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Pfizer Inc (PFE.N)

PFE.N on New York Stock Exchange

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24 Mar 2017
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Latest Key Developments (Source: Significant Developments)

FDA approves treatment for metastatic merkel cell carcinoma
Thursday, 23 Mar 2017 02:28pm EDT 

U.S. FDA: Granted accelerated approval to Bavencio for treatment of adults, pediatric patients 12 years and older with metastatic merkel cell carcinoma .Further clinical trials are required to confirm Bavencio’s clinical benefit.  Full Article

Servier, Pfizer announce FDA clearance of IND application for UCART19
Thursday, 9 Mar 2017 02:04am EST 

Pfizer Inc : Servier and Pfizer announce FDA clearance of IND application for UCART19 in adult relapsed/refractory acute lymphoblastic leukemia .Pfizer inc - U.S. FDA has granted Servier with an investigational new drug clearance to proceed in U.S. With clinical development of UCART19.  Full Article

Merck and pfizer announce U.S. Fda and EMA filing acceptances
Monday, 6 Mar 2017 08:00am EST 

Merck & Co Inc : Merck and Pfizer announce U.S. Fda and EMA filing acceptances of 3 marketing applications for ertugliflozin-containing medicines for adults with type 2 diabetes .Says prescription drug user fee act (PDUFA) action date from the FDA is in December 2017 for the three NDAS.  Full Article

Pfizer says FDA accepts Biologics License Application for Avelumab for priority review
Tuesday, 28 Feb 2017 07:00am EST 

Pfizer Inc : Pfizer Inc - FDA has set a prescription drug user fee act (PDUFA) target action date of august 27, 2017, for Avelumab in this indication .FDA accepts the Biologics License Application for Avelumab for the treatment of metastatic urothelial carcinoma for priority review.  Full Article

Pfizer announces pricing of $1.07 bln debt offering
Friday, 24 Feb 2017 01:12pm EST 

Pfizer Inc : Pfizer prices $1,065,000,000 debt offering . Pfizer Inc says pricing of $1.07 billion aggregate principal amount of 4.20% notes due 2047 . Offering is expected to be sold to professional institutional investors in Taiwan, with application to be made to list notes on Taipei Exchange .Closing of offering is expected to occur on March 17, 2017.  Full Article

Pfizer says monitoring potential impact related to any changes to ACA
Thursday, 23 Feb 2017 05:49pm EST 

Pfizer Inc : Pfizer Inc - In 2017, there likely will be federal legislative and administrative efforts to repeal, substantially modify or invalidate some or all of the provisions of the ACA .Pfizer Inc says co is monitoring any such actions to see if any changes to the ACA will be enacted that would impact co's business - SEC filing.  Full Article

Ronald Blaylock elected to Pfizer's board of directors
Thursday, 23 Feb 2017 04:15pm EST 

Pfizer Inc : Ronald Blaylock elected to Pfizer's board of directors .Blaylock was also appointed to corporate governance and science and technology committees of Pfizer's board.  Full Article

Pfizer said SIX swiss exchange approved delisting of its shares
Wednesday, 22 Feb 2017 01:05am EST 

Pfizer Inc : Said six swiss exchange approved its application to delist its shares from the six swiss exchange Further company coverage: [PFE.N] (Reporting by Silke Koltrowitz) ((silke.koltrowitz@thomsonreuters.com;)).  Full Article

Pfizer says U.S. FDA accepts regulatory submission for inotuzumab ozogamicin
Tuesday, 21 Feb 2017 08:00am EST 

Pfizer Inc : Pfizer announces acceptance of regulatory submission for inotuzumab ozogamicin by the U.S. Food and Drug Administration . Says prescription drug user fee act (PDUFA) goal date for a decision by FDA is in August 2017 .Pfizer - marketing authorization application for inotuzumab ozogamicin in same patient population currently under review by European Medicines Agency.  Full Article

Momenta Pharmaceuticals announces FDA warning letter to contracted Glatopa
Friday, 17 Feb 2017 07:02pm EST 

Momenta Pharmaceuticals Inc : Momenta Pharmaceuticals announces FDA warning letter to contracted glatopa (glatiramer acetate injection) fill/finish manufacturer . Momenta Pharmaceuticals Inc - approval of glatopa 40 mg ANDA will be dependent on resolution of Pfizer facility compliance issues . Momenta Pharmaceuticals Inc - warning letter does not restrict production or shipment of glatopa 20 mg . Momenta Pharmaceuticals Inc - company believes application review could be completed at any time . Momenta Pharmaceuticals Inc - Momenta expects that an approval in Q1 of 2017 is unlikely . Momenta - working with collaboration partner Sandoz to resolve this matter in order to allow for an ANDA approval as soon as possible .Momenta Pharmaceuticals - Pfizer indicated warning letter does not restrict production, shipment of glatopa 20 mg product currently marketed by Sandoz in U.S..  Full Article

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FDA approves Pfizer, German Merck immunotherapy for skin cancer

U.S. health regulators on Thursday approved a drug developed by Merck KGaA and Pfizer Inc that helps the immune system to fight a rare form of skin cancer once it has spread to other parts of the body.