PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act
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Outsourcing-Pharma presents its round-up of the latest appointments within the pharmaceutical industry, with news from Sucampo, Tranzyme, and Next Pharma.
Communication was the central theme at Patient Recruitment Outsourcing (PRO) 2011 in Boston, US this week, with attendees agreeing that better dialog between all stakeholders is vital to addressing the trial sector’s perennial recruitment headache.
Survey results have again surprised analysts by showing prices charged by CROs, particularly to large pharma, have increased in recent months.
DaVita Clinical Research will help sponsors prepare for US FDA advisory committee meetings through a new contract offering introduced this week.
Early adopters are effectively using social media for patient recruitment and retention but in general the industry is fearful, a panelist at Patient Recruitment Outsourcing (PRO) 2011 said.
Supplies of Johnson & Johnson’s Doxil cancer drug will be cut down in coming months as the company transitions to a new manufacturer.
Anti-cancer clinical trial specialist, South Texas Accelerated Therapeutics (START), has collaborated with China's largest cancer hospital to open a new Phase I cancer research center.
The EU Clinical Trials Register (EU-CTR) has been formally recognised by the World Health Organization (WHO) as one of the primary registries for its International Clinical Trials Registry Platform (ICTRP).
Clinical trial enrollment can be accelerated by better understanding patients and using EHRs to inform protocol design, panelists told an Outsourcing-Pharma conference.
Cambridge Major Laboratories Europe (CMLE) is set to start commercial API manufacturing at its facility in the Netherlands after approval by Dutch regulators.
The human tissue supply industry is under pressure from CROs demanding more complex samples, according to equity analyst Vadim Alexandre.
Teva Pharmaceutical Industries is set to buy out Kowa Company’s half of its joint Japanese venture for $150m (€111m).
Novozymes has achieved a successful supply chain and risk mitigation strategy through implementing its own policy with chemicals company SAFC, says Luke Dimasi.
Kellman Pharmaceutical Services (KPS) and trial management services firm Y-Prime have put pen to paper in a deal to develop a series of clinical electronic monitor visit reporting (e-MVR) tools.
UK-based SCM Pharma is to begin offering formulation development services as part of a collaborative deal with the University of Sunderland.
A new study claims that almost 60 per cent of clinical trial protocols for new drugs are amended during the trial, but one-third of those changes could have been avoided.
The Outsourcing-pharma.com team is heading to Boston, Massachusetts for Patient Recruitment Outsourcing – our exciting new US conference and networking event.
US pharmaceutical firm Eli Lilly says taking language, cultural diversity and site location into account helped boost ethnic minority participation in a recently completed trial.
PerkinElmer has launched its new Universal Operational Qualification (UOQ) service for pharmaceutical labs.
PPD will offer an expanded range of microbiology testing services in a bid to boost its central laboratory business.
West-Ward is working to win contract manufacturing market share and tackle drug shortages after buying assets from Baxter.
AAIPharma Services has created a 24/7 online quote generation and sample submission service to simplify raw material testing requests.
Amrutanjan Health Care plans to add contract manufacturing and custom synthesis to services offered by loss making fine chemicals business, according to various reports.
Medical Photography is a potentially valuable yet underused resource in clinical trials according to Illingworth Research, which aims to increase its exposure with a new service.
DHL has opened a logistics centre in China and taken full ownership of a cold chain joint venture to expand its life sciences capabilities.
Catalent has struck up a deal with Toyobo Biologics to launch its cell line engineering technology on the Japanese market.
Biopharm is continuing to spend on R&D in China despite the economic dip, and CROs in the region should benefit, an analyst said.
Frontage Laboratories and Spaulding Clinical Research have teamed up to target China’s rapidly expanding contract research sector.
The Russian Ministry of Health (MoH) has cleared nearly 600 trial sites for clinical research, easing concerns that the reaccreditation process was taking too long.
Outsourcing-Pharma presents its round-up of the movers and shakers within the pharmaceutical industry, including news from PPD, Omnicare, and Bio Nebraska.
PPD has named a new CEO and is now unlikely to be taken over by private equity because the deal environment has worsened, an equity analyst said.
UK CRO Preclinical Oncology Services Limited (Precos) has announced plans to double laboratory capacity in 2012.
SAFC announced its new aggressive growth strategy, including plans to expand in the developing markets, at its conference in Irvine, Glasgow last week.
Mid-tier CROs are being squeezed out of the post-marketing sector as sponsors choose providers with more scale or specialisation, market research found.
PharmaNet is to open a Phase I-IIa trial facility at Montreal General Hospital in conjunction with a Canadian university.
ShangPharma’s emerging discovery biology services unit has inked another antibody development partnership with a Chinese biopharm.
International nutra and pharma contract manufacturing organisation, Catalent, has expanded its Italian operations and diversified its potential in vitamins, minerals and supplements.
