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The Lead

Anti-Abuse Label Approved for Painkiller Embeda

October 17, 2014 8:36 pm | by The Associated Press | News | Comments

The U.S. Food and Drug Administration says it has approved new labeling for another opioid designed to limit painkiller abuse. The FDA said Friday that Pfizer Inc.'s Embeda can have labeling indicating that it has properties expected to reduce abuse of the drug when it is crushed and taken orally or snorted.

FDA Panel Votes to Keep Boxed Warning on Chantix

October 16, 2014 4:36 pm | by The Associated Press | News | Comments

Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix...

FDA: Little Evidence to Drop Chantix Boxed Warning

October 14, 2014 11:50 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal regulators say Pfizer has provided low-quality evidence to support its request to remove...

FDA Accepts Pfizer's Palbociclib New Drug Application for Priority Review

October 14, 2014 8:52 am | News | Comments

This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line...

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Safety Advocates Seek Stronger Warnings on Chantix

October 8, 2014 10:09 am | by MATTHEW PERRONE, AP Health Writer | 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.

Viagra Ads Target Women for First Time

October 1, 2014 8:30 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The maker of the world's top-selling erectile dysfunction drug on Tuesday will begin airing the first Viagra TV commercial that targets the less-obvious sufferers of the sexual condition: women.          

Drug and Device Firms Paid $3.5B to Care Providers

September 30, 2014 6:45 pm | by Ricardo Alonso-zaldivar - Associated Press - Associated Press | News | Comments

From research grants to travel junkets, drug and medical device companies paid doctors and leading hospitals billions of dollars last year, the government disclosed Tuesday in a new effort to spotlight potential ethical conflicts in medicine.  

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M&A Update: Abbott, CFR, Pfizer, InnoPharma

September 26, 2014 11:07 am | News | Comments

Pfizer announced that it has completed its acquisition of pharmaceutical development company, InnoPharma, Inc., and Abbott has acquired control of CFR Pharmaceuticals, more than doubling its Latin American-branded generics pharmaceutical presence.

New FDA Label Bolsters Safety Case for Chantix

September 24, 2014 11:43 am | News | Comments

New government-approved labeling on Pfizer's drug Chantix suggests that the anti-smoking medication may not carry the risks of suicidal behavior that first earned it the government's strongest warning more than five years ago.    

MedGenesis Enters Into Agreement with Pfizer for Potential Treatments for Parkinson's Disease

September 16, 2014 9:07 am | News | Comments

MedGenesis Therapeutix has entered into an agreement with Pfizer, granting Pfizer an exclusive, worldwide option to license its glial cell line-derived neurotrophic factor (GDNF) protein and convection enhanced delivery (CED) technology to be used in research for potential treatments for Parkinson's disease.

Pfizer and Protalix BioTherapeutics Announce FDA Approval of Pediatric Indication for ELELYSO™

August 28, 2014 1:41 pm | News | Comments

Pfizer and Protalix BioTherapeutics announced that the FDA approved ELELYSO™ for injection for pediatric patients. ELELYSO is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.

Pfizer’s Vaccine Candidate for Clostridium difficile Receives FDA Fast Track Designation

August 28, 2014 8:10 am | News | Comments

Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile -associated disease, which can include life-threatening diarrhea and pseudomembranous colitis.         

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Pfizer And Merck to Collaborate On Study Evaluating Novel Anti-Cancer Combination Regimen

August 26, 2014 8:35 am | News | Comments

Pfizer and Merck announced today that they have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer.

FDA Approves Eliquis For DVT And PE

August 21, 2014 3:39 pm | by Pfizer | News | Comments

Bristol-Myers Squibb Company and Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. 

FDA Accepts Pfizer's Biologics License Application For Investigational Meningococcal B Vaccine

August 15, 2014 8:12 am | News | Comments

Pfizer announced that the FDA has accepted for review the Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease.     

CDC Recommends Pfizer’s Prevnar 13® Vaccine in Adults Aged 65 Years and Older

August 14, 2014 8:16 am | News | Comments

Pfizer announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein])PCV13) for routine use to help protect adults aged 65 years and older against pneumococcal disease.

