Medidata has completed a method development project conducted in partnership with GlaxoSmithKline to evaluate the impact of combining mobile health (mHealth) devices with cloud-based technologies in a clinical trial.
The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn, though some are saying that number seems inflated.
Ricerca Biosciences has been bought by private equity group Main Market Partners in a deal that means the contract research organisation's (CRO) 199 employees keep their jobs.
Collaboration does not mean drugmakers have started playing nice, it’s just that the pain of shared problems has become unbearable according to TransCelerate Biopharma CEO, Dalvir Gill.
Drug companies are looking for ways to put biologics in topical creams or “zap” them into skin using electricity as more large molecules come off patent.
Dispatches from the Financial Times Global Pharmaceutical and Biotechnology Conference
2014 has seen record pharma M&A activity but top management of some of the key dealmakers – including Novartis, AstraZeneca and Shire – say size doesn’t always matter.
US FDA commissioner Margaret Hamburg is traveling to China this week and at least part of her trip will be devoted to securing visas for new drug manufacturing site inspectors.
Drug shortages could be an issue in the near future as some wholesale distributors and drug suppliers may not be able to meet a key Jan. 1 deadline from the Drug Supply Chain and Security Act (DSCSA), an expert says.
After fending off hostile takeover bids from Valeant for nearly seven months, Allergan is finally agreeing to a takeover, but with Ireland-based Actavis.
Ongoing concerns about marketing practices have taken the shine of a report suggesting Big Pharma efforts have improved parients' access to drugs in developing countries over the past two years.
Investors only back drug innovators because they have to according to Index Venture Management's Kevin Johnson, who says less risky 'first to be second' firms are actually much more attractive.
Last week CDMO Catalent acquired Micron Technologies, a provider of particle size engineering technologies, with the aim of improving its early stage tech offering.
With biologics declared as its main driver over the next few years, CDMO Wuxi is seeing rapid manufacturing growth and planning two new facilities in the next two years.
Recipharm has bought Portugal-based contractor Lusomedicamenta for SEK1bn ($1349m) following up on the plan to add manufacturing capacity that it outlined after going public this summer.
Isis Pharmaceuticals and AstraZeneca have expanded their partnership to develop novel delivery methods for antisense oligonucleotides in order to target the desired tissue more effectively.
Soon PPD and inVentiv will be the only privately-owned top eight CROs, which prompted us to weigh up the firms in the event that either goes public in the near future.
Making clinical trials more open has pros and cons for CROs and drugmakers according to experts from Amgen, Celgene, AstraZeneca, Icon and Lab Corp who spoke at an industry conference in Spain last week.
The EMA said Wednesday it will formally respond to a letter sent by EU ombudsman Emily O'Reilly to the agency in which she took particular issue with some redacted information from AbbVie’s CSRs (clinical study reports).
Biopharma companies are not likely to outsource a larger chunk of their manufacturing than they have in the past 10 years, according to a new report from PharmSource.
CRO Parexel is opening a new European Coordination Hub and Distribution Center in Berlin-Schönefeld, Germany, as well as new full-service clinical trial supply depots in Buenos Aires, Argentina, and São Paulo, Brazil.
Lack of funding is threatening development of a nasal spray vaccine shown to provide long-term protection for non-human primates against the Ebola virus, the lead researcher told this publication in an exclusive interview.
Unilife says its 15 year-wearable injector supply deal with Sanofi is “unprecendented” and could result in over $1bn of sales annually for the delivery device maker.
As PRA Health Services goes public this week, nearly all of the top CROs are now public and the top tier of these companies could control about half of the outsourcing industry, Parexel CFO Ingo Bank said Tuesday.
Power interruptions and remediation work at AMRI’s Albuquerque, New Mexico facility, as well as unexpected delays to API shipments have driven down the company’s Q3 profits.
Patient safety and efficacy endpoint data collector ERT has acquired eClinical Insights (eCI), a provider of cloud-based clinical trials management software, for an undisclosed sum.
Investing in GMP compliance regulations is key to success in sterile manufacturing says UK-based Symbiosis which is looking to capitalise on gaps left by recent CMO pullouts.
The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies.
The IPO boom for CROs is kicking off with INC Research’s stock offering, which as of Friday afternoon saw a nearly 10% rise, meaning the company raised more than $150m.
Indian CRO GVK BIO announced the signing of a definitive agreement to acquire Vanta Bioscience, a full service preclinical GLP toxicology and safety assessment CRO operating out of Chennai, India.
Heparin production may be moving back to Europe according to the EFCG, which cited the opening of Pharma Action’s processing plant as an indication that API buyers value quality and compliance throughout the supply chain.
GSK is keeping its Ebola vaccine production in-house, despite previously leaked documents which suggested the company could not ramp up volume of BS-2 manufacturing without impacting its other vaccine lines.
Using encapsulation machinery that is well serviced and appropriate to the type of powder being used can save drugmakers hundreds of thousands of dollars, according to Capsugel
A Pfizer Director has called for clearer manufacturing commitments in NDA and post-approval applications and the US FDA says, following its restructure, this will come.
Analytical and bioanalytical service provider SGS has made significant changes to its global network over the past few months to stay ahead of the competition curve.
Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed countries (LDC), according to a GSK scientist.
Lab Corp will buy Covance for $6.1bn in a surprise deal that follows another quarter in which early phase gains were offset by underperformance in central labs.
A generic version of Viagra launched in China contains the same amount of sildenafil citrate for a fraction of the price according to manufacturer Guangzhou Baiyuanshan Pharmaceutical Holdings (GBPH).
Sterigenics International has bought Italian gamma-ray sterilisation firm Gammarad in a deal that comes amid rumors that private equity owner GTCR is looking to offload the Illinois-based contractor.
Addicts struggling to kick a meth habit could be helped by gene therapy according to the team behind a US National Institutes of Health funded project.
Bio-Rad Laboratories, a provider of research and clinical diagnostic products, has paid more than $55m to settle past violations of the Foreign Corrupt Practices Act (FCPA) that occurred from 2005 to 2010 related to Thailand, Vietnam, and Russia.
Warburg Pincus has bought a 32% stake in Indian API maker Laurus Labs Private Limited citing the ARV drug ingredients market and international opportunities as drivers.
