NBY Phase 2b fail. CRIS CUDC-427 placed on partial hold. Upcoming data releases for IMUC FURX + updates for XLRN OCRX INCY ABIO ALXA ESPR DCTH ACAD ALNY

Nov 06, 2013 No Comments by

NovaBay Pharmaceuticals, Inc. (NYSE MKT: NBY $0.90) announced that the auriclosene Phase 2b clinical study of impetigo did not meet its primary clinical endpoint. Curis, Inc. (Nasdaq:CRIS $2.86) announced that the FDA has placed their Phase 1 study of CUDC-427 on partial clinical hold following the report of death of a patient who progressed to […]

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Updates for ALNY ZGNX INSV DNDN OGXI ANAC RPTP NPSP NKTR KERX APPA SRPT THLD OPXA BCRX IMUC INFI

Aug 09, 2013 No Comments by

Zogenix, Inc. (Nasdaq:ZGNX $1.52) said it continues to expect that the FDA will reach a decision regarding the Zohyrdo ER New Drug Application(NDA), during the summer of 2013. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP $18.10) said that it expects to submit its Biologic License Application in 4Q 2013 for Natpara for patients with hypoparathyroidism. It also plans to initiate […]

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AVEO MAA won’t be pursued. CELG granted priority review. Offering details for APPY APRI ALXA + MRK OGXI LPTN MACK updates

May 24, 2013 No Comments by

AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO) announced in a SEC filing that is was informed by its partner, Astellas Pharma Inc. that they will no longer submit a Marketing Authorization Application to the European Medicines Agency for tivozanib for the treatment of patients with advanced renal cell carcinoma. Astellas also informed AVEO that it does not […]

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RPTP PDUFA date extension. NPSP receives early approval. TSPT fails Phase 2 trial. ALXA approval + SPPI news

Dec 23, 2012 No Comments

Raptor Pharmaceutical Corp. (Nasdaq:RPTP) announced that FDA will require additional time to complete its review of the New Drug Application for RP103 (PROCYSBI), for the potential treatment of nephropathic cystinosis. The new PDUFA date has been extended from January 30, 2013 to April 30, 2013. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), announced that FDA approved Gattex for subcutaneous use for the treatment 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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LGND FDA Approval. ALXA MAA decision due Dec 14. OXGN reverse split vote Dec 21

Nov 19, 2012 No Comments

OXiGENE, Inc. (NASDAQ: OXGN), confirmed a special meeting of stockholders will be held on December 21, 2012 at 10:00 a.m., to seek approval of a reverse stock split of its common stock, at a ratio in the range of 1:5 to 1:20. Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) and partner GlaxoSmithKline (NYSE: GSK) announced it received approval from the FDA for PROMACTA […]

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IMGN PDUFA date set. Pipeline updates from ACRX ALXA ARNA TRGT INFI ISIS RIGL OGXI

Nov 07, 2012 No Comments

ImmunoGen, Inc. (Nasdaq: IMGN) announced that Roche has been granted priority review for trastuzumab emtansine for the treatment of people with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with Herceptin and a taxane chemotherapy. The PDUFA date is February 26, 2013. It also disclosed that its Marketing Authorization Application for trastuzumab emtansine for people […]

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ALXA PDUFA date for Adasuve set for December 21 2012

Jul 05, 2012 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that FDA accepted its resubmitted ADASUVE New Drug Application (NDA) and assigned a new PDUFA date of December 21, 2012. The company has previously received complete response letters (CRLs) in both October 2010 and a second in May 2012.  

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QRX issued CRL. SUPN receives tentative FDA Approval. DVAX PDUFA set for February. ALXA files shelf. OMER offering. ATRS NDA filing due 1Q 2013 + MDVN

Jun 27, 2012 No Comments

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today it received a Complete Response Letter (CRL) for MOXDUO in patients with moderate to severe acute pain. The Company has been granted a meeting with the FDA to clarify the steps required for approval. Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) received a tentative approval letter from the FDA for Trokendi XR, a once-daily extended release […]

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ALXA resubmits NDA. RGEN receives CRL. Mixed CHMP recommendations for NPSP and PLX+ ASTX news BIOD raises cash

Jun 22, 2012 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has resubmitted its ADASUVE New Drug Application (NDA), for treatment of agitation associated with schizophrenia or bipolar I disorder in adults. The resubmission is in response to a Complete Response Letter (CRL) received in May 2012.  A PDUFA date will be announced in the coming weeks but is […]

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ALXA reverse split. ALKS JNJ initiate Phase 3 schizophrenia. NYMX commences Phase 2 prostate cancer enrolment

Jun 13, 2012 No Comments

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced a 1-for-10 reverse split of its common stock effective immediately. The number of common stock outstanding will correspondingly be reduced from approximately 119.6 million to approximately 12.0 million. Alkermes plc (NASDAQ: ALKS) announced that Janssen Research & Development, LLC has initiated a Phase 3 trial for a three-month formulation of INVEGA SUSTENNA(paliperidone palmitate), an injectable medicine […]

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