US approval for Sanofi-Aventis’ H1N1 vaccine last week is an “example of extremely rapid action by [the] FDA” that should be used more widely, according to Parexel Consulting’s VP of global strategy services Alberto Grignolo.
The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.
The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A) meeting guidance to explain the process.
The Sentinel Initiative will help pharma and CROs pinpoint study objectives, according to a director at PRA who told Outsourcing-Pharma about the company’s postmarketing safety surveillance.
Funding increases have failed to boost pharma drug development productivity and, with budgets tightening, the industry must revise its operations to improve output, according to a research paper.
Recruiting patients with rare diseases for clinical trials could become easier if the US Congress passes a bill to allow patients on supplemental security income (SSI) benefits to receive compensation.
In 25 years most biotechs will be virtual, according to a director of preclinical CRO L2D who formed the company with a “completely novel business model” to target this huge growth opportunity.
Virtify says the new online version of its Virtx CTRR system can help drugmakers comply with the increasingly complex disclosure rules that regulators worldwide apply to clinical trials, in an automated approach that saves time and money.
Quintiles believes there is a “dire need” for trial sites that can raise standards and reduce inefficiencies in the clinical research process and is expanding its Prime Site programme to meet this demand.
Angel Biotechnology has inked a deal to manufacture the CTX stem cell line, which can now be frozen and thawed when needed, at its dedicated cell-based therapies plant that is equipped and licensed for the task.
Hyderabad, India-based Makro Care says its GCP “helpdesk” website has already proved to be an invaluable information source for contract research organisations (CRO), investigators and pharma trial sponsors.
The new partnership with Indian CRO Abridge Clinical Research (ACR) is a unique collaboration offering cost efficient and timely trial solutions according to Global Pharmaceutical Services (GPSI) spokesperson Keith Russell.
Transcrip Partners’ “augmentation” solution for contract R&D “differs from the normal consultancy alternative by fielding ‘doers’ who can think strategically and ‘thinkers’ who are happy to get their hands dirty” according to senior partner Paul Branthwaite.
Phlexglobal’s new contract with UCB will improve how the Belgian drug firm manages trials and is indicative of a wider industry move towards eTMF, according to CEO Nicola Murgatroyd.
Following a review of the backlog of postmarketing studies the FDA has initiated changes to improve its processes, including developing Manuals of Policies and Procedures (MAPP) to track the status of trials.
AstraZeneca (AZ) has dramatically cut the time taken to initiate a Phase I oncology trial by working with its strategic partner to improve administrative processes and eliminate delays, according to research.
Stemedica Cell Technologies’ new license to make stem cells for trials positions the firm as a “valuable resource for front line researchers,” according to VP of business development Dave McGuigan.
Pharmaceutical and cosmetics contract manufacturing organisations (CMOs) in India can now claim tax credit on their advertising spend following a recent appeal court victory for US beverage giant Coca-Cola.
Indian CRO Siro Clinpharm has set its sights on the European research market, signing a deal with UK based CambReg that it hopes will offer customers a path through the region’s complex regulations.
Catalent Pharma Soultions’ pharmaceutical softgels facility in Buenos Aires, Argentina has passed a US Food and Drug Administration (FDA) GMP audit and pre-approval inspection.
Amcor has temporarily halted trading on the Australian stock exchange, fuelling rumours that the group is finally about to move for Rio Tinto’s Alcan pharmaceutical packaging unit.
US pharmaceutical giant Pfizer has teamed up with China’s Fudan University to set up a Master’s degree programme in clinical data management and statistical programming.
Ecron Acunova’s global partnering team had a busy end to July with the Indian CRO entering into collaboration deals on both sides of the Atlantic to further expand its global reach.
US firm Isogen says the combination of aseptic filling, engineering and containment know-how on offer at its new Science Center is unique among facilities serving the clinical market.
Clinical trials in the developing world meet the same standards as those in Europe and the US and are vital for accelerating drug development says the Association of Clinical Research Organisations (ACRO).
The number of CROs operating in the United Arab Emirates (UAE) is set to rise, according to an expert on the region, as companies are attracted by the cost effectiveness and presence of big pharma.
Novartis and Jubilant Organosys are among several companies forced to recall generic drugs after manufacturing operations at their shared CMO, India’s MJ Biopharm, were found to be in breach of GMP guidelines.
UK contracting group Pharmaceutical Development Services (PDS) has set up an office in North Carolina, US to court North America pharma firms for the European development sector.
US group DZS Software Solutions says its new web ClinPlus CTMS technology will help sponsors and CROs ensure that trial procedures are being followed and eliminate redundant study management systems.
GE Healthcare hopes its new modular validation platform (MVP) will change the way drugmakers think about how they create new plants and bring existing manufacturing facilities up to code.
Industrial automation specialist Emerson Process Management has won the contract to help Swiss life sciences group Lonza design its new biopharmaceuticals plant in Singapore.
PRA International has opened a drug safety centre in São Paulo, Brazil, expanding its presence in Latin America and bringing its array of services to a new market.
The increasingly global clinical trial sector demands more effective ethical and regulatory scrutiny according to a study published in the latest edition of the New England Journal of Medicine (NEJM).
Definitive FDA guidance on adaptive trials cannot come soon enough for the pharmaceutical and biotech sectors, according to Perceptive Informatics (PI).
Drug delivery specialist Hospira has set up a “biologics clock” that counts the amount spent on cell culture-derived medications in the US in a bid to highlight the potential savings greater use of generics could provide.
Coast IRB has decided to close after a probe by US Government Accountability Office (GAO) and subsequent FDA warning letter resulted in the loss of “several key customers”.
Almac claims it can bring drugs to trial faster using an automated approach to compliance that cuts the time taken to validate manufacturing processes by several months.
Evolution is collaborating with C&QP to offer a more comprehensive range of GMP services to clients, covering plant and equipment qualification, calibration and maintenance.
TGaS Advisors' vice president Gary McWalters believes the drug industry must rethink its approach to regulatory compliance and how it works with healthcare professionals.
TGaS Advisors has launched a new version of its commercial compliance benchmark (CCB), which aims to help companies adhere to the array of guidance affecting their operations.
Pfizer has preempted the Sunshine Act by promising to disclose payments made to principal investigators, major academic institutions and research sites involved in Phase I to IV trials.
Icon has brought its operations in line with new FDA guidelines by implementing an electronic system to accelerate the adjudication of cardiovascular events in diabetes trials.
Active pharmaceutical ingredient (API) manufacturer Ash Stevens Inc has been accredited under an industry-backed scheme that certifies companies whose processes are environmentally sound and safe.
The rise in international, multi-centre clinical trials has complicated reporting pathways and led to institutional review boards (IRBs) being overloaded with adverse events, according to FDA guidance.
A FDA warning letter has been sent to a clinical investigator who administered incorrect doses of investigational drugs having taken the patient’s weight and height from their driving license.
Simple preclinical experiments should be able to predict whether immunotherapeutic medicines are safe to advance to preclinical testing in humans and avoid the Northwick Park trial that left six healthy volunteers hospitalised.
The US Food and Drug Administration has opened offices in three Chinese cities – Beijing, Shanghai and Guangzhou – to help improve the safety of medicines and ingredients imported into the US.
Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can...
