News Releases

Merck Expects FDA's Review for Ezetimibe Atorvastatin
Merck (NYSE: MRK ), known as MSD outside the United States and Canada, announced today that the US Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine.
Phase 3 DECISION Trial of Nexavar (sorafenib) Meets Primary Endpoint
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that a Phase 3 trial of Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement of progression-free survival.
FDA Approves Juxtapid for Homozygous Familial Hypercholesterolemia
Aegerion Pharmaceuticals, Inc. today announced that the US Food & Drug Administration (FDA) has approved JUXTAPID™ ( lomitapide ) capsules as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol ( LDL-C ), total cholesterol ( TC ), apolipoprotein B ( apo B) and non-high density lipoprotein cholesterol ( non-HDL ) in patients with homozygous familial hypercholesterolemia ( HoFH ).
FDA Approves Adasuve for Agitation with Schizophrenia, Bipolar I
Alexza Pharmaceuticals, Inc. announced today that the US Food and Drug Administration (FDA) approved Adasuve ( loxapine ) Inhalation Powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
New Thumb Makes a Dramatic Difference for Four-Year-Old Girl
All it took was one picture of two-year-old Ella, for David and Deanna Ballheim of Dearborn to fall in love with her. The couple, who were eager to adopt Ella from China, had their wish come true when they became Ella’s parents in 2010.
Botox and Surgery Does the Trick for Teen Suffering from Headaches
Taylor Williams, 17, of Wixom, Mich., has suffered from severe headaches for more than two years. The headaches, which caused Taylor to seek medical treatment including emergency care on a number of occasions, were continuous and the medications prescribed were not working.
Merck Drug Tredaptive Did Not Achieve Primary Endpoint
Merck, known outside the United States and Canada as MSD , today announced that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of TREDAPTIVE™ (extended-release niacin/ laropiprant ) did not meet its primary endpoint.
Black-Boxed Warning for Hepatitis Drug Incivek
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the INCIVEK® (telaprevir) label in the United States has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking INCIVEK combination treatment.
UK authority recommends against bevacizumab as advanced ovarian cancer treatment
The National Institute for Health and Clinical Excellence (NICE) has published draft guidance today (18 December) on the use of bevacizumab ( Avastin , Roche) as a treatment for women with advanced ovarian cancer. The draft guidance does not recommend the use of bevacizumab when used with paclitaxel and carboplatin for people with advanced disease, as a cost-effective treatment for the NHS. This draft guidance has now been issued for consultation: NICE has not yet published final guidance to the NHS. The Institute is aware that UK clinical practice is to prescribe bevacizumab at a d...
Gilead Announces Sustained Virologic Response Rate for Sofosbuvir
Gilead Sciences today announced topline results from the Phase 3 POSITRON study examining a 12-week course of once-daily sofosbuvir plus ribavirin ( RBV ) in patients with genotype 2 or 3 chronic hepatitis C virus ( HCV ) infection who are not candidates to take interferon ( IFN ).