ATRS files NDA. TSYM discontinues TZP-102 enrolment + GALE GTXI CEMP OMER ITMN CYCC ARIA news

Dec 18, 2012 No Comments

Antares Pharma, Inc. (NASDAQ: ATRS) today announced it has submitted its New Drug Application (NDA) for OTREXUP,  for the delivery of methotrexate (MTX) using Medi-Jet technology to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis. GTx, Inc. (Nasdaq: GTXI) announced that it has attained its enrollment goal for both of its pivotal Phase 3 […]

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CHMP issues negative opinion for VNDA. LGND PDUFA date set + news from CYTX INFI SRPT SNTA AUXL CERS THRX YMI SCMP ACAD SOMX

Dec 14, 2012 No Comments

Vanda Pharmaceuticals Inc.(NASDAQ: VNDA), announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Product for Human Use (CHMP) has issued a negative opinion recommending against approval of Fanaptum (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union. Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that it intends to […]

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DRTX Phase 3 data due Tuesday + updates for LGND EXAS ACRX DCTH ZGNX NBY CYTR TSRX

Dec 10, 2012 No Comments

Durata Therapeutics, Inc. (NASDAQ: DRTX) today announced that it will host a conference call and webcast at 9:00am Eastern Time on Tuesday, December 11, 2012 to present preliminary top-line results from its DISCOVER 1 Phase 3 study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by […]

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FDA upholds non approval PMA decision. CVM offering + CHTP THRX news

Dec 04, 2012 No Comments

Anika Therapeutics, Inc. (Nasdaq: ANIK) announced today that the FDA has upheld its non-approvable decision for the Monovisc PMA. The company plans to schedule a meeting with the FDA to determine the next steps concerning the Monovisc product. CEL-SCI Corporation (NYSE MKT: CVM) said it will sell 35 million shares of its common stock at a price per […]

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GERN discontinues GRN1005 development. AVEO initiates Phase 2 mBC trial

Dec 04, 2012 No Comments

Geron Corporation (Nasdaq: GERN) announced that the company has discontinued development of GRN1005. An inability to enrol its Phase 2 trial in patients with brain metastases arising from non-small cell lung cancer, and poor interim data from its Phase 2 trial in brain metastases arising from breast cancer, were listed as the reasons for discontinuing development of […]

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30 Upcoming Catalysts – PDUFA dates, FDA Advisory meetings and Clinical data releases

Dec 01, 2012 10 Comments

30 short and long term potential catalysts as of December 1, 2012. See the links in the FDA Calendar for more details about each catalyst. Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA):  PDUFA date December 21 2012 for the Class 2 resubmssion of Staccato loxapine (ADASUVE). CHMP (EMA) decision due December 14, 2012. A.P. Pharma, Inc. (OTCBB: APPA): PDUFA Mar 27, 2013 […]

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SCMP PDUFA date extension. BCRX terminates merger

Dec 01, 2012 No Comments

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) announced today that the FDA has extended the PDUFA date for its priority review of the supplemental new drug application (sNDA) for lubiprostone for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. The delay is due to the submission of FDA-requested supportive analyses which is seen as a major amendment to the […]

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SUPN prices offering. EXEL FDA Approval + updates for AMRN CYTK XOMA CRIS THRX INSV

Nov 30, 2012 No Comments

Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced the pricing of its public offering of 6m shares of its common stock at a price to the public of $8.00 per share with an option to issue 900,000 additional shares to cover over-allotments. Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) announced that it will offer 11m shares of its common stock at a price of $2.00 per […]

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AVEO PDUFA date set. PGNX offering + IRWD TTHI PRAN ECYT news

Nov 29, 2012 No Comments

AVEO Oncology(NASDAQ: AVEO) and Astellas Pharma Inc announced that the FDA has accepted for filing the New Drug Application (NDA) for tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC). The expected PDUFA date is July 28, 2013 Ironwood Pharmaceuticals, Inc.(NASDAQ: IRWD) announced that the European Commission has granted marketing authorization to Constella (linaclotide 290mcg) for the symptomatic […]

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