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The Lead

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...

Biogen Slides as MS Drug Linked to Inflammation

October 22, 2014 1:20 pm | News | Comments

Shares of Biogen Idec slumped 8% after the pharmaceutical said a patient who took its newest...

Third Point Urges Amgen to Consider Breakup

October 22, 2014 12:49 pm | News | Comments

A hedge fund run by a famed investor said it has taken a large stake in Amgen and now wants the...

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...

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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...

12,000 Boxes of Pain Relief Tablets Are Being Recalled

October 22, 2014 10:20 am | News | Comments

12,000 boxes of pain relief tablets sold at are being recalled because the cartons contain a different medication that could cause allergic reactions. 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...                    

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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...                                 

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...

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...

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NIH Awards $640,000 to Improve Diagnosis of Diseases

October 16, 2014 9:52 am | News | Comments

A two-year grant from the NIH will fund work by a Purdue Research Park-based company to improve methods to screen blood plasma samples for biomarkers, which are measurable indicators of a disease, to expedite diagnosis and treatment. 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...

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...

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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...

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...

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...

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... 

Salix Pharma Scuttles Cosmo Technologies Merger

October 3, 2014 10:10 am | News | Comments

Salix Pharmaceuticals is scrapping its merger with the subsidiary of an Italian drugmaker after the U.S. created new limitations on the tax benefits of incorporating overseas. Read more...

EU OKs Eli Lilly's $5.4B Bid for Novartis Division

October 3, 2014 10:00 am | News | Comments

The European Union's antitrust authority says it has approved the $5.4 billion sale of Novartis' animal health division to U.S. pharmaceutical firm Eli Lilly. The 28-nation bloc's executive Commission said Friday the sale won't hinder competition because the merged firm will continue to face a number of strong competitors. Read more...

Merck Completes Sale of Consumer Unit to Bayer

October 1, 2014 3:52 pm | News | Comments

Drugmaker Merck said that it completed the sale of its consumer care business, which makes products including Claritin allergy medication and Coppertone sun-care line, to German health care company Bayer for $14.2 billion. Read more...     

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