Further delays for AMRN. CLSN RNN offerings. Updates for ZIOP and GERN

Jan 15, 2014 No Comments by

Amarin Corporation plc (Nasdaq:AMRN $2.40) announced that the FDA notified the company that a determination on Amarin’s request for reconsideration of the October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement will be delayed.No definitive date has been given for the FDA response planned response. Celsion Corporation  (NASDAQ:CLSN $4.00)  announced they will issue approximately $15 million of […]

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NPSP files NDA. RIGL fails Phase 2 lupus trial + updates for BMRN NSPR THRX DVAX JNJ ZIOP ADHD PTLA

Oct 25, 2013 No Comments by

NPS Pharmaceuticals, Inc.(NASDAQ:NPSP $30.64) announced that they have submitted their Biologic License Application (BLA) to the FDA for Natpara for Hypoparathyroidism. Rigel Pharmaceuticals, Inc (NASDAQ:RIGL $3.49) announced that its Phase 2 trial of R333, in patients with discoid lupus erythematosus (DLE), did not meet the primary endpoint. Johnson & Johnson (NYSE:JNJ $92.35) announced that the Antiviral Drugs Advisory Committee of […]

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CSII receives PMA Approval. PFE to continue Remoxy development + updates for ZIOP AMRN CBST QCOR HALO ARRY

Oct 23, 2013 No Comments by

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII $26.75) announced that it has received PMA approval from the FDA for their Diamondback 360 Coronary Orbital Atherectomy System (OAS) as a treatment for severely calcified coronary arteries. Pain Therapeutics, Inc. (Nasdaq:PTIE $3.77) and DURECT Corporation(Nasdaq: DRRX $1.56) reported Pfizer Inc. will continue the development program for REMOXY (oxycodone) Extended-Release Capsules CII, with new […]

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POZN PDUFA date set. RMTI data due July. GSK Approval + updates for ANAC PCRX TRGT

May 30, 2013 No Comments

POZEN Inc. (NASDAQ: POZN) announced that the FDA has set a PDFUA date of  January 24, 2014 for PA32540/PA8140, for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. Rockwell Medical (NASDAQ: RMTI) announced that it has completed patient dosing of its CRUISE-1 Phase 3 efficacy study for SFP (Soluble Ferric Pyrophosphate) for the treatment […]

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Pipeline updates for ACHN BCRX BLRX CLVS RIGL INSM TRGT CBST INFI AEZS SCMP SGEN FURX EXEL FLML TSRX KERX ZIOP ISIS

May 08, 2013 No Comments

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) provided an update noting that interim RVR results from its Phase 2 ACH-3102 trials for the treatment of genotype 1 HCV are due in 3Q 2013 (-007 trial), followed by SVR results during 4Q 2013. BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) said it plans to initiate a Phase 2 trial of BCX4161 in patients with hereditary angioedema, later in 2013 […]

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ZIOP fails Phase 3 palifosfamide for soft tissue sarcoma + APPY BDSI updates

Mar 27, 2013 No Comments

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced that its Phase 3 trial of palifosfamide (ZIO-201) for the treatment of metastatic soft tissue sarcoma in the first-line setting (PICASSO 3) did not meet its primary endpoint of progression-free survival (PFS) and will discontinue further development. Venaxis, Inc. (Nasdaq: APPY) provided an update of its appendicitis test, APPY1, noting that it hopes to complete […]

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NAVB FDA Approval. ENDP Adcom meeting. DCTH ATM offering + updates for ZIOP SNSS SCMP OREX

Mar 14, 2013 No Comments

Delcath Systems, Inc. (NASDAQ: DCTH) noted today that it raised gross proceeds of $20.9 million between January 1, 2013 and February 28, 2013 and entered into a new ATM equity offering program, under which the they may sell up to $50 million of its common stock from time to time. Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) announced the FDA approval of […]

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Pipeline and news updates for BIIB TSRX SPPI ACAD ACRX FOLD PPHM BLRX XOMA GEVA ZIOP KERX ANX MSTX CYTR AEZS MDCO

Mar 13, 2013 No Comments

Biogen Idec (NASDAQ: BIIB) announced it has submitted a Biologics License Application (BLA) to the FDA for recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. On March 4, 2013 Biogen Idec announced the FDA accepted for review the company’s BLA for its factor IX candidate, rFIXFc, for use in patients with hemophilia B. Trius Therapeutics, Inc. (Nasdaq:TSRX) […]

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THRX GSK Adcom meeting postponed. AMAG PDUFA date set + updates for POZN ZIOP ZLCS

Mar 07, 2013 No Comments

Theravance, Inc. (NASDAQ:THRX) announceD that the FDA notified GlaxoSmithKline plc (GSK) that the March 7, 2013 Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting has been postponed due to forecasted adverse weather conditions.  The FDA is working to reschedule the meeting in a timely manner.  The new drug application (NDA) for fluticasone furoate and vilanterol dry powder inhaler (proposed trade […]

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ZIOP Phase 3 data due end of March + updates for DCTH POZN MELA VNDA BIOD SGEN CYTK OGXI IMGN

Feb 13, 2013 No Comments

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced that the Phase 3 (PICASSO 3) trial of palifosfamide (ZIO-201) in first-line metastatic soft tissue sarcoma has reached its target number of progression-free survival (PFS) events. Topline results from this trial will be released during the last week of March 2013. Delcath Systems, Inc. (NASDAQ: DCTH) said it continues to […]

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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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