News Releases
Toviaz More Effective Than Detrol In Reducing Urinary Incontinence
Pfizer Inc. announced that a Phase 4 study assessing the efficacy and safety of Toviaz (fesoterodine fumarate) in patients with overactive bladder (OAB) met its primary endpoint.
Genzyme Applies for Approval of Lemtrada
Genzyme , a Sanofi company announced that the company has submitted a supplemental Biologics License Application ( sBLA ) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application ( MAA ) to the European Medicines Agency ( EMA ) seeking approval of LEMTRADA ( alemtuzumab ) for treatment of relapsing multiple sclerosis ( RMS ).
Pfizer Announces Alzheimer’s Disease Study Results
Pfizer Inc. announced that the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in the Janssen Alzheimer Immunotherapy R&D LLC (Janssen AI)-led Phase 3 trial of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer’s disease who carry the ApoE4 ( apolipoprotein E epsilon 4) genotype (Study 302).
Merck HIV Drug Demonstrates Efficacy
Merck announced final results from the STARTMRK study – the longest double-blind Phase III non-inferiority study evaluating an integrase inhibitor in treatment-naïve adults with HIV-1.
European Drug for Menopause and Osteoporosis
Pfizer Inc. announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for postmenopausal women with a uterus for the treatment of estrogen deficiency symptoms and treatment of osteoporosis in women at risk of fracture.
FDA Clears Roche Accu-Chek Combo System
Roche announced that it has received clearance from the US Food and Drug Administration (FDA) for the Accu-Chek Combo system for insulin pump therapy.
Pfizer Drug Receives Positive Opinion for Lung Cancer
Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that crizotinib be granted conditional marketing authorization in the European Union (EU).
FDA Responds to Pfizer’s Tafamidis New Drug Application
Pfizer Inc. announced that it has received a Complete Response Letter from the US Food and Drug Administration (FDA) on its New Drug Application (NDA) for tafamidis meglumine .
New Overactive Bladder Drug Approved
The US Food and Drug Administration has approved Myrbetriq ( mirabegron ) to treat adults with overactive bladder, a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.
Pfizer Announces Positive Results From Xalkori Trial
Pfizer Inc. announced today that the PROFILE 1007 study demonstrated that XALKORI ( crizotinib ) significantly improved progression-free survival ( PFS ) when compared with pemetrexed or docetaxel , in previously treated patients with anaplastic lymphoma kinase ( ALK )-positive advanced non-small cell lung cancer ( NSCLC ).