Author Archive

FDA Advisory Committee votes against QRXPY. SRPT offering. ENTA files NDA + EVOK news

Apr 23, 2014 No Comments by

QRxPharma Limited (OTCMKTS:QRXPY)  announced that the FDA Advisory Committee has voted to against approval of Moxduo. Moxduo is a painkiller for the proposed treatment of intense pain. Evoke Pharma, Inc. (Nasdaq:EVOK) announced the initiation of its Phase 3 clinical trial of EVK-001, a nasal spray for the relief of symptoms associated with acute and recurrent diabetic […]

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SRPT intends to file NDA of eteplirsen this year. AGIO offering. CBST files NDA. GILD PDUFA date info

Apr 22, 2014 No Comments by

Sarepta Therapeutics, Inc.(NASDAQ:SRPT) announced it plans to submit a New Drug Application (NDA) by the end of 2014 for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy (DMD). The decision is based on a guidance letter from the FDA that proposed a submission of an NDA for eteplirsen under a potential Accelerated […]

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MDCO PDUFA date set. CYCC offering. BDSI initiates Phase 3 Clonidine Topical Gel trial.

Apr 04, 2014 No Comments by

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) announced that it intends to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering. BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for […]

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CPRX EXAS APPY announce offerings

Apr 03, 2014 No Comments

Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) announced that it intends to offer shares of its common stock in a public offering. Exact Sciences Corp. (NASDAQ: EXAS) announced that it is offering $125 million of shares of its common stock in a proposed underwritten public offering. Venaxis, Inc. (NASDAQ: APPY) also announced that it intends to offer shares of its common stock […]

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MNKD receives positive opinion from Adcom. ICPT offering + CPRX update.

Apr 02, 2014 No Comments

MannKind Corporation (Nasdaq:MNKD) announced that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 1 to recommend that AFREZZA Inhalation Powder be granted approval by the FDA to improve glycemic control in adults with Type 1 diabetes. They also voted 14 to 0 in favour of adults with Type 2 diabetes. The PDUFA date is April […]

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PRAN fails Phase 2 trial. DRTX postive Adcom vote. HRTX NDA filing due mid year + ANAC CRIS SYN updates

Apr 01, 2014 1 Comment

Prana Biotechnology (ASX:PBT/NASDAQ:PRAN) announced that they did not meet the primary endpoint in their Phase 2 trial of PBT2,  in Alzheimer’s Disease (IMAGINE Trial). Durata Therapeutics, Inc. (Nasdaq:DRTX) announced that the FDA Anti-Infective Drugs Advisory Committee voted 12 to 0 in favour of Dalvance (dalbavancin) for injection, for the treatment of adult patients with acute […]

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EXAS receives positive Adcom vote. PSDV ALIM resubmit NDA. INSV NDA due 2H 2014 + updates for ARNA PTLA and CNAT

Mar 28, 2014 No Comments

pSivida Corp. (NASDAQ: PSDV) announced that the New Drug Application for ILUVIEN for the treatment of chronic Diabetic Macular Edema has been resubmitted to the FDA by Alimera Sciences (NASDAQ: ALIM). They noted they responded to questions raised in the October 2013 complete response letter and provided a safety update, which included commercial experience with ILUVIEN in Europe. Exact Sciences […]

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AVNR PDUFA date set. INSM releases NTM data. MSTX initiates Phase 2 trial

Mar 26, 2014 No Comments

Insmed Incorporated (Nasdaq GS:INSM) announced that they did not meet the primary endpoint in their Phase 2 trial of ARIKAYCE, for the treatment of patients with treatment resistant nontuberculous mycobacterial (NTM) lung infections. The company noted that a key secondary endpoint, culture conversion, was met. Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced that the FDA has accepted their New […]

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INSM data due today. CYCC topline Sapacitabine data due 2015. EXEL data due later this year + BIND EVOK ECYT news

Mar 26, 2014 No Comments

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) said it expects to complete enrolment in their Phase 3 SEAMLESS trial of Sapacitabine in patients with acute myeloid leukemia (AML). Topline data are due in 2015. Insmed Incorporated (NASDAQ: INSM) will announce results from its U.S. phase 2 clinical trial of ARIKAYCE, to treat nontuberculous mycobacteria (NTM) lung infections on Wednesday, March 26, 2014 at approximately 7:00 a.m. […]

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QRXPY Adcom date set. RMTI submits NDA. ARIA and CYTR initiate pivotal trials.

Mar 25, 2014 No Comments

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced that the FDA has set 22 April 2014 as the date of the Advisory Committee meeting to consider the resubmitted Moxduo New Drug Application (NDA). The PDUFA date is 25 May, 2014. Rockwell Medical, Inc. (Nasdaq:RMTI)  announced the submission of a New Drug Application (NDA) to the FDA for Triferic (soluble […]

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CPRX Phase 3 data due 3Q. Offerings for SGMO NBY + update for PTLA

Mar 20, 2014 No Comments

Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced that it has commenced a $100 million underwritten public offering of shares of its common stock. NovaBay Pharmaceuticals, Inc. (NYSE MKT: NBY) announced that it intends to offer shares of its common stock and warrants in an underwritten public offering. Portola Pharmaceuticals (Nasdaq:PTLA) announced that it has initiated a Phase 3 […]

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