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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Weekly summary – AFFY QLTI RPRX CRIS CHTP CELG AEZS ONCY ACHN GTXI CLSN SYN IMMU VVUS GENT ITMN NPSP IMGN

Feb 24, 2013 No Comments

Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited (Takeda) have decided to recall all lots of OMONTYS (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of […]

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UTHR THRX PDUFA dates set. ACRX pipeline update. ONCY offering. CRTX takeover + EXAS ISIS news

Feb 19, 2013 No Comments

GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc.(NASDAQ: THRX) announced that the New Drug Application (NDA) for the  once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the FDA. The PDUFA date is 18 December 2013. United Therapeutics Corporation (NASDAQ: UTHR) announced last week that the FDA has set a PDUFA date […]

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ZIOP Phase 3 data due end of March + updates for DCTH POZN MELA VNDA BIOD SGEN CYTK OGXI IMGN

Feb 13, 2013 No Comments

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) announced that the Phase 3 (PICASSO 3) trial of palifosfamide (ZIO-201) in first-line metastatic soft tissue sarcoma has reached its target number of progression-free survival (PFS) events. Topline results from this trial will be released during the last week of March 2013. Delcath Systems, Inc. (NASDAQ: DCTH) said it continues to […]

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CELG PDUFA date for REVLIMID sNDA set. Updates for CPRX RPRX GEVA

Feb 12, 2013 No Comments

Celgene Corporation (NASDAQ: CELG) announced that its application for REVLIMID in patients with relapsed or refractory mantle cell lymphoma (MCL) after prior therapy that included bortezomib has been accepted by the FDA under priority review with a PDUFA date of June 5, 2013. Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX) gave a pipeline update regarding the development of Firdapse for the treatment of […]

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CELG receives FDA Approval for POMALYST. GILD completes YMI acquisition. Updates for NBIX and PTIE

Feb 09, 2013 No Comments

Celgene Corporation (NASDAQ: CELG) announced the FDA has approved POMALYST brand therapy (pomalidomide) for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy. Gilead Sciences, Inc. (Nasdaq: GILD) announced that it has completed its acquisition of YM […]

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ALNY pipeline update. Offering details for OPXA MDGN

Feb 08, 2013 No Comments

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) gave a pipeline update noting that expects to report data from its Phase 2 trial of ALN-TTR02 for transthyretin-mediated amyloidosis (ATTR) in mid-2013. Assuming positive results from the Phase 2 trial, Alnylam expects to start a Phase 3 trial for ALN-TTR02 in familial amyloidotic polyneuropathy (FAP) patients by the end of 2013. It […]

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VICL Phase 3 Allovectin data due mid 2013. OXGN Phase 2 ovarian data due 2013

Feb 07, 2013 No Comments

Vical Incorporated (Nasdaq:VICL) gave a pipeline update noting that top-line data from its Phase 3 registration trial of Allovectin vs. chemotherapy in patients with metastatic melanoma, are expected to be released in mid-2013. It also said that its partner Astellas, is planning to initiate a Phase 3 trial of TransVax for hematopoietic stem cell transplant (HSCT) recipients and to […]

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NKTR initiates Phase 2 NSCLC. CYTK update. BMTI responds to FDA + CLSN news

Feb 06, 2013 No Comments

Nektar Therapeutics (NASDAQ:NKTR) announced the start of a Phase 2 investigator-initiated trial of etirinotecan pegol in patients with metastatic and recurrent NSCLC. Cytokinetics, Incorporated (Nasdaq: CYTK) gave a pipeline update noting that it intends to release data in 2013 from both its Phase 2b trial (BENEFIT-ALS), evaluating tirasemtiv in patients with amyotrophic lateral sclerosis, and its Phase 2b trial […]

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