United States. Food and Drug Administration

Pharmaceutical industry

Centocor Ortho Biotech Submits Abiraterone Acetate NDA to FDA for Metastatic Advanced Prostate Cancer Treatment

Centocor Ortho Biotech Inc, a Johnson & Johnson (NYSE: JNJ) company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic, advanced prostate cancer in patients who have received prior chemotherapy

Pharmaceutical industry

Clinical Data Completes Strategic Transition to Pharmaceutical Company with PDUFA Date for Vilazodone

Clinical Data, Inc. has signed a definitive asset purchase agreement with Transgenomic, Inc. to sell its genetic and pharmacogenomic testing and biomarker development business for approximately $15.4 million. This sale completes Clinical Data's transformation to a pharmaceutical company, focusing on advancing its late-stage therapeutic programs, including vilazodone,

Pharmaceutical industry

Merck's GARDASIL Vaccine Receives FDA Panel's Recommendation for Anal Cancer Prevention

The US Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee has advised that the data presented by Merck support an indication for GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia

Pharmaceutical industry

Impax Laboratories Initiates Patent Challenge for Generic Version of Daiichi Sankyo's Welchol

Impax Laboratories Inc has taken the first step in challenging the patents associated with Daiichi Sankyo's Welchol by filing an Abbreviated New Drug Application (ANDA) with a paragraph IV certification with the US Food & Drug Administration (FDA). Following acceptance of the ANDA for filing, Impax notified the

Pharmaceutical industry

FDA Lifts Clinical Hold on Advanced Cell Technology's Phase I/II Clinical Trial for Stargardt's Macular Dystrophy

Advanced Cell Technology, Inc., a biotechnology company applying cellular technology in the field of regenerative medicine, has announced that the US Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to initiate a Phase I/II multicenter clinical trial using retinal cells derived

Pharmaceutical industry

FDA Approves Pradaxa for Stroke Risk Reduction in Non-Valvular Atrial Fibrillation

The US Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate), a novel oral direct thrombin inhibitor, for the reduction of stroke risk in patients with non-valvular atrial fibrillation (AF). This approval marks the first new oral anticoagulant to be approved in the US in over 50 years. Pradaxa&

Pharmaceutical industry

FDA Approval of Bydureon to Impact Pharmaceutical Companies, Investors

The US Food and Drug Administration is expected to approve Bydureon, a once-weekly treatment for Type 2 diabetes, during the third week of October 2010. The approval will affect three companies: Amylin Pharmaceuticals Inc, Eli Lilly and Co, and Alkermes Inc. While estimates of the drug's sales exceed

Pharmaceutical industry

FDA Approves Higher Dose Formulations of High Blood Pressure Medication Diovan HCT

The US Food and Drug Administration (FDA) has approved two new, higher dose formulations of the high blood pressure medication Diovan HCT (valsartan/hydrochlorothiazide): 320/12.5 mg and 320/25 mg. These new formulations provide more options for physicians to effectively manage their patients' high blood pressure. The

Pharmaceutical industry

Abbott's Stock Drops Amid Efficacy Concerns and Regulatory Rejection

Abbott's pharmaceutical company saw its stock plummet last year following the rejection of its experimental drug for prostate cancer by the FDA. The company also lost US patent protection on some of its best-selling products. Despite this, Abbott's blockbuster rheumatoid arthritis drug, Humira, saw a significant

Pharmaceutical industry

South Korea's Hanmi Pharmaceutical Produces Generic Tamiflu Prototype

South Korea's Hanmi Pharmaceutical Co. has successfully produced a generic version of Tamiflu, the world's only antiviral drug against avian influenza. The company will submit the new drug to the Korean Food and Drug Administration (KFDA), following the KFDA's call for local producers to

Pharmaceutical industry

GlaxoSmithKline Share Price Plummets Following FDA Ruling on Asthma Treatment

Investors severely reacted to a recent US Food and Drug Administration (FDA) ruling on how GlaxoSmithKline should label its best-selling asthma drug, Advair. The ruling came on Friday, recommending that Advair, sold as Seretide in Europe, should be re-labelled to indicate it should only be prescribed for patients who have

Pharmaceutical industry

FDA Warns Companies Making False Claims About Dietary Supplements and Skin Creams

Federal officials have sent warning letters to multiple companies, including One Life USA and HealthCore21, for falsely claiming that their dietary supplements and skin creams can prevent cancer and other diseases without scientific proof. The U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have targeted companies