BioPharmCatalyst 3rd Birthday – What lies ahead

Jun 28, 2013 2 Comments

It’s official, BioPharmCatalyst celebrates its third anniversary today, while the FDA Calendar reaches four years old. Firstly, a big thank you to all the readers and followers of BioPharmCatalyst, whether you have been a user of the FDA Calendar since 2009, or if you have only just recently become a reader of the site. The […]

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RVX PPHM fail Phase 2 trials. GSK granted BT designation for drisapersen + CRPX KBIO NAVB updates

Jun 28, 2013 1 Comment

GlaxoSmithKline plc (GSK) announced that drisapersen (previously GSK2402968/PRO051) has been granted Breakthrough Therapy designation by the FDA for the potential treatment of patients with Duchenne Muscular Dystrophy. Resverlogix Corp. (TSX:RVX) announced that its Phase 2b ASSURE clinical trial evaluating RVX-208 in high-risk cardiovascular patients with low high-density lipoprotein (HDL) did not meet its primary endpoint. […]

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QRXPY Adcom and PDUFA delay. DCTH further reduces staff + BAYRY AMBI PTLA updates

Jun 26, 2013 No Comments

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced the planned Advisory Committee for its NDA of MOXDUO, originally scheduled for 17 July 2013, will be delayed in order to allow time to consider results of recent findings from a previous study. The PDUFA date was originally set for 26 August 2013. However, this will also need […]

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ETRM submits PMA. VICL initiates Phase 3 TransVax trial.

Jun 26, 2013 No Comments

EnteroMedics Inc. (NASDAQ: ETRM) announced that it has submitted a Premarket Approval (PMA) application to the FDA for approval of the Maestro Rechargeable System’s VBLOC vagal blocking therapy as a treatment for obesity. Vical Incorporated (Nasdaq:VICL) and Astellas Pharma Inc. (TOKYO:4503) announced the initiation of a multinational Phase 3 trial of TransVax in approximately 500 hematopoietic cell transplant (HCT) recipients. […]

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CTIC Tosedostat placed on partial clinical hold. CYTK reverse split. CYTR aldoxorubicin data due 2H 2013 + PBMD ANTH updates

Jun 25, 2013 No Comments

Cell Therapeutics, Inc. (NASDAQ:CTIC) was informed by the FDA that a partial clinical hold has been placed on Tosedostat, for the treatment of blood-related cancers. This follows the death of a patient from myocarditis. The FDA has requested additional data on patients treated with Tosedostat, including additional information about the patient that died. These data will […]

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AMRN Adcom meeting date set. CCXI data on track for 3Q. Offering news for PGNX RPRX BIOD.

Jun 19, 2013 No Comments

Amarin Corporation plc (Nasdaq:AMRN) announced that the FDA will convene an advisory committee on October 16, 2013 for the  Supplemental New Drug Application (sNDA) for the use of Vascepa in the treatment of adult patients with high triglycerides with mixed dyslipidemia. The PDUFA date is December 20, 2013. ChemoCentryx, Inc. (Nasdaq:CCXI) announced that it has completed the target enrollment of 270 […]

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CYTK Phase 2b data due Sept. BIOD and OGXI offering news + ICPT EXAS

Jun 19, 2013 No Comments

Biodel Inc. (Nasdaq:BIOD) announced that it is offering to sell shares of its common stock in an underwritten public offering. Cytokinetics Incorporated (NASDAQ:CYTK) announced that results from the Phase 2b ATOMIC-AHF trial of omecamtiv mecarbil  in patients with left ventricular systolic dysfunction who are hospitalized with acute heart failure, will be presented at the European Society of Cardiology (ESC) […]

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SNTS IGXT PDUFA dates set. MNKD on track for summer data release. FOLD NDA filing delayed + ICPT RPRX EXAS offerings

Jun 18, 2013 No Comments

Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) announced that the FDA has set a PDUFA date of  April 16, 2014 for RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). The companies indicated that they will most likely be required to appear before the  Blood Products Advisory Committee prior to the PDUFA […]

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News updates for CEMP ECTE SNSS AMGN LLY EPZM XOMA

Jun 14, 2013 No Comments

Cempra, Inc. (Nasdaq: CEMP) announced its intention to offer and sell shares of its common stock in an underwritten public offering. Echo Therapeutics, Inc. (Nasdaq: ECTE) announced the pricing of a previously announced underwritten public offering of 4,025,000 shares of its common stock, offered at a price to the public of $2.70 per share, for gross proceeds […]

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