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  • TOP STORY: Cempra sags as reviewers fret over Solithera worries

    Cempra Inc. (NASDAQ:CEMP) plummeted $11.35 (61%) to $7.30 on Wednesday after FDA reviewers said hepatotoxicity findings from clinical studies of oral and IV Solithera solithromycin constitute a "genuine liver injury …

    Published on 11/2/2016
  • TOP STORY: Pfizer discontinues PCSK9 program

    In its 3Q16 earnings report, Pfizer Inc. (NASDAQ:PFE) said it will discontinue global development of PCSK9 inhibitor bococizumab (PF-4950615) and halt the SPIRE-1 and SPIRE-2 cardiovascular outcomes trials (CVOTs) of …

    Published on 11/1/2016
  • TOP STORY: Third Rock closes fourth fund at $616M

    Third Rock Ventures closed its Fund IV at $616 million, exceeding its $600 million target. The firm intends to launch or invest in 10-12 early stage companies focused on oncology, immunology, neurology, cardiovascular …

    Published on 10/31/2016
  • TOP STORY: Pricing woes pummel biopharma stocks

    Biopharmas suffered sell-offs on Friday as investors digested concerns about drug pricing that affected the outlook for Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Amgen Inc. (NASDAQ:AMGN) and AbbVie Inc. (NYSE:ABBV).Novo …

    Published on 10/28/2016
  • TOP STORY: BMS rises on earnings, promise of cost containment

    Along with reporting 3Q16 earnings that beat estimates and raising full-year guidance, Bristol-Myers Squibb Co. (NYSE:BMY) on Thursday announced it would keep non-GAAP operating expenses "roughly flat" in 2016-20, even …

    Published on 10/27/2016
  • TOP STORY: Biogen reports Tecfidera growth, ends S1P program

    In its 3Q16 earnings report, Biogen Inc. (NASDAQ:BIIB) said sales of multiple sclerosis drug Tecfidera dimethyl fumarate grew 10% compared to 3Q15. The company also said it discontinued development of autoimmune …

    Published on 10/26/2016
  • TOP STORY: Novartis says CAR T on track

    Novartis AG (NYSE:NVS; SIX:NOVN) on Tuesday said it remains on track to submit a BLA to FDA early next year for its CTL019 chimeric antigen receptor (CAR) T cell therapy to treat pediatric acute lymphoblastic leukemia (…

    Published on 10/25/2016
  • TOP STORY: FDA approves Keytruda as first-line NSCLC therapy

    Merck & Co. Inc. (NYSE:MRK) said late Monday FDA approved Keytruda pembrolizumab as a first-line treatment for metastatic non-small lung cancer patients with ≥50% PD-L1 expression and with no EGFR or anaplastic …

    Published on 10/24/2016
  • TOP STORY: Keytruda passes Phase III bladder cancer test

    Merck & Co. Inc. (NYSE:MRK) said PD-1 mAb Keytruda pembrolizumab met the co-primary overall survival (OS) endpoint in the Phase III KEYNOTE-045 trial to treat bladder cancer. The pharma stopped the study early on the …

    Published on 10/21/2016
  • TOP STORY: Alkermes rises after MDD therapy passes Phase III test

    Alkermes plc (NASDAQ:ALKS) gained $19.47 (45%) to $62.98 in early after-hours trading Thursday after it said the higher of two doses of ALKS 5461 met the primary endpoint of the FORWARD-5 trial as an adjunctive therapy …

    Published on 10/20/2016
  • TOP STORY: FDA approves Lilly's Lartruvo for STS

    FDA granted accelerated approval to Lartruvo olaratumab from Eli Lilly and Co. (NYSE:LLY) in combination with doxorubicin to treat advanced soft tissue sarcoma patients who cannot be cured with radiation or surgery and …

    Published on 10/19/2016
  • TOP STORY: LLS launches collaborative AML trial

    On Tuesday, the Leukemia & Lymphoma Society launched the collaborative Phase IIa/IIb Beat AML trial, which will evaluate multiple candidates to treat first-line acute myelogenous leukemia.The trial will enroll newly …

