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Pfizer Inc (PFE)

PFE on New York Consolidated

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25 Sep 2017
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Latest Key Developments (Source: Significant Developments)

Merck KGaA's Bavencio drug wins EU approval for Merkel cell carcinoma
Thursday, 21 Sep 2017 03:11am EDT 

Sept 21 (Reuters) - Merck KGaA ::European commission approves Bavencio (avelumab) for metastatic Merkel cell carcinoma.  Full Article

‍Pfizer files lawsuit against Johnson & Johnson​
Wednesday, 20 Sep 2017 09:10am EDT 

Sept 20 (Reuters) - Johnson & Johnson :‍Pfizer says filed suit in U.S. District Court for Eastern District of Pennsylvania against Johnson & Johnson​.Pfizer says suit alleges J&J's "exclusionary" contracts, "anticompetitive" practices have denied U.S. patients access to therapeutic options.Pfizer - suit further claims J&J'S efforts related to remicade by excluding biosimilar competitors violates federal antitrust laws​‍​.Pfizer - suit further claims J&J'S efforts related to remicade by excluding biosimilar competitors violates federal antitrust laws​‍​‍​.  Full Article

Transgene says first patient treated in a phase 1B/2 trial of TG4001
Tuesday, 19 Sep 2017 11:45am EDT 

Sept 19 (Reuters) - TRANSGENE SA ::TRANSGENE: FIRST PATIENT TREATED IN A PHASE 1B/2 TRIAL OF TG4001 IN COMBINATION WITH AVELUMAB IN HPV-POSITIVE CANCERS.‍FIRST RESULTS EXPECTED IN 2018​.  Full Article

Astellas Pharma and Pfizer say positive top-line results from phase 3 prosper trial of XTANDI (enzalutamide)
Thursday, 14 Sep 2017 05:17am EDT 

Sept 14 (Reuters) - Astellas Pharma Inc <4503.T>:Co and Pfizer Inc <<>> announced that the Phase 3 PROSPER trial evaluating XTANDI®(enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic (M0) CastrationResistant Prostate Cancer (CRPC) met its primary endpoint of improved metastasis-free survival (MFS) .The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of XTANDI in previous clinical trials.  Full Article

Pfizer, Astellas report positive top-line results from phase 3 PROSPER trial of XTANDI
Thursday, 14 Sep 2017 05:00am EDT 

Sept 14 (Reuters) - Pfizer Inc ::Pfizer and Astellas announce positive top-line results from phase 3 prosper trial of XTANDI (enzalutamide) in patients with non-metastatic castration-resistant prostate cancer.Phase 3 prosper trial met its primary endpoint​.Preliminary safety analysis of PROSPER trial appears consistent with safety profile of XTANDI in previous clinical trials​.In study of patients taking XTANDI who earlier received docetaxel, 1% of XTANDI patients versus 0.3% of placebo patients died from infections or sepsis​.In study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death​.In placebo-controlled patients taking XTANDI who earlier got docetaxel, grade 3 or higher adverse reactions reported among 47% of XTANDI patients​.In placebo-controlled study of chemotherapy-naïve patients, grade 3-4 adverse reactions were reported in 44% of XTANDI patients​.In bicalutamide-controlled study of chemotherapy-naïve patients, grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients​.Hypertension occurred in 11% of xtandi patients and 4% of placebo patients in two placebo-controlled trials​.No patients experienced hypertensive crisis​.  Full Article

Pfizer receives FDA approval for MYLOTARG (gemtuzumab ozogamicin)
Friday, 1 Sep 2017 11:38am EDT 

Sept 1 (Reuters) - Pfizer Inc ::Pfizer receives FDA approval for MYLOTARG (gemtuzumab ozogamicin).  Full Article

U.S. FDA approves Pfizer's Mylotarg for treatment of acute myeloid leukemia
Friday, 1 Sep 2017 11:11am EDT 

Sept 1 (Reuters) - U.S. Food and Drug Administration::U.S. FDA approves Pfizer's Mylotarg for treatment of acute myeloid leukemia.Prescribing information for Mylotarg includes a boxed warning that severe or fatal liver damage occurred in some patients who took mylotarg​.Also approved Mylotarg for patients aged 2 years, older with CD33-positive AML experiencing relapse/ who have not responded to initial treatment​.  Full Article

Pfizer says U.S. FDA and EMA accept regulatory submissions for bosuliffor
Tuesday, 29 Aug 2017 07:00am EDT 

Aug 29 (Reuters) - Pfizer Inc :U.S. FDA and European Medicines Agency accept regulatory submissions for Bosulif® (bosutinib) for the treatment of patients with newly diagnosed Ph+ chronic myeloid leukemia.Says ‍prescription drug user fee act (PDUFA) goal date for a decision by FDA is in December 2017​.  Full Article

Pfizer and Sangamo updates on early stage trial on its blood disorder therapy
Friday, 25 Aug 2017 08:00am EDT 

Aug 25 (Reuters) - Pfizer Inc ::Sangamo and Pfizer announce first patient receives treatment in Phase 1/2 clinical trial evaluating SB-525 investigational gene therapy for Hemophilia A.  Full Article

Pfizer receives FDA approval for BESPONSA (inotuzumab ozogamicin)
Thursday, 17 Aug 2017 01:57pm EDT 

Aug 17 (Reuters) - Pfizer Inc :Pfizer receives U.S. FDA approval for BESPONSA (inotuzumab ozogamicin).  Full Article

Merck KGaA, Pfizer's cancer drug Bavencio gets EU nod

FRANKFURT European regulators on Thursday granted market approval for Merck KGaA and Pfizer's immuno-oncology drug Bavencio to treat a rare and aggressive type of skin cancer called Merkel cell carcinoma.