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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News updates for SNTS ACHN SRPT ACOR CCXI NKTR SYN AGN GTXI DRRX

Apr 17, 2013 No Comments

Allergan, Inc. (NYSE: AGN) announced that the FDA has issued a Complete Response Letter (CRL) for LEVADEX (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults. The main issues cited in the CRL were already identified by the FDA in prior discussions with Allergan. Based on Allergan’s current understanding of the FDA’s CRL, the company estimates that the next FDA action will […]

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News updates for BRLX MRK SGYP SSH

Apr 11, 2013 No Comments

BioLineRx (NASDAQ:BLRX; TASE:BLRX) announced that it will soon commence a Phase 2a trial for BL-8040, for the treatment of Acute Myeloid Leukemia (AML), with partial results expected in 4Q 2013 and final data due in 2H 2014. Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) announced that it has commenced an underwritten public offering of its common stock. […]

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