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  • 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
  • TOP STORY: Pfizer acquiring Anacor for $5.2B

    Pfizer Inc. (NYSE:PFE) will acquire Anacor Pharmaceuticals Inc. (NASDAQ:ANAC), giving it atopic dermatitis candidate crisaborole (AN2728). The pharma will pay $99.25 per share in cash, or about $5.2 billion. The price …

    Published on 5/16/2016
  • TOP STORY: White House launches National Microbiome Initiative

    On Friday, the White House Office of Science and Technology Policy (OSTP) announced the National Microbiome Initiative (NMI), which will seek to enhance the understanding of microbiome behavior and promote healthy …

    Published on 5/13/2016

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