The high cost and complexity of producing biopharmaceuticals for clinical trials limits supplies and makes effective logistics even more important than for small molecule studies says Almac.
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An under-attended investor day at Quintiles, the world’s largest CRO, is indicative of waning interest in the clinical sector according to a William Blair analyst.
Early phase CRO (contract research organization) Charles River Laboratories will lay off between 26 and 30 employees following the US National Cancer Institute’s decision to terminate a contract in which the company supplied rodent models for cancer research.
The International Society for Pharmaceutical Engineering (ISPE) last week offered up a preview to its plan to help manufacturers avoid or mitigate drug shortages due to manufacturing or quality issues.
AMRI has added protein expression and purification services to its drug discovery services citing the shift in pipelines towards larger molecule drugs as a driver.
Meda has sold a New Jersey facility dedicated to its intra-urethral erectile dysfunction drug Muse as part of a strategic review of its manufacturing network.
Pharma’s biggest players have donated more than $102m ($78m) of technology in a project to transform data sharing in clinical trials and “save the industry billions of dollars.”
Divested sterile manufacturer Ben Venue has continued to cause trouble for Boehringer Ingelheim with a second recall this year of an injectable drug made at the now defunct site.
Xellia has agreed to invest $100m in equipment, retain staff and create 40 full time jobs at the plant it bought in Raleigh, North Carolina in return for business incentives.
CRO Pharmaceutical Product Development (PPD) announced today that it has acquired for an undisclosed sum RCT Logic’s exclusive license from Massachusetts General Hospital (MGH) for the portfolio of patents related to its sequential parallel comparison...
Parexel’s future course may depend on the outlook of competing CROs (contract research organizations), a couple of which could potentially go public in the near future, Ingo Bank, SVP and CFO of Parexel, said Wednesday at the Baird 2014 Healthcare Conference.
Ohio-based CRO (contract research organization) Ricerca Biosciences is holding “ongoing discussions with several parties” about the possible sale of one or more of its divisions or the entire company, CEO Tim Derrington told us.
West Pharmaceutical Services has confirmed it is evaluating potential expansions but says rumours that it plans to pay €100m ($130m) for a facility in Ireland are premature.
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...
A former researcher of the now dissolved CRO Cetero Research told us the warning letter he received from US FDA was “contrived” because of the way the inspection was conducted.
ZMapp, the experimental Ebola therapy given to a handful of infected patients in West Africa, is being produced in tobacco plants for Mapp Biopharmaceutical by CMO Kentucky Bioprocessing in collaboration with drugmaker Defyrus.
Increasing the predictivity of in vitro systems could cut the costs of drug development and shift preclinical research away from animal models, according to Crown Bioscience.
Pharma firms must provide imaginative solid dosage alternatives to tablets and capsules, says research claiming more than half of patients have problems swallowing traditional pills.
A German biobank has made stem cells available to active pharmaceutical ingredient (API) firms this week in a bid to support industry drug development efforts.
European organisations representing academic CROs and nuclear medicine researchers have established an accreditation programme for a novel Zirconium-PET imaging technique, used in early development of monoclonal antibodies.
Millions of fake pharmaceuticals seized earlier today were imported from Asia by an organised crime group that planned to sell them online say European law enforcement agencies that co-ordinated the swoop.
Patheon has sliced four weeks off its Quick-to-Clinic service saying speedier supply of materials for first in human trials increases pharma’s return on investment.
The US FDA import ban imposed on Apotex in 2009 was legal and the firm was not treated more harshly than generics rival Teva according to a State Department arbitration panel.
Biopharmaceutical firm Merck Serono will make small molecule drugs at the new plant it is building in China according to a company spokeswoman, who told us the firm will supply both local and international markets.
Contract research organisations (CROs) are turning to technology to fight dual patient enrolment in trials, but rival service companies refuse to sync their methods, says an early-phase expert.
Smaller pipelines make keeping to timelines particularly important in biopharmaceutical trials according to Exco InTouch, which says this pressure is driving EDC tech adoption.
A candidate Ebola vaccine that uses Immunovaccine's formulation technology has stopped cynomolgus monkeys from catching the disease in a preclinical study.
Regulators are showing interest in a database of clinical trial endpoints to cut redundant research, although contract research organisation Parexel has expressed reservations.
Brussels airport has become the first European shipping hub to adopt a cold-chain certification programme for pharmaceutical cargo that industry group IATA claims “goes beyond” GDP requirements.
Poppies will continue to be the main source of industrial opiates long-term according to GSK, despite a recent breakthrough in efforts to produce it in GM yeast.
Dr Reddy’s Laboratories says accusations by the US Government’s Consumer Product Safety Commission (CPSC) that it violated childproof packaging rules could cause significant losses for the company.
Pfizer is rumoured to be eyeing up Actavis three months after failing to woo AstraZeneca in a $120bn megamerger, but what would such a deal bring to the Pharma Giant? In-Pharmatechnologist investigates.
Patheon has acquired Gallus BioPharmaceuticals adding two US biologics plants and says with an industry shift towards medium sized bioreactors it now holds the market advantage.
CROs must design their abuse liability studies to cope with volunteers who arrive under the influence or give misleading patient histories, says a specialist consultancy.
Parallel deals to invest in Isofol Medical and manufacture the alternative chemotherapy agent Modufolin on its behalf are evidence of Recipharm’s ambitious growth strategy, the CDMO says.
Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.
Roche has bought InterMune for $8.3bn (€6.3bn) and says it will continue contracts with Catalent and two API suppliers for the manufacture of its lead product Esbriet (pirfenidone).
