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  • TOP STORY: Sarepta hammered after FDA outlines eteplirsen concerns

    Sarepta Therapeutics Inc. (NASDAQ:SRPT) sank $8.69 (44%) to $11.02 on Monday after FDA released a second set of briefing documents expressing concerns about the company's data package for eteplirsen (AVI-4658) to treat …

    Published on 4/21/2016
  • TOP STORY: First clinical data for BioMarin hemo A gene therapy

    At its R&D day on Wednesday, BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) reported preliminary data from the first eight patients with severe hemophilia A who received a single dose of IV BMN 270 in an ongoing dose-…

    Published on 4/20/2016
  • TOP STORY: J&J raises guidance, hits all-time high

    Johnson & Johnson (NYSE:JNJ) gained $1.75 to $112.68 on Tuesday, touching an all-time intraday high of $113.95, after it reported 1Q16 earnings and raised its 2016 sales guidance to $71.2-$71.9 billion from $70.8-$71.5 …

    Published on 4/19/2016
  • TOP STORY: Illumina cuts growth forecast after soft 1Q16

    Illumina Inc. (NASDAQ:ILMN) shed $32.93 (18%) to $145.20 in after-hours trading Monday after the company reported preliminary 1Q16 revenues of $572 million, shy of analysts' $596.3 million consensus estimate. The …

    Published on 4/18/2016
  • TOP STORY: Illumina launches new VC firm with $100M

    Illumina Inc. (NASDAQ:ILMN) is investing $100 million in the first fund of Illumina Ventures, a new independently managed venture firm. Former Illumina SVP of Corporate and Venture Development Nicholas Naclerio is the …

    Published on 4/15/2016
  • TOP STORY: IMS: Drug spending growth slows in 2015

    The IMS Institute for Healthcare Informatics said U.S. drug spending grew 8.5% to $309.5 billion on a net price basis in 2015, according to a report published Thursday. On a conference call, Executive Director Murray …

    Published on 4/14/2016
  • TOP STORY: Parker Foundation launches cancer institute with $250M

    Entrepreneur Sean Parker's The Parker Foundation established a cancer immunotherapy institute to bring together six academic research centers, and granted the institute $250 million.The newly launched Parker Institute …

    Published on 4/13/2016
  • TOP STORY: FDA panel: Delay decision on Clovis' rociletinib

    FDA's Oncologic Drugs Advisory Committee voted 12-1 on Tuesday that FDA should await the outcome of the confirmatory Phase III TIGER-3 trial of rociletinib (CO-1686) from Clovis Oncology Inc. (NASDAQ:CLVS) before the …

    Published on 4/12/2016
  • TOP STORY: Intellia partners with Regeneron, files for IPO

    Intellia Therapeutics Inc. (Cambridge, Mass.) filed for an IPO and granted Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) exclusive rights to use its CRISPR-Cas9 (CRISPR-associated protein 9) technology against up to 10 …

    Published on 4/11/2016
  • TOP STORY: Clovis sinks as rociletinib questions linger

    Clovis Oncology Inc. (NASDAQ:CLVS) lost $3.40 (18%) to $15.77 on Friday after FDA reviewers asked an advisory committee whether the company will need to submit more data before the agency decides whether to approve lung…

    Published on 4/8/2016
  • TOP STORY: FDA panel unanimously backs Intercept's Ocaliva

    Members of FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) voted 17-0 that there is substantial evidence to support accelerated approval of Ocaliva obeticholic acid (OCA) from Intercept Pharmaceuticals Inc. (…

    Published on 4/7/2016
  • TOP STORY: Allergan in AD deal after calling off Pfizer merger

    Less than a day after Allergan plc (NYSE:AGN) and Pfizer Inc. (NYSE:PFE) called off their proposed merger, Allergan obtained rights to a portfolio of muscarinic agonists from the Heptares Therapeutics Ltd. subsidiary of…

    Published on 4/6/2016
  • TOP STORY: FDA reviewers mull surrogate endpoint for Intercept's OCA

