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.
The delivery technologies and development solutions provider Catalent Pharma Solutions today announced it has completed a $5.5m expansion program at its 200,000+ square foot Philadelphia, PA.
China is becoming a fundamental player and is expected to reach market parity with the combined top five European countries by 2022, though the US still dominates, says industry expert.
PharmaCyte’s live-cell encapsulation technology could change the way solid tumor cancers are treated, says CEO, as the biotech moves forward with CRO selection ahead of its Ph IIb clinical trial – which will is expected to cost between $15 and $17m.
Pharma must brace itself for production scheduling clashes and cost challenges ahead of next year’s Falsified Medicines Directive (FMD) says PharmSource.
To bridge the gap between clinical research and health care, the industry must connect with marginalized practitioners and patients – and create greater incentives for collaboration.
ImmunoPrecise Antibodies has acquired ModiQuest Research BV to create a “single source provider of services across the full antibody discovery value chain,” says CRO.
LabCorp is investing $30m in a new operations center at the former GSK campus in Research Triangle Park with support from a job development grant worth more than $8m.
Pharma must look outward to innovate and find new areas of growth, as research and development productivity and returns on innovation continue to decline, says industry expert.
The mobile health platform from Oracle Health Sciences enables clinical study teams to collect remote patient data from sensors, wearables, and apps – and promises to deliver “a new level of patient centricity.”
Parexel and Meiji Pharmaceutical University have announced a new academic program to develop the biopharmaceutical workforce in Japan and meet the industry’s demand for talent in clinical research.
Pfizer will recruit patients with rare diseases and identify clinical trial sites with support from the TriNetX global health research network, which is becoming "the defacto platform" for research, says CEO.
The US FDA has sent a warning letter to Tris Pharma, a New Jersey-based manufacturer that makes ADHD drug Quillivant XR (methylphenidate HCl) for Pfizer.
Frontage Laboratories has acquired Concord Biosciences, taking a “significant step” towards the company’s goal of building a global organization, says CEO.
Patient recruitment is underway for a genomics-based pilot program to study opioid abuse and addiction – a first step in extending precision medicine into clinical practice for addiction, says CRO Genemarkers.
ClinicalRM – which ICON acquired in 2016 – has become ICON Government and Public Health Solutions (GPHS), providing full-service clinical trial execution and functional services to government, NGOs, and commercial customers.
Ferring Pharmaceuticals is buying Rebiotix and says its lead candidate has the potential to be the first human microbiome product approved anywhere in the world.
KBI will provide services to ReForm to further develop and validate its biologic formulation platform and in turn, will gain access to ReForm’s proprietary excipient technologies.
Regulations are changing across the globe as patients, the scientific community, and other stakeholders call for increased clinical trial data transparency.
With less than a year until the full implications of Brexit set in, Parexel consultants urge the industry to not wait – assess potential risks, such as to the clinical supply chain, and take actions to mitigate them.
Project Data Sphere aims to accelerate research by providing cancer clinical trial data from various sources to “any and all scientists” – and has named pharma industry veteran Bill Louv as its new president to ensure it delivers.
The synthetic DNA provider Twist Bioscience Corporation has completed a private placement of $50m to advance its proprietary, silicon-based DNA Synthesis Platform.
The CRO industry is expected to grow at a CAGR of 5-6% over the next 5 years, despite a move by Big Pharma to take more control of clinical trials, bringing work back in-house.
Nanoparticle delivery technology that transports compounds to the bloodstream and cells can increase bioavailability and reduce adverse effects of cannabinoids and bioactive compounds, says NanoSphere Health Sciences.
Exactis Innovation is standardizing its sequencing labs as it aims to quickly match at-risk cancer patients with clinical trials through its longitudinal, biopsy-led registry.
CMAB Biopharma has raised $34m in Series B financing to upgrade its GMP facilities – and has entered into collaboration agreements with “several” biopharma clients, says CDMO.
Align Clinical CRO is "committed to operating with speed" as it aims to solve common pre-competitive industry challenges to improve clinical trial execution and collaboration between sponsors and CROs, says exec.
Accelovance and Linical are merging to create a contract research organization (CRO) with a global footprint in response to the need for large-scale, multinational clinical trials.
