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November 2008

PSI ACES FDA INSPECTIONS Download pdf

Week 47

• PSI reached an interim enrollment milestone of 100 randomized pediatric patients in a phase II study of a novel antiemetic for the prevention of post-operative nausea and vomiting.
• PSI completed enrollment in a phase III study of a novel antibiotic in patients with community-acquired pneumonia.
• PSI reached an interim enrollment target of 100 randomized patients in a phase III study of a novel biological agent in relapsing-remitting multiple sclerosis.
• PSI met an interim enrollment objective of 50 randomized patients in a phase II study of a novel antibiotic in hospital-acquired pneumonia.

Week 46

• PSI met an interim enrollment target of 250 randomized patients in a phase III study of a novel insulin formulation in type I diabetes.
• PSI reached an interim enrollment milestone of 50 randomized patients in a phase III study of a novel antineoplastic agent in advanced ovarian cancer.
• PSI achieved an interim enrollment objective of 150 randomized patients in a phase III study of a novel opioid antagonist in substance abuse.
• PSI reached an interim enrollment target of 50 randomized patients in a phase II study of a novel biological agent for the prevention of febrile neutropenia.
   

Week 45

• PSI completed enrollment in a phase III study of a novel antiemetic for the prevention of chemotherapy-induced nausea and vomiting.
• PSI completed the active treatment period of a phase III study of a novel antiviral product in patients with oral herpes.
• PSI completed the active treatment period of a phase II study of a novel antipsychotic in patients with schizophrenia.
• PSI completed a phase III study of a novel hormonal agent in patients with hormone-sensitive prostate cancer.
• PSI completed a proof-of-principle study of a novel disease-modifying agent in patients with rheumatoid arthritis.
• PSI reached an interim objective of 150 randomized patients in a phase III study in metastatic NSCLC.
• PSI reached an interim enrollment objective of 200 randomized patients in a phase II study of a novel prostaglandin modulator in persistent asthma.

October 2008

Week 44

• PSI launched a phase III study of a novel anticancer agent in patients with metastatic breast cancer.
• PSI reached an interim enrollment objective of 150 randomized patients in a phase III study of a novel antibiotic in patients with community-acquired pneumonia.
• PSI initiated enrollment in a phase III study of a novel anti-inflammatory agent in patients with knee osteoarthritis.
• PSI completed an exploratory study of a novel cancer vaccine in patients with renal cell carcinoma.
• PSI completed a phase II study of a novel analgesic in patients with post-surgical pain.
• PSI completed a proof-of-concept study of a novel immunomodulator in patients with allergic rhinitis.

Week 43

Week 42

• PSI reached an interim enrollment target of 100 randomized patients in a phase III study of a novel opioid antagonist in substance abuse.
• PSI launched a phase III study of a novel anticancer agent in patients with head and neck cancer.
• PSI launched a phase II study of a novel biological agent in patients with rheumatoid arthritis.
• PSI reached an interim enrollment objective of 100 randomized patients in a phase II study of a novel biological agent in acute myeloid leukemia.

Week 41

• PSI reached an interim enrollment objective of 600 randomized patients in a phase II study of a novel antiemetic for the prevention of chemotherapy-induced nausea and vomiting.
• PSI launched a proof-of-concept study of a novel biological agent in patients with allergic rhinitis.
• PSI launched a phase II study of a novel prostaglandin antagonist in patients with overactive bladder.
• PSI reached an interim enrollment milestone of 100 randomized patients in a phase III study of a novel anticancer agent in metastatic NSCLC.

Week 40

• PSI launched a proof-of-concept study of a novel biological agent in patients with rheumatoid arthritis.
• PSI completed the active treatment period of a phase III study of a novel antibiotic in patients with community-acquired pneumonia.
• PSI completed a phase II, dose-ranging study of a novel antihyperglycemic in patients with type 2 diabetes.

September 2008

Week 39

• PSI launched a phase II study of a novel anti-inflammatory agent in patients with osteoarthritis.
• PSI completed a phase III study of a novel antibiotic in patients with complicated skin and skin structure infections.
• PSI completed a proof-of-concept study of a novel biological agent in patients with systemic lupus erythematosus.

Week 38

• PSI reached an interim enrollment objective of 100 randomized patients in a phase II study of a novel prostaglandin modulator in persistent asthma. 
• PSI completed enrollment in a phase II study of a novel antibiotic in patients with complicated skin and skin structure infections. 
• PSI completed a phase III study of a novel antihyperglycemic in patients with type 2 diabetes. 
• PSI completed a proof-of-concept study of a novel disease-modifying agent in patients with rheumatoid arthritis.

