FDA

DaVita Clinical Research expands nephrology clinical trial capabilities in Europe

Thursday, May 28, 2015 03:09 PM

DaVita Clinical Research (DCR), a specialty CRO based in Minneapolis has expanded its clinical trials capabilities in Europe. DCR now will be able to facilitate the conduct of late phase clinical trials in several medical centers outside of the U.S. Physician leaders from Germany, Poland and Portugal, with a combined 20 years of research experience, will collaborate with DCR to provide data and knowledge-based insights to its clients.

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Quest Diagnostics

Actavis receives FDA approval for Viberzi (eluxadoline) for adult IBS-D

Thursday, May 28, 2015 03:01 PM

Actavis’ Viberzi (eluxadoline) has been approved by the FDA as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist and a kappa receptor agonist.

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AbbVie completes acquisition of Pharmacyclics

Wednesday, May 27, 2015 12:17 PM

AbbVie has completed the acquisition of Pharmacyclics, enhancing AbbVie's scientific and commercial presence in oncology. Pharmacyclics primarily is aligned with the $24 billion global hematological oncology market with Imbruvica (ibrutinib), a BTK-inhibitor used to treat hematological cancers.

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The Global Drug-Lag Problem

Tuesday, May 26, 2015 08:00 AM

For all the advancements in medical research, certain regions of the world still wait to benefit from timely access to new drugs.

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FDA approves Invega Trinza, only four-times-a-year treatment for schizophrenia

Thursday, May 21, 2015 02:27 PM

The FDA has approved under Priority Review Janssen Pharmaceuticals’ New Drug Application (NDA) for the three-month long-acting atypical antipsychotic Invega Trinza. Invega Trinza, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months. Priority Review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

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Lannett to acquire Silarx Pharmaceuticals

Wednesday, May 20, 2015 03:17 PM

Lannett, a Philadelphia, Pa.-based developer and marketer of generic pharmaceutical products, has signed a definitive agreement to acquire privately held, New York-based Silarx Pharmaceuticals and a related real estate entity, a manufacturer and marketer of liquid generic pharmaceutical products. The transaction is expected to close in early June, subject to customary closing conditions. Strategic benefits of the acquisition include an FDA-approved manufacturing facility, research R&D experience and added diversity to Lannett’s portfolio of existing and pipeline products.  

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Janssen, Rutgers School of Engineering expand collaboration

Wednesday, May 20, 2015 03:13 PM

Janssen Supply Chain has expanded its partnership with the Rutgers University School of Engineering by providing over $6 million to expand ongoing research efforts supporting the company’s introduction of continuous manufacturing techniques for pharmaceuticals.

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Endo to acquire Par Pharmaceutical for $8 billion

Monday, May 18, 2015 01:06 PM

Ireland-based Endo International has agreed to acquire privately held, Woodcliff Lake, N.J.-based Par Pharmaceutical from TPG for $8.05 billion, including assumption of Par debt. The transaction has been unanimously approved by the boards of directors of both Endo and Par and is supported by the management teams of both companies. There are no further shareholder approvals required.

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West Nile virus vaccine now in phase I clinical trials

Thursday, May 14, 2015 10:48 AM

A novel investigational West Nile virus vaccine discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University is being evaluated in an NIH-sponsored phase I, first-in-human, clinical trial at Duke University. Although several early-stage West Nile virus vaccine clinical trials have been completed to date, no human vaccine has been approved for commercial use.

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FDA lifts clinical hold on NeuroDerm’s ND0612 for Parkinson's

Monday, May 11, 2015 10:30 AM

The FDA has lifted the clinical hold on U.S. clinical studies of ND0612H and ND0612L, primary product candidates based on proprietary, subcutaneously-delivered Levodopa/Carbidopa (LD/CD) liquid formulation for the treatment of Parkinson's disease, owned by NeuroDerm, a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases. The hold was lifted after the FDA reviewed additional information related to the product candidates' delivery devices. U.S. clinical development of these product candidates is therefore cleared to proceed in the second half of 2015.

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CWWeekly

May 26

inVentiv Health aims to help sponsors prepare for new E.U. regulations on observational studies

ACRP partners with CRO Analytics to measure investigative sites' views of clinical trial quality

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The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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