Author Archive

TRGT fails Phase 2 ADHD. OXGN SPA agreement for Phase 3 ATC trial. ANTH plans Phase 3 lupus trial

Sep 18, 2012 2 Comments

Targacept, Inc. (NASDAQ: TRGT) today announced it failed its Phase 2 trial of TC-5619 as a treatment for inattentive-predominant attention deficit/hyperactivity disorder (ADHDi). OXiGENE, Inc. (Nasdaq:OXGN) announced that it has come to agreement with the FDA on a Special Protocol Assessment (SPA) for its Phase 3 clinical trial (FACT 2) of ZYBRESTAT for the treatment of anaplastic thyroid […]

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Pipeline and financial updates for TZYM RPRX OPXA TSPT CUR OREX PSTI BIOD BDSI CLSN ONCY

Sep 17, 2012 No Comments

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) said it is on track to submit a New Drug Application (NDA) for BEMA Buprenorphine/Naloxone (BNX), for the potential treatment of opioid dependence, during 2Q 2013. Biodel Inc. (Nasdaq: BIOD) announced the initiation of a Phase 2 clinical trial of its proprietary recombinant insulin (RHI)-based ultra-rapid-acting mealtime insulin candidate, BIOD-123.  Top-line Phase […]

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SNSS increases Phase 3 enrolment of Valor trial. GENT MAA decision due 4Q.

Sep 12, 2012 No Comments

Sunesis Pharmaceuticals, Inc.(Nasdaq:SNSS) announced that it will increase enrollment to 675 patients in its Phase 3 VALOR trial of vosaroxin in acute myeloid leukemia (AML). This is in response to the recommendation of the trial’s independent Data and Safety Monitoring Board (DSMB). Sunesis anticipates full enrollment of VALOR in 2013, with unblinding of the trial expected in […]

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NAVB receives CRL. GERN and ZLCS Phase 2 failures. SQNM offering + ASTX and CYTK news

Sep 11, 2012 No Comments

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) announced that it received a Complete Response Letter (CRL)  for Lymphoseek Injection, due to  third-party manufacturing concerns. Zalicus Inc. (NASDAQ: ZLCS) announced that it will discontinue development of Synavive following top line results from its Phase 2b clinical trial in rheumatoid arthritis that showed that while it met its endpoint, it missed the […]

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SPEX reverse split. PTN halts obesity development + DRTX STEM IMGN PPHM news

Sep 08, 2012 No Comments

Spherix Inc. (NASDAQ: SPEX) said that it will effect a reverse split of its common stock at a ratio of 1 for 20, on September 21,2012. Palatin Technologies, Inc. (NYSE MKT: PTN) today announced that its partner, AstraZeneca, has decided to discontinue further development of AZD2820, for the treatment of obesity, due to safety concerns. StemCells, […]

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HPTX SLXP PDUFA dates delayed. ACAD Phase 3 data due November. RPRX ARRY ZLCS TGTX NPSP RIGL OREX AVNR BPAX SRPT MNOV news

Sep 06, 2012 No Comments

Hyperion Therapeutics, Inc. (Nasdaq:HPTX) announced that the PDUFA date for Ravicti (glycerol phenylbutyrate) has been extended by three months to January 23, 2013 following the submission of additional information by the company. ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)  announced the completion of enrollment in its pivotal Phase 3 trial with pimavanserin in patients with Parkinson’s disease psychosis (PDP). Top-line […]

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MDVN XTANDI granted early FDA approval. MNKD and DCTH shelf filings. IMGN set to raise authorised shares + TSRX financing

Sep 01, 2012 No Comments

Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) announced that the FDA has approved XTANDI (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. The decision was ahead of schedule, with its PDUFA date set for November 22, 2012, under priority review. Delcath Systems, Inc. (NASDAQ: DCTH) filed a […]

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IRWD receives early FDA Approval. ACHN raising cash. ARIA submits ponatinib MAA. SPPI repurchases shares and PPHM + TTHI news

Aug 31, 2012 No Comments

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories, Inc. (NYSE: FRX) announced that the U.S. Food and Drug Administration approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults. Linzess is a capsule taken once daily on an empty stomach, at least 30 minutes before the first meal of […]

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EXEL Adcom meeting cancelled. CTIC set to double Authorised Shares prior to reverse split. ARQL suspends Phase 3 ATTENTION enrolment

Aug 30, 2012 2 Comments

Exelixis, Inc.(NASDAQ: EXEL) said that the FDA’s Oncologic Drugs Advisory Committee has cancelled its tentatively scheuduled meeting to discuss its New drug application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer. The PDUFA action date remains November 29, 2012. Cell Therapeutics, Inc. (NASDAQ: CTIC) confirmed that it intends to […]

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MDVN forward split. DVAX Adcom meeting. CPRX raises cash + AEZS DEPO RVX news

Aug 29, 2012 No Comments

Medivation, Inc. (NASDAQ: MDVN) announced a 2-for-1 forward split of its common stock with a Record Date of September 7, 2012. The forward split will take effect on September 21, 2012. Dynavax Technologies Corporation (NASDAQ: DVAX)  announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to discuss HEPLISAV at its meeting on November 14-15, 2012, pursuing […]

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CYCC Reverse Split. ZLCS files mixed shelf. IMGN announces that Genentech files trastuzumab BLA

Aug 27, 2012 No Comments

ImmunoGen, Inc. (Nasdaq: IMGN) announce that Genentech has submitted a Biologics License Application (BLA) for trastuzumab emtansine to the US FDA, and that Roche expects to soon submit a Marketing Authorization Application (MAA) to the EMA. Zalicus Inc. (NASDAQ: ZLCS)  filed a mixed shelf where it may sell any combination of common or preferred stock, debt securities and or warrants either […]

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