The US FDA has issued Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. a warning letter, in which it says the API maker admitted to deleting test data by accident.
PSI CRO has opened a new office in the California Bay Area to support continued growth organically – which, according to the company, is what drives its success.
Novartis has launched FocalView, a new app that aims to allow researchers to track ophthalmic disease progression by collecting real-time data from patients.
The US FDA has issued a warning letter to Mexican drugmaker Degasa SA. de C.V for violating good manufacturing practice (GMP) regulations for finished pharmaceuticals.
Sterling Pharma Solutions is boosting its small to mid-scale active pharmaceutical ingredient manufacturing capabilities, marking the CDMO’s second £6m investment in as many years.
UK-headquartered RxCelerate has acquired the specialist bioanalytical contract research organization Total Scientific – increasing its staff to 37 following its expansion stateside in November 2017.
Johnson & Johnson has reported plans to cut costs across its supply chain as it looks to shifts focus from “older parts” of its portfolio to newer technologies and capabilities, such as in biologics, says CFO.
Next-generation regenerative and personalised medicines may be attracting increased industry attention, but small molecule drugs are here to stay, say executives.
Enteris BioPharma has completed recruitment and initial dosing of all subjects for an additional treatment arm of its Phase IIa clinical trial, which is being conducted by Syneos.
The R&D facility will help clients advance pharmaceutical ingredients from preclinical to commercial stage, says the contract development and manufacturing organisation.
By Doug Peddicord, PhD, executive director, Association of Clinical Research Organizations
The CRO market is expected to reach $45bn by 2022, with outsourcing work having increased by 40% in the past decade — yet the industry remains largely elusive, until now.
Cambrex has completed construction and validation of a new $3.2m, 11,000 square foot analytical laboratory at the former PharmaCore facility in High Point, NC.
Regulators have published results from a six-year international active pharmaceutical ingredient inspection programme that Johnson Matthey says benefits companies and authorities.
Following one of the worst flu seasons in years, several companies are working to develop a universal vaccine, with the first clinical trials in humans now underway.
Catalent plans to invest $5m to create a new drug development center of excellence focusing on preclinical to clinical phase IIb formulation, analytical, and manufacturing solutions.
There is no slowdown in sight, says Avid Bioservices CEO, as the company today announces further expansion to support new client projects and optimize its novel CHO-based expression system.
STA Pharmaceutical is manufacturing PhoenixMD’s kinase inhibitor drug candidate for IND-enabling toxicology studies and a Phase I study in women with triple-negative breast cancer.
A continued need for specialized services and expertise will keep smaller firms in business – though many have forecasted the “death of small- to mid-sized CROs” as the industry continues to consolidate, say experts.
Acurian and Synexus have introduced a new clinical trial enrollment solution for patients with nonalcoholic fatty liver disease, which is often underdiagnosed.
Dr. Bertalan Mesko discusses the role of artificial intelligence in the future of health care, how patients are driving adoption – and the seemingly thin line between “healing” and “upgrading.”
WuXi AppTec is converting its Plainsboro, NJ lab into a fully GLP-regulated bioanalytics facility after opening a new site in Cranbury which doubles the company’s total operation space to more than 115,000 square feet.
Wacker Chemie has acquired SynCo Bio’s site for manufacturing biopharmaceuticals, live microbial products, and vaccines, as well as its associated business, including more than 100 employees.
Glenmark Pharmaceuticals has suspended a Phase II clinical trial at a site in India following media reports that villagers were allegedly “deceived” into participating.
The contract research organization (CRO) Synteract today announced the creation of “therapeutic centers of development” as it looks to deepen its footprint in the mid-size CRO market space.
Mayne Pharma has opened a new 126,000-square-foot oral solid-dose manufacturing facility to meet demand driven by new product launches – and new revenue stream from its CDMO business.
The fourth industrial revolution is here, and some countries are embracing digitisation and advanced manufacturing techniques faster than others, says Siemens exec.
Pills embedded with sensor technology that verifies a patient has taken their medication can improve adherence and provide data on adverse effects, says Proteus Digital Health’s Nik Leist.
The industry’s current research model is failing patients who live in a mobile world and will not sustain if clinical trials continue to take years to recruit, says industry expert.
Tufts Medical Center has joined TriNetX’s research network to improve its clinical trial process, further expanding the company’s reach as it looks to grow internationally and introduce new offerings in 2018.
Almac Group has expanded its commercial packaging capabilities to meet a “significant increase” in demand for complex kit assembly as biopharma brings more advanced sterile and biological products to the market, says CDMO.
The US FDA has issued a recall of non-expired products marketed as sterile made by Coastal Meds after an investigation of the outsourcing facility found poor sterile production practices.
Poor animal study design and reporting raise concerns about whether current processes are the best way to conduct effective and efficient drug development.
Charles River Laboratories and PathoQuest have expanded their strategic partnership to help move vaccine, biologic, and gene-therapy candidates through the drug discovery and development pipeline.
The acquisition of Analytica Laser adds real-world effectiveness prediction and value assessment to Certara's service portfolio – as it aims to “tackle trial to real-world value translation,” says exec.
