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

Jan 11, 2014 No Comments by

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 by

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 by

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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Plenty of news from NBIX CNDO FLML PSDV MDCO ACHN MRK AVNR ONXX INSM CTIC ALNY THLD

Jul 02, 2013 No Comments

Alnylam Pharmaceuticals, Inc.(Nasdaq: ALNY) announced positive clinical results from its Phase 2 trial of ALN-TTR02, for the treatment of TTR-mediated amyloidosis (ATTR). Interim results show that multiple doses of ALN-TTR02 led to robust and statistically significant (p<0.001) knockdown of serum TTR protein levels of up to 93%. The company also mentioned that it intends to start a […]

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News for ARRY ISIS ALNY ENTA CELG CYTR

May 07, 2013 No Comments

Array BioPharma Inc. (NASDAQ: ARRY) announced that it will initiate a Phase 3 trial called MILO (MEK Inhibitor in Low Grade Serous Ovarian Cancer) of MEK162 compared to standard chemotherapy, in patients with recurrent low-grade serous ovarian cancer (LGSOC) during the summer of 2013. Isis Pharmaceuticals, Inc.(NASDAQ: ISIS) announced the initiation of a Phase 1b/2a trial of ISIS-STAT3Rx in patients with advanced […]

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ALNY pipeline update. Offering details for OPXA MDGN

Feb 08, 2013 No Comments

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) gave a pipeline update noting that expects to report data from its Phase 2 trial of ALN-TTR02 for transthyretin-mediated amyloidosis (ATTR) in mid-2013. Assuming positive results from the Phase 2 trial, Alnylam expects to start a Phase 3 trial for ALN-TTR02 in familial amyloidotic polyneuropathy (FAP) patients by the end of 2013. It […]

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ALNY and PCRX offering details. APPY initiates pivotal blood-based appendicitis trial

Jan 15, 2013 No Comments

Venaxis, Inc. (Nasdaq: APPY) today announced that it has begun enrolling patients into its pivotal study of its blood-based appendicitis test, APPY1.  It anticipates completing the study in 3Q 2013 and filing with the FDA for regulatory clearance in 4Q 2013. Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) today announced the pricing of an underwritten registered public offering of 8,000,000 shares […]

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SNTS FDA Approval for UCERIS. ITMN and ALNY raise cash

Jan 14, 2013 No Comments

Santarus, Inc. (NASDAQ: SNTS) announced today that the FDA has approved UCERIS (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. The company received approval two days before the set PDUFA date. InterMune, Inc. (Nasdaq: ITMN) today announced that it plans to offer $85.0 million aggregate principal amount of convertible senior […]

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DCTH expects May Adcom meeting. EDIT – BLRX + Pipeline updates for ALNY CLVS INFI OREX FOLD ICPT

Jan 07, 2013 No Comments

BioLineRx (NASDAQ: BLRX) announced today that the results of the interim analysis of its Phase 2/3 CLARITY trial of BL-1020, for the treatment of schizophrenia, are expected during the week beginning March 18, 2013. EDIT: DMC will provide estimate of the total number of patients required in the study in order to achieve statistical significance in the Phase 2/3 data […]

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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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