Archive for July, 2012

Pipeline profiles of recent Biotech Initial Public Offerings – DRTX TSRO HPTX MACK CCXI CEMP

Jul 28, 2012 No Comments by

Hyperion Therapeutics, Inc (NASDAQ:HPTX) - Initial public offering July 2012.  PIPELINE Ravicti: PDUFA date October 23, 2012 for urea cycle disorders. Phase 2 trial completed for hepatic encephalopathy, or HE. End of Phase 2 meeting with the FDA planned for 4Q 2012. Durata Therapeutics Inc (NASDAQ:DRTX) - Initial public offering July 2012.  PIPELINE Dalbavancin: Phase 3 trial for the treatment of patients with acute bacterial skin and skin […]

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SLXP PGNX issued CRL. FURX resubmits NDA. ARIA initiates Phase 3 CML. CTIC confirms possibility of reverse split + ACUR

Jul 28, 2012 4 Comments by

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals (NASDAQ:PGNX) today received a Complete Response Letter (CRL) for its Supplemental New Drug Application (sNDA) for RELISTOR injection for subcutaneous use for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain. The CRL requests additional clinical data. Salix and Progenics intend to request an End-of-Review meeting with the Division […]

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THR/TBGNF positive Adcom vote. AMRN and HZNP FDA Approval. SCMP files sNDA. SNTA offering. EXEL initiates Phase 2 NSCLC trial.AEZS update.

Jul 27, 2012 No Comments by

ThromboGenics NV (Euronext Brussels: THR) (PINK:TBGNF) - The FDA Dermatologic and Ophthalmic Drugs Advisory Committee recommended that ocriplasmin be granted approval for the treatment of symptomatic Vitreomacular Adhesion (VMA) by a vote of 10 to 0. The PDUFA date is 17 October, 2012. Amarin Corporation plc (Nasdaq:AMRN) announced the FDA has approved Vascepa capsules (AMR101) as a treatment to reduce triglyceride levels in […]

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APPA to file NDA this September. LGND PDUFA set for November. FLML NDA due this year. XNPT offering + CYTR

Jul 26, 2012 No Comments

A.P. Pharma, Inc. (OTCBB: APPA.OB) announced that it now hopes to re-file its NDA of APF530, for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting, during September 2012. The company had previously given guidance of a filing during “mid-2012″. The company also said it has issued 102m shares at $0.525 per share, resulting in gross proceeds of approximately $53.6 […]

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CRTX Advisory Committee date set. MAPP Levadex NDA update. ZGNX offering + updates for ITMN MDVN AEZS DVAX NKTR CADX

Jul 25, 2012 No Comments

Cornerstone Therapeutics, Inc. (NASDAQ:CRTX) – The Cardiovascular and Renal Drugs Advisory Committee will meet on September 13, 2012, to discuss the NDA of lixivaptan, for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) said it hopes to resubmit its NDA of LEVADEX for the […]

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New tool added – FDA Historical Calendar – A look back in history.

Jul 23, 2012 2 Comments

I am pleased to inform you that I have added another tool to the website. As users of the FDA Calendar may be aware, once a PDUFA catalyst has been completed the event is removed from the calendar. However, many readers have noted that they would prefer access to past FDA decisions. In light of […]

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ONXX receives FDA Approval. SGEN and ASTX granted positive CHMP recommendations. ANTH and SOMX offering details + PSDV SGYP ARRY news

Jul 20, 2012 No Comments

Onyx Pharmaceuticals (Nasdaq: ONXX) today announced that it received accelerated approval from the FDA for Kyprolis (carfilzomib) for Injection, for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. Ligand […]

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ALIM NSPH ANTH raising cash.INFI brings forward data release. ALXA MAA update.

Jul 19, 2012 No Comments

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), announced that it intends to offer and sell shares of its common stock in a public offering. Nanosphere, Inc. (Nasdaq: NSPH) also announced that it intends to offer shares of its common stock in a public offering. Alimera Sciences, Inc., (Nasdaq:ALIM) (Alimera) announced that will raise cash through a $40 million Series […]

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ZGNX PDUFA date confirmed. PATH resubmits NDA for migraine. HGSI to be acquired by GSK + MDGN RPRX updates

Jul 17, 2012 No Comments

Zogenix, Inc. (Nasdaq:ZGNX) announced that the FDA has set a PDUFA date of March 1, 2013 for the Zohydro ER New Drug Application (NDA), for the treatment of moderate to severe chronic pain. NuPathe Inc. (NASDAQ: PATH) announced that it has resubmitted its NDA for its migraine patch (NP101), with a likely six-month review period by the FDA. GlaxoSmithKline plc (LSE: GSK) […]

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ACAD Phase 3 data expected 4Q. SUPN PDUFA date confirmed. THRX file NDA and MAA for COPD

Jul 15, 2012 No Comments

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) said in a SEC filing that it expects to complete enrolment in its Phase 3 efficacy, tolerability and safety trial with pimavanserin for Parkinson’s disease psychosis, during August 2012. Data is expected later in 4Q 2012. Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) confirmed the PDUFA date for SPN-804 (extended-release oxcarbazepine) for epilepsy, is October […]

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AVII reverse split and name change. CPRX Phase 2b data due September. AMPE offering

Jul 13, 2012 1 Comment

AVI BioPharma, Inc. (NASDAQ: AVII)  announced that it has changed its name to Sarepta Therapeutics, Inc.  (NASDAQ: SRPT)  and also effected a 1-for-6 reverse split. Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX)  announced that it expects to report top-line results from its CPP-109 (vigabatrin) Phase 2b trial around the end of September 2012 versus the previous guidance of early in […]

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