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Holiday News from AEGR AUXL SGYP OMER and a Happy New Year!

Jan 01, 2013 2 Comments

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), announced that the FDA has set a PDUFA date of September 6, 2013, for its supplemental Biologics License Application (sBLA) for XIAFLEX (collagenase clostridium histolyticum or CCH), for the potential treatment of Peyronie’s disease (PD). Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR) announced that the FDA approved JUXTAPID (lomitapide) capsules,to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol […]

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RPTP PDUFA date extension. NPSP receives early approval. TSPT fails Phase 2 trial. ALXA approval + SPPI news

Dec 23, 2012 No Comments

Raptor Pharmaceutical Corp. (Nasdaq:RPTP) announced that FDA will require additional time to complete its review of the New Drug Application for RP103 (PROCYSBI), for the potential treatment of nephropathic cystinosis. The new PDUFA date has been extended from January 30, 2013 to April 30, 2013. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), announced that FDA approved Gattex for subcutaneous use for the treatment of […]

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HEB negative AdCom vote. FOLD disappoints with Phase 3 data + OGXI ANX CEMP ICPT ONTY MDCO AMRN VPHM HALO FOLD

Dec 20, 2012 No Comments

Hemispherx Biopharma (AMEX: HEB) – The FDA Arthritis Advisory Committee voted 5-8 against recommending approval for Ampligen, for the treatment of Chronic Fatigue Syndrome. Amicus Therapeutics (Nasdaq:FOLD) and GlaxoSmithKline plc (GSK)  announced that 6-month primary treatment period results from the first Phase 3 trial (Study 011) of oral migalastat HCl monotherapy in males and females with Fabry disease, […]

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OREX obesity update. VNDA Phase 3 Tasimelteon data. NBIX GALE GENT BIOD PRAN THRX

Dec 19, 2012 No Comments

Orexigen Therapeutics, Inc. (Nasdaq: OREX) said it remains on target to conduct an interim analysis of the Light Study for its obesity candidate, Contrave in 2013, with a possible NDA resubmission in 2Q 2013. Galena Biopharma (Nasdaq:GALE) announced the pricing of its offering of 15,156,250 units at a price of $1.60 per unit, or total gross proceeds of […]

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ATRS files NDA. TSYM discontinues TZP-102 enrolment + GALE GTXI CEMP OMER ITMN CYCC ARIA news

Dec 18, 2012 No Comments

Antares Pharma, Inc. (NASDAQ: ATRS) today announced it has submitted its New Drug Application (NDA) for OTREXUP,  for the delivery of methotrexate (MTX) using Medi-Jet technology to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis. GTx, Inc. (Nasdaq: GTXI) announced that it has attained its enrollment goal for both of its pivotal Phase 3 […]

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CHMP issues negative opinion for VNDA. LGND PDUFA date set + news from CYTX INFI SRPT SNTA AUXL CERS THRX YMI SCMP ACAD SOMX

Dec 14, 2012 No Comments

Vanda Pharmaceuticals Inc.(NASDAQ: VNDA), announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Product for Human Use (CHMP) has issued a negative opinion recommending against approval of Fanaptum (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union. Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that it intends to […]

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DRTX Phase 3 data due Tuesday + updates for LGND EXAS ACRX DCTH ZGNX NBY CYTR TSRX

Dec 10, 2012 No Comments

Durata Therapeutics, Inc. (NASDAQ: DRTX) today announced that it will host a conference call and webcast at 9:00am Eastern Time on Tuesday, December 11, 2012 to present preliminary top-line results from its DISCOVER 1 Phase 3 study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by […]

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FDA upholds non approval PMA decision. CVM offering + CHTP THRX news

Dec 04, 2012 No Comments

Anika Therapeutics, Inc. (Nasdaq: ANIK) announced today that the FDA has upheld its non-approvable decision for the Monovisc PMA. The company plans to schedule a meeting with the FDA to determine the next steps concerning the Monovisc product. CEL-SCI Corporation (NYSE MKT: CVM) said it will sell 35 million shares of its common stock at a price per […]

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GERN discontinues GRN1005 development. AVEO initiates Phase 2 mBC trial

Dec 04, 2012 No Comments

Geron Corporation (Nasdaq: GERN) announced that the company has discontinued development of GRN1005. An inability to enrol its Phase 2 trial in patients with brain metastases arising from non-small cell lung cancer, and poor interim data from its Phase 2 trial in brain metastases arising from breast cancer, were listed as the reasons for discontinuing development of […]

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

Dec 01, 2012 10 Comments

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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SCMP PDUFA date extension. BCRX terminates merger

Dec 01, 2012 No Comments

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) announced today that the FDA has extended the PDUFA date for its priority review of the supplemental new drug application (sNDA) for lubiprostone for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. The delay is due to the submission of FDA-requested supportive analyses which is seen as a major amendment to the […]

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