Author Archive

FURX Phase 3 data due 1Q 2014. INSM offering. TZYM merges to become OCRX

Jul 16, 2013 No Comments

Ocera Therapeutics, Inc. and Tranzyme, Inc. (Nasdaq:TZYM) announced that their merger has closed and the combined company will be named Ocera Therapeutics, Inc. and will trade from July 16, 2013 on the NASDAQ Global Market under the symbol “OCRX”. Insmed Incorporated (NASDAQ: INSM) announced that it is offering $60 million of its common stock in a proposed underwritten public […]

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Website update

Jul 13, 2013 No Comments

Unfortunately, I have been laid up in bed over the last week but the good news is that I have just updated the Company Pipeline Database and FDA Calendar with the last week’s news. To find the latest week’s updates, go to the Company Pipeline Database and sort using by date in the “Updated” column […]

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Biotech news from MDCO CLDX and ARRY

Jul 03, 2013 No Comments

The Medicines Company (NASDAQ: MDCO) announced results for its Phase 3 SOLO II trial of oritavancin, for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria. In SOLO II, all protocol-specified primary and secondary efficacy endpoints were met. The company anticipates submitting an NDA in 4Q 2013 and a European MAA […]

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Jul 02, 2013 No Comments

Alnylam Pharmaceuticals, Inc.(Nasdaq: ALNY) announced positive clinical results from its Phase 2 trial of ALN-TTR02, for the treatment of TTR-mediated amyloidosis (ATTR). Interim results show that multiple doses of ALN-TTR02 led to robust and statistically significant (p<0.001) knockdown of serum TTR protein levels of up to 93%. The company also mentioned that it intends to start a […]

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INSM Phase 3 data to be released Monday. CHMP approvals for HALO DNDN RPTP + CRL for JNJ

Jun 30, 2013 No Comments

Insmed Incorporated (NASDAQ: INSM) announced that it will report top-line results from its European and Canadian Phase 3 study of ARIKACE to treat cystic fibrosis patients with Pseudomonas aeruginosa lung infections on Monday, July 1, 2013 at 7:00 a.m. Eastern time. Cell Therapeutics, Inc. (NASDAQ: CTIC and MTA: CTIC) announced the resignation of Steven E. Benner, M.D., M.H.S., Senior Vice President, Chief Medical […]

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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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