FLML FDA Approval + updates for ADRO ALNY ARGS CEMP CERU GNVC MACK MCRB MRNS NWBO PRTK RGLS TBRA TNXP TRVN XNCR

May 03, 2016 No Comments by

Updates to the Company Pipeline Database for May 2, 2016, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ADRO 13.27 CRS-207 and GVAX Pancreas – ECLIPSE trial Pancreatic cancer Phase 2b Phase 2b top-line data to be released 2Q 2016 ADRO 13.27 CRS-207 and GVAX Pancreas and nivolumab – […]

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APRI data due this month + updates for ABUS ALNY CNAT CYNA GNVC MRTX OGXI ONCE TBPH TRVN XOMA

Mar 09, 2016 No Comments by

Updates to the Company Pipeline Database for March 9, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ABUS 3.88 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 […]

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INCY discontinues Phase 3 JANUS trial + updates for GNCA ALNY NAVB

Feb 12, 2016 No Comments by

Updates to the Company Pipeline Database for February 11, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ALNY 56.96 Patisiran APOLLO Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR Phase 3 Phase 3 enrolment completed late January 2016. Data due 2017, with NDA to be filed late 2017 assuming […]

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ALNY completes Phase 3 APOLLO enrollment + updates for ARIA CBYL DSCO REPH TENX TTHI

Feb 02, 2016 No Comments

Updates to the Company Pipeline Database for February 1, 2016 are as follows. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ALNY 69.75 Patisiran APOLLO Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR Phase 3 Phase 3 enrolment completed late January 2016. Data due 2017, with NDA to be filed late 2017 assuming […]

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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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61 pipeline updates for 42 companies from May 7 and 8

May 09, 2015 1 Comment

Latest updates to the Company Pipeline Database for May 7 and 8, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Summary ACHN 9.43 ACH-3422 in combination with ACH-3102 HCV Hepatitis C – treatment durations of 6, 8 and 12 weeks Phase 2 Phase 2 to be initiated 2Q 2015. SVR4 results are expected […]

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NBIX meets Phase 3 endpoint + updates for ALNY CNAT CYTR PLX GALE GWPH INFI IXPL KMDA LGND OTIC RGLS SGYP VSAR VSTM

Jan 09, 2015 No Comments

Latest updates to the Company Pipeline Database from January 8, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Text Updated ALNY 101.70 Patisiran APOLLO Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR Phase 3 Phase 3 trial initiated Nov 2013, continues to enrol patients as of Nov 2014. Expects […]

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MNKD Adcom date set. BDSI Ph3 data due soon. ATHX BOTA offerings. ALNY RIGL pipeline updates + STEM news

Jan 11, 2014 No Comments

MannKind Corporation (Nasdaq:MNKD $5.92) announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is tentatively scheduled on April 1, 2014 to review their New Drug Application (NDA) for AFREZZA, for patients with type 1 or type 2 diabetes. The PDUFA date is April 15, 2014. BioDelivery Sciences International, Inc. (NASDAQ: BDSI $6.20) provided a pipeline update as follows: Phase […]

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VPHM acquired by SHPG. BMY Adcom December + updates for ALNY GALE

Nov 12, 2013 No Comments

Bristol-Myers Squibb Co (NYSE:BMY $52.58) The Endocrinologic and Metabolic Drugs Advisory Committee will meet on December 12, 2013 to discuss the efficacy and safety of new drug application (NDA) dapagliflozin. Dapagliflozin is a sodiumglucose cotransporter 2 inhibitor developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Shire plc (LSE: SHP, NASDAQ: SHPG $135.33) and ViroPharma Incorporated […]

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NBY Phase 2b fail. CRIS CUDC-427 placed on partial hold. Upcoming data releases for IMUC FURX + updates for XLRN OCRX INCY ABIO ALXA ESPR DCTH ACAD ALNY

Nov 06, 2013 No Comments

NovaBay Pharmaceuticals, Inc. (NYSE MKT: NBY $0.90) announced that the auriclosene Phase 2b clinical study of impetigo did not meet its primary clinical endpoint. Curis, Inc. (Nasdaq:CRIS $2.86) announced that the FDA has placed their Phase 1 study of CUDC-427 on partial clinical hold following the report of death of a patient who progressed to […]

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Updates for ALNY ZGNX INSV DNDN OGXI ANAC RPTP NPSP NKTR KERX APPA SRPT THLD OPXA BCRX IMUC INFI

Aug 09, 2013 No Comments

Zogenix, Inc. (Nasdaq:ZGNX $1.52) said it continues to expect that the FDA will reach a decision regarding the Zohyrdo ER New Drug Application(NDA), during the summer of 2013. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP $18.10) said that it expects to submit its Biologic License Application in 4Q 2013 for Natpara for patients with hypoparathyroidism. It also plans to initiate […]

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