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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...

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...

FDA Votes to Keep Boxed Warning on Chantix

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

Federal health advisers say a bold-letter warning...

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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...

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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...

2nd Person Tests Positive for Ebola

October 15, 2014 10:21 am | by Emily Schmall and Nomaan Merchant | News | Comments

 A second Dallas hospital worker who provided care for the first Ebola patient diagnosed in the U.S. has tested positive for the disease, pointing to lapses beyond how one individual may have donned and removed personal protective garb. Read more...     

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Nuvilex Applies for Orphan Drug Designation for Pancreatic Cancer Treatment

October 13, 2014 2:43 pm | News | Comments

Nuvilex Inc. (NVLX), a clinical-stage biotechnology company developing cell therapy solutions for the treatment of diseases, announced that it has submitted an application to the FDA for Orphan Drug Designation for its Cell-in-a-Box(R) treatment for pancreatic cancer. Read more...

FDA Approves First Drug-Coated Angioplasty Balloon Catheter for PAD

October 10, 2014 3:23 pm | News | Comments

The U.S. Food and Drug Administration approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). Read more...                              

FDA Approves Drug for Nausea, Vomiting Associated With Chemo

October 10, 2014 12:18 pm | News | Comments

The FDA approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Read more...                                         

Janssen Seeks Approval of Psoriasis Drug

October 10, 2014 10:34 am | News | Comments

Janssen-Cilag International NV (Janssen) announced that a Type 2 Variation has been filed with the European Medicines Agency seeking approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Read more...

Amgen's ALL Drug Receives FDA Priority Review

October 10, 2014 10:23 am | News | Comments

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for the investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. Read more...

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Endo Intl to Buy Auxilium in Deal Worth $2.6B

October 9, 2014 3:09 pm | News | Comments

Ireland's Endo International is planning to buy Auxilium Pharmaceuticals in a sweetened cash-and-stock deal valued at $2.6 billion a few weeks after Auxilium rejected a lower bid. The Auxilium board embraced the latest offer but its shareholders get to vote on it. Read more...

Purdue Pharma Launches Smaller Dosage of Chronic Pain Patch

October 9, 2014 3:03 pm | News | Comments

Purdue Pharma L.P. announced the U.S. commercial launch of the new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans are now available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour. Read more...

Amgen Says Version of Humira Meets Study Goal

October 9, 2014 10:42 am | by The Associated Press | News | Comments

Amgen said that its version of Humira, the best-selling drug in the world, worked as well as the original medication in a late-stage clinical trial. Read more...                             

Safety advocates seek stronger warnings on Chantix

October 8, 2014 1:13 pm | by Matthew Perrone - AP Health Writer - Associated Press | News | Comments

Public safety advocates are asking the federal government to strengthen warnings on Pfizer's anti-smoking drug Chantix, even as the drugmaker prepares to argue that a bolded warning about psychiatric problems should be removed from its medicine's label. Read more...

Genentech’s Diabetic Retinopathy Drug Gets FDA Priority Review

October 8, 2014 12:47 pm | News | Comments

Genentech, a member of the Roche Group announced that the FDA has accepted to file the company's supplemental sBLA and granted Priority Review of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7 million Americans. Read more...

Michael J. Fox Foundation Sues New Jersey Facility

October 8, 2014 12:36 pm | News | Comments

Actor Michael J. Fox's foundation is suing a New Jersey research organization, saying a freezer was left open, compromising scientific samples and hurting research efforts it was funding. Read more...

Majority of CROs Exchange TMFs Via Outdated Methods

October 8, 2014 11:05 am | News | Comments

The vast majority of contract research organizations (CROs) surveyed lag clinical trial sponsors in how they exchange trial master file (TMF) documents, according to the Veeva 2014 Paperless TMF Survey: The State of CRO TMFs. Read more...

What Kind of Research Can We Trust?

October 8, 2014 10:40 am | News | Comments

Research involving pharmaceutical company input is notoriously compromised. While not all industry ties lead to biased research, and not all biases are a consequence of industry ties, many studies show industry influence can make drugs look safer and more effective than they really are. Read more...

BMS Won't Pursue FDA Approval for HCV Treatment

October 7, 2014 2:56 pm | News | Comments

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue U.S. Food and Drug Administration (FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir. Read more...

Sunesis Pharma Shares Sink

October 6, 2014 3:13 pm | News | Comments

Shares of Sunesis Pharmaceuticals tanked Monday, wiping out all their gains for 2014 and then some, after the drug developer said its treatment for an aggressive form of blood cancer missed its main goal in late-stage testing. Read more...       

Ariad and Bellicum Announce Revised License Agreement

October 6, 2014 2:52 pm | News | Comments

Ariad Pharmaceuticals Inc. and Bellicum Pharmaceuticals Inc. announced a restructuring of their license agreement for Ariad’s cell-signaling technology. Ariad will receive $50 million in exchange for a fully paid up license to this technology and return of its equity stake in closely held Bellicum. Read more... 

Actavis Buying Durata Therapeutics for $616.4

October 6, 2014 10:39 am | News | Comments

Specialty pharmaceutical company Actavis is buying Durata Therapeutics Inc. for about $616.4 million to help bolster its infectious disease portfolio. Read more...                                    

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