Week 37

• PSI reached an interim enrollment objective of 500 randomized patients in a phase II study of a novel antiemetic for the prevention of chemotherapy-induced nausea and vomiting.
• PSI reached an interim enrollment objective of 200 randomized patients in a phase III study of a novel insulin formulation in patients with type I diabetes.
• PSI reached an interim enrollment objective of 50 randomized patients in a phase II study of a novel opioid antagonist in substance abuse.

Week 36

• PSI completed the active treatment period in a proof-of-concept study of a novel immunomodulator in patients with allergic rhinitis.
• PSI reached an interim enrollment objective of 50 randomized patients in a phase III study of a novel anticancer agent in metastatic NSCLC.
• PSI completed the active treatment period in a phase III study of a novel combination product in COPD.
• PSI launched a proof-of-concept study of a novel vaccine for the prevention of tuberculosis.
   

August 2008

Week 35

• PSI completed enrollment in a proof-of-concept study of a novel anticancer agent in patients with chronic lymphocytic leukemia.
• PSI initiated recruitment in a phase II study of a novel biological agent in patients with breast cancer at high risk of febrile neutropenia.
• PSI completed the active treatment period in a proof-of-concept study of a novel biological agent in patients with rheumatoid arthritis.
   

Week 34

• PSI completed enrollment in a proof-of-principle study of a novel immunomodulator in patients with allergic rhinitis.
• PSI initiated enrollment in a phase II study of a novel antiemetic in children at risk of post-operative nausea and vomiting.
• PSI launched a phase II study of a novel anticancer agent in patients with metastatic renal cancer .
• PSI reached an interim enrollment objective of 50 randomized patients in a phase II study of a novel hematopoietic factor in anemia due to chronic kidney disease.
• PSI initiated enrollment in a phase II study of a novel biological agent in patients with receptor-positive advanced breast cancer.

Week 33

• PSI reached an interim enrollment objective of 400 randomized patients in a phase II study of a novel antiemetic for the prevention of chemotherapy-induced nausea and vomiting.
• PSI reached an interim enrollment objective of 100 randomized patients in a phase III study of a novel antimicrobial agent in community-acquired pneumonia.
• PSI launched a phase II study of a novel immunomodulator in patients with moderately severe asthma.
• PSI completed a phase II study of a novel antithrombotic agent in patients with acute myocardial infarction.
• PSI reached an interim enrollment target of 50 randomized patients in a phase III study in relapsing-remitting multiple sclerosis.

Week 32

• PSI reached an interim enrollment objective of 50 randomized patients in a phase II study of a novel prostaglandin modulator in persistent asthma.
• PSI reached an interim enrollment objective of 50 randomized patients in a phase II study of a novel antibiotic in complicated skin and skin structure infections.
• PSI reached an interim enrollment objective of 50 randomized patients in a phase II study of a novel biological agent in patients with rheumatoid arthritis.
• PSI reached an interim enrollment objective of 50 randomized patients in a phase II study of a novel biological agent in acute myeloid leukemia.
   

Week 31

• PSI initiated enrollment in a proof-of-principle study of a novel immunomodulator in patients with allergic rhinitis.
• PSI initiated enrollment in a phase II study of a novel anticancer agent in patients with chronic lymphocytic leukemia.
• PSI completed a phase III study of a novel endocrine agent in patients with hormone-sensitive prostate cancer.
• PSI completed the active treatment period in a phase II dose-ranging study of a novel anticancer agent in patients with metastatic NSCLC.
   

July 2008

Week 30

• PSI reached an interim enrollment objective of 300 randomized patients in a phase II/III study of a novel biological agent in metastatic renal cancer.
• PSI completed a phase II study of a novel biological agent in patients in rheumatoid arthritis.
• PSI completed enrollment in a phase III study of a novel antibiotic in patients with community-acquired pneumonia.
• PSI reached an interim enrollment objective of 50 patients in a phase II study of a novel anticancer agent in hormone-refractory prostate cancer.
• PSI completed a proof-of-principle study of a novel anticancer agent in patients with metastatic NSCLC.
   

Week 29

• PSI completed enrollment in a phase II study of a novel antipsychotic in patients with schizophrenia.
• PSI initiated enrollment in a phase III study of a novel biological agent in patients with multiple sclerosis.
• PSI launched a phase III study of a novel bisphosphonate in patients with osteoporotic hip fractures.
• PSI completed the active treatment phase in a phase II study of a novel biological agent in patients with ulcerative colitis.
• PSI initiated enrollment in a phase II study of a novel antihyperglycemic in patients with type 2 diabetes.
   

