Author Archive

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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TRGT fails Phase 2 ADHD. OXGN SPA agreement for Phase 3 ATC trial. ANTH plans Phase 3 lupus trial

Sep 18, 2012 2 Comments

Targacept, Inc. (NASDAQ: TRGT) today announced it failed its Phase 2 trial of TC-5619 as a treatment for inattentive-predominant attention deficit/hyperactivity disorder (ADHDi). OXiGENE, Inc. (Nasdaq:OXGN) announced that it has come to agreement with the FDA on a Special Protocol Assessment (SPA) for its Phase 3 clinical trial (FACT 2) of ZYBRESTAT for the treatment of anaplastic thyroid […]

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Pipeline and financial updates for TZYM RPRX OPXA TSPT CUR OREX PSTI BIOD BDSI CLSN ONCY

Sep 17, 2012 No Comments

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) said it is on track to submit a New Drug Application (NDA) for BEMA Buprenorphine/Naloxone (BNX), for the potential treatment of opioid dependence, during 2Q 2013. Biodel Inc. (Nasdaq: BIOD) announced the initiation of a Phase 2 clinical trial of its proprietary recombinant insulin (RHI)-based ultra-rapid-acting mealtime insulin candidate, BIOD-123.  Top-line Phase […]

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SNSS increases Phase 3 enrolment of Valor trial. GENT MAA decision due 4Q.

Sep 12, 2012 No Comments

Sunesis Pharmaceuticals, Inc.(Nasdaq:SNSS) announced that it will increase enrollment to 675 patients in its Phase 3 VALOR trial of vosaroxin in acute myeloid leukemia (AML). This is in response to the recommendation of the trial’s independent Data and Safety Monitoring Board (DSMB). Sunesis anticipates full enrollment of VALOR in 2013, with unblinding of the trial expected in […]

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NAVB receives CRL. GERN and ZLCS Phase 2 failures. SQNM offering + ASTX and CYTK news

Sep 11, 2012 No Comments

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) announced that it received a Complete Response Letter (CRL)  for Lymphoseek Injection, due to  third-party manufacturing concerns. Zalicus Inc. (NASDAQ: ZLCS) announced that it will discontinue development of Synavive following top line results from its Phase 2b clinical trial in rheumatoid arthritis that showed that while it met its endpoint, it missed the […]

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