Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug (Certara LP)
(Source: Certara LP) Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) May 11, 2015 U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA® TITUSVILLE, N.J., May 11, 2015 /PRNewswire/ -- Janssen...
View ArticlePre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole)...
(Source: Otsuka Pharmaceutical Co Ltd) Pharmaceuticals Pre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole) Prolonged-Release Suspension for Injection, Used in the Treatment of...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) Titusville, NJ, May 11, 2015 - Janssen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding...
View ArticleCariprazine Approved for Schizophrenia, Bipolar Disorder (ASHP - American...
(Source: ASHP - American Society of Health-System Pharmacists) BETHESDA, MD 18 Sep 2015- FDA and Actavis on September 17 announced the approval of cariprazine oral capsules for the treatment of...
View ArticleModeling and Simulation Guides Dosing for a New Anti-psychotic Drug (Certara LP)
(Source: Certara LP) Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) May 11, 2015 U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA® TITUSVILLE, N.J., May 11, 2015 /PRNewswire/ -- Janssen...
View ArticlePre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole)...
(Source: Otsuka Pharmaceutical Co Ltd) Pharmaceuticals Pre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole) Prolonged-Release Suspension for Injection, Used in the Treatment of...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) Titusville, NJ, May 11, 2015 - Janssen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding...
View ArticleNew Study Published in JAMA Psychiatry Found Three-Month Paliperidone...
TITUSVILLE, N.J., March 29, 2015 /PRNewswire/ -- Three-month paliperidone palmitate, an investigational atypical antipsychotic, significantly delayed time to relapse compared to placebo in patients...
View ArticleModeling and Simulation Guides Dosing for a New Anti-psychotic Drug (Certara LP)
(Source: Certara LP) Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) May 11, 2015 U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA® TITUSVILLE, N.J., May 11, 2015 /PRNewswire/ -- Janssen...
View ArticlePre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole)...
(Source: Otsuka Pharmaceutical Co Ltd) Pharmaceuticals Pre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole) Prolonged-Release Suspension for Injection, Used in the Treatment of...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) Titusville, NJ, May 11, 2015 - Janssen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding...
View ArticleCariprazine Approved for Schizophrenia, Bipolar Disorder (ASHP - American...
(Source: ASHP - American Society of Health-System Pharmacists) BETHESDA, MD 18 Sep 2015- FDA and Actavis on September 17 announced the approval of cariprazine oral capsules for the treatment of...
View ArticleModeling and Simulation Guides Dosing for a New Anti-psychotic Drug (Certara LP)
(Source: Certara LP) Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) May 11, 2015 U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA® TITUSVILLE, N.J., May 11, 2015 /PRNewswire/ -- Janssen...
View ArticlePre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole)...
(Source: Otsuka Pharmaceutical Co Ltd) Pharmaceuticals Pre-Filled Dual Chamber Syringe for Abilify Maintena® (Aripiprazole) Prolonged-Release Suspension for Injection, Used in the Treatment of...
View ArticleU.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label...
(Source: Johnson & Johnson) Titusville, NJ, May 11, 2015 - Janssen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding...
View ArticleNew Study Published in JAMA Psychiatry Found Three-Month Paliperidone...
TITUSVILLE, N.J., March 29, 2015 /PRNewswire/ -- Three-month paliperidone palmitate, an investigational atypical antipsychotic, significantly delayed time to relapse compared to placebo in patients...
View Article