Pfizer to Pay $35M to Settle Drug Marketing Case

August 6, 2014 4:38 pm | by The Associated Press | News | Comments

Pfizer will pay $35 million to resolve allegations by 42 states that its subsidiary, Wyeth Pharmaceuticals, illegally marketed an organ transplant drug for unapproved uses. The states' attorneys general said Wednesday that Wyeth, which Pfizer bought in 2009, trained sales representatives to prescribe Rapamune for uses other than preventing rejection of transplanted kidneys.

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Baxter to Sell Commercial Vaccines Business to Pfizer

July 30, 2014 8:06 am | News | Comments

Baxter International has entered into a definitive agreement to sell its two commercially marketed vaccines and related production facilities to Pfizer Inc. for a total cash consideration of $635 million, subject to certain adjustments.   

European Commission Approves Eliquis for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

July 29, 2014 8:38 am | News | Comments

Bristol-Myers Squibb and Pfizer announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults. The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway.

Pfizer's Second Quarter Profit Sinks 79% But Tops Forecasts

July 29, 2014 8:30 am | News | Comments

Pfizer's second-quarter earnings plunged 79 percent from last year, when the world's second-largest drugmaker booked a business spinoff gain of more than $10 billion, but results in the most recent quarter still edged analyst expectations.  

Obama Wants Limits on US Company Mergers Abroad

July 25, 2014 8:32 am | News | Comments

Staking out a populist stand ahead of the midterm elections, President Barack Obama on Thursday demanded "economic patriotism" from U.S. corporations that use legal means to avoid U.S. taxes through overseas mergers.      

Pfizer Survey Reveals 87% of Americans have a Fear of Getting Old (FOGO)

July 16, 2014 11:15 am | News | Comments

Life expectancy continues to climb — up to more than 81 years for women and 76 years for men – but many of us have concerns around aging. Pfizer is challenging Americans to address their #FOGO – Fear of Getting Old – as the next phase of Get Old, an initiative by Pfizer around aging, encouraging honest conversations and celebrating getting “old” at whatever stage of life you are.

Pfizer to Acquire InnoPharma

July 16, 2014 9:34 am | News | Comments

Pfizer and InnoPharma, a privately held pharmaceutical development company, today announced that they have entered into an agreement under which Pfizer will acquire InnoPharma. Under the terms of the agreement, Pfizer will acquire InnoPharma for an upfront cash payment of $225 million, with up to $135 million of contingent milestone payments.

Pfizer & Cellectis Enter Into Global Strategic Cancer Immunotherapy Collaboration

June 18, 2014 9:19 am | by Pfizer | News | Comments

 Pfizer Inc. and Cellectis announced that they have entered into a global strategic collaboration to develop Chimeric Antigen Receptor T-cell (CAR-T) immunotherapies in the field of oncology directed at select targets.                           

Pfizer Submits BLA For Investigational Meningococcal Vaccine

June 17, 2014 9:17 am | by Pfizer | News | Comments

Pfizer Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25 year olds.

Pfizer Official Receives Diamond Award For Pharmaceutical Manufacturing

June 16, 2014 9:55 am | News | Comments

Patricia A. English is recognized by Continental Who's Who as 2014 Diamond Professional of the Year in the field of Pharmaceutical Manufacturing as a result of her role as Director of Oncology Statistics with Pfizer.               

New Pfizer Discount Keeps Brand-Name Lipitor Cheap

June 2, 2014 6:51 am | by Linda A. Johnson - AP Business Writer - Associated Press | News | Comments

Patients who prefer brand-name cholesterol drug Lipitor to an inexpensive generic version will find it more affordable, thanks to a new discount offer from drugmaker Pfizer Inc. They'll be able to get Lipitor, the highest-selling prescription medicine in history, for $30 or less per month— not much more than a generic.

Pfizer Names Chief Scientific Officer, Cardiovascular and Metabolic Disease Research

May 29, 2014 11:33 am | News | Comments

Pfizer announced that Morris J. Birnbaum, M.D., Ph.D., has joined the company as Chief Scientific Officer for Cardiovascular and Metabolic Disease Research. He will report directly to Rod MacKenzie, Ph.D., Group Senior Vice President and Head of PharmaTherapeutics Research & Development, and will be based in a key Pfizer R&D hub in Cambridge, MA.

Pfizer Launches OTC Nexium® 24HR

May 27, 2014 8:49 am | News | Comments

Pfizer today announced the introduction in the U.S. of over-the-counter (OTC) Nexium® 24HR, making The Purple Pill® available for the treatment of frequent heartburn (two or more days a week) in adults (18 years and older).     

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