Drug Developers struggle to find PK-PD providers that are fast and efficient says US CRO ClinPharm Consulting, after launching a new suite of services designed to cut risk and maximize return on R&D investment.
Preclinical CRO Porsolt has opened a new research centre and laboratory space citing industry demand for large scale studies as the key driver for the investment.
CRO Pharmaron is housing Merck Serono’s Chinese laboratory at its 600,000 sq ft Beijing campus as part of a partnership.
DaVita Clinical Research has opened a biorepository to help drug discovery teams develop personal medicines by understanding patient populations.
Australian preclinical services firm vivoPharma has opened a new vivarium and laboratory facility in the US as part of an effort to expand its global reach.
The FDA has sent a warning letter to Lonza’s Hopkinton, MA plant after inspectors found faults with how it produces an oncology API for Eisai.
Pharma industry sponsors want more effective ways of measuring CRO performance according to the team behind a new project aiming to develop a validated set of analysis tools.
Outsourcing-Pharma presents a roundup of eClinical news, including developments at BioClinica, OmniComm, ePharmaSolutions and MedNet.
Contract manufacturer CMC Biologics has ramped-up bioreactor capacity to meet demand for biologic drugs for Phase III clinical trials and beyond.
Patheon is exiting semi-solids, clinical packaging and cutting facilities in response to ‘poor historical performance’.
CRO performance across late stage, Phase I and central laboratories should improve in 2012 as strategic deals develop and smaller clients return, an analyst said.
Florida, US-based Advanced Pharma CR says decision to move to University of Miami Life Science and Technology Park (UMLSTP) was driven by demand.
Shares in drug discovery company Sareum have soared by 36 per cent after the firm announced the selection of a preclinical development candidate for its Checkpoint kinase 1 (Chk1) inhibitor programme.
Phase I-focused CROs are winning business from larger rivals as sponsors seek specialists to run more complex studies, market research found.
Outsourcing-Pharma presents its round-up of the latest appointments within the pharamceutical industry, with news from Campbell Alliance, Medivation, Sucampo, and Assure RX.
Ireland-based CRO Icon says CEO’s departure will not impact operations or strategic relationships thanks to knowledge and expertise in executive team.
Contract manufacturing organisation (CMO) Aurobindo Pharma has teamed up with Russian supplement maker OJSC Diod to establish a manufacturing joint-venture.
SGS Life Sciences has added cell-based bioassays to the range of services available at its Poitiers, France, facility in what it says is part of its new aggressive growth strategy.
The US Department of Health and Human Services is set to hand $94m to GlaxoSmithKline (GSK) to support research and clinical testing for an antibiotic discovered by Anacor Pharmaceuticals.
Ireland-based CRO Icon says that CEO Peter Gray will retire next month.
Contract research organisations (CROs) in Andhra Pradesh, India have set up a forum designed to improve the transparency of clinical research conducted in the region.
Esoterix Clinical Trials Services has forged a strategic alliance with the David H. Murdock Research Institute (DHMRI) to provide its clients with access to enhanced assay development services.
Brooks Laboratories had a torrid first day on the Bombay Stock Exchange (BSE) with high volume trading taking the firm’s share price on a rollercoaster ride of highs and lows.
AmerisourceBergen has bought informatics firm IntrinsiQ for $35m (€25m) continuing the spending spree it began earlier this week with the acquisition of market access consultancy Premier Source.
Cetero has strengthened its infrastructure with expansions in multiple clinical dermatology and transdermal delivery system (TDDS) services at four of its facilities.
Japanese CMO Toyobo says it will increase capacity for injectable drugs to secure its position as a service provider in the expanding biopharmaceutical sector.
Outsourcing-Pharma presents a round-up of the latest news and developments in EDC technology, including news from Clinovo, Vistakon, and MedNet.
Ipca Laboratories has added scale to the Phase II support services offered by recent acquisition Onyx Scientific in a bid to build in the US contract manufacturing sector.
AmerisourceBergen has bought US consulting group Premier Source putting into practice the growth-through-acquisition strategy it outlined last month.
The US Pharmacopeial Convention (USP) has expanded its quality testing laboratory in Hyderabad in an effort to further strengthen ties with Indian drugmakers and regulators.
Asterand says it must raise additional funds after share prices dropped by more than half last week.
Outsourcing-Pharma presents its round up of the latest appointments within the pharmaceutical industry, with news from Nycomed, Numira, Isotechnika, and Corcept.
Royal DSM and Sinochem’s anti-infective manufacturing and distribution JV in China has been given the green light by competition authorities.
Electronic contract manufacturer Distron Corporation is poised to expand its business when it cuts the ribbon on a newly expanded production facility today.
Advantar Labs has allied with DavosPharma to accelerate clients’ development programmes with chemistry and analytical services.
Mayo Clinic has recruited patients into a study in one week using a rare disease-specific social networking site.
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