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  • 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
  • TOP STORY: First data for Spark's hemophilia B gene therapy

    Spark Therapeutics Inc. (NASDAQ:ONCE) gained $5.94 (14%) to $47.17 on Thursday after it and partner Pfizer Inc. (NYSE:PFE) said the first three hemophilia B patients enrolled in a Phase I/II study of SPK-9001 (SPK-FIX) …

    Published on 5/19/2016
  • TOP STORY: FDA approves Genentech's PD-L1 for bladder cancer

    FDA granted accelerated approval to Tecentriq atezolizumab (MPDL3280A) from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) to treat locally advanced or metastatic urothelial carcinoma that has progressed on or …

    Published on 5/18/2016
  • TOP STORY: Celgene, Agios form new oncology deal, revise another

    Celgene Corp. (NASDAQ:CELG) and Agios Pharmaceuticals Inc. (NASDAQ:AGIO) formed a new research collaboration to explore metabolic immuno-oncology. The companies also amended their 2010 cancer metabolism deal, returning …

    Published on 5/17/2016

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