ENDO offers to acquire AUXL. NKTR FDA Approval + OGXI AGRX updates

Sep 17, 2014 No Comments by

Nektar Therapeutics (NASDAQ:NKTR) announced that their partner AstraZeneca announced that the FDA approved MOVANTIK (naloxegol) tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced that patient enrollment has been completed in the Phase 3 AFFINITY […]

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AVNR meets endpoint in AVP-923 trial. SLXP Approval. OPXA offering. TGTX finalises SPA agreement + AMRN

Sep 16, 2014 No Comments by

Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that it met the primary endpoint in a Phase 2 trial of AVP-923 for the treatment of agitation in patients with Alzheimer’s disease. Treatment with AVP-923 was associated with significantly reduced agitation as measured by the primary endpoint, the agitation/aggression domain score of the neuropsychiatric inventory (NPI) compared to […]

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HALO FDA Approval. NPSP positive Adcom vote. AMRN SPA appeal denied + ASTM ONTY GNCA

Sep 14, 2014 No Comments by

NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) announced that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 8 to 5 that the available data support the approval of Natpara for the long-term treatment of Hypoparathyroidism. The PDUFA date is October 24, 2014. Halozyme Therapeutics, Inc., (NASDAQ: HALO) and Baxter International Inc. (NYSE: BAX) announced that the FDA approved HYQVIA for the treatment of adult patients […]

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OREX MDVN FDA Approval. Updates for PTCT ENTA CLVS.

Sep 11, 2014 No Comments

Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. (NASDAQ: OREX) announced that the FDA has approved Contrave for the treatment of obesity. They plan to launch Contrave in the fall of 2014. Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. announced that the FDA approved a new indication for the use of XTANDI (enzalutamide) capsules to treat patients with metastatic […]

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EVOK Phase 3 data due ahead of schedule + updates for PTN EVOK GALE

Sep 10, 2014 No Comments

Evoke Pharma, Inc. (Nasdaq:EVOK) announced that it has completed enrollment of its Phase 3 trial of EVK-001 for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Top-line data are due later in 2014, rather than in mid-2015 as was noted in previous guidance. Palatin Technologies, Inc. (NYSE MKT: PTN) provided […]

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TSRO OPK submit rolapitant NDA. HPTX terminates DiaPep277 trial + VTL update

Sep 09, 2014 No Comments

OPKO Health, Inc. (NYSE:OPK) announced that TESARO, Inc. (Nasdaq:TSRO) has submitted a New Drug Application (NDA) to the FDA for oral rolapitant, for the prevention of chemotherapy-induced nausea and vomiting (CINV). Vital Therapies, Inc. (Nasdaq:VTL) provided an update on their VTI-208 clinical trial  in alcohol induced liver decompensation noting that preliminary results are expected in 1H 2015. Hyperion […]

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KERX FDA Approval + updates for ALKS FLXN BLRX

Sep 06, 2014 No Comments

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced that the FDA has approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. Alkermes plc (NASDAQ: ALKS) announced completion of patient enrollment in a Phase 2 trial of ALKS 3831, for the treatment of schizophrenia. Top-line data are […]

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Clinical updates for SPHS MEIP SLXP CLSN CNAT ADHD TTPH

Sep 03, 2014 No Comments

Sophiris Bio Inc. (NASDAQ: SPHS) announced that it has fully enrolled its ongoing Phase 3 trial (referred to as PLUS-1) of PRX302 as a treatment for lower urinary tract symptoms of BPH. An interim analysis is due around the end of 2014, with complete data in 2H 2015. MEI Pharma, Inc. (Nasdaq: MEIP) announced that it has completed […]

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EXEL Phase 3 COMET-1 trial fails to meet primary endpoint.

Sep 02, 2014 No Comments

Exelixis, Inc. (NASDAQ:EXEL) announced that it did not meet the primary endpoint following release of top-line results from their Phase 3 COMET-1 of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide. The median OS for the cabozantinib arm of the trial was 11.0 […]

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