Archive for October, 2011

PCRX FDA Approval. AVNR submits NUEDEXTA to EMA. CYTR data

Oct 31, 2011 No Comments by

Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX) announced that the FDA has approved EXPAREL(TM) (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia. Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced today that it has submitted an application to the European Medicines Agency (EMA) seeking marketing authorization for NUEDEXTA (dextromethorphan HBr and quinidine sulfate) […]

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ALXA AFFY AdCom Meetings. EXEL data. CTIC resubmits NDA + ADLR SGEN ANTH RPTP ANX :

Oct 26, 2011 No Comments by

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced on Monday the FDA has scheduled a meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) for December 12, 2011, at which the ADASUVE New Drug Application (NDA) will be discussed. In August 2011, Alexza received notification that the FDA had accepted the resubmission of the ADASUVE NDA and assigned […]

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ALTH and AMAG terminate merger. HALO releases Phase 2 diabetes results

Oct 21, 2011 No Comments by

Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that the Agreement and Plan of Merger and Reorganization entered into by and among Allos, AMAG and Alamo Acquisition Sub, Inc. on July 19, 2011, as amended on August 8, 2011, has been terminated. Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced positive results from two Phase 2 clinical […]

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NEOP NDA accepted. RGRX data due soon. ONTY IMGN initiate trials

Oct 20, 2011 No Comments

Neoprobe Corporation (NYSE Amex: NEOP), announced after hours yesterday that its New Drug Application (NDA) for Lymphoseek (tilmanocept) has been accepted for review by the FDA. Neoprobe submitted the Lymphoseek NDA on August 10, 2011. Oncothyreon Inc. (Nasdaq: ONTY) today announced it has initiated the Phase 2 portion of its ongoing Phase 1-2 trial of […]

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SNSS obtains $25m tranched loan facility + DCTH VRTX news

Oct 19, 2011 No Comments

Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that it has entered into a $25 million tranched loan facility. Under the terms of the loan agreement, Sunesis received $10 million upon closing, with the remaining $15 million available for draw at its discretion following the planned interim analysis of the VALOR trial by an independent Data and […]

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VVUS resubmits NDA. ANDS bought out by Roche +INFI SQNM MRNA MNOV

Oct 17, 2011 No Comments

VIVUS, Inc. (NASDAQ: VVUS) today announced that it has resubmitted the New Drug Application (NDA) for Qnexa. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients, or overweight patients with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, […]

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INSM Phase 3 ARIKACE still on hold. CAPS reduces staff. OXGN terminates CEFF

Oct 14, 2011 No Comments

Insmed Incorporated (Nasdaq CM: INSM) today announced that it has been notified by the FDA that it is continuing the clinical hold previously placed on its Phase 3 trial for ARIKACE (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease. As announced on August 1, 2011, the clinical holds placed on ARIKACE […]

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Data releases from DEPO ISTA POZN ANDS. Updates for MITI CYCC

Oct 13, 2011 No Comments

Depomed, Inc. (Nasdaq:DEPO) today announced top-line results from BREEZE 3, a Phase 3 trial evaluating the efficacy and safety of Serada (extended-release gabapentin tablets) for menopausal hot flashes. Efficacy data from the trial were positive and statistically significant for three of the four pre-specified primary endpoints of frequency and severity at four and 12 weeks. […]

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Clinical trial updates for BPAX and OMER

Oct 11, 2011 No Comments

Omeros Corporation (NASDAQ: OMER) said today that it expects data from its first double-blind, placebo-controlled trial of OMS302 in intra-ocular lens replacement surgery, to be released during 1Q 2012. This compares with earlier guidance of a data release duirng 1H 2012. BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), announced today that the independent Data Monitoring Committee (DMC) […]

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CXM 510k approval for Excellagen + INSM LGND news

Oct 10, 2011 No Comments

Cardium Therapeutics (NYSE Amex: CXM) announced today that it has received 510k clearance from the FDA to market and sell Excellagen(TM) professional-use, sterile, syringe-based advanced wound care product for the management of diabetic foot ulcers and other dermal wounds. Directions for use indicate the application of Excellagen immediately following surgical debridement, which is routinely practiced […]

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