Week 28

• PSI reached an interim enrollment objective of 300 randomized patients in a phase III study of a novel antibiotic in community-acquired pneumonia.
• PSI reached an interim enrollment objective of 300 randomized patients in a phase II study of a novel antiemetic for the prevention of chemotherapy-induced nausea and vomiting.
• PSI completed the active treatment period in a phase II, dose-ranging study of a novel antihyperglycemic in patients with type 2 diabetes.
   

Week 27

• PSI completed a phase II study of a novel biological agent in patients with rheumatoid arthritis.
• PSI initiated enrollment in a phase III study of a novel opioid antagonist in patients with substance abuse.
• PSI reached an interim enrollment objective of 100 randomized patients in a phase III study of a novel insulin formulation in type 1 diabetes.

June 2008

PSI GAINS A FIRM FOOTHOLD IN LATIN AMERICA  Download pdf

Week 26

• PSI launched a phase II study of a novel anticancer agent in patients with advanced colorectal cancer.
• PSI completed a phase III study of a novel antibiotic in patients with complicated skin and skin structure infections.
   

Week 25

• PSI completed the active treatment period in a phase II study of a novel antithrombotic agent in patients with acute myocardial infarction.
• PSI reached an interim enrollment objective of 100 randomized patients in a phase II study of novel antipsychotic for the treatment of schizophrenia.
   

Week 24

• PSI initiated enrollment in a phase III study of a novel anticancer agent in patients with metastatic NSCLC.
• PSI completed the active treatment period of a phase III study of a novel antihyperglycemic in patients with type 2 diabetes.
• PSI launched a phase II study of a novel antiplatelet agent in patients with acute coronary syndrome.
   

Week 23

• PSI completed enrollment in a phase II study of a novel anticancer agent in patients with advanced colorectal cancer.
• PSI completed enrollment in a phase II study of a novel anticancer agent in patients with metastatic renal cancer.
• PSI completed a phase III study of a novel antimicrobial agent in patients with complicated skin and skin structure infections.
   

May 2008

Week 22

• PSI reached an interim enrollment objective of 200 randomized patients in a phase II study of a novel antiemetic for the prevention of chemotherapy-induced nausea and vomiting.
• PSI launched a phase III study of a novel anti-inflammatory agent in patients with knee osteoarthritis.
• PSI initiated enrollment in a phase II study of a novel product for the treatment of moderately severe asthma.

Week 21

• PSI launched a phase III study of a novel hemostatic agent in patients with hemophilia.
• PSI reached an interim recruitment target of 250 randomized patients in a phase II/III study of a novel biological agent in metastatic renal cancer.
• PSI launched a proof-of-concept study of a novel anticancer agent in patients with solid tumors.
• PSI completed enrollment in a phase III study of a novel anticancer agent in patients with non-Hodgkin’s lymphoma.
• PSI completed the active treatment period of a proof-of-concept study in systemic lupus erythematosus.

Week 20

• PSI completed a phase II study of a novel antineoplastic product in cancer patients with hepatic insufficiency.
• PSI initiated enrollment in a phase II study of a novel hematopoietic factor in patients with anemia due to chronic kidney disease.
• PSI completed a phase II study of a novel anticancer agent in patients with metastatic NSCLC.
   

Week 19

• PSI launched a phase II study of a novel biological agent in patients with rheumatoid arthritis.
• PSI completed the active treatment part of a phase III trial of a novel biological agent in patients with cervical dystonia.
• PSI completed a phase II study of a novel disease-modifying agent for the treatment of rheumatoid arthritis.

Week 18

• PSI completed enrollment in a phase II study of a novel anticancer agent in patients with metastatic NSCLC.
• PSI launched a phase II study of a novel antiaggregant in patients with intermittent claudication.
• PSI launched a phase III study of a novel anticancer agent in patients with metastatic breast cancer.

April 2008

Week 17

• PSI initiated enrollment in a phase II study of a novel biological agent in patients with rheumatoid arthritis.
• PSI reached an interim enrollment target of 200 patients in a phase II study of a novel anticancer agent in patients with renal cell carcinoma.
• PSI reached an enrollment milestone of 250 patients in a phase III study of a novel antibiotic in patients with community-acquired pneumonia.

Week 16

• PSI initiated enrollment in a phase II study of a novel biological agent in patients with ulcerative colitis.
• PSI initiated enrollment in a phase II study of a novel antibiotic in patients with complicated skin and skin structure infections.

Week 15

• PSI initiated enrollment in a phase III study of a novel insulin formulation in patients with type I diabetes mellitus.
• PSI reached an interim enrollment objective of 100 randomized patients in a phase II study of a novel antiemetic for the prevention of chemotherapy-induced nausea and vomiting.

