Author Archive

FOLD meets endpoints in Phase 3 trial. NBY fails Phase 2 conjunctivitis trial.

Aug 21, 2014 No Comments

NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) announced that its NVC-422 ophthalmic formulation did not meet the primary or secondary endpoints in a Phase 2 clinical study in patients with adenoviral conjunctivitis. Amicus Therapeutics (Nasdaq:FOLD) announced that it met both co-primary endpoints following positive 18-month data from its second Phase 3 study (Study 012) of  migalastat HCl (migalastat) in […]

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ASPX Phase 3 data due 4Q. ONTY fails Phase 1/2 NSCLC trial.

Aug 19, 2014 No Comments

Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX) announced that it has completed the enrollment in its Phase 3 trial of SD-809 for the treatment of chorea associated with Huntington’s disease (HD). The company expects to announce top-line data in 4Q 2014. Oncothyreon Inc. (NASDAQ:ONTY) was informed by their partner Merck KGaA that a Phase 1/2 study, EMR 63325-009, of tecemotide […]

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Updates to FDA Calendar

Aug 18, 2014 No Comments

BioPharmCatalyst is pleased to update readers that following the recent filing of financial reports for 2Q, all catalysts in the FDA Calendar have been updated using the most recent press releases and filings. Readers can find the updated FDA Calendar HERE. Daily news updates will resume from tomorrow.

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Updates to Company Pipeline database

Aug 09, 2014 No Comments

This is a brief note to inform readers that although there have not been daily posts made over the last few days, the Company Pipeline Database continues to be updated. Over 100 updates have been made to the Company Pipeline Database over the last week. Corresponding updates have also been made to the FDA Calendar. Click the “Updated” […]

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INSM to initiate two Phase 3 ARIKAYCE trials. HRTX NDA filing due 4Q + NPSP IRWD HTBX trial updates

Aug 05, 2014 No Comments

Heron Therapeutics, Inc. (NASDAQ: HRTX) noted that their new drug application (NDA) of SUSTOL for the prevention of delayed-onset chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) agents will be filed in 4Q 2014. Insmed Incorporated (Nasdaq: INSM) announced that it will initiate two Phase 3 studies of ARIKAYCE for the treatment of nontuberculous mycobacteria (NTM) lung […]

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Pipeline updates and news over the previous week from 20 companies.

Aug 03, 2014 No Comments

Pacira Pharmaceuticals, Inc.(NASDAQ: PCRX) noted that the FDA has set a PDUFA date of March 5, 2015 for the supplemental New Drug Application (sNDA) for a nerve block indication for EXPAREL. NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) said that their BAYnovation trial for viral conjunctivitis has been completed and top-line results are due in mid-August 2014. Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) maintained guidance that the pre-planned […]

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ACRX receives CRL. TSRO NDA filing due by early September + pipeline updates for GLMD ESPR

Jul 27, 2014 No Comments

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application (NDA) for Zalviso. The CRL contains requests for additional information on the Zalviso System to ensure proper use of the device. Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) provided an update noting that Phase 2b interim data from their […]

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EGRX FDA Approval. INO meets endpoint. INCY fails to meet endpoint.

Jul 24, 2014 No Comments

Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) announced that the FDA has approved Ryanodex for injectable suspension indicated for the treatment of malignant hyperthermia (MH). Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity. Incyte Corporation(Nasdaq: INCY) […]

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PBYI releases positive Phase 3 data. LJPC offering. Trial updates for ATRS HALO

Jul 23, 2014 No Comments

Puma Biotechnology, Inc. (NYSE: PBYI) announced positive top line results from their Phase 3 clinical trial of PB272 (neratinib) for the extended adjuvant treatment of breast cancer (ExteNET Trial) in women with early stage HER2-positive breast cancer. The primary endpoint of the trial was disease free survival (DFS). The results of the trial demonstrated that treatment […]

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Trial initiations and updates for TTNP RXDX GNCA DPRX SNTA

Jul 22, 2014 No Comments

Titan Pharmaceuticals, Inc. (TTNP.OB) announced enrollment of the first patients in the Phase 3 trial to support the resubmission of the New Drug Application (NDA) for Probuphine, for the maintenance treatment of opioid dependence. The study, which is expected to be completed by the middle of 2015, followed by their resubmission of the NDA in late 2015. […]

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SGYP Phase 2 SP-333 data due 4Q + trial initiations for ASPX ISIS

Jul 18, 2014 1 Comment

Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced that it has completed patient enrollment for its Phase 2 trial of SP-333, in patients with opioid-induced constipation (OIC). Top-line data are due 4Q 2014. Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX) announced the enrollment of the first patients in a pivotal Phase 2/3 trial of SD-809 (deutetrabenazine), for the treatment of tardive […]

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