News Releases
Merck Drug for Insomnia
Merck, known as MSD outside the United States and Canada, provided an update on the development program for suvorexant , the company's investigational orexin receptor antagonist, which, if approved, will be a new mechanism for the treatment of insomnia.
Pfizer Announces Recall Of Birth Control
Pfizer Inc. announced that it has voluntarily recalled 14 lots of Lo/ Ovral-28 ( norgestrel and ethinyl estradiol ) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic)for customers in the U.S. market.
FDA Approved New Type 2 Diabetes Drug
Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto ( linagliptin / metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 ( DPP-4 ) inhibitor, linagliptin , and metformin .
FDA Approves Advanced Basal Cell Cancer Drug
Roche announced that Erivedge ( vismodegib ) capsule was approved by the U.S. Food and Drug Administration (FDA) for adults with a type of skin cancer, called basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation.
FDA Approves Subcutaneous Administration of Takeda Drug Velcade
The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application ( sNDA ) for Velcade ( bortezomib ).
Novartis Drug Treats Cushing's Disease
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) adopted a positive opinion for Signifor ( SOM230 , pasireotide ) for the treatment of Cushing's disease.
Bayer’s Metastatic Colorectal Cancer Drug Presented
Results from the Phase III CORRECT study will be presented as a late breaking abstract in an oral abstract session on January 21 at the 2012 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology ( ASCO-GI ).
Alzheimer’s Drug Phase 3 Results Not Good
Medivation , Inc. and Pfizer Inc. announced results from the CONCERT trial, which is a Phase 3 trial that evaluated Dimebon ( latrepirdine ) when added to ongoing treatment with donepezil HCL tablets in patients with mild-to-moderate Alzheimer’s disease.
New Application for Bayer Heart Drug
Bayer’s cooperation partner, Janssen Research & Development, L.L.C. has submitted a Supplemental New Drug Application ( sNDA ) to the U.S. Food and Drug Administration (FDA) for the oral anticoagulant Xarelto ( rivaroxaban ) in combination with standard antiplatelet therapy to reduce the risk of (thrombotic) cardiovascular events in patients with Acute Coronary Syndrome (ACS).
Prevnar 13 Approved for New Age Category
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s pneumococcal conjugate vaccine Prevnar 13 ( Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults. Prevnar 13 is indicated for adults 50 years of age and older for active immunization for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae (S. pneumoniae ) serotypes contained in the vaccine.