    Published on 10/18/2016
  • TOP STORY: Pfizer preparing Inflectra launch

    Pfizer Inc. (NYSE:PFE) said it will launch Inflectra infliximab-dyyb, a biosimilar of Remicade infliximab, in late November at a 15% discount to Remicade's wholesale acquisition cost. Inflectra would be the first …

    Published on 10/17/2016
  • TOP STORY: Ariad shares dive after Sanders' attack

    Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) fell $1.93 (15%) to $11.14 on Friday after Sen. Bernie Sanders (I-Vt.) criticized the company's pricing strategy for leukemia drug Iclusig ponatinib. In a Twitter post, Sanders …

    Published on 10/14/2016
  • TOP STORY: Esperion expanding Phase III program for bempedoic acid

    Esperion Therapeutics Inc. (NASDAQ:ESPR) gained $0.69 to $13.01 on Thursday after it said bempedoic acid (ETC-1002) met the primary endpoint in a Phase II PK/PD study and subsequently amended the ongoing Phase III …

    Published on 10/13/2016
  • TOP STORY: Adaptimmune slips after updating ovarian cancer study

    Adaptimmune Therapeutics plc (NASDAQ:ADAP) said it amended the preconditioning regimen of a Phase I/IIa study of its NY-ESO SPEAR T cell therapy to treat ovarian cancer after the company observed no objective clinical …

    Published on 10/12/2016
  • TOP STORY: Illumina sinks on preliminary 3Q miss

    Illumina Inc. (NASDAQ:ILMN) tumbled $45.86 (25%) to $138.99 on Tuesday for a loss of $6.7 billion in market cap on Tuesday after it reported preliminary 3Q16 revenues that were well below analyst estimates and the …

    Published on 10/11/2016
  • TOP STORY: BMS, Merck present PD-1 data in first-line NSCLC

    Bristol-Myers Squibb Co. (NYSE:BMY) sank $5.62 (10%) to $49.81 on Monday, shedding $9.4 billion in market cap, after it and Merck & Co. Inc. (NYSE:MRK) each announced detailed data from Phase III studies of their PD-1 …

    Published on 10/10/2016
  • TOP STORY: Clovis slides as rucaparib response data disappoints

    Clovis Oncology Inc. (NASDAQ:CLVS) fell $6.36 (18%) to $29.41 on Friday after reporting response data for PARP inhibitor rucaparib (CO-338) that disappointed investors. The compound is under FDA Priority Review to treat…

    Published on 10/7/2016
  • TOP STORY: Alnylam sheds nearly half its value

    RNAi company Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) lost $34.02 (48%) to $36.22 on Thursday after it said it will discontinue development of revusiran (ALN-TTRsc). The company reported after market hours Wednesday …

    Published on 10/6/2016
  • TOP STORY: Alnylam ends revusiran development due to safety concerns

    Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) plummeted $29.40 (42%) to $40.90 in early after-hours trading Wednesday after it said it will discontinue development of revusiran (ALN-TTRsc) due to an "imbalance of mortality…

    Published on 10/5/2016
  • TOP STORY: CBO says Part B demo would save $1.1B

    CMS's proposal to conduct a nationwide test of new reimbursement formulas for Part B drugs would save the government $1.1 billion over a decade, according to a Congressional Budget Office report released Tuesday. The …

    Published on 10/4/2016
  • TOP STORY: J&J's guselkumab tops Humira in Phase III psoriasis trial

    Johnson & Johnson (NYSE:JNJ) said its anti-IL-23 antibody guselkumab (CNTO 1959) showed superiority to Humira adalimumab from AbbVie Inc. (NYSE:ABBV) and placebo in the Phase III VOYAGE 1 trial to treat moderate to …

    Published on 10/3/2016
  • TOP STORY: Boehringer returns olmutinib rights to Hanmi

    Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940) fell W112,000 (18%) to W508,000 after Boehringer Ingelheim GmbH (Ingelheim, Germany) said it returned rights for olmutinib (HM61713; BI 1482694) to the Korean company. …

    Published on 9/30/2016
  • TOP STORY: GOP leaders pushing for 21st Century Cures Act

    Passing the 21st Century Cures Act during the lame duck session of Congress following the elections is a high priority, Senate Majority Leader Mitch McConnell (R-Ky.) and House Speaker Paul Ryan (R-Wis.) each said …

    Published on 9/29/2016

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