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  • 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
  • TOP STORY: Ellison donates $200M to create USC cancer institute

    Larry Ellison donated $200 million to the University of Southern California (Los Angeles, Calif.) to establish the Lawrence J. Ellison Institute for Transformative Medicine of USC, which aims to combine research with …

    Published on 5/12/2016
  • TOP STORY: Cigna gets outcomes-based discounts for PCSK9s

    Cigna Corp. (NYSE:CI) said Wednesday that it signed outcomes-based pricing contracts covering cholesterol-lowering PCSK9 drugs Praluent alirocumab and Repatha evolocumab. Cigna said the contracts include a negotiated …

    Published on 5/11/2016
  • TOP STORY: CNS company Aptinyx raises $65M series A

    Aptinyx Inc. (Evanston, Ill.) raised a tranched $65 million series A round led by New Leaf Venture Partners. New investors Frazier Healthcare Partners, Longitude Capital and Osage University Partners also participated …

    Published on 5/10/2016
  • TOP STORY: NewLink's IMPRESS results disappoint

    NewLink Genetics Corp. (NASDAQ:NLNK) sank $5.50 (33%) to $11 in early after-hours trading Monday after it said HyperAcute Pancreas algenpantucel-L missed the primary overall survival endpoint in the Phase III IMPRESS …

    Published on 5/9/2016
  • TOP STORY: Intellia surges in first trading day

    Gene editing company Intellia Therapeutics Inc. (NASDAQ:NTLA) rose $4.10 (23%) to $22.10 in its first day of trading Friday after it raised a combined $163 million in an IPO and concurrent private placements (see …

    Published on 5/6/2016
  • TOP STORY: venBio closes $315M fund

    venBio closed its Global Strategic Fund II with $315 million, above its initial target of $250 million. Strategic LPs Amgen Inc. (NASDAQ:AMGN), Merck & Co. Inc. (NYSE:MRK) and Baxalta Inc. (NYSE:BXLT) contributed most …

    Published on 5/5/2016
  • TOP STORY: CMS mulling modifications to proposed Part B model

    CMS's Patrick Conway told reporters Wednesday that the agency is listening to congressional criticisms and concerns about its proposed change to reimbursement policies for Medicare Part B drugs, and will make …

    Published on 5/4/2016
  • TOP STORY: Biogen to spin off hemophilia business

    Biogen Inc. (NASDAQ:BIIB) said it plans to spin off its hemophilia business into a separate public company by early 2017. It intends to distribute shares in the still-unnamed company to Biogen stockholders.The newco …

    Published on 5/3/2016
  • TOP STORY: Regeneron's anti-NGF mAb meets Phase II/III endpoint

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said fasinumab (REGN475) met the primary endpoint of significantly improving pain relief vs. placebo in a Phase II/III study to treat moderate to severe osteoarthritis (OA) …

    Published on 5/2/2016
  • TOP STORY: Medivation rejects Sanofi bid

    To little surprise, Medivation Inc. (NASDAQ:MDVN) rejected an unsolicited bid from Sanofi (Euronext:SAN; NYSE:SNY) to acquire the company for $52.50 per share in cash, or about $9.3 billion. Sanofi made its offer public…

    Published on 4/29/2016
  • TOP STORY: AbbVie acquiring Stemcentrx

    AbbVie Inc. (NYSE:ABBV) will acquire Stemcentrx Inc. (South San Francisco, Calif.) for about $5.8 billion in upfront cash and stock. The deal gives AbbVie Rova-T rovalpituzumab tesirine, which is in the registrational …

    Published on 4/28/2016
  • TOP STORY: Lawmakers preparing response to CMS Part B changes

    Republicans in the House and Senate plan to send letters this week to Andy Slavitt, acting CMS administrator, urging him to withdraw proposed changes to reimbursement for drugs administered under Medicare Part B. …

    Published on 4/27/2016
  • TOP STORY: The Column Group closes third fund

    The Column Group closed its third fund at $535 million, founder and Managing Partner Peter Svennilson disclosed to BioCentury. He said the firm intends to invest the new fund in about eight companies. TCG closed its …

    Published on 4/26/2016
  • TOP STORY: FDA panel doubts Sarepta has shown eteplirsen's efficacy

    Members of FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 7-3 with three abstentions that clinical results provided by Sarepta Therapeutics Inc. (NASDAQ:SRPT) did not provide substantial …

    Published on 4/25/2016

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