Oral tolerability concerns have prompted the US biotech to close Ph II clinical trial investigations of FLX-787 in amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT).
Saama has launched a set of artificial intelligence (AI) capabilities designed to understand "typical life science domain questions" to better support clinical trial planning, feasibility, and conduct.
Marken this week has announced the relocation of its Chicago logistics hub into a new, larger facility equipped with cold chain technology for clinical trial materials shipments.
Alcami began work on Flexion Therapeutics's ZILRETTA in the fall of 2014 and today announced that it will further support commercial supply of the product, which is approved for the treatment of OA-related knee pain.
Cambrex’s news that it will be constructing a research and development laboratory at its Italy-based site follows on the heels of its recently announced plans to begin a $5m expansion in Sweden.
Sanofi Pasteur has teamed with Translate Bio to develop mRNA vaccines for infectious diseases, using a platform developed by subsidiaries of Shire plc.
Covance has acquired Sciformix in a deal that augments the CRO’s pharmacovigilance capabilities for post-approval safety solutions and expands its global footprint.
Wasdell Group is investing £500k ($669k) in a new laboratory as the first phase of an expansion strategy, which includes a similar investment in Ireland "to cater for all situations after Brexit," says managing director.
Following on from the success of last year's survey, Outsourcing-Pharma is running another 'state of the industry' survey to gauge views about the current state of the pharmaceutical contract services industry.
SIGA is slated to receive FDA approval for the world’s first antiviral drug to treat smallpox – a milestone not reached in isolation, but in collaboration with several CROs, government agencies, and others.
Blockchain is gaining momentum in the pharmaceutical industry, but consultant Pasi Kemppainen says he would be “cautious” to implement the technology across the entire digital supply chain.
The preclinical contract research organization (CRO) Admescope has acquired MetaSafe in a deal which will bolster its drug metabolism services for clinical phase projects.
The Centre for Process Innovation (CPI) has confirmed its role in a UK initiative to accelerate vaccine production and eliminate the need for cold-chain shipping.
Analytical testing concerns and ‘inadequate’ investigations into failed results were among the GMP deviations observed by the US FDA at IDT Australia Limited’s facility.
PPD Laboratories SVP says its been a substantial undertaking – for every company in the CRO industry – to meet the demand for biopharmaceuticals as the industry's pipeline continues to expand.
China’s pharmaceutical market has outpaced Japan’s to become the second largest market globally – as both aim to be the location of choice for companies developing new innovations, say Parexel consultants.
AMRI will support the development and manufacture of active pharmaceutical ingredients (API) and drug product for Phase I clinical studies under a seven-year contract with the NIH.
Celltrion has launched Bio CDMO, its new contract development and manufacturing business and part of the company's "open innovation strategy" to expand its drug pipeline portfolio.
The US FDA has agreed to recognise GMP inspections of API and drug product facilities carried out by Ireland's and Lithuania’s respective regulatory authorities.
Alcami Corporation is set to be acquired by MDP – a private equity firm which believes the CDMO could double or triple in size as a strong brand in a highly fragmented market.
Almac Group has reported a 19% growth in revenue to £531m ($709.86m) – a first for the company as it continues to invest globally and drive a strategy of strategically entering new markets, says finance director.
The US FDA has issued a warning letter to Chinese API maker Jilin Shulan Synthetic Pharmaceutical Co., citing lax electronic data security and inadequate batch records.
Drugmakers should allow time to test packaging and implement changes if needed, before the November DSCSA deadline, says contract packaging organization.
Syngene International has inked a non-exclusive partnering agreement with the emerging immuno-oncology company Zumutor Biologics after collaborating for more than a year.
Ergomed has added specialist pharmacoepidemiology services at its PrimeVigilance subsidiary to support increasing demand from regulators globally, says CEO.
Altasciences has entered into a strategic alliance with Altreos Research Partners to help clients navigate the “complexities of human abuse potential studies,” says CEO.
Several teams recently competed in the Popup Star clinical trial awareness contest to help raise grassroots awareness of clinical research as a care option within local communities.
The European Commission has angered the biopharma industry by proposing to relax the rules detailing when companies can manufacture biosimilars and generics in the region.
Recipharm has established a Brexit taskforce and plans to hire additional staff to navigate any potential effects of the UK’s departure from the EU in less than a year.
The Northern Ireland development agency Invest NI has awarded Fusion Antibodies a grant worth up to £213,000 ($283,231), which will help the CRO double its capacity and employee count.
Elligo Health Research has acquired ePatientFinder’s Clinical Trial Exchange technology platform and referring practice network as it aims to continue expanding its own network.
The global cancer drug market is expected to reach $200bn by 2022 as the industry experiences rapid changes in treatment guidelines and pathways – and increasing complexity, says Iqvia exec.
Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.
Pharmaceutical companies could learn from the start-up methodology when adopting next-gen technologies, says founding editor-in-chief of WIRED Magazine UK.
LabConnect has completed phase one of three to increase its capacity for peripheral blood mononuclear cell (PBMC) processing at its facility in Johnson City, TN.
