Latest pipeline updates. 40 in total!

Jan 13, 2015 No Comments by

Latest updates to the Company Pipeline Database from January 12 and 13, 2015. Refer to the FDA Calendar for upcoming catalysts: Ticker Price Drug Indication Stage Text Updated ATRS 2.46 VIBEX QuickShot Testosterone deficiency Phase 3 Phase 3 initiated July 2014. Final patient dosed Nov 2015. Top-line pharmacokinetic data due 2Q 2015 1/14/2015 CPRX 2.87 […]

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Pipeline updates and news over the previous week from 20 companies.

Aug 03, 2014 No Comments by

Pacira Pharmaceuticals, Inc.(NASDAQ: PCRX) noted that the FDA has set a PDUFA date of March 5, 2015 for the supplemental New Drug Application (sNDA) for a nerve block indication for EXPAREL. NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY) said that their BAYnovation trial for viral conjunctivitis has been completed and top-line results are due in mid-August 2014. Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) maintained guidance that the pre-planned […]

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EXAS receives positive Adcom vote. PSDV ALIM resubmit NDA. INSV NDA due 2H 2014 + updates for ARNA PTLA and CNAT

Mar 28, 2014 No Comments by

pSivida Corp. (NASDAQ: PSDV) announced that the New Drug Application for ILUVIEN for the treatment of chronic Diabetic Macular Edema has been resubmitted to the FDA by Alimera Sciences (NASDAQ: ALIM). They noted they responded to questions raised in the October 2013 complete response letter and provided a safety update, which included commercial experience with ILUVIEN in Europe. Exact Sciences […]

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Jan 13, 2014 No Comments

Curis, Inc.(NASDAQ:CRIS) provided an update noting that Phase 2 data of everolimus for Operable Nodular BCC (basal cell carcinoma) are due 1Q 2014. Their submission to the FDA regarding the partial clinical hold of CUDC-427 is due shortly. A Phase 2 trial of Debio 0932 is due to be to initiated in 2H 2014. Galena Biopharma (Nasdaq:GALE) announced it has […]

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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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Negative Adcom votes for DCTH and AVEO. ARNA withdraws MAA + pipeline updates for ACOR RPRX DCTH AGN INCY ECYT NBIX OGXI NBY CLDX

May 03, 2013 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced that it will be withdrawing the BELVIQ Marketing Authorization Application (MAA) for obesity in the European Union. Acorda Therapeutics, Inc. (Nasdaq: ACOR) noted that it remains on track to submit its NDA for Diazepam Nasal Spray in 2013. Repros Therapeutics Inc.(Nasdaq:RPRX) announced that it has completed enrolment in its second pivotal trial of (ZA-302) […]

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ARNA EMA update. AGN to acquire MAPP. PGNX adds to pipeline. IPXL receives CRL + BDSI update

Jan 23, 2013 No Comments

Arena Pharmaceuticals (NASDAQ:ARNA) said in a filing today that it has received the Day 180 List of Outstanding Issues from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its Marketing Authorization Application (MAA) of BELVIQ (lorcaserin HCl) for obesity. The major concerns from the EMA include issues such as tumors in rats, valvulopathy and psychiatric events, […]

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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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FDA approves ARNA Belviq for obesity. ANTH fails Phase 2b trial. Pipeline updates for XOMA INSM INFI. EMA rejects Folotyn + SNSS news

Jun 28, 2012 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced that the FDA has approved BELVIQ  for the treatment of obesity. Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus.  The pre-specified primary efficacy endpoint, clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose […]

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ARNA offering. RIGL Phase 2 asthma trial to be initiated this summer

May 17, 2012 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced the pricing of an underwritten public offering of 11m shares at a price to the public of $5.50 per share. The gross proceeds to Arena from this offering are expected to be $60.5 million with a 30-day option to offer up to an aggregate of 1,650,000 additional shares. Rigel Pharmaceuticals, Inc., (Nasdaq: RIGL) said […]

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ARNA positive Adcom vote. APPA NDA due mid-2012. PATH to resubmit NDA 3Q + TZYM OMER BIOD CTIC MNOV ANAC PBTH updates

May 10, 2012 No Comments

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, to recommend approval of lorcaserin in patients with obesity. The current PDUFA date is June 27, 2012. However, this may be extended by three months if further data is provided by the company. A.P. Pharma, Inc.(OTCBB:APPA.OB) […]

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