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

Mar 25, 2014 No Comments by

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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UTHR FDA Approval. BCRX files NDA. AUXL files sBLA. AMRN SPA decision due by Jan 15, PDUFA delayed + ARIA update

Dec 20, 2013 No Comments by

United Therapeutics Corporation (NASDAQ: UTHR $87.84) announced today that the FDA has approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension (PAH). BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX $6.92) announced that it has submitted a New Drug Application (NDA) for intravenous peramivir, for the treatment of acute uncomplicated influenza in adults. Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL $20.59)  announced […]

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FDA says no to early NDA filing for SRPT + CHTP offering+ updates for APPA GTXI OREX SNSS SNTA SPPI ARIA PBYI CLSN KBIO ARIA PBYI OXGN BDSI SGYP ONTX MGNX

Nov 13, 2013 No Comments by

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it plans to offer shares of its common stock in an underwritten public offering. A.P. Pharma, Inc. (OTCBB: APPA.OB) said that their resubmission of the NDA for Sustol (formerly known as APF530) is targeted for 1Q 2014 GTx, Inc. (Nasdaq: GTXI) said that they expect to complete enrollment of their Phase […]

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Pipeline and news updates for INCY ARRY CLVS VICL BMRN SGYP ACOR GENT ENMD DSCO MACK ARIA

Nov 02, 2013 No Comments

Incyte Corporation(Nasdaq: INCY $40.40) provided a pipeline update noting that Phase 3 data of Jakafi (ruxolitinib) in patients with polycythemia vera (PV), are expected in early 2014, with a potential NDA filing in 1H 2014. Data from their Phase 3 trial measuring disease-related symptoms in patients with PV (RELIEF) are due in mid-2014. In addition, Phase 2 data from […]

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CHTP PDUFA date set. RMTI meets endpoints + updates for TTNP ENDO BDSI ARIA THRX

Sep 05, 2013 No Comments

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP $3.09) announced that the FDA has accepted the New Drug Application (NDA) resubmission of NORTHERA, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). The PDUFA date is February 14, 2014. ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA $20.35)  announced enrollment of fifty percent of the patients planned in its randomized Phase 3 […]

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Updates for SPPI DRTX NAVB VNDA CSII ARIA ASTM XOMA FOLD RCPT

Aug 07, 2013 No Comments

Spectrum Pharmaceuticals (NasdaqGS: SPPI $8.22) announced that its Belinostat NDA filing is expected in 4Q 2013, while its pivotal trial Captisol-enabled melphalan pivotal trial is expected to complete enrolment later this year with a NDA submission in 2014. Durata Therapeutics, Inc. (Nasdaq:DRTX $8.58) said that it is on track to file its NDA for Dalbavancin in late September, […]

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SLXP and PGNX set to appear before Adcom + BOTA ARIA NBY CERS updates

Jun 12, 2013 No Comments

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals (NASDAQ:PGNX) announced that the FDA will hold an Advisory Committee meeting regarding the Supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, for opioid-induced constipation, or OIC, in patients with chronic pain. A date has yet to be set. Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) announced that it has commenced dosing in a Phase 2 clinical […]

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AZN RIGL report mixed Phase 3 fostamatinib data. ARIA ASTM updates + INSV reverse split vote May

Apr 05, 2013 No Comments

InSite Vision Incorporated (OTCBB: INSV) will hold a meeting on Wednesday, May 29, 2013, where shareholders will vote to give permission for the company to effect a reverse split. ARIAD Pharmaceuticals, Inc.(NASDAQ: ARIA) provided an update on its progress noting that its Phase 3 EPIC trial of Iclusig, in patients with newly diagnosed CML, should have interim analysis available […]

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CHMP offers MAA opinions for BIIB ARIA GENT GILD BAX HALO ISIS

Mar 23, 2013 No Comments

Isis Pharmaceuticals Inc.(NASDAQ: ISIS) announced that following Genzyme’s request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) confirmed its previous position and has maintained a negative opinion regarding the marketing authorization application (MAA) for KYNAMRO (mipomersen) as a treatment for patients with Homozygous Familial Hypercholesterolaemia (HoFH). Baxter International Inc. (NYSE: BAX) and Halozyme […]

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Adcom dates set for TTNP DCTH AVEO. PDUFA delay for ZGNX. AMRN files sNDA + DVAX TSRO DRTX DNDN ARIA CBST IPXL NKTR ISIS

Feb 26, 2013 No Comments

Delcath Systems, Inc (NASDAQ: DCTH) – The Oncologic Drugs Advisory Committee will discuss the new drug application of the Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System, for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver, during the afternoon session on May 2, 2013. Titan Pharmaceuticals, Inc (TTNP) – The Psychopharmacologic Drugs Advisory Committee will discuss new […]

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BIIB positive Phase 3 data. CBST pipeline update.ANTH offering + SGEN ARIA ACOR news

Jan 25, 2013 No Comments

Biogen Idec (NASDAQ: BIIB) announced that it met the primary endpoint, the annualized relapse rate (ARR) at one year, for both the two-week and four-week doses in its Phase 3 pivotal clinical trial, ADVANCE, of peginterferon beta-1a as a potential treatment for relapsing-remitting multiple sclerosis (RRMS). It also mentioned that it met the secondary endpoints of risk of 12-week […]

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