ANAC receives FDA Approval. INSY and INSV NDA filing updates + news for LJPC SGYP ONCY CNCE

Jul 08, 2014 1 Comment

Anacor Pharmaceuticals, Inc. (NASDAQ: ANAC) announced that the FDA has approved KERYDIN (tavaborole) topical solution, for the topical treatment of onychomycosis of the toenails. InSite Vision Incorporated (OTCBB:INSV) announced that it intends to submit a New Drug Application (NDA) for DexaSite as a treatment for blepharitis in adults during 2015. The company had previously guided for a submission during 2H […]

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BDSI meets endpoint in pivotal trial. Offerings for RARE BLUE. CLDN pipeline update.

Jul 08, 2014 No Comments

Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE) announced that it has commenced an underwritten public offering of 2,017,349 shares of its common stock. The offering is expected to consist of 1,311,277 shares to be offered by Ultragenyx and 706,072 shares to be offered by selling stockholders. bluebird bio, Inc. (Nasdaq: BLUE) also announced that it has commenced an underwritten […]

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ITMN PDUFA date set. FDA approves SPPI belinostat

Jul 04, 2014 No Comments

InterMune, Inc. (Nasdaq: ITMN) announced that the FDA has acknowledged receipt of the resubmitted Class 2 New Drug Application for pirfenidone. The PDUFA date is November 23, 2014. Spectrum Pharmaceuticals (NasdaqGS: SPPI) announced that the FDA approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was […]

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EGRX granted tentative FDA Approval. ZGNX to file sNDA by October. RGDO to undergo DSMB review.

Jul 02, 2014 No Comments

Zogenix, Inc. (Nasdaq:ZGNX) announced that they expect to file a supplemental new drug application (sNDA) by October 2014 for a formulation of Zohydro ER Extended-Release Capsules designed to make it more difficult to abuse by injection or nasal administration. Zohydro ER is currently indicated for the management of pain. Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) announced today that the FDA has granted tentative […]

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POZN resubmits NDA. Trial updates for CTIC OGXI THLD RARE

Jul 02, 2014 No Comments

POZEN Inc. (NASDAQ: POZN) announced that it has resubmitted the NDA for PA8140/PA32540 to the FDA. They expect to hear back from the FDA within 14 days of receipt of the NDA whether or not the submission will be accepted, and if accepted, what the new PDUFA date will be. The FDA will determine whether a two month or six month review […]

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FLML FDA Approval. FOLD data due 3Q. XOMA Eyeguard-B delay. THRX files sNDA for asthma + updates for NPSP GEVA

Jul 01, 2014 No Comments

Flamel Technologies (NASDAQ: FLML) announced that the FDA has approved their New Drug Application (NDA) for VAZCULEP (phenylephrine hydrochloride). VAZCULEP Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. XOMA Corporation (Nasdaq:XOMA) provided an update on their Phase 3 EYEGUARD-B trial of Gevokizumab for […]

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MNKD FDA Approval. AUXL and QLTI to merge. OGXI offering + BDSI Clonidine update

Jun 28, 2014 No Comments

MannKind Corporation (Nasdaq:MNKD) announced that the FDA has approved AFREZZA to improve glycemic control in adult patients with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal. BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has completed enrollment of all patients required for […]

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AERI positive Phase 2b data. AMPE data now due 4Q + TRGT LGND updates.

Jun 25, 2014 No Comments

Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) reported that their Phase 2b trial for once-daily, quadruple-action Roclatan, met the primary endpoint in patients with Glaucoma. The company is now planning its Phase 3 trial program. Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE)  noted that they expect data from their OptimEyes trial for the treatment of Diabetic Macular Edema, during 4Q 2014. This compares […]

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HRTX offering. OHRP Phase 2 data + KPTI initiates AML trial

Jun 25, 2014 No Comments

Heron Therapeutics, Inc. (NASDAQ: HRTX) announced its intention to offer and sell shares of its common stock in an underwritten offering. Karyopharm Therapeutics Inc.(Nasdaq:KPTI) announced the initiation of its Phase 2 study of Selinexor (KPT-330) in patients 60 years of age or older with relapsed or refractory acute myeloid leukemia (AML). Ohr Pharmaceutical, Inc. (Nasdaq:OHRP) announced […]

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