Author Archive

ZGNX Advisory Committee date set + pipeline updates for CLSN TZYM OGXI OGXN SNSS CPRX GTXI IGXT SCMP POZN ZCLS NPSP ZIOP CEMP CYTR CUR + ARRY MYRX SPEX news

Nov 10, 2012 No Comments

Celsion Corporation (NASDAQ: CLSN) announced that it projects that it has reached its target of 380 events in its Phase 3 HEAT Study, of ThermoDox in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer. Top line results are expected to be released in January 2013. Zogenix, […]

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Pipeline updates for SNTS BCRX ANAC VNDA ATRS AUXL ITMN ALIM NKTR CHTP VICL

Nov 08, 2012 No Comments

Vical Incorporated (Nasdaq:VICL) said that it has revised  its projection for reaching the target number of death events in its Phase 3 Allovectin melanoma trial, to mid-2013. The company also noted that Astellas is planning to initiate a multinational pivotal Phase 3 trial of TransVax in hematopoietic cell transplant (HCT) recipients and a Phase 2 trial of TransVax for solid organ […]

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IMGN PDUFA date set. Pipeline updates from ACRX ALXA ARNA TRGT INFI ISIS RIGL OGXI

Nov 07, 2012 No Comments

ImmunoGen, Inc. (Nasdaq: IMGN) announced that Roche has been granted priority review for trastuzumab emtansine for the treatment of people with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin and a taxane chemotherapy. The PDUFA date is February 26, 2013. It also disclosed that its Marketing Authorization Application for trastuzumab emtansine for people […]

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DRRX OMER VTUS on track to file NDAs in 2013 + updates for FOLD ACRX ACAD CLVS TSRX ALNY

Nov 06, 2012 No Comments

DURECT Corporation (Nasdaq: DRRX) said that Pfizer expects to meet the FDA in late March 2013 to discuss data from its ongoing confirmatory bioavailability study to assess the pharmacokinetic profile of modified REMOXY formulation compositions.  Based on feedback Pfizer receives from the FDA at the meeting, Pfizer will subsequently determine the next steps and/or required timing to respond to […]

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DCTH PDUFA date set. CRTX CRL. Pipeline updates for IDIX CLDX THLD KERX INCY ECYT RPTP SGEN ISIS PCRX PLX

Nov 04, 2012 No Comments

Delcath Systems, Inc. (NASDAQ: DCTH) announced a PDUFA date of June 15, 2013, for the resubmission of its New Drug Application (NDA) of its chemosaturation system with melphalan hydrochloride as a treatment for patients with unresectable metastatic melanoma in the liver. Cornerstone Therapeutics Inc. (NASDAQ: CRTX) announced that it received a Complete Response Letter (CRL) for […]

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TTNP files NDA. NAVB refiles NDA. NBIX pipeline update

Nov 01, 2012 No Comments

Navidea Biopharmaceuticals, Inc. (NAVB) announced that on October 30, 2012 it resubmitted its New Drug Application (NDA) for Lymphoseek in response to the Complete Response Letter (CRL) received in September 2012. Titan Pharmaceuticals, Inc. (TTNP) filed its NDA for Probuphine for the maintenance treatment of opioid dependence in adult patients, seeking a 6-month priority review and […]

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AVEO reduces workforce. ANIK expects FDA response this year + pipeline updates for IMGN GTXI GERN ISIS CYTK

Oct 31, 2012 No Comments

ImmunoGen, Inc. (Nasdaq: IMGN) gave a pipeline update noting that it expects data from its Phase 3 MARIANNE trial of T-DM1, for first-line treatment of HER2+ metastatic breast cancer, in late 2013/early 2014. It also noted that Roche has initiated a trial assessing T-DM1 for second-line treatment of 2nd-line metastatic HER2+ gastric cancer and expects to apply for marketing approval […]

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DRTX NDA due 2Q 2013. OREX prices offering. ZIOP Phase 2 melanoma data due 1H 2013 + ZCLS TSRO updates

Oct 26, 2012 No Comments

Durata Therapeutics (NASDAQ: DRTX) announced that it has completed its target enrollment for DISCOVER 2, the second Phase 3 trial of dalbavancin, under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria. The company intends to file a New Drug Application (NDA) during 2Q 2013. Orexigen Therapeutics, Inc. (Nasdaq: […]

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ARIA ponatinib PDUFA date set. XNPT ANTH Phase 3 updates. OREX XOMA offerings. ASTX ONCY MDCO trial updates + DSCO news

Oct 24, 2012 No Comments

ARIAD Pharmaceuticals, Inc.(NASDAQ: ARIA) announced that the FDA has accepted the NDA filing of ponatinib, in patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The PDUFA date under priority review is March 27, 2013. XenoPort, Inc. (Nasdaq: XNPT) noted today that it now expects preliminary top-line results of its Phase 3 arbaclofen […]

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SUPN FDA Approval. OREX safety trial update. XOMA NVAX raise cash. UTHR CRL + MNOV FOLD ANX news

Oct 24, 2012 No Comments

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) received approval from the FDA for Oxtellar XR , a novel once-daily extended release formulation of oxcarbazepine (formerly known as SPN-804) for patients with epilepsy. The company intends to launch Oxtellar XR in 1Q 2013. Orexigen Therapeutics, Inc. (NASDAQ: OREX) announced an update of its Light Study, the cardiovascular outcomes trial evaluating Contrave for obesity. […]

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Website update – apologies for the inconvenience

Oct 03, 2012 7 Comments

Apologies all for the inconvenience caused by my lack of updates. I have been overseas for the last two or so weeks with work and have no access to a latop, which makes it not possible to make updates to the calendars and other parts of the website when just I ‘m operating with an […]

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