listed on NASDAQ +MDGN news

Apr 17, 2012 No Comments

Depomed, Inc. (Nasdaq:DEPO) today announced that following a pre-NDA meeting with the FDA, it intends to file a new drug application (NDA) during 2H 2012 for Serada in patients with menopausal hot flashes. In its BREEZE 3, Phase 3 trial, it met three of the four primary endpoints. Australian healthcare company Prima BioMed Ltd (ASX: […]

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AVII data due Monday. RPTP ISIS NDA filings. TELK reverse split + ONTY XOMA EXEL RIGL CYCC CUR DEPO STEM IMGN news

Mar 31, 2012 No Comments

AVI BioPharma, Inc. (NASDAQ: AVII) announced it will hold a conference call at 8:00 a.m. EDT (5:00 a.m. PDT) on Monday, April 2, 2012 to discuss top-line results from its Phase 2b study evaluating eteplirsen for the treatment of Duchenne Muscular Dystrophy (DMD). Raptor Pharmaceutical Corp.  (Nasdaq:RPTP) submitted its New Drug Application (NDA) seeking approval […]

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Pipeline updates for ZGNX ACHN AEZS THLD + ANX RIGL shelf filings + SNTS AMLN news

Mar 09, 2012 No Comments

ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) filed a mixed shelf allowing it to from time to time, offer up to $150m of common stock, preferred stock, debt securities, warrants to purchase common stock, preferred stock or debt securities. RIGEL PHARMACEUTICALS INC (NasdaQ: RIGL) filed a shelf allowing it to from time to time, offer up to $200m of common […]

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SNTS NDA filing soon. ISTA due 1Q 2012 + DEPO CYTK VICL ALNY:

Nov 02, 2011 No Comments

Santarus, Inc. (NASDAQ:SNTS) said today that they are on track to file their NDA for UCERIS 9 mg by the end of 2011. Depomed, Inc. (Nasdaq:DEPO) today reported financial results for the third quarter ended September 30, 2011 and noted that they plan to meet with the FDA during 1Q 2012 to discuss their menopausal […]

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Data releases from DEPO ISTA POZN ANDS. Updates for MITI CYCC

Oct 13, 2011 No Comments

Depomed, Inc. (Nasdaq:DEPO) today announced top-line results from BREEZE 3, a Phase 3 trial evaluating the efficacy and safety of Serada (extended-release gabapentin tablets) for menopausal hot flashes. Efficacy data from the trial were positive and statistically significant for three of the four pre-specified primary endpoints of frequency and severity at four and 12 weeks. […]

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