Krka, d.d., Novo mesto formally notified The European Medicines Agency after deciding to withdraw their application for the centralized marketing authorization for Desloratadine Krka (desloratadine), 5 mg film coated tablets, intended to relief symptoms linked to allergic rhinitis and urticaria due to changes in the company's marketing strategy. The medication ...

Valeant Pharmaceuticals International, Inc. announced that its wholly owned subsidiary, Valeant International (Barbados) SRL, has received notice that the New Drug Submission for colesevelam hydrochloride (colesevelam), an oral bile acid sequestrant for hypercholesterolemia, has been approved by the Canadian regulatory authority Health Canada.

Frankfurt, Prime Standard: QIA) announced it has completed its second U.S. submission of the therascreen® KRAS RGQ PCR Kit for use as a companion diagnostic paired with Erbitux® (cetuximab), a leading drug for treatment of patients with metastatic colorectal cancer (mCRC). Erbitux is marketed in the United States by Bristol-Myers ...

Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. (NYSE: FRX) have announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aclidinium bromide, a long-acting inhaled antimuscarinic agent developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The submission includes ...

Laureate Biopharmaceutical Services, Inc. announced that the U.S. Food and Drug Administration ("FDA") approved its application for an Electronic Submissions Gateway (ESG) to the Agency. The gateway will allow Laureate to offer clients a validated, direct electronic path for IND (Investigational New Drug), NDA (New Drug Application) and BLA (Biologic ...

H. Lundbeck A/S (Lundbeck) announced the completion of the final study (ESENSE2) in the phase III clinical programme for nalmefene in patients with alcohol dependence. In this multi-center, double-blind, placebo-controlled study, 718 individuals were randomized to receive oral administration of 20 mg of nalmefene or placebo on an as-needed basis ...

ImmunoGen, Inc., a biotechnology company that develops targeted antibody-based anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced that Bayer HealthCare Pharmaceuticals' submission of an Investigational New Drug (IND) application for the TAP compound, BAY 94-9343, triggers a $2 million milestone payment to ImmunoGen.

In its submission made in response to the Department of Health and Ageing's Draft Concept of Operations - Relating to the introduction of a Personally Controlled Electronic Health Record (PCEHR) system, the Royal Australian College of General Practitioners (RACGP) has urged the government to acknowledge the central role of GPs ...

Affymax, Inc. (NASDAQ:AFFY) and Takeda Pharmaceutical Company Limited (TSE: 4502, "Takeda") today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational agent peginesatide (formerly known as Hematide™) for the treatment of anemia associated with chronic renal failure (CRF) in ...

The 'seriously flawed' NHS 'reform' bill with its privatisation agenda should be scrapped, Unite, the largest union in the country, said today. Unite, which has 100,000 members in the health service, outlined 11 key points in its submission to the government's 'listening exercise' as to why the Health ...

InSite Vision Incorporated (OTCBB:INSV) today announced that the Company recently received eight minor recommendations regarding its proposed agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the design of InSite's Phase 3 clinical trial of AzaSite Plus™ (ISV-502) and DexaSite™ (ISV-305) in ...

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement containing data providing for the removal of the Indium-111 ZEVALIN® (ibritumomab tiuxetan) ...