    FDA reviewers questioned the utility of alkaline phosphatase (ALP) as a surrogate endpoint for approval of obeticholic acid (OCA; DSP-1747) from Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) to treat primary biliary …

    Published on 4/5/2016
  • TOP STORY: Gilead acquiring Nimbus' NASH subsidiary

    Gilead Sciences Inc. (NASDAQ:GILD) is acquiring the Nimbus Apollo Inc. subsidiary of Nimbus Therapeutics LLC (Cambridge, Mass.) for $400 million up front and up to $800 million in development milestones. The deal gives …

    Published on 4/4/2016
  • TOP STORY: Dupilumab hits marks in Phase III dermatitis trials

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) said dupilumab (REGN668) met the primary endpoint in two identical Phase III trials to treat moderate to severe atopic dermatitis.…

    Published on 4/1/2016
  • TOP STORY: GSK relaxing IP approach in poorer countries

    On a conference call Thursday, CEO Andrew Witty said GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) is taking steps to align its patent filing and enforcement policies with various nations' levels of "economic maturity." Witty…

    Published on 3/31/2016
  • TOP STORY: Califf says staffing is top priority

    In a blog post Wednesday, new FDA Commissioner Robert Califf said improvements to the hiring system and retention of FDA staff were top priorities."I will pursue a workforce initiative designed to improve the hiring …

    Published on 3/30/2016
  • TOP STORY: NICE eyes alternative payment models for cell therapies

    An expert advisory group created by the U.K.'s NICE found that the committee's appraisal methods and decision framework are applicable to regenerative medicines and cell therapies, and recommended that NICE develop …

    Published on 3/29/2016
  • TOP STORY: Alder rises on Phase IIb chronic migraine data

    Alder Biopharmaceuticals Inc. (NASDAQ:ALDR) gained $8.52 (50%) to $25.70 on Monday after reporting that two doses of IV ALD403 met the primary endpoint in a Phase IIb trial to prevent chronic migraine.The calcitonin …

    Published on 3/28/2016
  • TOP STORY: FDA reviewers question Nuplazid benefit

    In documents released ahead of Tuesday's meeting of FDA's Psychopharmacologic Drugs Advisory Committee, agency reviewers questioned whether Nuplazid pimavanserin from Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) showed …

    Published on 3/25/2016
  • TOP STORY: Portola falls on betrixaban Phase III miss

    Portola Pharmaceuticals Inc. (NASDAQ:PTLA) sank $8.35 (29%) to $20.27 on Thursday after its oral Factor Xa inhibitor betrixaban (PRT054021) failed to show superiority to standard of care enoxaparin in the Phase III APEX…

    Published on 3/24/2016
  • TOP STORY: BMS acquiring Padlock

    Bristol-Myers Squibb Co. (NYSE:BMY) will acquire autoimmune play Padlock Therapeutics Inc. (Cambridge, Mass.) for $225 million in upfront and near-term milestone payments. Padlock shareholders are eligible for $375 …

    Published on 3/23/2016
  • TOP STORY: Jury sides with Merck, Ionis in Gilead HCV suit

    A federal jury upheld the validity of two patents held by Merck & Co. Inc. (NYSE:MRK) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) in a dispute with Gilead Sciences Inc. (NASDAQ:GILD) concerning IP for HCV treatments.…

    Published on 3/22/2016
  • TOP STORY: Mixed Phase III PKU results for BioMarin's pegvaliase

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) lost $2.75 to $78.19 on Monday after its pegvaliase (BMN 165) met the primary endpoint of the Phase III PRISM-2 study to treat phenylketonuria (PKU), but did not lead to …

    Published on 3/21/2016
  • TOP STORY: Oncologists, biopharmas, patients protest Part B plan

    In a letter sent to Congress Thursday, 316 groups representing oncologists and other physicians, drug developers and patients called for CMS to "permanently withdraw the Part B Drug Payment Model" it proposed on March …

    Published on 3/18/2016

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