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Anti-arrhythmic agents linked to increased risk of falls

Anti-arrhythmic drugs, particularly those used to treat atrial fibrillation, could increase the risk of fall-related injuries, a new study found.

29 Jul 2019

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.

8 May 2014

FDA approves OLYSIO (simeprevir) for treatment of chronic hepatitis C infection

Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration has approved OLYSIO (simeprevir), an NS3/4A protease inhibitor, for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.

23 Nov 2013

Janssen receives positive opinion from EMA CHMP for ZYTIGA to treat mCRPC

Janssen-Cilag International NV (Janssen) announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of the oral, once-daily medication ZYTIGA for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

19 Nov 2012

Study supports catheter ablation as first-line treatment for paroxysmal atrial fibrillation

Patients with the heart rhythm disorder atrial fibrillation (AFib) who received first-line catheter ablation treatment had a longer arrhythmia-free interval than patients receiving antiarrhythmic drugs, the standard first-line treatment.

11 May 2012

Par Pharmaceutical reports second quarter total revenues of $224.2 million

Par Pharmaceutical Companies, Inc. today reported results for the second quarter ended June 30, 2011.

3 Aug 2011

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Merck, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELIS (boceprevir) for the treatment of chronic hepatitis C virus genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

20 May 2011

Data from Phase IV study of Bystolic tablets in Hispanic patients with hypertension presented at ASH 2010

Forest Laboratories, Inc. today presented data from a Phase IV study evaluating the effects of Bystolic (nebivolol) tablets in Hispanic patients with hypertension at the 2010 annual scientific meeting of the American Society of Hypertension.

4 May 2010

KV Pharmaceutical makes agreement with U.S. Department of Justice to resolve investigation on ETHEX

KV Pharmaceutical Company today announced that it has reached an agreement, subject to court approval, with the United States Attorney for the Eastern District of Missouri and the Office of Consumer Litigation of the United States Department of Justice to resolve an investigation regarding certain activities of ETHEX Corporation, its generic pharmaceutical marketing and distribution subsidiary, which occurred in 2008.

26 Feb 2010

Forest Laboratories' Bystolic tablets for treatment of stable CHF failed to receive FDA approval

Forest Laboratories, Inc. announced today that the U.S. Food and Drug Administration did not approve the additional indication for Bystolic® (nebivolol) tablets as a treatment for stable chronic heart failure (CHF) as requested in the company’s Supplemental New Drug Application (sNDA).

23 Feb 2010

FDA grants approval for Abbott's antiretroviral medication Norvir

Abbott announced today that the U.S. Food and Drug Administration (FDA) has granted approval of a new tablet formulation of the company's antiretroviral medication Norvir ® (ritonavir). The new Norvir tablets can be stored at room temperature and do not require refrigeration, making it more convenient for patients.

11 Feb 2010