Zosano completes site qualification batches for its subcutaneous investigational migraine treatment and readies itself for NDA submission by the end of year.
Seqens opens new center of excellence that houses R&D capabilities, onsite consulting, and space for coworking and collaboration in Porcheville, France.
CRF Bracket – newly-rebranded as Signant Health – is looking to build momentum around eConsent, rethink the patient’s connection to the supply chain, and build out a stronger analytics platform, says CEO.
The drug discovery, development, and analytical service provider has opened a new facility in Sandwich, UK to support the development and manufacturing of APIs – a market expected to top $270bn by 2026.
US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.
In a bid to increase clinical trial diversity, the FDA published a draft guidance suggesting sponsors rethink exclusion criteria, include children in adult studies when appropriate, use adaptive trials, and make sure other logistical barriers to participation...
The clinical trials marketplace for patient recruitment, SubjectWell, has raised $10m in Series A funding and will further expand its services “into the rest of the English-speaking world,” says CEO.
Analytical software provider and CRO, Cytel, and biostatistics company, Axio Research, merge to deliver analytical solutions for clinical research drug development challenges.
Valisure detects fourth probable carcinogen in valsartan medication and criticises the US FDA’s daily exposure limits as lacking a ‘rational basis’ and being ‘of significant concern’.
Transforming statistical data into a surrogate endpoint can enable comprehension of trial results sooner than usual, but few make the cut after formal validation, says drug development expert and DIA panelist.
A new 3D-printed, all-liquid device automates complex chemical reactions on demand – enabling drug screening with limited materials, such as patient biopsies, says researcher.
Females as caregivers, clinical trial participants, and biopharma leaders are among the different roles to be carefully considered as the industry aims for increased inclusion, says BBK executive.
In which areas is artificial intelligence most mature? What are the challenges to widespread adoption? Tufts and DIA recently teamed up to explore these questions.
The US FDA is set to center its drug compounding regulatory program in an office focused on stopping poor quality, unsafe and ineffective drugs reaching patients.
New this year to the discussion at DIA is the conversation around data ownership, as the industry continues to face a deluge of information from more sources than ever.
The Russian all-cargo airline AirBridgeCargo Airlines (ABC) has expanded its SkyCell partnership through which it will lease SkyCell’s containers as sales of temperature-sensitive products boom.
The HIPAA-compliant patient engagement digital platform was developed for clinical trial participants who recently joined or finished a study, providing resources across a range of health conditions.
Zenith-Cognizant Technologies emerges from an acquisition aimed to streamline solutions as more complex “smart factories” become a greater focus in the biopharmaceutical industry.
To investigate blockchain processes and make distribution information retrieval more efficient, the FDA tapped big name companies for a supply chain security pilot program.
A report from the EUIPO demonstrated that a shift in the focus of counterfeited goods to include pharmaceutical products has caused significant loss of sales and employment.
Datacubed Health’s mobile platform has been selected to support a longitudinal Alzheimer’s study aimed at better understanding the disease and finding effective treatments.
Lonza expands its HPAPI production capacity at its Switzerland facility after entering an agreement with AstraZeneca, and invests in manufacturing to establish efficiency.
Two US Attorney Generals have opened an investigation into the data breach at AMCA that compromised a combined nearly 20 million patients at LabCorp and Quest Diagnostics – as the companies’ efforts to notify the public are called into question.
Illingworth Research Group has accepted the challenge and set up shop in the US, the CEO says, as an increase in patient-focused protocol drives demand for the company’s mobile research nurse offering.
Iqvia leads the real world evidence market, which is at an inflection point, as pharma furthers its investment and vendors improve capabilities, according to a recent report.
San Diego, CA-based NanoComposix received its drug manufacturing license which it said will ensure clients are able to use one vendor throughout the product life cycle.
Marken has opened a new depot and increased its logistics warehouse capacity fourfold to accommodate client needs for clinical drug product, clinical drug substance, and medical device storage.
Parexel forms a strategic partnership with Clariness to deploy the ClinLife platform in the Greater China area as the CRO looks to recruit and engage patients in their native language and via social media channels.
Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.
Dassault Systèmes is set to acquire Medidata in an all-cash transaction valued at $5.8bn – a deal which will combine the power of modeling and simulation with data science to “catalyze the next generation of patient-inclusive therapeutics,” says CEO.
As regulators work to advance the modern clinical trial, the risk-averse clinical research industry is falling behind in the race to bring new therapies to patients, says an industry expert, echoing the former FDA commissioner’s calls for innovation.
The CRO is adding two new offices in the US to support what has been significant growth over the past several years from pharma and biotech customers working in rare diseases and immune-oncology.
Saga Diagnostics AB secures venture-backed financing to advance its precision oncology genomics testing technology, which is being used to monitor patient responses in clinical trials, among other applications.
