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  • COMPANY NEWS: Alexion names CEO Bell chairman

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) named CEO Leonard Bell as its chairman, three days after the passing of former chairman Max Link (see BioCentury Extra, Oct. 8).Bell, a principal founder of Alexion, remains …

    Published on 10/9/2014
  • COMPANY NEWS: Auxilium accepts Endo's richer buyout bid

    Endo International plc (NASDAQ:ENDP; TSX:ENL) won its bid to acquire Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL), striking a deal they valued at $33.25 per share in stock and cash, or $2.6 billion. Auxilium agreed to …

    Published on 10/9/2014
  • COMPANY NEWS: CMS confirms national coverage for Cologuard

    CMS finalized its National Coverage Determination for the Cologuard non-invasive DNA screening test for colorectal cancer from Exact Sciences Corp. (NASDAQ:EXAS), the first product that has undergone a pilot parallel …

    Published on 10/9/2014
  • COMPANY NEWS: FDA approves Velcade for first-line MCL

    FDA approved an sNDA from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) to expand the label of Velcade bortezomib to include first-line mantle cell lymphoma (MCL). The pharma said Velcade is the first treatment to be …

    Published on 10/9/2014
  • COMPANY NEWS: FDA wants pediatric ADHD data from Shire

    FDA requested additional pediatric data from Shire plc (LSE:SHP; NASDAQ:SHPG) to support resubmission of an NDA for SHP465 triple-bead mixed amphetamine salts (MAS) to treat ADHD in adults.Prior to FDA's request, Shire…

    Published on 10/9/2014
  • COMPANY NEWS: Priority Review for Amgen's blinatumomab BiTE

    FDA accepted and granted Priority Review to a BLA for blinatumomab (AMG 103) from Amgen Inc. (NASDAQ:AMGN) to treat adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (…

    Published on 10/9/2014
  • COMPANY NEWS: "Surprised" Arrowhead responds

    Shares of Arrowhead Research Corp. (NASDAQ:ARWR) were off $0.11 to $6.92 on Thursday after the company issued an "open letter" in which it said it was taken "by surprise" by shareholder reaction to publication of an …

    Published on 10/9/2014
  • COMPANY NEWS: Vertex gives update in CF

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) updated the progress of multiple programs as it prepared to present data at the North American Cystic Fibrosis Conference beginning today in Atlanta. The company said it has …

    Published on 10/9/2014
  • COMPANY NEWS: Choppy trading day for Chimerix

    Chimerix Inc. (NASDAQ:CMRX) slipped $0.32 to $32.91 on heavy volume Wednesday, as investors digested multiple news items. The stock traded as high as $35.98 early in the day after preliminary data from the pilot phase …

    Published on 10/8/2014
  • COMPANY NEWS: Deal-maker Max Link passes away

    Max Link, chairman of Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Celsion Corp. (NASDAQ:CLSN) and CytRx Corp. (NASDAQ:CYTR) died on Oct. 5. Alexion said Link, who was 74, died unexpectedly while traveling on business.…

    Published on 10/8/2014
  • COMPANY NEWS: FDA approves Uceris rectal foam

    FDA approved an NDA for Uceris budesonide rectal foam from Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) to induce remission of mild to moderate distal ulcerative colitis (UC) extending up to 40 cm from the anal verge. Salix…

    Published on 10/8/2014
  • COMPANY NEWS: Nabriva's lefamulin gets QIDP and Fast Track

    Nabriva Therapeutics AG (Vienna, Austria) said FDA granted its lefamulin (BC-3781) Qualified Infectious Disease Product (QIDP) and Fast Track designations to treat community-acquired bacterial pneumonia (CABP) and acute…

    Published on 10/8/2014
  • COMPANY NEWS: ODAC dates for Novartis' panobinostat, Rockwell's Triferic

    FDA's Oncologic Drugs Advisory Committee will meet on Nov. 6 to discuss NDAs for panobinostat (LBH589) from Novartis AG (NYSE:NVS; SIX:NOVN) and Triferic soluble ferric pyrophosphate citrate from Rockwell Medical Inc. (…

