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  • TOP STORY: Lilly's Lechleiter retiring

    John Lechleiter intends to retire as president and CEO of Eli Lilly and Co. (NYSE:LLY), effective Dec. 31. David Ricks, SVP and president of Lilly Bio-Medicines, will succeed Lechleiter on Jan. 1, 2017.Lechleiter, who …

    Published on 7/27/2016
  • TOP STORY: Kadmon raises $75M in IPO

    Kadmon Holdings Inc. (NYSE:KDMN) raised $75 million through the sale of 6.3 million shares at $12 in an IPO underwritten by Citigroup, Jefferies, JMP Securities and H.C. Wainwright. The IPO price values the company at $…

    Published on 7/26/2016
  • TOP STORY: Gilead lowers guidance amid slowing HCV sales

    Gilead Sciences Inc. (NASDAQ:GILD) slipped $3.53 to $85.02 in early after-hours trading after it reported HCV revenues that missed Street estimates and lowered its 2016 guidance, largely to reflect slowing sales and …

    Published on 7/25/2016
  • TOP STORY: Puma rises on neratinib survival data, NDA submission

    Puma Biotechnology Inc. (NYSE:PBYI) jumped $7 (20%) to $41.52 on Friday after the company disclosed interim five-year disease-free survival (DFS) data from the Phase III ExteNET trial of oral neratinib (PB272) and said …

    Published on 7/22/2016
  • TOP STORY: Biogen CEO Scangos departing

    Biogen Inc. (NASDAQ:BIIB) gained $20.04 to $282.45 on Thursday after disclosing strong 2Q16 financial results and saying CEO George Scangos will depart "in the coming months" after the company identifies a successor. …

    Published on 7/21/2016
  • TOP STORY: Audentes inches up after pricing $75M IPO

    Gene therapy company Audentes Therapeutics Inc. (NASDAQ:BOLD) added $0.13 to $15.13 on its first day of trading Wednesday after raising $75 million through the sale of 5 million shares at $15 in an IPO. The IPO price …

    Published on 7/20/2016
  • TOP STORY: Zafgen discontinues beloranib development

    Zafgen Inc. (NASDAQ:ZFGN) sank $2.83 (42%) to $3.92 in early after-hours trading after it said it will discontinue development of subcutaneous beloranib (ZGN-440) and focus instead on second-generation methionine …

    Published on 7/19/2016
  • TOP STORY: Tagrisso shows survival benefit in NSCLC Phase III

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said Tagrisso osimertinib met the primary endpoint of significantly improving progression-free survival (PFS) vs. platinum-based doublet chemotherapy in the confirmatory Phase III …

    Published on 7/18/2016
  • TOP STORY: User fee inflation to slow in PDUFA VI

    Industry and FDA have agreed to restructure PDUFA fees as part of the PDUFA VI agreement goals letter released Friday. The new structure is intended to make FDA funding more predictable, and is expected to slow the fees…

    Published on 7/15/2016
  • TOP STORY: Santhera sags on FDA delay for Raxone

    Santhera Pharmaceuticals Holding AG (SIX:SANN) sank CHF30.85 (37%) to CHF52.65 on Thursday after it said FDA would not support its plan to submit an NDA for Raxone idebenone to treat Duchenne muscular dystrophy (DMD) …

    Published on 7/14/2016
  • TOP STORY: FDA panel backs Sandoz's biosimilar Enbrel

    On Wednesday, FDA's Arthritis Advisory Committee voted unanimously to recommend approval of GP2015 from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN), a biosimilar version of Enbrel etanercept from Amgen Inc. (…

    Published on 7/13/2016
  • TOP STORY: FDA lifts hold on Juno's JCAR015

    Juno Therapeutics Inc. (NASDAQ:JUNO) gained $6.96 (25%) to $34.75 in early after-hours trading Tuesday after it said FDA lifted a clinical hold on the company's Phase II ROCKET trial of JCAR015 to treat relapsed or …

