Positive Adcom vote for THRX. CCXI disappoints. DRTX NDA filing due this month + updates for EXEL CUR OMER IRWD

Sep 11, 2013 No Comments

GlaxoSmithKline plc (LSE: GSK $50.52) and Theravance, Inc. (NASDAQ: THRX $37.79) announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease […]

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NBIX fails Phase 2b trial + updates for CMRX PPHM KYTH ZLCS MRK ONCY BIIB ISIS

Sep 10, 2013 No Comments

Neurocrine Biosciences, Inc. (NASDAQ: NBIX $11.85) announced that the 50mg dose of NBI-98854, a small molecule VMAT2 inhibitor in development for tardive dyskinesia, did not meet the primary endpoint in the Phase 2b Kinect study. Chimerix, Inc. (Nasdaq:CMRX $19.07) announced the initiation of dosing in the Phase 3 SUPPRESS trial. SUPPRESS is evaluating brincidofovir (CMX001) for the […]

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ASTX acquired by Otsuka. ENDP PDUFA date set. CPRX CUR NLNK to raise cash + RIGL update

Sep 05, 2013 No Comments

Endo Pharmaceuticals Inc.(Nasdaq: ENDP $43.05) announced that the FDA has accepted for review the complete response submission made by Endo to the new drug application (NDA) for its long-acting testosterone undecanoate injection, AVEED, intended for men diagnosed with hypogonadism. The PDUFA date is Febraury 28, 2014. Otsuka Pharmaceutical Co., Ltd. and Astex Pharmaceuticals, Inc. (Nasdaq:ASTX $8.55) […]

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CHTP PDUFA date set. RMTI meets endpoints + updates for TTNP ENDO BDSI ARIA THRX

Sep 05, 2013 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $3.09) announced that the FDA has accepted the New Drug Application (NDA) resubmission of NORTHERA, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The PDUFA date is February 14, 2014. ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA $20.35)  announced enrollment of fifty percent of the patients planned in its randomized Phase 3 […]

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CYTK fails Phase 2 trial. RMTI data due Wed. ARQL requested to reduce Phase 3 dosage + ESPR ELN TTPH ZLCS updates

Sep 04, 2013 No Comments

Rockwell Medical (NASDAQ: RMTI $5.54) will host a conference call on Wednesday, September 4th at 8:30am EDT to review top-line results from their Phase 3 (CRUISE-2) efficacy study of SFP, for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. Cytokinetics Incorporated (NASDAQ:CYTK $7.65) and Amgen (NASDAQ:AMGN) announced that they did not meet the primary endpoint […]

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ESPR data due Tuesday. PCYC awarded priority review for ibrutinib. NBIX initiates second Phase 3 trial.

Aug 31, 2013 No Comments

Esperion Therapeutics, Inc. (Nasdaq:ESPR) announced that it will host a conference call and webcast on Tuesday, September 3, 2013 at 8:30 a.m. Eastern Time (ET) to present top-line results from a Phase 2a clinical study of its lead product candidate, ETC-1002, as an add-on to statin therapy in patients with hypercholesterolemia. Neurocrine Biosciences, Inc. (NASDAQ:NBIX) 1nnounced that the second Phase 3 […]

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AUXL PDUFA date extension + ARNA NKTR MACK news

Aug 29, 2013 No Comments

Auxilium Pharmaceuticals, Inc.(Nasdaq: AUXL) announced that the FDA has extended the PDUFA date for their supplemental biologics license application (sBLA) for XIAFLEX for the treatment of Peyronie’s disease (PD) from September 6, 2013 to December 6, 2013. The extension is due to recently submitted revisions regarding their proposed Risk Evaluation and Mitigation Strategy (REMS) program and other aspects related […]

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CPRX receives Breakthrough Designation. RIGL fails Phase 2 trial. OREX NDA due end of 2013 + updates for SGMO QRXPY OGXI ONXX AMGN IMMU

Aug 28, 2013 No Comments

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX $2.01)  announced that Firdapse, currently in Phase 3 development, has received “Breakthrough Therapy Designation” by the FDA for the treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL $3.11) announced that R343, for patients with allergic asthma, did not meet the primary or secondary endpoints in a Phase 2 […]

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Updates for ATHX SUPN LLY ASTM MDCO IMMY

Aug 14, 2013 No Comments

Athersys, Inc. (NASDAQ: ATHX) noted that data from their Phase 2 trial of MultiStem in patients suffering from ulcerative colitis, are due in early 2014. Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) said that it continues to expect final approval of Trokendi XR  in 3Q 2013. Eli Lilly and Company (NYSE: LLY) announced that they met the primary endpoint in […]

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