Archive for June, 2012

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 by

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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BioPharmCatalyst Celebrates Second Anniversary!

Jun 27, 2012 5 Comments by

It’s official. BioPharmCatalyst.com celebrates its second birthday today and it’s time to thank those who made it all happen! The site has grown in readership significantly over the past two years and it is your positive feedback that gives me the energy to continue providing FREE unbiased tools to assist you in your investing and […]

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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 by

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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VTUS fails Phase 3 trial. MAPP due to refile NDA by early 4Q. CYTR Phase 2b data due 2013 + LXRX CUR RPTP news

Jun 26, 2012 No Comments

Ventrus Biosciences, Inc. (Nasdaq:VTUS) today reported that its Phase 3, randomized, double-blind, placebo-controlled clinical trial of iferanserin (VEN 309) in patients with hemorrhoidal disease did not meet its endpoints. CytRx Corporation (NASDAQ: CYTR) announced the recommendation by the Data Safety Monitoring Board (DSMB) to continue with its Phase 2b trial of tamibarotene in combination with chemotherapeutical agents […]

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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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GENT expects CHMP decision 3Q 2012. STEM initiates Phase 1/2 AMD trial. DEPO acquires Zipsor

Jun 21, 2012 No Comments

Gentium S.p.A. (Nasdaq:GENT)  announced today that it has submitted its responses to the Day 180 List of Outstanding Issues received from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) with respect to its Marketing Authorization Application (MAA) for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic […]

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ONXX receives positive recommendation from ODAC. POZN bio-equivalence of PA32540 not shown. CYTK offering. CTIC President resigns

Jun 21, 2012 No Comments

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 11-0 [with 1 abstention] in favour of  Kyprolis (carfilzomib) for the treatment of relapsed and refractory multiple myeloma. The PDUFA date  for accelerated approval is July 27, 2012. Cytokinetics, Incorporated (Nasdaq: CYTK) priced two underwritten offerings for total gross proceeds of $60m. […]

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RIGL license agreement. NLNK interim Phase 3 data due early 2013. FURX initiates Phase 3 IBS trial. APPY CVM offerings + PTN

Jun 20, 2012 No Comments

AstraZeneca and Rigel Pharmaceuticals, Inc., (Nasdaq: RIGL) announced a worldwide license agreement for the global development and commercialization of R256, which is being investigated as a treatment for moderate to severe chronic asthma. AstraZeneca will have exclusive rights to commercialize R256 around the world. Rigel will receive an upfront payment of $1 million with an additional $8.25 million in early milestone payments […]

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INFI stops Phase 2 trials. RPTP Phase 2/3 Cysteamine data due 1H 2014 + CTIC news

Jun 19, 2012 No Comments

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) announced that following disappointing initial data it will be stopping its Phase 2 trials of saridegib (IPI-926) in patients with metastatic or locally advanced, inoperable chondrosarcoma and in patients with myelofibrosis. Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC) announced that the University of Washington has begun enrolment in a Phase 2 trial of […]

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SNSS interim Phase 3 VALOR analysis due September. DYAX discontinues Phase 2 ecallantide. AEGR prices offering.

Jun 15, 2012 No Comments

Dyax Corp. (NASDAQ: DYAX) announced that it will discontinue its Phase 2 trial of ecallantide in the acute treatment of angiotensin converting enzyme (ACE) inhibitor-induced angioedema following an interim analysis showing it not to be statistically effective. Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) said that it expects interim analysis of its Phase 3 VALOR trial of vosaroxin, in patients with […]

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RPTP late January 2013 likely PDUFA date. AEGR proposed offering

Jun 14, 2012 No Comments

Raptor Pharmaceutical Corp.  (Nasdaq:RPTP) today that the FDA accepted its New Drug Application (“NDA”) for Cysteamine Bitartrate Delayed-release Capsules (RP103), for the potential treatment of nephropathic cystinosis. A standard 10-month review was issued. A PDUFA date was not issued but the company released a press release on March 30, 2012 that it had filed its […]

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