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Daily news and top headlines for drug research professionals

Valeant Raises Outlook after Completing Purchase of Salix

April 29, 2015 4:18 pm | by The Associated Press | News | Comments

Valeant's biggest businesses include dermatology, eye health, and neurology. Read more...

FDA Accepts Otonomy's NDA for Middle Ear Effusion

April 29, 2015 12:27 pm | News | Comments

​Otonomy, Inc. a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that its New Drug Application (NDA) for the approval of AuriProTM. Read more...

FDA Accepts BLA For Biogen, AbbVie MS Treatment

April 29, 2015 12:14 pm | News | Comments

Today Biogen and AbbVie announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ Biologics License Application (BLA) requesting marketing approval of ZINBRYTA (daclizumab high-yield process) for relapsing forms of multiple sclerosis (MS). Read more...

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FDA to Review Amgen's High Cholesterol Drug

April 29, 2015 11:58 am | News | Comments

Amgen announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) will review data supporting the Company's Biologics License Application (BLA) for RepathaTM (evolocumab) for the treatment of high cholesterol at a meeting on June 10, 2015. Read more...

Breaking Ground on Biologics

April 29, 2015 11:01 am | by Ryan Bushey, Associate Editor | Articles | Comments

One of the final sessions for the 2015 Experimental Biology Conference in Boston, Massachusetts was on biologics. Over the course of two and a half hours, a panel of scientists and experts discussed their research and where they see opportunity in this field. Read more...

Takeda Agrees to Pay $2.4B in Diabetes Drug Suit

April 29, 2015 8:26 am | by Mari Yamaguchi, Associated Press | News | Comments

Takeda has faced product liability lawsuits in the U.S. involving about 9,000 people who say the company failed to inform them of the drug's cancer risks. Read more...

OncoGenex Regains Right to Custirsen from Teva

April 29, 2015 8:22 am | News | Comments

This transfer of rights occurs in connection with the termination of the 2009 collaboration agreement between OncoGenex and Teva. Read more...

Novartis Announces Phase 3 Study of CLL Drug Met Primary Endpoint

April 28, 2015 4:34 pm | News | Comments

The safety profile observed in this trial is consistent with other trials of Arzerra and no new safety signals were observed. Read more....

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Pfizer, Despite Dollar and Generics Fight, Still Impresses

April 28, 2015 1:22 pm | by Associated Press | News | Comments

Pfizer overcame a strong dollar and patent expirations to beat Wall Street projections for the first quarter, though it cut its outlook for the year citing both. Read more...

The Story of Biogen's Alzheimer's Drug, Aducanumab

April 28, 2015 10:28 am | by Cynthia Fox, Science Editor | Articles | Comments

The Biogen anti-amyloid antibody, aducanumab, took the 12th International Conference on Alzheimer’s and Parkinson’s Diseases in Nice, France by storm last month. The drug seemed able to significantly reduce amyloid in patients’ brains, while demonstrably slowing cognitive degeneration. It had analysts and scientists alike buzzing. Read more...

Molecular Health Gains European Patent for Novel Receptor

April 28, 2015 8:54 am | News | Comments

It addresses unmet need in treatment of millions of cancer patients. Read more...

GSK Shingles Vaccine Demonstrates 97.2% Efficacy in Phase 3 Study

April 28, 2015 8:37 am | News | Comments

GlaxoSmithKline presented detailed data from a randomized phase 3 study of its investigational vaccine candidate for the prevention of shingles. Read more...

Ebola Scare May Inform U.S.'s Response to Bioterrorism

April 27, 2015 2:50 pm | by Seth Augenstein, Digital Reporter | Articles | Comments

Last year’s Ebola scare might provide a blueprint for a response to the unthinkable: a bioterrorist attack in the U.S. Read more...

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Mylan Declines Teva's $40B Takeover Attempt

April 27, 2015 12:08 pm | by Ryan Bushey, Associate Editor | Articles | Comments

The executive chairman for Mylan wrote a letter to Teva citing a number of issues as to why this merger would be a bad idea. Read more...

Lilly's Cyramza Receives Fourth FDA Approval

April 27, 2015 12:07 pm | News | Comments

Eli Lilly and Company has received its fourth U.S. Food and Drug Administration (FDA) approval for Cyramza (ramucirumab). Read more...

Allergan to Cut Hundreds of U.S. Jobs

April 27, 2015 9:50 am | by Ryan Bushey, Associate Editor | Articles | Comments

A total of 674 staff members have been let go from Allergan’s operations in California so far since 2014. Read more...

MedDay Reports Positive Phase 3 Results from MS Drug Study

April 27, 2015 8:37 am | News | Comments

The study demonstrated evidence of the efficacy and safety of MD1003, a highly-concentrated pharmaceutical-grade biotin administered at a dose of 300 mg per day in the treatment of primary and secondary progressive multiple sclerosis, a major area of unmet medical need. Read more....

Bristol-Myers Gets Positive EMA Opinion for Immunotherapy Drug, Opdivo

April 24, 2015 12:36 pm | by Stephanie Guzowski, Editor | Articles | Comments

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Bristol-Myers Squibb’s Opdivo today for the treatment of melanoma. Read more..

FDA Grants Priority Review for AbbVie's Hepatitis C Treatment

April 24, 2015 12:16 pm | News | Comments

AbbVie has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for the company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV).  Read more...

J&J Hikes Quarterly Dividend by 7 Percent

April 24, 2015 12:06 pm | by Linda A. Johnson, AP Business Writer | News | Comments

Johnson & Johnson on Thursday said it's raising its quarterly dividend by 7 percent, marking its 53rd straight year of dividend increases. Read more...

Manchester Joins European Consortium to Develop Liquid Biopsies

April 24, 2015 8:47 am | by University of Manchester | News | Comments

An international project to validate blood-based biomarkers for cancer has added a new member. Read more...

FDA Grants Priority Review for Boehringer Ingelheim's Idarucizumab

April 23, 2015 2:06 pm | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for idarucizumab. Read more...

FDA Accepts Filing of Bayer's MS Treatment

April 23, 2015 2:03 pm | News | Comments

Bayer is pleased to announce today that the U.S. Food and Drug Administration (FDA) has accepted the filing for Bayer's supplemental Biologics License Application (sBLA) for Betaconnect (proposed name), another delivery option for Betaseron (interferon beta-1b), a treatment for relapsing-remitting multiple sclerosis. 

Abbvie Raises Outlook as Humira Again Delivers Earnings Beat

April 23, 2015 1:36 pm | by Matthew Perrone, AP Health Writer | News | Comments

Drugmaker AbbVie is raising its full-year earnings guidance after reporting better-than-expected first quarter adjusted results on continued growth of its blockbuster anti-inflammatory drug Humira. Read more...

Pipeline Advancements, Asset Acquisitions Fueled Mid-Cap Biotech R&D Spend in 2014

April 23, 2015 12:22 pm | by Adam Dion, GlobalData's Senior Industry Analyst | Articles | Comments

The combined spend on research and development (R&D) for the peer group of 35 mid-cap biotech companies increased by nearly $2 billion to reach a total of $9.7 billion in 2014. Read more...

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