    Published on 7/12/2016
  • TOP STORY: Obama calls for drug pricing reforms

    In a commentary published in the Journal of the American Medical Association, President Obama called for congressional action to address drug costs. Obama wrote that the federal government should have authority to …

    Published on 7/11/2016
  • TOP STORY: Investors dump Juno on clinical hold

    Juno Therapeutics Inc. (NASDAQ:JUNO) fell 32% on Friday, as investors sold on late Thursday's news that FDA placed a clinical hold on the Phase II ROCKET trial of JCAR015 following two patient deaths from cerebral edema…

    Published on 7/8/2016
  • TOP STORY: Juno's JCAR015 Phase II on clinical hold

    Juno Therapeutics Inc. (NASDAQ:JUNO) fell $11.68 (29%) to $29.14 in early after-hours trading Thursday after FDA placed a clinical hold on the Phase II ROCKET trial of JCAR015 to treat relapsed or refractory acute …

    Published on 7/7/2016
  • TOP STORY: Moderna, Vertex aiming for CFTR solution

    Moderna Therapeutics Inc. (Cambridge, Mass.) and Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) partnered to discover and develop mRNA therapeutics to address the underlying cause of cystic fibrosis by producing functional …

    Published on 7/6/2016
  • TOP STORY: Medivation fielding takeout bids

    Medivation Inc. (NASDAQ:MDVN) said it has entered confidentiality agreements with multiple parties. One of the suitors is Sanofi (Euronext:SAN; NYSE:SNY), which has been publicly pursuing the cancer company since April.…

    Published on 7/5/2016
  • TOP STORY: Leo gets rights to two AZ dermatology candidates

    AstraZeneca plc (LSE:AZN; NYSE:GSK) granted Leo Pharma A/S (Ballerup, Denmark) exclusive, global rights to tralokinumab (CAT-354) for dermatological indications and European rights to brodalumab (KHK4827). AZ and …

    Published on 7/1/2016
  • TOP STORY: Morphic raises $51.5M for oral integrin inhibitors

    Morphic Therapeutic (Waltham, Mass.) raised $51.5 million in a series A round co-led by SR One and Pfizer Venture Investments. Omega Funds and AbbVie Ventures also invested, along with existing investors Polaris …

    Published on 6/30/2016
  • TOP STORY: Tesaro doubles after niraparib shows survival benefit

    Tesaro Inc. (NASDAQ:TSRO) soared $40.19 (108%) to $77.40 on Wednesday, adding $1.8 billion in market cap, after it said niraparib (MK-4827) met the primary endpoint of improving progression-free survival (PFS) in the …

    Published on 6/29/2016
  • TOP STORY: FDA approves Gilead's pan-genotypic HCV combo

    FDA approved Epclusa sofosbuvir/velpatasvir from Gilead Sciences Inc. (NASDAQ:GILD) to treat HCV in patients with and without cirrhosis. The agency said the combination is the first regimen it has approved to treat all …

    Published on 6/28/2016
  • TOP STORY: Regulus sinks on clinical hold

    Regulus Therapeutics Inc. (NASDAQ:RGLS) said FDA placed a full clinical hold on RG-101 after the company reported a second case of jaundice, a severe adverse event (SAE), in an ongoing Phase I study to treat chronic HCV…

    Published on 6/27/2016
  • TOP STORY: Brexit sparks competition for EMA headquarters

    The London-based EMA declined to speculate Friday about the implications of the U.K.'s decision to leave the EU, but national pharmaceutical industry trade associations have already begun lobbying for the right to host …

    Published on 6/24/2016
  • TOP STORY: Hengrui Therapeutics raises $100M

    Newco Hengrui Therapeutics Inc. (Princeton, N.J.) said it received a $100 million investment from HR Bio Holdings Ltd., a JV between Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:600276) and an undisclosed investment firm…

    Published on 6/23/2016
  • TOP STORY: IPAB delay boosts biotech markets

    Biotech stocks posted moderate gains Wednesday after the Medicare Board of Trustees released a report that said spending growth had not met the threshold required to trigger savings recommendations from the Independent …

    Published on 6/22/2016

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