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 […]

Daily News Read more

Updates for GALE SCMP BLRX APPA RPTP ACOR RLYP INFI HALO ARNA CLVS SGEN ICPT GILD CUR MRK CYCC CRIS ACHN

Jan 13, 2014 No Comments by

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 […]

Daily News Read more

AUXL PDUFA date extension + ARNA NKTR MACK news

Aug 29, 2013 No Comments by

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 […]

Daily News Read more

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) […]

Read more

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, […]

Read more

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 […]

Read more

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 […]

Read more

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 […]

Read more

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) […]

Read more

Upcoming FDA and clinical catalysts as of April 10 2012

Apr 10, 2012 No Comments

Some short and long term potential catalysts as of April 9, 2012 (share prices as at the close of trading Monday, April 9, 2012). See the links in the FDA Calendar for more details about each catalyst. The possible catalysts listed below represent both short and long opportunities. It is NOT a recommendation to take […]

Read more

MAPP receives CRL. ISTA buyout. RPTP NDA filing this week. APPA NDA mid-2012 + ASTX VVUS ARNA CLVS NBIX news

Mar 26, 2012 No Comments

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced it received a Complete Response letter for LEVADEX. The FDA noted that the company will need to address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also noted that it had requested the company to provide information of […]

Read more