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  • 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 soared 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 Payment …

    Published on 6/22/2016
  • TOP STORY: Human CRISPR study clears NIH committee hurdle

    NIH's Recombinant DNA Advisory Committee (RAC) voted in favor of a proposal from the University of Pennsylvania's Perelman School of Medicine to begin a clinical trial studying CRISPR/Cas9 gene editing to treat cancer, …

    Published on 6/21/2016
  • TOP STORY: Circassia plummets after Phase III cat allergy failure

    Circassia Pharmaceuticals plc (LSE:CIR) fell 179.30p (66%) to 91p and shed L510.8 million in market cap Monday after its Cat-SPIRE missed the primary endpoint in the Phase III CATALYST study to treat moderate to severe …

    Published on 6/20/2016
  • TOP STORY: Follow-ons ramping up

    Nine biotechs have raised nearly half a billion dollars in follow-ons this month, already making June the second best month for follow-ons in 2016. In March, investors told BioCentury that an open follow-on window could…

    Published on 6/17/2016
  • TOP STORY: Keytruda shows PFS benefit in first-line NSCLC study

    Merck & Co. Inc. (NYSE:MRK) said PD-1 inhibitor Keytruda pembrolizumab met the primary endpoint in the Phase III KEYNOTE-024 trial as a first-line therapy for patients with metastatic non-small cell lung cancer with …

    Published on 6/16/2016
  • TOP STORY: MedPAC recommends Part B and D changes

    The Medicare Payment Advisory Commission released recommendations for the Medicare program in its report to the U.S. Congress. The commission proposed changes to Part B and Part D reimbursements and payment systems that…

    Published on 6/15/2016
  • TOP STORY: GSK's Slaoui to retire

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said Moncef Slaoui will retire as chairman of global vaccines on June 30, 2017. He will remain a member of the pharma's board until March 31, after which he will serve as an …

    Published on 6/14/2016
  • TOP STORY: FDA rejects KemPharm's Apadaz

    KemPharm Inc. (NASDAQ:KMPH) fell $1.79 (28%) to $4.35 in early after-hours trading Monday after it received an FDA complete response letter for Apadaz benzhydrocodone/acetaminophen (KP201/APAP). The candidate was under …

    Published on 6/13/2016
  • TOP STORY: Global Blood gains on 90-day sickle cell data

    Global Blood Therapeutics Inc. (NASDAQ:GBT) gained $2 to $24.15 on Friday after newly presented 90-day data showed sickle disease candidate GBT440 led to durable reductions in hemolysis in an ongoing dose-escalation …

    Published on 6/10/2016
  • TOP STORY: Merck acquiring Afferent

    Merck & Co. Inc. (NYSE:MRK) is acquiring Afferent Pharmaceuticals Inc. (San Mateo, Calif.) for $500 million in cash. The deal gives the pharma Afferent's chronic cough candidate AF-219, a purinergic receptor P2X ligand-…

    Published on 6/9/2016
  • TOP STORY: J&J, GSK unveil first detailed Phase III sirukumab data

    Johnson & Johnson (NYSE:JNJ) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said sirukumab (CNTO 136) met the co-primary endpoints in the Phase III SIRROUND-D study to treat moderately to severely active rheumatoid…

    Published on 6/8/2016
  • TOP STORY: Biogen's anti-LINGO-1 mAb fails Phase II test

    Biogen Inc. (NASDAQ:BIIB) fell $36.98 (13%) to $252.86 on Tuesday after reporting that opicinumab (BIIB033) plus Avonex interferon beta-1a missed the primary endpoint vs. placebo plus Avonex in the Phase II SYNERGY …

    Published on 6/7/2016
  • TOP STORY: Darzalex CASTOR data shine at ASCO

    Data presented at the American Society of Clinical Oncology annual meeting revealed a reduced risk of disease progression and higher response rates among patients treated with Darzalex daratumumab plus Velcade …

    Published on 6/6/2016
  • TOP STORY: Vermont governor signs price transparency bill

    Vermont Gov. Peter Shumlin signed into law S. 216, a bill requiring drugmakers to justify wholesale acquisition cost (WAC) increases for some drugs.Vermont's Green Mountain Care Board and Department of Vermont Health …

    Published on 6/3/2016
  • TOP STORY: FDA clarifies expanded access process

    FDA clarified its expanded access policies in a series of documents issued Thursday, including a Q&A that outlines the process of obtaining expanded access, guidance that describes how companies may charge for therapies…

    Published on 6/2/2016
  • TOP STORY: Dermira reports Phase III hyperhidrosis data

    Dermira Inc. (NASDAQ:DERM) said DRM04 met both co-primary endpoints in the Phase III ATMOS-2 trial and one of two co-primary endpoints in the Phase III ATMOS-1 study to treat primary axillary hyperhidrosis. The company …

    Published on 6/1/2016
  • TOP STORY: Jazz acquiring Celator for $1.5B

    Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is to acquire Celator Pharmaceuticals Inc. (NASDAQ:CPXX) for $30.25 per share, or about $1.5 billion in cash. The price is a 73% premium on its Friday close of $17.53, and a 1,701%…

    Published on 5/31/2016
  • TOP STORY: FDA rejects AZ's ZS-9

    AstraZeneca plc (LSE:AZN; NYSE:AZN) received a complete response letter (CRL) from FDA for hyperkalemia treatment ZS-9 sodium zirconium cyclosilicate. AZ gained the candidate via its $2.7 billion acquisition of ZS …

    Published on 5/27/2016
  • TOP STORY: Ionis hammered after GSK opts against TTR study

    Ionis Pharmaceuticals Inc. (NASDAQ:IONS) plummeted $13.90 (39%) to $21.36 on Thursday, shedding nearly $1.7 billion in market cap, after it said partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) will not start the Phase …

    Published on 5/26/2016
  • TOP STORY: FDA extends eteplirsen decision

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) gained $4.91 (27%) to $23.35 on Wednesday after it said FDA will delay its decision whether to approve eteplirsen (AVI-4658) beyond the candidate's Thursday PDUFA date. Eteplirsen…

    Published on 5/25/2016
  • TOP STORY: FDA panel backs Novo's IDegLira

    FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 on Tuesday that available data support approval of combination therapy IDegLira insulin degludec/liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:…

    Published on 5/24/2016
  • TOP STORY: Exelixis' Cabometyx meets in first-line RCC

    Exelixis Inc. (NASDAQ:EXEL) gained $0.44 to $7 on Monday after its Cabometyx cabozantinib met the primary endpoint in the Phase II CABOSUN study evaluating the drug as a first-line therapy for advanced intermediate- or …

    Published on 5/23/2016
  • TOP STORY: FDA reviewers question IDegLira's superiority to Tresiba

    In briefing documents released ahead of a May 24 advisory committee meeting, FDA reviewers cast doubt on whether Novo Nordisk A/S (CSE:NVO; NYSE:NVO) had shown its Type II diabetes combination therapy IDegLira insulin …

    Published on 5/20/2016

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