FDA Panel recommends approval of Probuphine. ENTA IPO. ALIM NDA refiling due this month + updates for ANAC AEZS KYTH

Mar 22, 2013 No Comments

 Titan Pharmaceuticals, Inc. (OTCBB:TTNP) announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) members voted for approval (10 positive votes, 4 negative votes and 1 abstention) of Probuphine for the maintenance treatment of adult patients with opioid dependence. The PDUFA date is April 30, 2013. – Alimera Sciences, Inc. […]

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THRX GSK Adcom rescheduled. BLRX failure. ANAC data due Thur + TTPH CCXI AMGN BIIB RMTI VRX OMPI CSII

Mar 21, 2013 No Comments

GSK and Theravance, Inc. (NASDAQ: THRX) – On April 17, 2013 the FDA Pulmonary-Allergy Drugs Advisory Committee will discuss the new drug application (NDA) for fluticasone furoate and vilanterol dry powder inhaler (proposed trade name BREO ELLIPTA), sponsored by GlaxoSmithKline plc (GSK), for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic […]

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NPSP regains Gattex rights for $80m. CSII offering + IGXT BDSI updates

Mar 20, 2013 No Comments

Cardiovascular Systems, Inc.  (Nasdaq: CSII) announced that it intends to offer and sell shares of its common stock in an underwritten public offering. NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) and Takeda Pharmaceutical Company Limited announced that NPS has re-gained the full worldwide rights to teduglutide (Gattex in US, Revestive in Europe) and PTH 1-84 (Natpara in US, Preotact in Europe). Gattex is […]

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AFFY reduces workforce. SGEN files sBLA + updates for MACK AGN CYTK MELA INCY INSM NVAX INO RMTI ICPT OMER

Mar 19, 2013 No Comments

Affymax, Inc. (Nasdaq: AFFY) announced in a filing that it will reduce its workforce by approximately 230 employees (or 75%) following the recall of OMONTYS.  The company is considering all possible alternatives, including further restructuring activities, wind-down of operations or even bankruptcy proceedings. If they are unable to rapidly identify and rectify the causes of the safety concerns […]

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NVS receives Breakthrough Therapy designation. CYTK reverse split vote May + CSII CUR updates

Mar 16, 2013 No Comments

Novartis (NYSE:NVS) announced that LDK378 has received Breakthrough Therapy designation by the FDA for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who had progressed during treatment with, or were intolerant to, crizotinib. Breakthrough Therapy designation is intended to expedite the development and review of drugs that treat serious […]

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Pipeline updates and news for MACK NBY ANAC CCXI VNDA SNTA CERS

Mar 15, 2013 No Comments

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) announced that it expects to release overall survival results from its GALAXY-1 trial evaluating ganetespib as second-line treatment of non-small cell lung cancer, during mid-2013 and intends to commence enrolment in its Phase 3 GALAXY-2 trial this month. Interim and final data are expected in 2014. Updates from its Phase 2 ENCHANT trial, of ganetespib monotherapy […]

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NAVB FDA Approval. ENDP Adcom meeting. DCTH ATM offering + updates for ZIOP SNSS SCMP OREX

Mar 14, 2013 No Comments

Delcath Systems, Inc. (NASDAQ: DCTH) noted today that it raised gross proceeds of $20.9 million between January 1, 2013 and February 28, 2013 and entered into a new ATM equity offering program, under which the they may sell up to $50 million of its common stock from time to time. Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) announced the FDA approval of […]

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Pipeline and news updates for BIIB TSRX SPPI ACAD ACRX FOLD PPHM BLRX XOMA GEVA ZIOP KERX ANX MSTX CYTR AEZS MDCO

Mar 13, 2013 No Comments

Biogen Idec (NASDAQ: BIIB) announced it has submitted a Biologics License Application (BLA) to the FDA for recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A. On March 4, 2013 Biogen Idec announced the FDA accepted for review the company’s BLA for its factor IX candidate, rFIXFc, for use in patients with hemophilia B. Trius Therapeutics, Inc. (Nasdaq:TSRX) […]

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Pipeline updates for CLDX and OGXI. PCYC offering + JNJ files canagliflozin MAA

Mar 08, 2013 No Comments

Janssen-Cilag International NV (Janssen) today announced it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat adult patients with type 2 diabetes. Pharmacyclics, Inc. (NASDAQ: PCYC) announced that it has commenced an underwritten registered public offering of […]

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