    Published on 10/8/2014
  • COMPANY NEWS: Allied Minds launches Novare Pharmaceuticals

    Allied Minds plc (LSE:ALM) has launched Novare Pharmaceuticals (Boston, Mass.), a newco aimed at developing hyaluronan-mediated motility receptor (RHAMM) modulators. The company was previously an Allied Minds subsidiary…

    Published on 10/7/2014
  • COMPANY NEWS: BrainStorm's NurOwn granted Fast Track for ALS

    BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) said FDA granted Fast Track designation to its cell-based NurOwn to treat ALS. NurOwn comprises autologous mesenchymal stromal cells induced to differentiate into …

    Published on 10/7/2014
  • COMPANY NEWS: Bellicum pays Ariad for room to run

    After raising $55 million in August, Bellicum Pharmaceuticals Inc. (Houston, Texas) on Monday committed to pay $50 million to Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) for exclusive worldwide rights to use the latter's …

    Published on 10/6/2014
  • COMPANY NEWS: BMS, Novartis to test combinations for NSCLC

    Bristol-Myers Squibb Co. (NYSE:BMY) and Novartis AG (NYSE:NVS; SIX:NOVN) have partnered to run two Phase I/II trials to evaluate combinations of BMS' Opdivo nivolumab with three Novartis compounds to treat non-small …

    Published on 10/6/2014
  • COMPANY NEWS: Eylea approved for BRVO ahead of PDUFA

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA on Monday approved an sBLA for Eylea aflibercept ophthalmic solution to treat macular edema following retinal vein occlusion including branch retinal vein occlusion…

    Published on 10/6/2014
  • COMPANY NEWS: Texas Ebola patient gets Chimerix therapy

    Texas Health Presbyterian Hospital said Monday a patient with Ebola was given brincidofovir from Chimerix Inc. (NASDAQ:CMRX) on Oct. 4. Chimerix said FDA had granted its emergency IND application to investigate …

    Published on 10/6/2014
  • COMPANY NEWS: FDA approves Gilead's Tybost, Vitekta

    FDA approved two resubmitted NDAs from Gilead Sciences Inc. (NASDAQ:GILD) in advance of this week's PDUFA dates for both HIV compounds.On Sept. 24, the agency approved Tybost cobicistat, an inhibitor of cytochrome P450 …

    Published on 10/3/2014
  • COMPANY NEWS: Lee's gets China rights to Sorrento's anti-PD-L1

    Lee's Pharmaceutical Holdings Ltd. (HKSE:0950) obtained exclusive rights to STI-A1014 human mAb against PD-L1 in greater China, including mainland China, Hong Kong, Macau and Taiwan from Sorrento Therapeutics Inc. (…

    Published on 10/3/2014
  • COMPANY NEWS: Esperion outlines more milestones

    Esperion Therapeutics Inc. (NASDAQ:ESPR) added $2.58 (11%) to $27 on Thursday in the wake of positive Phase IIb results for the company's cholesterol-lowering molecule ETC-1002 in patients with hypercholesterolemia, …

    Published on 10/2/2014
  • COMPANY NEWS: HHS seeks to boost ZMapp production

    HHS said it is in talks with biomanufacturing company Caliber Biotherapeutics LLC (Bryan, Texas) to produce the experimental Ebola drug ZMapp.Mapp Biopharmaceutical Inc. (San Diego, Calif.) produces the combination of 3…

    Published on 10/2/2014
  • COMPANY NEWS: NICE rebuffs Roche's Gazyvaro for CLL

    The U.K.'s NICE issued draft guidance recommending against the use of Gazyvaro obinutuzumab from Roche (SIX:ROG; OTCQX:RHHBY) in combination with chlorambucil as first-line therapy for chronic lymphocytic leukemia (CLL)…

    Published on 10/2/2014
  • COMPANY NEWS: Mesoblast cell therapy submitted in Japan

    Regenerative medicine company Mesoblast Ltd. (ASX:MSB; Pink:MBLTY) said partner JCR Pharmaceuticals Co. Ltd. (Tokyo:4552) is seeking Japanese approval of JR-031 to treat graft-versus-host disease (GvHD) in children and…

    Published on 10/1/2014

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