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The Lead

The Cystic Fibrosis Foundation's Controversial New Cash

November 26, 2014 12:00 pm | by Ryan Bushey, Associate Editor | Articles | Comments

Concerns have been raised relating to a lucrative investment the Cystic Fibrosis Foundation made in a biotechnology company. Read more...                    

Valeant Receives FDA Approval for Acne Treatment

November 26, 2014 8:58 am | News | Comments

Valeant Pharmaceuticals announced it has received FDA approval of a gel that can treat acne...

Transposagen, Janssen to Collaborate on CAR-T Therapies

November 25, 2014 1:46 pm | by Drug Discovery & Development Staff | News | Comments

Transposagen...

Vascular Solutions Gets Clearance for Tumor Treating Gel-Block

November 25, 2014 9:44 am | News | Comments

Vascular Solutions gets clearance from the FDA for tumor treating gel blocks. Read more......

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Researchers Seek New Regulations for Digital Pharma Marketing

November 24, 2014 2:22 pm | by Ryan Bushey, Associate Editor | Articles | Comments

The researchers feel that the current policies for pharmaceutical marketing need to be updated as soon as possible. Read more...                      

Improving The Odds of Beating Opioids

November 24, 2014 1:16 pm | by Sue McGreevy, Harvard University | News | Comments

Research indicates that live-in programs may result in higher levels of abstinence than the outpatient treatment that is currently the standard of care. Read more...                

BMS to Collaborate on Immunotherapy Evaluation

November 24, 2014 1:01 pm | News | Comments

BMS and Five Prime Therapeutics Inc. announced that they have entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of immunotherapy drugs. Read more...       

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BioMarin Pharma Offers About $680M for Prosensa

November 24, 2014 12:41 pm | News | Comments

The company also said it will make two approximately $80 million milestone payments to Prosensa shareholders. Read more...                       

Health Care M&A Leads Global Deal Surge

November 24, 2014 9:17 am | by Linda A. Johnson and Steve Rothwell, AP Business Writers - Associated Press | News | Comments

In a big year for deal making, the health care industry is a standout. Large drugmakers are buying and selling businesses to control costs and deploy surplus cash. A rising stock market, tax strategies and low interest rates are also fueling the mergers and acquisitions. Read more...

Soaring Generic Drug Prices Draw Senate Scrutiny

November 21, 2014 11:10 am | by Matthew Perrone, AP Health Writer - Associated Press | News | Comments

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington lawmakers. Read more...

UK Investment to Develop Lung Cancer Drugs

November 21, 2014 9:58 am | News | Comments

A new collaboration in the UK will develop a promising class of cancer inhibitors. Read more...                            

BI's IPF Drug Gains Positive Opinion in Europe

November 21, 2014 9:52 am | News | Comments

Boehringer Ingelheim's announced that its idiopathic pulmonary fibrosis drug gained a positive opinion in Europe. Read more...                      

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Shire Relocates 500 Jobs to Massachusetts

November 20, 2014 1:54 pm | News | Comments

Shire is transferring 500 jobs to Massachusetts. Read more...                                  

Global Oncology Market to Hit $109B

November 20, 2014 9:19 am | News | Comments

Cancer, with a death toll exceeding that of AIDS (Acquired Immune Deficiency Syndrome), tuberculosis and malaria collectively, accounted for 8.3 million deaths in 2013. With a skyrocketing incidence of 469.6 per 100,000 in the US alone, the oncology market is poised to grow at a substantial CAGR of around 7% to $109 billion by 2020. Read more...

Camurus, Braeburn Pharmaceuticals Sign Exclusive License for Opioid Treatment

November 20, 2014 9:15 am | News | Comments

Camurus and Braeburn Pharmaceuticals announced that they have entered into an exclusive license agreement for Camurus' weekly and monthly subcutaneous buprenorphine injection products (CAM2038) for the treatment of opioid addiction and pain. Read more...   

Royalty Pharma Pays $3.3B for Cystic Fibrosis Royalties

November 19, 2014 1:51 pm | News | Comments

Royalty Pharma announced its acquisition of royalties on Vertex Pharmaceuticals' cystic fibrosis treatments owned by Cystic Fibrosis Foundation Therapeutics' ("CFFT"), an affiliate of the Cystic Fibrosis Foundation, for a cash payment of $3.3 billion. Read more...

HHS, NIH To Enhance Transparency of Clinical Trial Results

November 19, 2014 1:43 pm | News | Comments

The U.S. Department of Health and Human Services today issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Read more...

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$2.6B: Cost to Develop, Win Marketing Approval for New Drug

November 19, 2014 1:35 pm | News | Comments

Developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to the Tufts Center for the Study of Drug Development. Read more...

Janssen Seeks European Approval of Chronic Inflammatory Disease Drug

November 19, 2014 10:16 am | News | Comments

Janssen submitted an application for European approval regarding a drug intended to treat chronic inflammatory disease of the spine. Read more...                    

Sub-Standard Meds Flood Afghan Market

November 19, 2014 9:24 am | News | Comments

Up to 300 companies in Pakistan produce poor quality drugs exclusively for Afghanistan because their products do not meet Pakistani government standards. Read more...                

Actavis to Buy Allergan for $66B

November 17, 2014 2:34 pm | by Tom Murphy - AP Business Writer | News | Comments

Actavis will pay $66 billion to buy fellow drugmaker Allergan in a deal that could finally end a months-long takeover push from Valeant Pharmaceuticals. Read more...                

Genzyme's MS Drug Gains FDA Approval

November 17, 2014 12:56 pm | News | Comments

The FDA approved Genzyme's new drug for the treatment of multiple sclerosis. Read more...                             

DEA Agents Raid NFL Medical Staffs After Games

November 17, 2014 12:39 pm | by Jim Litke - AP Sports Writer | News | Comments

The DEA investigation comes during a turbulent time for the NFL. Read more...                               

FDA Accepts Janssen's Schizoaffective Disorder Drug sNDA

November 14, 2014 12:11 pm | News | Comments

Janssen Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. Read more...

Oxford to Lead Trial of Experimental Drug for Ebola

November 14, 2014 10:07 am | News | Comments

A clinical trial is to be carried out in West Africa to see whether a novel antiviral drug is effective against Ebola. Read more...                       

Online Tool Provides Health Info by ZIP Code, District

November 13, 2014 1:15 pm | News | Comments

For the first time, anyone can easily access comprehensive California health statistics by ZIP code, city and legislative district thanks to a new web tool created by the UCLA Center for Health Policy Research.  Read more...

Roche Teams Up with LabCentral to Support Biotech Startups

November 13, 2014 12:27 pm | News | Comments

LabCentral and Roche announced an agreement in which Roche would provide technology and financial support to LabCentral, a first-of-its-kind shared laboratory space designed as a launchpad for high-potential life-sciences and biotech startups. Read more...

Ebola Drug Testing Sparks Ethics Debate

November 13, 2014 9:36 am | by Matthew Perrone, AP Health Writer - Associated Press | News | Comments

Health officials are scrambling to begin human testing of a handful of experimental drugs for Ebola. But the effort has sparked an ethical debate over how to study unproven medicines amid an outbreak that has killed nearly 5,000. Read more...

FDA Accepts Amgen's BLA for Cholesterol-Lowering Drug

November 11, 2014 10:27 am | News | Comments

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's Biologics License Application (BLA) for evolocumab for the treatment of high cholesterol. Read more...

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