Week 14

• PSI completed a phase III study of a novel anticancer agent in patients with metastatic breast cancer.
• PSI completed enrollment in a phase II study of a novel anticancer agent in patients with hormone-resistant prostate cancer.

March 2008

Week 13

• PSI completed enrollment in a phase III study of a novel adjunct cancer therapy in patients with metastatic NSCLC.
• PSI completed a phase II study of a novel anticancer agent in patients with metastatic pancreatic cancer.

Week 12

• PSI completed enrollment in a phase III study in a phase III study of a novel cancer vaccine in metastatic renal cancer.
• PSI initiated enrollment in a phase III study of a novel biological agent in patients with relapsing-remitting multiple sclerosis.

Week 11

• PSI completed enrollment in a phase II study of a novel antithrombotic agent in patients with acute myocardial infarction.
• PSI completed the active treatment period in a phase II study of a novel disease-modifying agent in patients with rheumatoid arthritis.

Week 10

• PSI launched a phase II study of a novel antihyperglycemic agent in patients with type II diabetes.
• PSI reached an interim enrollment milestone of 200 randomized patients in a phase II/III study of a novel biological agent in metastatic renal cell carcinoma.
• PSI launched a phase II study of a novel anticancer agent in patients with metastatic breast cancer.

February 2008

Week 9

• PSI reached an interim enrollment target of 600 patients in a phase III study of a novel cancer vaccine in metastatic renal cancer.
• PSI reached an interim enrollment target of 200 randomized patients in a phase III study of a novel antibiotic in community-acquired pneumonia.
• PSI completed a phase II study of a novel immunomodulator in patients with mild to moderate asthma.

Week 8

• PSI reached an interim enrollment target of 400 randomized patients in a phase III study of a novel adjunct cancer therapy in metastatic NSCLC.
• PSI launched a phase II study of a novel cardiovascular agent in patients with acute coronary syndrome.

Week 7

• PSI initiated enrollment in a phase III study of a novel antimicrobial agent in patients with community-acquired pneumonia.
• PSI completed enrollment in a phase II dose-ranging study of a novel antihyperglycemic in patients with type II diabetes.
• PSI completed a phase III study of a novel enzymatic agent in patients with peripheral artery occlusion.

Week 6

• PSI initiated recruitment in a phase II study of a novel antiemetic in patients at risk of chemotherapy-induced nausea and vomiting.
• PSI completed a phase III study of a novel endocrine agent in patients with hormone-sensitive prostate cancer.
• PSI completed a phase II study of a novel agent for the prevention of in-stent restenosis.

January 2008

Week 5

• PSI reached an interim recruitment milestone of 100 patients in a phase II study of a novel anticancer agent in renal cell carcinoma.
• PSI launched a proof-of-concept study of a novel disease-modifying agent in patients with rheumatoid arthritis.
• PSI completed a phase II study of a novel anticancer agent in patients with metastatic breast cancer.

Week 4

• PSI launched a phase II study of a novel recombinant product in patients with hemophilia.
• PSI reached an interim enrollment target of 500 randomized patients in a phase III study of a novel cancer vaccine in metastatic renal cancer.
• PSI completed enrollment in a phase II study of a novel biological agent in patients with rheumatoid arthritis.

Week 3

• PSI completed the active treatment period in a phase III study of a novel anticancer agent in patients with metastatic breast cancer.
• PSI reached an interim enrollment target of 150 randomized patients in a phase III study of a novel antibiotic in community-acquired pneumonia.
• PSI completed the active treatment period in a phase III study of a novel antiviral product in adolescent patients with recurrent herpes labialis.

Week 2

• PSI initiated enrollment in a phase III study of a novel anticancer agent in patients with metastatic ovarian cancer.
• PSI initiated enrollment in a phase II study of a novel anticancer agent in patients with hormone-resistant prostate cancer.

Week 1

• PSI launched an exploratory study of a novel immunomodulator in patients with allergic rhinitis.
• PSI launched a phase II study of a novel antibiotic in patients with complicated skin and skin structure infections.

• PSI initiated enrollment in a phase III study of a novel biological agent in patients with severe hemophilia.
• PSI completed the active treatment period of a phase II study a novel antibiotic in patients with complicated skin and skin structure infections.
• PSI reached an interim enrollment target of 150 randomized patients in a phase II study of a novel prostaglandin modulator in persistent asthma.
• PSI reached an interim enrollment objective of 50 randomized pediatric patients in a phase II study of a novel antiemetic for the prevention of post-operative nausea and vomiting.
• PSI reached an interim enrollment objective of 350 randomized patients in a phase II/III study of a novel biological agent in patients with metastatic renal cancer.