Regulatory Affairs - Latest News  

Samantha Ng, Senior Recruitment Consultant joins CK Clinical heading up the Regulatory Affairs recruitment Team. Having worked in the Pharmaceutical recruitment field since 2003, Sam is a real asset to the team.

Pharmacovigilance gaining in importance after Vioxx problems-our new report analyses post-marketing assessment from the present onwards-Pharmacovigilance has been expanding in recent years, as companies are required to monitor drug safety post launch

CK Clinical are now using Twitter to keep job seekers and candidates up to date with vacancies as soon as they come in

Natural Health, Beauty and Personal Care Products consultant Idea MKT Solutions launches its new corporate image at www.ideamktsolutions.com

Troubled e-clinical specialist Datatrak International (Cleveland, Ohio) could be up for sale shortly, depending on the outcome of a review of strategic options now under way.

In the latest of five acquisitions, Worldwide Clinical Trials (Beverley Hills, California) has completed the purchase of Serbian CRO MediQuest (Belgrade).

Canadian CRO Algorithme Pharma (Laval, Quebec) has acquired a US clinical research centre from Bioanalytical Systems (BASi - West Lafayette, Indiana) for US$850,000 in cash.

US e-clinical specialist Datatrak International (Cleveland, Ohio) has decided to close its office in Bonn, Germany. Global help-desk services previously carried out by the office will now be provided from the company’s Cleveland headquarters.

Report Buyer, the online destination for business intelligence for major industry sectors, has added a new report offering invaluable information about the pharmaceutical regulatory affairs in the EU and US.

Today a small delay in gaining market access means huge loss in terms of market share and revenue generated. The key to success for pharmaceutical companies lies in obtaining timely marketing approval from regulators.Regulatory Affairs Outsourcing...

Regulatory Affairs consulting agency launches new website for marketing their outsourced compliance and regulatory affairs services targeting pharmaceutical, healthcare, biotech and medical companies.

Veeda Oncology (Columbus, Ohio) has acquired French cancer trials specialist Biologie et Industrie for an undisclosed sum.

Quintiles Transnational (Research Triangle Park, North Carolina) has signed an agreement to acquire Eidetics (Boston, Massachusetts), a privately held healthcare market research and consulting firm. Financial terms were not disclosed.

Pharmaceutical services company i3 (Basking Ridge, New Jersey) has acquired Russian CRO Lege Artis (Moscow). Financial terms were not disclosed.

Mixed results for Novartis’s first-in-class direct renin inhibitor, Rasilez (aliskiren), have been reported from the ALLAY study at the American College of Cardiology meeting in Chicago, US.

Parexel International (Boston, Massachusetts) has sold its stand-alone bioanalytical laboratory in Poitiers, France, to privately owned Indian CRO Synchron Research Services (Ahmedabad, Gujarat)

Quintiles Transnational (North Carolina) has signed an agreement with Medca Japan to provide central laboratory services in Japan. Quintiles will have its own staff at the Medca Japan laboratory in Saitama, a city in the Greater Tokyo area

QPS (Newark, Delaware) has acquired early-phase specialist Bio-Kinetic Clinical Applications (Springfield, Missouri). Bio-Kinetic has a 240-bed Phase I facility - one of the largest in the US owned by an independent CRO.

US biotechnology company GeoVax Labs’ (Atlanta, Georgia) HIV/AIDS vaccine is expected to enter Phase IIa human trials in mid-2008.

Clinical technology specialist ClinPhone (Nottingham, UK) has rejected a preliminary approach from Parexel International regarding a possible offer for the company.

Polish CRO KCR (Warsaw) has acquired its Czech counterpart DUX Consulting (Prague). The value of the transaction was not disclosed.

Quintiles Transnational (Research Triangle Park, North Carolina) is to expand its global central laboratories and clinical development service (CDS) units in Beijing, China.

The US Food and Drug Administration has lifted its clinical hold on Vion Pharmaceuticals’ Phase III trial of its lead anti-cancer agent, Cloretazine (VNP40101M), in combination with Ara-C (cytarabine) in relapsed acute myelogenous leukaemia (AML).

US CRO Clinsys Clinical Research (Bedminster, New Jersey) and its French counterpart ITEC Services (Cenon, Bordeaux) have entered into a strategic alliance agreement.

