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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...

Mali On High Alert With New Ebola Cluster

November 17, 2014 9:19 am | by Baba Ahmed - Associated Press | News | Comments

 Mali had been spared the virus now blamed for killing more than 5,000 people across West...

Using Real-World Data for Outcomes Research and Comparative Effectiveness Studies

November 4, 2014 10:17 am | by Christina Mack, Ph.D., MSPH, Associate Director, Epidemiology, Real-World & Late Phase Research, Quintiles, and Kathy Lang, Ph.D., Senior Director, Emerging Businesses Data & Analytics, Real-World & Late Phase Research, Quintiles | Articles | Comments

Biopharma is...

BDSI's Opioid Dependence Treatment Now Available in U.S.

November 3, 2014 1:23 pm | News | Comments

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Actavis, Durata Therapeutics Get FTC Clearance

November 3, 2014 1:08 pm | News | Comments

Actavis plc and Durata Therapeutics, Inc. announced that the U.S. Federal Trade Commission (FTC) has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 ("HSR") with respect to Actavis' pending acquisition of Durata. Read more...

Biosimilar Medications Could Create Billions in Savings

November 3, 2014 12:59 pm | News | Comments

Introducing competing “biosimilar” versions of complex biologic drugs used to treat illnesses such as cancer and rheumatoid arthritis could cut spending on biologics in the United States by $44 billion over the next decade, according to new analysis from the RAND Corporation. Read more...

Regulatory Data: Vital for DDI Risk-Mitigation Efforts

November 3, 2014 11:04 am | by Philip MacLaughlin, Product Director, PharmaPendium, Elsevier | Articles | Comments

Unanticipated adverse drug-drug interactions (DDIs) have led to the withdrawal of several high-profile drugs that had been available for a number of years, including terfenadine, astemizole, cisapride, grepafloxacin and mibefradil.  Read more... 

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Daiichi Sankyo's Heart Drug Gets FDA Recommendation

October 31, 2014 10:11 am | News | Comments

Daiichi Sankyo announced that the FDA Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily Savaysa (edoxaban) 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF). Read more...

Boehringer Ingelheim, Lilly Restructure Diabetes Alliance

October 29, 2014 10:01 am | News | Comments

In a move that will strengthen their alliance by enhancing efficiencies and enabling greater focus on product launches, Boehringer Ingelheim and Eli Lilly and Company are changing the operational and financial structure of their diabetes alliance in certain countries. Read more...

Valeant: We'll Bump Allergan Offer to $200 a Share

October 27, 2014 11:03 am | News | Comments

The Canadian drugmaker Valeant said it would be willing to raise its takeover bid for Allergan by almost 12%, which would mean $200 or more per share for the maker of Botox. Read more...

CSL to Acquire Novartis Influenza Vaccine Business

October 27, 2014 10:51 am | News | Comments

CSL Limited announced that it has agreed to acquire Novartis’ global influenza vaccine business for $275 million. The business will be combined with CSL’s subsidiary, bioCSL. Read more...

Cancer Innovation Forum Calls for Improving Research Progress

October 24, 2014 1:37 pm | News | Comments

At a time when cancer drug development is at a critical juncture, accelerating the delivery of promising new treatments will depend on one critical requirement: ensuring that patients, individually and collectively, are actively involved in the cancer research and drug development process from beginning to end.  Read more...

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PhosImmune, PureMHC Working Together on Cancer Immunotherapies

October 22, 2014 1:28 pm | News | Comments

PhosImmune Inc. and PureMHC LLC announced they have entered into a license and collaboration agreement to develop novel antibody-based immunotherapies designed to target cancers. Read more...

Study Finds Drugs Still in Recalled Supplements

October 22, 2014 11:48 am | by Lindsey Tanner, AP Medical Writer | News | Comments

Dietary supplements containing potentially dangerous prescription drug ingredients may still be for sale even years after safety recalls, a study found. Read more...                              

Actavis Signs Option to Acquire Rhythm Subsidiary

October 22, 2014 10:24 am | News | Comments

Actavis plc, a leading global specialty pharmaceutical company, and Rhythm, a biopharmaceutical company, announced that Actavis has been granted an exclusive option to acquire Rhythm's wholly owned subsidiary, Rhythm Health Inc. Read more...

