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

Jul 02, 2014 No Comments by

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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AEZS file NDA. IMGN fail Phase 2 trial. ECYT decision due Dec-Jan. ADHD data due Dec. KERX positive data + updates for STEM SGEN PTLA ISIS INSM ZGNX ITMN

Nov 06, 2013 No Comments by

Aeterna Zentaris Inc. (NASDAQ: AEZS $1.39) announced that it has submitted a NDA for AEZS-130 for adult growth hormone deficiency (“AGHD”). ImmunoGen, Inc. (Nasdaq: IMGN $13.41) announced that it will discontinue their Phase 2 trail of IMGN901 for SCLC, following the recommendation from the Data Monitoring Committee (DMC) due to a higher rate of infection and […]

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Offering news for ITMN ZGNX TTPH. ZLCS data due 4Q. RPRX to request lift of Proellex clinical hold + MSTX BLRX updates

Nov 04, 2013 No Comments by

InterMune, Inc. (NASDAQ: ITMN $14.95) announced that it plans to offer 6,500,000 shares of its common stock in an underwritten public offering. Zogenix, Inc. (Nasdaq:ZGNX $2.54) announced today that it intends to offer $60 million of shares of its common stock in an underwritten public offering. Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH $12.28) also announced it has commenced an underwritten public offering […]

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ZGNX FDA Approval. GILD gets Adcom thumbs up. Offering news for MEIP DVAX CUR + updates for IMGN and SNTS

Oct 26, 2013 No Comments

Zogenix, Inc. (Nasdaq:ZGNX $3.04) announced that the FDA has approved Zohydro ER (hydrocodone bitartrate) extended-release capsules, for the management of pain. Zogenix expects to launch Zohydro ER in approximately four months. Gilead Sciences, Inc. (Nasdaq: GILD $69.68) announced that the Antiviral Drugs Advisory Committee of the FDA voted unanimously (15-0) in favour of sofosbuvir in combination with ribavirin for the treatment […]

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Updates for ALNY ZGNX INSV DNDN OGXI ANAC RPTP NPSP NKTR KERX APPA SRPT THLD OPXA BCRX IMUC INFI

Aug 09, 2013 No Comments

Zogenix, Inc. (Nasdaq:ZGNX $1.52) said it continues to expect that the FDA will reach a decision regarding the Zohyrdo ER New Drug Application(NDA), during the summer of 2013. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP $18.10) said that it expects to submit its Biologic License Application in 4Q 2013 for Natpara for patients with hypoparathyroidism. It also plans to initiate […]

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CELG Approval for REVLIMID + updates for BMRN IDRA ZGNX OPK PBTH RCPT MELA

Jun 05, 2013 No Comments

Celgene Corporation (NASDAQ: CELG) announced the FDA approved the supplemental new drug application (sNDA) for REVLIMID (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced that it has initiated the Phase 3 program (165-301) for PEG-PAL (PEGylated […]

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Pipeline updates for OPK VNDA SNSS SRPT NKTR INSV VICL PBYI ANAC SPPI NPSP IMUC ZGNX + OMER offering

May 10, 2013 No Comments

OPKO Health, Inc. (NYSE: OPK) noted that Phase 3 data of CTAP 101 Capsules for the treatment of Secondary Hyperparathyroidism (SHPT) are due mid-2014, while Phase 3 data from its licensee trial (TESARO, Inc.) of rolapitant for the prevention of chemotherapy induced nausea and vomiting, are expected during 2H 2013. Vanda Pharmaceuticals Inc.(Vanda) (NASDAQ: VNDA) maintained guidance […]

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ASTM stops Phase 3 REVIVE trial. NDA filings for IGXT POZN. BIIB FDA approval + updates for NBIX ZGNX ARRY NAVB CPRX KBIO

Mar 27, 2013 No Comments

Aastrom Biosciences, Inc. (Nasdaq:ASTM) announced that it will stop enrollment and end the Phase 3 REVIVE clinical trial of  ixmyelocel-T in patients with critical limb ischemia (CLI) due to an inability to secure a partner, and challenges with enrollment. The company will  now focus its resources on its Phase 2b trial of ixmyelocel-T, for the treatment […]

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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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DRTX Phase 3 data due Tuesday + updates for LGND EXAS ACRX DCTH ZGNX NBY CYTR TSRX

Dec 10, 2012 No Comments

Durata Therapeutics, Inc. (NASDAQ: DRTX) today announced that it will host a conference call and webcast at 9:00am Eastern Time on Tuesday, December 11, 2012 to present preliminary top-line results from its DISCOVER 1 Phase 3 study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by […]

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30 Upcoming Catalysts – PDUFA dates, FDA Advisory meetings and Clinical data releases

Dec 01, 2012 10 Comments

30 short and long term potential catalysts as of December 1, 2012. See the links in the FDA Calendar for more details about each catalyst. Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA):  PDUFA date December 21 2012 for the Class 2 resubmssion of Staccato loxapine (ADASUVE). CHMP (EMA) decision due December 14, 2012. A.P. Pharma, Inc. (OTCBB: APPA): PDUFA Mar 27, 2013 […]

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