Dutch contract manufacturer PharmaCell B.V has signed a three-year Manufacturing Services Agreement to make cancer cell therapies for Lion Biotechnologies.
Industry group the ABPI has called on the next UK Government to support local drug production, increase National Health Service (NHS) funding and put life sciences at the heart of its post-Brexit plan.
The UK MHRA saw an increase in sterility issues at drug plants in 2016 although quality system problems remained the most common deficiency seen during inspections.
Sanofi Pasteur says heavy investment in messenger RNA (mRNA) is warranted as such technology could revolutionise vaccine development and manufacturing.
Spaulding Clinical Research will conduct Evoke Pharma’s planned comparative exposure pharmacokinetic (PK) trial for its lead product candidate, Gimoti.
The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.
LabCorp will relocate its UK CMC services unit to a larger site and has said it is confident the Government will maintain its commitment to the drug industry after Brexit.
Drug track and trace rules introduced in Saudi Arabia prompted a €300,000 ($326,078) investment in processing technology and software according to Sweden-based contractor Recipharm.
Certara has launched a new solution for preparing, analyzing, and submitting pharmacokinetic (PK) data in Clinical Data Interchange Standards Consortium (CDISC) format.
The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.
Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the MHRA limit communication to essential information.
TransCelerate has chosen the Veeva Vault SiteExchange to simplify investigative site collaboration as part of its Shared Investigator Platform Initiative.
Caligor Opco LLC is providing regulatory and logistical management for Puma Biotechnology’s expanded access program (EAP) for its investigational breast cancer therapy, neratinib.
Randomized controlled trials are the fastest way to identify vaccines in an outbreak, but more collaboration is needed among international researchers – including CROs.
The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.
Plasticell is advancing multiple projects through which it will develop and manufacture red blood cell substitutes for human clinical transfusion and progress preclinical trials.
Partnering and collaborating to advance drug delivery innovation is essential, now more than ever, say industry experts from Boehringer-Ingelheim and Merck.
DermTech, Inc. has announced two new collaborations with pharmaceutical companies and expects more to follow as the demand for personalized, precision medicine increases.
Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.
The US FDA completed an inspection of Aurobindo Pharma Limited’s manufacturing plant in Bachupally, Hyderabad yesterday, issuing the Indian drug firm with a Form 483 detailing six observations.
Deutsche Post DHL Group’s contract logistics business, DHL Supply Chain, has announced its intention to acquire Brazilian transport service provider Polar Transportes.
LiveLeaf, Inc. has announced a collaboration with the contract research organization (CRO), Emery Pharma, to advance its development of novel prodrugs for FDA approval.
Medical device clinical trials have increased 63% since 2012 and a market void for mid-size device CROs could present a significant opportunity for growth.
BioCelerate has partnered with Accenture to develop a platform that will aggregate and analyze preclinical and clinical information to "drive additional industry value."