Johnson & Johnson Announces New Spending Plan for Ebola Vaccine

October 22, 2014 10:05 am | News | Comments

Johnson & Johnson announced that it has made a commitment of up to $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. Read more...                    

Rho Awarded New Federal Contract

October 21, 2014 2:46 pm | News | Comments

Rho, a contract research organization (CRO) providing clinical research services in both the commercial and federal market, has been awarded the renewal of their existing federal contract with the National Institute of Dental and Craniofacial Research (NIDCR). Read more...

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AbbVie to Pay Shire $1.64B Fee Over Nixed Merger

October 21, 2014 10:13 am | News | Comments

AbbVie is walking away from its proposed $55 billion takeover bid of Shire and has agreed to pay the rival drugmaker a $1.64 billion breakup fee. Read more...                            

Anti-Abuse Label Approved for Painkiller Embeda

October 20, 2014 11:45 am | News | Comments

The U.S. Food and Drug Administration (FDA) says it has approved new labeling for another opioid designed to limit painkiller abuse. Read more...                                 

NewLink Genetics, Genentech Enter Into Exclusive Worldwide License

October 20, 2014 10:44 am | News | Comments

NewLink Genetics Corp., a biopharmaceutical company focused on discovering, developing, and commercializing novel immunotherapeutics to improve treatment options for patients with cancer, announced that they have entered into an exclusive worldwide license agreement with Genentech, a member of the Roche Group, for the development of NLG919, NewLink's IDO pathway inhibitor. Read more...

Amgen Files Lawsuit Against Sanofi, Regeneron for Patent Infringement

October 17, 2014 12:57 pm | News | Comments

Amgen announced that it filed a lawsuit against Sanofi and Regeneron Pharmaceuticals, Inc. for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. Read more...

FDA Votes to Keep Boxed Warning on Chantix

October 17, 2014 10:26 am | News | Comments

Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Read more...

FDA Approves Boehringer Ingelheim's Drug for Lung Disease

October 16, 2014 10:30 am | News | Comments

 Boehringer Ingelheim announced that the FDA approved OFEV (nintedanib) capsules for oral use for the treatment of idiopathic pulmonary fibrosis (IPF). Read more...

AbbVie Sours on $55B Shire Deal After Tax Changes

October 16, 2014 10:13 am | News | Comments

AbbVie's board is telling shareholders vote against its own $55 billion takeover bid for the Irish drugmaker Shire after the U.S. made reincorporating overseas a less lucrative tax maneuver. Read more...

U.S. Steps Up Response As Ebola Worries Grow

October 16, 2014 10:06 am | by Jim Kuhnhenn | News | Comments

The revelation that a second Dallas nurse who is ill with Ebola was cleared to fly the day before her diagnosis raised new alarms as leaders of the nation's public health system prepared to defend their efforts to contain the deadly virus before a congressional hearing. Read more...

FDA: Little Evidence to Drop Chantix Boxed Warning

October 15, 2014 1:22 pm | by Matthew Perrone, AP Health Writer | News | Comments

Federal regulators say Pfizer has provided low-quality evidence to support its request to remove a bold-letter warning from its anti-smoking drug Chantix about suicidal behavior. Read more...

Shire Says AbbVie Should Proceed with $55B Buyout

October 15, 2014 1:05 pm | by Tom Murphy | News | Comments

The drugmaker Shire wants AbbVie to stick with its roughly $55 billion acquisition bid, and it is reminding its U.S. counterpart of the hefty breakup fee it could receive if things don't work out. Read more...

Ex-Financial Analyst at Merck Faces Insider Trading Charge

October 15, 2014 12:43 pm | News | Comments

A former senior finance analyst at Merck & Co. is facing an insider trading charge after authorities said that he passed secrets to a friend he met at college that earned $722,000 in illegal profits. Read more...

Selecta, JDRF, Sanofi Collaborate on SVP Immunotherapy for Type 1

October 15, 2014 10:31 am | News | Comments

Selecta Biosciences and JDRF, announced that they have extended their joint research collaboration and attracted Sanofi as a partner in support of their program to develop an SVP immunotherapy with the long-term goal to treat and potentially prevent the underlying cause of type 1 diabetes. Read more...

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