Skip to main content
Home > The Daily Extra > Top Story

Chronological Index of : Top Story

 Current Issue
  • TOP STORY: Amgen submits BLA for Humira biosimilar

    Amgen Inc. (NASDAQ:AMGN) said Wednesday it submitted a BLA to FDA for ABP 501, a biosimilar version of Humira adalimumab from AbbVie Inc. (NYSE:ABBV).Amgen said the application includes Phase III comparative efficacy …

    Published on 11/25/2015
  • TOP STORY: FDA panel finds Kyndrisa efficacy inconclusive

    Panelists at a meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee to discuss Kyndrisa drisapersen from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) generally agreed that the therapy's efficacy…

    Published on 11/24/2015
  • TOP STORY: Pfizer, Allergan advance mega-merger

    Pfizer Inc. (NYSE:PFE) and Allergan plc (NYSE:AGN) agreed to a merger valued at $160 billion, telling both Wall Street and Washington that investors and regulators should look at the strategic merits rather than the tax…

    Published on 11/23/2015
  • TOP STORY: FDA reviewers question efficacy of BioMarin's DMD therapy

    In briefing documents released ahead of a Nov. 24 advisory committee meeting, FDA reviewers expressed doubts that Kyndrisa drisapersen from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) is effective to treat Duchenne …

    Published on 11/20/2015
  • TOP STORY: Boston Pharmaceuticals debuts with $600M

    Gurnet Point Capital formed Boston Pharmaceuticals (Cambridge, Mass.) and committed $600 million with which the newco intends to build a portfolio of 20-25 assets. Boston Pharmaceuticals plans to in-license products …

    Published on 11/19/2015
  • TOP STORY: Pfizer-Allergan rumors intensify

    Allergan plc (NYSE:AGN) rallied in after-hours trading Wednesday, gaining $2.20 to $313 after media reports said Pfizer Inc. (NYSE:PFE) is nearing a deal to acquire it for up to $380 per share, or about $150 billion.…

    Published on 11/18/2015
  • TOP STORY: Califf breezes through confirmation hearing

    On Tuesday, members of the Senate Health, Education, Labor and Pensions (HELP) Committee expressed strong support for confirming Robert Califf as FDA commissioner.In an opening statement at the confirmation hearing, …

    Published on 11/17/2015
  • TOP STORY: Clovis plunges on rociletinib update

    Clovis Oncology Inc. (NASDAQ:CLVS) shed $69.19 (70%) to $30.24 on volume of 30.6 million shares Monday after disclosing the rate of confirmed responses to lung cancer compound rociletinib (CO-1686) was lower than …

    Published on 11/16/2015
  • TOP STORY: FDA approves AZ's Tagrisso, companion diagnostic

    FDA granted accelerated approval to Tagrisso osimertinib (AZD9291) from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat T790M EGFR mutation-positive advanced non-small cell lung cancer (NCSLC) patients whose disease has …

    Published on 11/13/2015
  • TOP STORY: Derma misses 'one shot' at drug development

    Derma Sciences Inc. (NASDAQ:DSCI) fell $1.56 (28%) to $4.04 on Thursday on news it will terminate development of aclerastide (DSC127), the only candidate in the company's drug development portfolio. Derma said that …

    Published on 11/12/2015
  • TOP STORY: IPO quartet pulls in combined $290.1M

    Advanced Accelerator Applications S.A. (NASDAQ:AAAP), Voyager Therapeutics Inc. (NASDAQ:VYGR), Wave Life Sciences Ltd. (NASDAQ:WVE) and Curetis AG (Euronext:CURE) all priced IPOs, raising a combined $290.1 million. …

    Published on 11/11/2015
  • TOP STORY: Astellas buying Ocata for $379M

    Astellas Pharma Inc. (Tokyo:4503) announced late Monday night that it will acquire cell therapy company Ocata Therapeutics Inc. (NASDAQ:OCAT) for $8.50 per share, or $379 million in cash. The price represents a 91% …

    Published on 11/10/2015
  • TOP STORY: Harvard Pilgrim picks Repatha

    Regional insurance company Harvard Pilgrim Health Care Inc. granted Repatha evolocumab from Amgen Inc. (NASDAQ:AMGN) exclusive preferred status on its formulary in exchange for undisclosed discounts on the lipid-…

