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  • 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
  • TOP STORY: Retiring Witty reveals new GSK initiatives

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said Andrew Witty will retire as CEO on March 31, 2017. The pharma's board said it will seek a successor. Witty became CEO in 2008.In his first speech after announcing the news, …

    Published on 3/17/2016
  • TOP STORY: Sanofi, DiCE form discovery collaboration

    Sanofi (Euronext:SAN; NYSE:SNY) and DiCE Molecules SV LLC (Redwood City, Calif.) entered a five-year collaboration on Wednesday to co-develop small molecules against up to 12 targets using DiCE's small molecule …

    Published on 3/16/2016
  • TOP STORY: Lilly changes primary endpoint of mild AD trial

    Eli Lilly and Co. (NYSE:LLY) said Tuesday it is changing one of two co-primary endpoints to a secondary endpoint in the Phase III EXPEDITION3 trial of solanezumab (LY2062430) to treat mild Alzheimer's disease (AD).The …

    Published on 3/15/2016
  • TOP STORY: GW soars after Epidiolex meets Phase III endpoint

    GW Pharmaceuticals plc (LSE:GWP; NASDAQ:GWPH) said Epidiolex cannabidiol met the primary endpoint of significantly reducing convulsive seizures vs. placebo in a Phase III trial to treat Dravet syndrome, a rare form of …

    Published on 3/14/2016
  • TOP STORY: Sarilumab tops Humira in RA Phase III

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NYSE:SNY) said sarilumab (REGN88, SAR153191) met the primary endpoint of superiority to Humira adalimumab from AbbVie Inc. (NYSE:ABBV) in the Phase …

    Published on 3/11/2016
  • TOP STORY: New date for meeting to discuss Sarepta's eteplirsen

    FDA's Peripheral and Central Nervous System Drugs Advisory Committee will meet on April 25 to discuss an NDA for eteplirsen (AVI-4658) from Sarepta Therapeutics Inc. (NASDAQ:SRPT) to treat Duchenne muscular dystrophy (…

    Published on 3/10/2016
  • TOP STORY: Senate Dems tying budget bump to innovation bills

    Democratic members of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee said they will support biomedical innovation bills in committee but would try to block a vote of a total package on the Senate…

    Published on 3/9/2016
  • TOP STORY: CMS proposes Part B changes

    CMS proposed a rule that would change the traditional "buy and bill" model for Medicare Part B drugs to remove an incentive for physicians to prescribe expensive medicines over cheaper, equally effective alternatives.…

    Published on 3/8/2016
  • TOP STORY: Celldex sinks after halting GBM Phase III

    Celldex Therapeutics Inc. (NASDAQ:CLDX) fell $4.40 (54%) to $3.79 on Monday after it said it will stop the Phase III ACT IV trial of Rintega rindopepimut to treat newly diagnosed glioblastoma multiforme. The decision …

    Published on 3/7/2016
  • TOP STORY: Victoza reduces risk of CV events

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said diabetes drug Victoza liraglutide plus standard of care met the primary endpoint of significantly reducing cardiovascular risk vs. placebo plus SOC in the LEADER CV outcomes …

    Published on 3/4/2016
  • TOP STORY: BioMarin planning to submit Batten therapy

    BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) plans to submit U.S. and EU regulatory applications mid-year for cerliponase alfa (BMN 190) to treat late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, a form…

    Published on 3/3/2016
  • TOP STORY: Syndax prices IPO

    Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) raised $52.8 million through the sale of 4.4 million shares at $12 in an IPO underwritten by Morgan Stanley, Citigroup, JMP Securities and Oppenheimer & Co. The price valued the…

    Published on 3/2/2016
  • TOP STORY: Bach analyzes "waste" of cancer drugs

    Memorial Sloan Kettering Cancer Center's Peter Bach and colleagues estimated that waste of cancer drugs due to mismatches between single-dose vial size and dose will account for about 10% of the projected $18 billion in…

    Published on 3/1/2016
  • TOP STORY: Exelixis, Ipsen in cabozantinib partnership

    Exelixis Inc. (NASDAQ:EXEL) gained $0.43 (12%) to $4.07 in early after-hours trading after it granted Ipsen Group (Euronext:IPN; Pink:IPSEY) exclusive rights to develop and commercialize cancer drug cabozantinib (XL184)…

    Published on 2/29/2016
  • TOP STORY: PTC may delist Translarna in Germany

    PTC Therapeutics Inc. (NASDAQ:PTCT) said it is considering removing Duchenne muscular dystrophy (DMD) drug Translarna ataluren from the German pharmacy ordering system after an arbitration process between the company …

    Published on 2/26/2016
  • TOP STORY: Obama promotes precision medicine

    At the White House Precision Medicine Initiative (PMI) Summit on Thursday, President Obama promoted precision medicine as a tool for improving and reducing the cost of healthcare. "What we are now seeing is the …

    Published on 2/25/2016
  • TOP STORY: Califf confirmed as FDA commissioner

    The U.S. Senate confirmed Robert Califf as FDA commissioner on Wednesday by an 89-4 vote. The confirmation came nearly eleven months after Margaret Hamburg stepped down as commissioner. Stephen Ostroff, who has served …

    Published on 2/24/2016
  • TOP STORY: PTC falls after FDA refuses Translarna NDA

    PTC Therapeutics Inc. (NASDAQ:PTCT) sank $17.42 (62%) to $10.84 on Tuesday after it said FDA issued a refusal to file letter for its NDA for Translarna ataluren to treat nonsense mutation Duchenne muscular dystrophy (…

    Published on 2/23/2016
  • TOP STORY: Senate moves toward Califf confirmation

    The U.S. Senate voted 80-6 Monday to cut off debate on a vote to confirm Robert Califf as the next FDA commissioner, setting up a final confirmation vote that could come this week. Califf received strong bipartisan …

    Published on 2/22/2016

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