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

Jul 27, 2014 No Comments by

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 by

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 by

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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SLXP Pharming FDA Approval. POZN receives Class 2 resubmission + GNCA RPRX news

Jul 17, 2014 No Comments

POZEN Inc. (NASDAQ: POZN) announced that the FDA has set a PDUFA date of December 30, 2014 for the Class 2 re-submission of the New Drug Application (NDA) for PA8140/PA32540. Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced the initiation of a Phase 3 clinical program for fostamatinib, in patients with ITP (immune thrombocytopenic purpura). Results are expected at year-end 2015. Salix […]

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TRGT fails Phase 2b. Positive news for SLXP PGNX EXEL. Phase 3 data due soon for ADHD ZSPH + AERI SGYP VTUS ANTH GNCA updates

Jul 15, 2014 No Comments

Targacept, Inc. (NASDAQ: TRGT) announced that it did not meet the primary endpoint in their Phase 2b monotherapy trial of TC-1734 as a treatment for mild to moderate Alzheimer’s disease. Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals(NASDAQ:PGNX) announced that the FDA has informed Salix that RELISTOR Subcutaneous Injection, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic […]

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KYTH PDUFA date set. Offering details for TXNP ASPX

Jul 12, 2014 No Comments

KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) announced that the FDA has assigned a PDUFA date for their New Drug Application (NDA) of ATX-101 (deoxycholic acid) of May 13, 2015. The company also expects that an Advisory Committee meeting will also be held. Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) announced it will issue 657,000 shares of common stock at a price of […]

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ACST data due 3Q. OCRX offering. VTL pipeline update + THLD ACOR news

Jul 10, 2014 No Comments

Acasti Pharma Inc. (NASDAQ: ACST) announced the completion of two trials, the Phase 2 (TRIFECTA) study of CaPre in reducing triglyceride levels in patients with mild to severe hypertriglyceridemia and the Pharmacokinetic (PK) trial. Top-line data from both trials are due at the end of September with full data in 4Q 2014. Ocera Therapeutics (Nasdaq:OCRX) announced […]

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