Pfizer announced that the FDA has granted accelerated approval of TRUMENBA ® (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
On a per-share basis, the New York-based company said it had profit of 42 cents. Earnings,...
Pfizer says it approved the repurchase of $11 billion in company stock. The company did not say...
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.
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. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning.
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. The twice-a-day tablet has carried the FDA's strongest warning label, known as a black box, since 2009 following reports of suicidality, hostility and depression among some patients.
This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.
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.
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.
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.
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 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 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 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.
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.
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.
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.
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.
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 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.
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 EmbolismJuly 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 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.
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.
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 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 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 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.
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