Industry group TransCelerate Biopharma has developed a new recommended approach for protecting patients’ personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others as part of plans to release more data under consideration...
As the US FDA, EMA and Japan’s PMDA have released guidelines and related position papers on multi-regional clinical trials, the ICH is now proposing to do the same but with a more multi-national approach.
Pricks are a problem for the drug industry according to Prometheon Pharma, which has launched a crowdfunding campaign to help it develop a needle-free alternative delivery tech.
Fine chemicals manufacturer Ashland has laid down plans to expand a Klucel hydroxypropylcellulose (HPC) plant in Virginia to meet growing pharma demand.
In order to ensure uniformity on the state and federal levels, India’s CDSCO (Central Drugs Standard Control Organization) has released seven procedural criteria for state drug inspectors to abide by.
Big pharma employees are among the brightest minds in the world, and data released yesterday on their Wikipedia use shows their interests spread beyond drug development into lighter fare.
Big pharma is moving towards strategic partnerships with CMOs, according to speakers at the Global Pharmaceutical Contract Manufacturing (GPCM) Conference, with the ideal number of partners being ten.
CRO BioClinica will acquire Blueprint Clinical, which offers a cloud-based site scoring tool to help pharma address risk-based monitoring strategies for trials.
The advocacy campaign to raise awareness about falsified and fake drugs has added 11 new partners to its cause, including US-based GPhA (Generic Pharmaceutical Association).
As biotech funding saw one of the strongest quarters since 2004, Covance CEO Joe Herring predicts that the CRO industry is poised see an even higher percentage of biopharma R&D to be outsourced.
Sponsors trialling drugs in Asia should insist on the highest manufacturing standards and consider local production to successfully navigate the varied and complex regulations that govern research in the region says Almac.
Medidata will provide metrics and analytics help to industry group TransCelerate to answer questions on the benefits and challenges associated with a risk-based approach to monitoring of clinical trial sites.
The European Medicines Agency (EMA) has published guidance for departing employees intended to ensure there is no conflict of interest in their new roles.
As the European Medicines Agency (EMA) announces final consultations on its clinical trial data policy will begin at the start of May, we take a look at the issues surrounding trial transparency in Europe.
Genentech says its collaboration with PatientsLikeMe will enable more effective clinical trial recruitment but will not affect its partnerships with CROs.
Pharmaceutical companies will be made to publish all European clinical trials in a public database under a draft law passed by the European Parliament yesterday.
CRO BioClinica has signed two multi-year contract extensions worth $30m for cloud-based technologies and professional services and training across its e-clinical product suite.
US pharmaceutical firms ‘fear change’ and need guidance on assessing safe excipient supply to become more like their European counterparts, says a senior IPEC expert.
Harlan is looking to take advantage of a dearth of new products in pharma clients’ pipelines with an early drug development partnership with France’s Bertin Pharma.
Current economic problems may have hit Spanish drugmakers hard, but the downturn has not dampened demand for contract manufacturing services according to IDIFarma.
Strategic partnerships were put on trial yesterday at PCT and with a number of alliances coming up for renewal, Pfizer, Novartis, Amgen and Baxter spoke about the issues affecting a sponsor-CRO relationship.
India’s Supreme Court has called for all of the data supporting the approval of 162 clinical trials between July and August of this year by the Drug Controller General of India.
The panic behind the patent cliff for big pharma is now hitting generic companies, which are increasingly turning to service providers and consultants to help find solutions for holes in their pipelines.
Industry bodies say they support the sharing of trial data following allegations yesterday they used patient groups to lobby new EU transparency regulations.
The EFPIA has selected software firm Solidsoft for its anti-counterfeit European Medicines Verification System (EMVS) powered by Microsoft's cloud-based platform Windows Azure.
Ernst & Young (E&Y) analysts will try to illuminate the Sunshine Act for Greenphire's customers in the third collaboration the trial payment technology firm has signed in as many weeks.
Sanofi's top dog calls for EU collaboration as he takes on the Presidency of the EFPIA, and a new Director at Qu - Welcome to in-Pharmatechnologist.com's People on the Move.
Lonza has launched a service to help biopharmas decide if promising protein drug candidates are worth developing, from an immunogenicity and manufacturing standpoint.
The ever-expanding market in China has plenty of room for 3rd party pharmaceutical distribution and logistics companies says UPS as it opens a new facility in Zhejiang Province.
Dispatches from Excipient Fest in Baltimore - UPDATE
As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and excipients, questions still remain on whether the manufacturers will be able to comply with the looming requirements.
Efforts to update SUPAC guidance on immediate and modified release dosage forms will end in faster approvals, if regulatory and financial hurdles can be overcome, says expert.
DKSH has upgraded its cold chain infrastructure in Southeast Asia as both small and large manufacturers increase their access needs to emerging markets.
Globalisation, outsourcing and a move towards biopharmaceuticals are leading innovation for pharma distribution companies, according to DHL Global Forwarding.
An EMA report says increased Russian participation in European submitted clinical trials is part of a trend away from traditional regions, yet fluctuating legislation may affect numbers.
