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  • COMPANY NEWS: Priority Review for Pfizer's palbociclib

    Pfizer Inc. (NYSE:PFE) said FDA accepted for filing and granted Priority Review to an NDA for palbociclib in combination with Femara letrozole as first-line treatment for postmenopausal women with estrogen receptor-…

    Published on 10/13/2014
  • COMPANY NEWS: Exact up on Cologuard reimbursement

    Exact Sciences Corp. (NASDAQ:EXAS) jumped $6.48 (36%) to $24.60 on Friday, adding $537.4 million in market cap to $2 billion, on news CMS has proposed reimbursement of $502 for Cologuard, the company's non-invasive DNA…

    Published on 10/10/2014
  • COMPANY NEWS: FDA approves Helsinn's Akynzeo combo for CINV

    FDA approved Akynzeo netupitant/palonosetron from Helsinn Healthcare S.A. (Lugano, Switzerland) to treat chemotherapy-induced nausea and vomiting (CINV).Akynzeo, previously known as NEPA, is a fixed-dose combination of …

    Published on 10/10/2014
  • COMPANY NEWS: Management tracks

    Roth Capital Partners named John Chambers vice-chairman. Chambers, who joined ROTH in 2009, remains head of its healthcare investment banking group. He was previously the head of the healthcare and investment banking …

    Published on 10/10/2014
  • 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

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