HEB issued CRL for Ampligen. IDIX discontinues IDX184 trial + CLDX offering

Feb 04, 2013 No Comments

Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX) announced that it will cease development of IDX184, in phase 2b testing for the treatment of hepatitis C virus (HCV) infection. IDX184 was placed on partial clinical hold in August 2014 due to cardiac adverse events seen in a competitor’s phase 2 clinical trial of BMS-986094. In February 2013, the FDA communicated that the IDX184 […]

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HPTX FDA Approval for RAVICITI. KBIO IPO pipeline profile. EDAP files PMA

Feb 01, 2013 No Comments

Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the FDA has approved RAVICTI for the treatment of Urea Cycle Disorders (UCD) in patients two years of age and older. The drug is expected to be commercially available by the end of April 2013. KaloBios Pharmaceuticals, Inc (NASDAQ: KBIO) – Recent IPO: Pipeline profile KB001-A  is in a Phase […]

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CLSN fails Phase 3 ThermoDox trial. Updates for SPPI ARQL VNDA CYTR

Feb 01, 2013 No Comments

Celsion Corporation (NASDAQ: CLSN) announced that ThermoDox in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase 3 trial in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer. Daiichi Sankyo Company, Limited (TSE 4568) and ArQule, Inc. (Nasdaq: ARQL)  announced that the first patient has been enrolled in the pivotal Phase […]

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CLSN Phase 3 data due Thursday. STML pipeline profile. Offering details for NLNK NAVB VTUS + ANX MDGN updates

Jan 30, 2013 No Comments

Celsion Corporation (NASDAQ: CLSN) today announced that it will host a conference call and webcast at 8:00 a.m. Eastern Time on Thursday, January 31, 2013 to present the top-line results from its pivotal Phase 3 HEAT Study with ThermoDox in combination with radiofrequency ablation (RFA) in patients with intermediate hepatocellular carcinoma (HCC) versus those patients receiving RFA alone. Stemline Therapeutics, Inc […]

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ISIS FDA Approval. ANAC meets endpoint but disappoints. Offering news for KERX VTUS NLNK

Jan 30, 2013 No Comments

Anacor Pharmaceuticals (NASDAQ:ANAC) announced positive preliminary results from the first of two Phase 3 trials of tavaborole, for onychomycosis, a fungal infection of the nail and nail bed. 6.5% of patients treated with tavaborole met the primary endpoint of “complete cure” vs. 0.5% of patients treated with vehicle (p=0.001) at week 52. However, data disappointed traders […]

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ANAC data and new biotech IPO Tuesday. RPRX data delay.KERX postive data release. SPPI NDA due mid 2013 + BCRX news

Jan 28, 2013 No Comments

Anacor Pharmaceuticals (NASDAQ:ANAC) will release preliminary results from the first of two Phase 3 studies of tavaborole for onychomycosis tomorrow, January 29, 2013 at approximately 7:00 a.m. ET. The announcement will be followed by a conference call at 8:00 a.m. ET to discuss the results. Stemline Therapeutics, Inc., (NASDAQ: STML) today announced the pricing of its initial public offering of […]

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FURX FDA Approval. THLD initiates Phase 3 pancreatic trial. IMGN pipeline update + ANTH

Jan 27, 2013 No Comments

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) said that Takeda Pharmaceutical Company Limited received approval from the FDA for three new type 2 diabetes therapies, NESINA (alogliptin) and the fixed-dose combination therapies, OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl), for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise. […]

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BIIB positive Phase 3 data. CBST pipeline update.ANTH offering + SGEN ARIA ACOR news

Jan 25, 2013 No Comments

Biogen Idec (NASDAQ: BIIB) announced that it met the primary endpoint, the annualized relapse rate (ARR) at one year, for both the two-week and four-week doses in its Phase 3 pivotal clinical trial, ADVANCE, of peginterferon beta-1a as a potential treatment for relapsing-remitting multiple sclerosis (RRMS). It also mentioned that it met the secondary endpoints of risk of 12-week […]

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ARIA offering. VNDA NDA filing due mid 2013. ENMD initiated Phase 2 Soft Tissue Sarcoma

Jan 24, 2013 No Comments

ARIAD Pharmaceuticals, Inc.(NASDAQ: ARIA) announced that it has commenced an underwritten public offering of shares of its common stock. EntreMed, Inc. (ENMD) announced the initiation of a single-center Phase 2 trial of Oral ENMD-2076 in patients with Advanced/Metastatic Soft Tissue Sarcoma. Vanda Pharmaceuticals Inc.(NASDAQ: VNDA) announced positive results for the second Phase 3 study of […]

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