    Published on 11/9/2015
  • TOP STORY: AZ scoops up ZS ahead of PDUFA date

    AstraZeneca plc (LSE:AZN; NYSE:AZN) is grabbing ZS Pharma Inc. (NASDAQ:ZSPH) for $2.7 billion in cash, betting the biotech's ZS-9 for hyperkalemia will generate $1 billion in peak year sales after approvals starting …

    Published on 11/6/2015
  • TOP STORY: CMS wants HCV company input on Medicaid best price

    CMS sent letters to four HCV companies on Thursday seeking information on value-based pricing arrangements to help inform future guidance around Medicaid best price. CMS sent the letters to AbbVie Inc. (NYSE:ABBV), …

    Published on 11/5/2015
  • TOP STORY: Democrats attack drug prices

    Standing on the lawn of the U.S. Capitol in front of posters of CEO Martin Shkreli of Turing Pharmaceuticals AG (New York, N.Y.) and Chairman and CEO Michael Pearson of Valeant Pharmaceuticals International Inc. (TSX:…

    Published on 11/4/2015
  • TOP STORY: Obama administration, House Dems target drug prices

    The White House and U.S. House Democrats dialed up the political heat on drug pricing Tuesday with separate announcements of public initiatives to address the issue.HHS announced a public forum "to explore …

    Published on 11/3/2015
  • TOP STORY: Shire builds on HAE franchise with Dyax takeout

    Shire plc (LSE:SHP; NASDAQ:SHPG) will acquire Dyax Corp. (NASDAQ:DYAX) for $37.30 per share, or $5.9 billion in cash. The price represents a 35% premium to Dyax's close of $27.53 on Oct. 30, the last trading day before …

    Published on 11/2/2015
  • TOP STORY: AbbVie expects continued Humira strength

    AbbVie Inc. (NYSE:ABBV) gained $5.45 (10%) to $59.55 on Friday after reporting 3Q15 earnings and forecasting revenues of $37 billion by 2020, driven largely by sales of Humira adalimumab.Humira sales were $3.6 billion …

    Published on 10/30/2015
  • TOP STORY: Pfizer, Allergan in merger talks

    Allergan plc (NYSE:AGN) said Pfizer Inc. (NYSE:PFE) has approached it regarding a potential merger. Both companies said they are in "preliminary friendly discussions" for a deal. Neither company disclosed terms. Pfizer …

    Published on 10/29/2015
  • TOP STORY: Amgen lifts guidance, beats estimates

    Amgen Inc. (NASDAQ:AMGN) raised its 2015 guidance and reported 3Q15 revenues above consensus estimates. The company said it now expects 2015 revenue of $21.4-$21.6 billion, up from $21.1-$21.4 billion, and estimated …

    Published on 10/28/2015
  • TOP STORY: Gilead tops estimates as HCV sales level off

    Gilead Sciences Inc. (NASDAQ:GILD) reported $4.8 billion in HCV sales in 3Q15, up 70% from $2.8 billion in 3Q14. Quarterly sales of Harvoni ledipasvir/sofosbuvir were $3.3 billion, while sales of Sovaldi sofosbuvir …

    Published on 10/27/2015
  • TOP STORY: Vertex, CRISPR enter research partnership

    Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) and CRISPR Therapeutics AG (Basel, Switzerland) entered a four-year research collaboration to discover and develop treatments using CRISPR's gene editing technology. The …

    Published on 10/26/2015
  • TOP STORY: FDA approves Alexion's Strensiq

    FDA approved Strensiq asfotase alfa from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) to treat perinatal, infantile and juvenile-onset hypophosphatasia (HPP) and granted the company a Priority Review voucher through the …

    Published on 10/23/2015
  • TOP STORY: AbbVie, Enanta tumble on FDA warning for HCV regimens

    AbbVie Inc. (NYSE:ABBV) shed $5.56 (10%) to $48.27 and Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) plummeted $16.35 (41%) to $23.90 on Thursday after FDA issued a safety warning linking HCV therapies Viekira Pak and …

    Published on 10/22/2015

< Previous   1  2  3  4  5  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993