PPD (Wilmington, North Carolina) has appointed Dr Philip Mathew as director of strategic development, to lead its Phase II-IV operations and expansion in India.

US cancer biotechnology company AVEO Pharmaceuticals (Cambridge, Massachusetts) has signed a collaborative agreement with Eli Lilly to use AVEO's Human Response Platform in a pilot project.

Covance (Princeton, New Jersey) has purchased from Eli Lilly a partially constructed insulin manufacturing facility on a 47-acre site in Prince William County's technology park (Virginia, US).

Private equity firm Sequoia Capital has invested Rs 1 billion ($25 million) in Indian CRO GVK Biosciences (Hyderabad). GVK BIO plans to use the funds to build a state-of-the-art campus on a 25-acre site at Hyderabad.

UK CRO Chiltern International (Slough, Berkshire) has acquired the independent US CRO Clinical Trial Management Services. Terms were not disclosed.

Targeted Genetics (Boston, Massachusetts) says that final tests support earlier indications that a patient death during a trial of its injectable anti-arthritis drug, tgAAC94, was not caused by the drug.

MDS Pharma Services (King of Prussia, Pennsylvania) has expanded its central lab operations in China, moving to a new, 25,000 sq ft facility near Beijing airport.

Quintiles Transnational (Research Triangle Park, North Carolina) has acquired Central American CRO Bio-Trials. The purchase was made by Quintiles’ Latin American subsidiary, based in Buenos Aires, Argentina.

Isotechnika (Edmonton, Canada) has received permission from the US Food and Drug Administration for the long-term use of ISA247 for the prevention of rejection in patients currently participating in its Phase IIb kidney transplant (PROMISE) trial.

The US Food and Drug Administration has sent a warning letter to Sanofi-Aventis, detailing failings in Aventis’s oversight of investigators involved in a clinical trial of the antibiotic Ketek (telithromycin) in 2001-02.

Development of Takeda Pharmaceutical’s cholesterol-lowering agent, TAK-475 (lapaquistat), will be held back following a request from the US Food and Drug Administration for additional clinical data.

BioReliance (Rockville, Maryland) has contracted with Gentronix (Manchester, UK) to offer its GreenScreen HC in vitro assay as a major part of BioReliance’s portfolio of genotoxicity screening services.

India is expected to host 30% of the world's contract research within the next 10-15 years, driven by the attractions of low cost and high quality standards, says the India Brand Equity Foundation, IBEF.

Results from a Phase I/IIb trial of GlaxoSmithKline’s malaria vaccine, Mosquirix (RTS,S/AS02D), published in The Lancet, indicate that it is safe, well tolerated and immunogenic in African infants.

UK pharmaceutical development and custom manufacturing specialist Penn Pharmaceutical Services has set up a US subsidiary, Penn Pharmaceutical Services US Inc, in Philadelphia, Pennsylvania

The European Medical Research Councils, part of the European Science Foundation (ESF, Strasbourg, France), is to undertake a review of how best to implement clinical trials that are initiated by investigators.

Farmavita.Net and regulanet® AG have established FarmavitaR+®, a joint venture company delivering high-quality regulatory affairs services to clients for pharmaceutical projects in Central, Eastern and Southern Europe

AstraZeneca has opened its first clinical pharmacology unit in China as part of a co-operative agreement with Peking University Third Hospital.

Charles River Laboratories International (Wilmington, Massachusetts) is to build a new 300,000 sq ft preclinical facility in the recently constructed Sherbrooke Biomedical Park in Quebec, Canada.

Indian IT company Patni Computer Systems (Mumbai) has acquired US regulatory consultancy Taratec Development for $27.2 million in cash, including contingency payments.

Premier Research (Berkshire, UK) has appointed Chris Nowell as vice-president, clinical trial management for its international division. Mr Nowell will also be responsible for training clinical project management and clinical monitoring functions

China and India have joined the World Health Organisation’s clinical trial registry platform. Both countries have a rapidly expanding clinical trial research sector

The US FDA is reviewing ongoing trials involving adeno-associated virus vectors (AAVs) as a precaution following the death of a patient during a trial of Targeted Genetics’ injectable anti-arthritis drug, tgAAC94.

In a move that would take it out of public ownership, PRA International (Reston, Virginia) has entered into a definitive merger agreement to be acquired by affiliates of private equity firm Genstar Capital (San Francisco) for some $790 million.