Author Archive

News for ARRY ISIS ALNY ENTA CELG CYTR

May 07, 2013 No Comments

Array BioPharma Inc. (NASDAQ: ARRY) announced that it will initiate a Phase 3 trial called MILO (MEK Inhibitor in Low Grade Serous Ovarian Cancer) of MEK162 compared to standard chemotherapy, in patients with recurrent low-grade serous ovarian cancer (LGSOC) during the summer of 2013. Isis Pharmaceuticals, Inc.(NASDAQ: ISIS) announced the initiation of a Phase 1b/2a trial of ISIS-STAT3Rx in patients with advanced […]

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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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ALIM PSDV PDUFA date set. CHTP NDA update + updates for SHPG GSK PCYC VPHM ETRM JNJ OGXI

May 02, 2013 No Comments

Alimera Sciences, Inc. (NASDAQ: ALIM) and partner pSivida Corp. (NASDAQ:PSDV) announced that they have been assigned a PDUFA date of October 17, 2013 for the resubmission of its NDA for ILUVIEN for treatment of chronic diabetic macular edema (DME). Chelsea Therapeutics International (Nasdaq:CHTP) reported they intend on resubmitting its Northera New Drug Application, late in 2Q or early 3Q 2013, with […]

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RPTP FDA Appovel + Pipeline updates for GTXI SNTA OGXI MNTA IDIX DVAX QCOR

May 01, 2013 No Comments

Raptor Pharmaceutical Corp. (Nasdaq: RPTP) announced that the FDA has approved PROCYSBI (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. Dynavax Technologies Corporation (NASDAQ: DVAX) reported that it will meet in the first half of June with the FDA regarding the its Biologic License Application (BLA) for HEPLISAV, […]

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GILD receives CRLs. MRK and PFE collaboration for diabetes + updates for MACK TRGT INCY BLRX

Apr 30, 2013 No Comments

BioLineRx (NASDAQ: BLRX) (TASE: BLRX) said that enrollment has commenced in its Phase 1/2 trial for BL-8020, an orally available, interferon-free treatment for the Hepatitis C virus (HCV). Up to 32 HCV-infected patients of any genotype who have previously failed or relapsed following treatment with the standard-of-care,will take part in the trial. Partial results are due at the […]

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20 Upcoming Non-PDUFA Catalysts as of April 29 2013

Apr 29, 2013 No Comments

20 short and long term potential catalysts as of April 29, 2013. See the links in the FDA Calendar for more details about some of the catalysts. AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX): Phase 3 topline data for Sufentanil NanoTab PCA System in patients after major orthopedic surgery (second pivotal) due 2Q 2013. Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE): Phase 3 data […]

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Website update! – Company Pipeline and Financial Databases updated

Apr 29, 2013 No Comments

I have spent the last few weeks making significant updates to both the Company Pipeline Database and the Financial Database. COMPANY PIPELINE DATABASE This database now contains 1000 products from approximately 250 companies that have had or are currently trialling drugs in development (Phase 2 onwards). Over the past weeks updates have been made to […]

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Pipeline updates for DSCI TSRO CELG CEMP GERN MDGN THRX

Apr 26, 2013 No Comments

Cempra, Inc. (Nasdaq: CEMP) provided an update noting that it will hold an end of Phase 2 meeting with the FDA in 2Q 2013 for Solithromycin, with the initiation of the IV-to-oral Phase 3 clinical trial in community-acquired bacterial pneumonia, or CABP, in 2H 2013, pending available resources. Regarding its Taksta programme, top-line Phase 2 data in patients with prosthetic joint infection patients, are […]

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Pipeline updates for PTIE DRRX OXGN ITMN BMRN CERS XNPT ACRX JNJ + SUPN NAVB offerings

Apr 25, 2013 No Comments

Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results and noted that Pfizer met with the FDA in March to discuss the concerns outlined in the June 2011 Complete Response Letter for REMOXY, for patients with moderate-to-severe chronic pain. The company noted that they had not received minutes of the meeting from Pfizer. Pfizer have their conference call for their […]

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SCMP FDA Approval + updates for HALO CYTR ISIS CVM AMRN OPK PBTH AFFY TZYM CLVS

Apr 24, 2013 No Comments

Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced the initiation of a Phase 2 multicenter, randomized clinical trial evaluating PEGPH20 as a first-line therapy for patients with stage IV metastatic pancreatic cancer. Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) announced that FDA approved its supplemental new drug application (sNDA) for AMITIZA (lubiprostone) (24 mcg twice daily) for the […]

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FDA Calendar – Glossary

Apr 21, 2013 2 Comments

A glossary of key terms used in the FDA Calendar is now available. This page is aimed at novice investors wanting to familiarise themselves with some of the key language used in the calendar. The glossary covers definitions regarding clinical trials, new PDUFA guidelines and other FDA related information. Readers can access the glossary under […]

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