Author Archive

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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OHRP interim Phase 2 wet-AMD data due Tuesday + updates for ASPX XNPT GNCA

Jun 24, 2014 No Comments

Ohr Pharmaceutical, Inc. (Nasdaq:OHRP) announced that it will host a conference call and webcast on Tuesday, June 24th at 8:30am EST to discuss Squalamine interim Phase 2 data in wet age-related macular degeneration (wet-AMD). Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX) maintained previous guidance that they expect data from their Phase 3 ARC-HD trial of SD-809 for the […]

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CBST FDA Approval. OPK conference call Tue regarding hGH-CTP. TTPH IGNITE 2 trial update + MACK.

Jun 21, 2014 No Comments

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announced the FDA approved SIVEXTRO (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI). Cubist Pharmaceuticals also announced that the FDA has accepted their New Drug Application (NDA) of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections, under Priority […]

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INSM granted Breakthrough Therapy Designation. NRX initiates Phase 3 trial + PLX news

Jun 19, 2014 No Comments

NephroGenex, Inc. (Nasdaq:NRX) announced it has initiated patient enrollment in the first of two pivotal Phase 3 studies in the PIONEER program for oral Pyridorin. The trial will evaluate the safety and efficacy of Pyridorin in slowing disease progression in patients with diabetic nephropathy. Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) announced that the first Gaucher patient has been […]

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ETRM Advisory Committee results. EXAS approval decision due August. ECYT vintafolide rights returned by MRK + RCPT GALE news

Jun 18, 2014 No Comments

EnteroMedics Inc. (NASDAQ: ETRM) announced that the FDA Advisory Gastroenterology and Urology Devices Panel (GUDP) voted 8 to 1 in favour that the device is safe, 4 to 5 against its efficacy and 6 to 2 in favour, with 1 abstention, that the relative benefits outweighed the relative risk. The FDA is not bound by the GUDP’s recommendation, but will take it into consideration when […]

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