TTNP wins positive Advisory Committee vote for Probuphine + updates for ABIO PVCT ESPR IONS

Jan 13, 2016 No Comments

Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted 12 to 5 in favor of approving Probuphine, for the maintenance treatment of opioid addiction. Previously, the FDA issued a Complete Response Letter (CRL) in April 2013. The company resubmitted their New Drug Application (NDA) in August 2015 and their PDUFA date […]

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65 pipeline updates predominantly from companies attending the JP Morgan Healthcare Conference

Jan 12, 2016 No Comments

Pipeline updates galore as companies give latest guidance at the JP Morgan Healthcare Conference. Click HERE to register for meeting information and webcasts. Latest updates to the Company Pipeline Database from January 11, 2016. Refer to the FDA Calendar for upcoming catalysts: ACOR 39.98 Dalfampridine Post stroke deficits Phase 2b/3 Phase 3 interim data due 2016 ACOR 39.98 CVT-301 […]

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Pipeline updates from VRTX IMGN ABUS

Jan 10, 2016 No Comments

Latest updates to the Company Pipeline Database from January 10, 2016. Refer to the FDA Calendar for upcoming catalysts: ABUS 4.02 ARB-1467 (TKM-HBV, RNAi) Hepatitis B virus infection (HBV) Phase 2 Phase 2 initiated December 2015.HBsAg reduction results from single dose due 3Q 2016, multiple dose data due 4Q 2016 ABUS 4.02 TKM-PLK1 Hepatocellular carcinoma (HCC) Phase 2 Phase […]

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Latest pipeline updates for ADXS CEMP CHMA CLBS CTIC CVM CYTK DERM KMDA OCRX ONTX ORMP RVNC SYN TKAI

Jan 09, 2016 No Comments

Please find below latest updates to the Company Pipeline Database added on January 8, 2016. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADXS 7.94 Axalimogene filolisbac – AIM2CERV Trial High-risk, locally advanced cervical cancer Phase 3 Phase 3 to commence in mid-2016 ADXS 7.94 Axalimogene filolisbac – GOG 0265 study Cervical cancer […]

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33 IPOs added to the Pipeline Database + updates from DVAX QURE FGEN MSTX ARWR ANAC

Jan 08, 2016 No Comments

2015 IPOs have been added to the Company Pipeline Database and FDA Calendar, accordingly. The companies added are as follows: COLL, AAAP, ACRS, ADAP, ADRO, AIMT, AXON, AXSM, BLPH, CATB, CDTX, CHMA, CLCD, DMTX, DNAI, EDGE, EYEG, GBT, ITEK, KMPH, LIFE, LNTH, MCRB, NBRV, NEOS, NVCR, NVLS, RGNX, RTTR, VKTX, VTVT, VYGR, ZYNE. In addition, […]

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Pipeline and trial updates for APRI CCXI TLOG REPH PRTK

Jan 07, 2016 No Comments

Latest updates to the Company Pipeline Database for January 6, 2016. Refer to the FDA Calendar for upcoming catalysts: APRI 4.17 RayVa Secondary Raynaud’s Phenomenon Phase 2a Phase 2b trial to be initiated 2H 2016 APRI 4.17 Fispemifene Men with symptomatic secondary hypogonadism. Phase 2 Phase 2b initated June 2015. Topline data due 1Q 2016 APRI 4.17 […]

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Pipeline updates for ARDX CANF CNAT VCEL RDUS

Jan 06, 2016 2 Comments

Latest updates to the Company Pipeline Database for January 4, 2016. Refer to the FDA Calendar for upcoming catalysts: ARDX 16.46 RDX022 Hyperkalemia Phase 3 Phase 3 program to be initiated 2H 2016 CANF 2.85 CF101 Rheumatoid arthritis Phase 3 Phase 3 trial protocal submitted January 2016 – Israel CNAT 2.87 Emricasan Liver Cirrhosis Phase 2 Phase […]

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RPRX to meet with FDA in February re CRL. AKBA initiates Phase 3 trial

Jan 05, 2016 No Comments

Latest updates to the Company Pipeline Database for January 4, 2016. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary RPRX 1.30 Enclomiphene Secondary hypogonadism CRL CRL November 30 2015. Announced early January 2016 that they plan to meet with the FDA in 2016 to discuss CRL. MAA to be submitted mid-2016 […]

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FDA Calendar and Company Pipeline databases have been updated!

Jan 03, 2016 4 Comments

A very special Happy New Year to all readers of BPC. As mentioned in the previous post, the FDA Calendar, PDUFA Calendar and Company Pipeline databases have all been updated over the past couple weeks. Approximately 70% of all FDA Calendar entries are either new or have had their catalyst dates changed from the previous […]

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