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FDA Puts HCV Drug On Fast Track
June 27, 2007
ViroPharma, Inc.'s HCV-796 for hepatitis C virus infection has been granted fast track designation by the FDA. HCV-796, an orally dosed non-nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (H…   Read More »
Pfizer's Lyrica Gains FDA Approval For Fibromyalgia
June 22, 2007
Pfizer received approval for Lyrica capsules for the management of fibromyalgia, a chronic, widespread pain condition affecting more than six million Americans. Characterized by relentless chronic pain, fibromyalgia is usually accompanied by poor sle…   Read More »
FDA Approves Exforge For Hypertension
June 22, 2007
Novartis received approval from the FDA for Exforge, a once-daily tablet combination of two high blood pressure medicines: Diovan, an angiotensin receptor blocker, and Norvasc, a calcium channel blocker. The approval was supported by an extensiv…   Read More »
Pfizer Discontinues Lung Cancer Drug
June 21, 2007
Pfizer has discontinued a development program for PF-3512676, an investigational compound, in combination with cytotoxic chemotherapy in lung cancer. The program includes two Phase III trials and two Phase II trials. Pfizer licensed the compound from…   Read More »
BMS Breast Cancer Drug Gets On Fast Track
June 19, 2007
The FDA has granted fast track status to Bristol-Myers Squibb's ixabepilone, an epothilone B analog. Ixabepilone has been submitted as a monotherapy to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline…   Read More »
FDA Approves Cephalon's Nuvigil
June 18, 2007
Cephalon, Inc. received approval from the FDA to market Nuvigil Tablets, a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sl…   Read More »
Novo Nordisk Earns Neose Milestone
June 15, 2007
Novo Nordisk has initiated a Phase I clinical trial of GlycoPEGylated Factor VIIa, a long-acting version of NovoSeven Coagulation Factor VIIa, triggering an undisclosed milestone payment to Neose Technologies, Inc. under the companies' license agreem…   Read More »
FDA Advisory Committee Votes Against Obesity Drug
June 14, 2007
The FDA Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of Sanofi-Aventis' rimonabant (Zimulti / Acomplia) to the FDA for use in obese and overweight patients with associated risks factors. The company will continue t…   Read More »
Eurand Files Zentase NDA
June 12, 2007
Eurand Pharmaceuticals Ltd. initiated the rolling submission of its NDA with the FDA for Zentase for the treatment of Exocrine Pancreatic Insufficiency (EPI), a deficiency of digestive enzymes normally produced by the pancreas that can result from a…   Read More »
Humira Gets EU Approval For Crohn's Disease
June 8, 2007
Abbott received marketing authorization from the European Commission for the use of Humira as a treatment for severe Crohn's disease. Humira is the first self-administered biologic for the treatment of Crohn's disease, offering a convenient treatment…   Read More »
Remicade Gets EU Approval For Pediatric Crohn's Disease
June 7, 2007
Centocor, Inc. and Schering-Plough received approval from the European Commission for a new indication for Remicade for the treatment of severe, active Crohn's disease (CD) in pediatric patients, aged 6 to 17 years, who have not responded to conventi…   Read More »
Millennium Advances Cancer Program
June 4, 2007
Millennium Pharmaceuticals, Inc. has made two significant advancements in its Aurora A kinase program. The company achieved positive preliminary results from a Phase I study of MLN8054, a first-in-class small molecule to the Aurora A kinase. Also, th…   Read More »
NDA Accepted For Progenics, Wyeth OIC Drug
May 31, 2007
The FDA has accepted for review an NDA from Progenics Pharmaceuticals and Wyeth for subcutaneous methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care. The FDA has set a Prescription Drug User F…   Read More »
FDA Approves Wyeth's Toricel
May 31, 2007
Wyeth has received FDA approval to market Torisel for patients with advanced renal cell carcinoma (RCC). Torisel is the first targeted renal cancer therapy proven to extend median overall survival versus interferon- alpha, an active comparator, in th…   Read More »
HGS, GSK Begin LymphoStat-B Phase III Trial
May 30, 2007
Human Genome Sciences and GlaxoSmithKline have begun dosing for BLISS-52, the second of two Phase III trials of LymphoStat-B in patients with active systemic lupus erythematosus (SLE). Dosing in BLISS-76, the first Phase III trial of the drug, began…   Read More »
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