Analytical testing, QC

FDA outlines benefit-risk approach to drug or biologic product quality assessment

10-May-2022 By Jane Byrne

The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.

The right tech can fill gap between lab scientist and data: ACD/Labs

16-Mar-2022 By Jenni Spinner

An expert from the R&D tech provider discusses how automation, integration, and other tools can help with effective access and analysis of lab information.

Stanford laboratory aligns with Pepper Bio to target tough cancers

03-Mar-2022 By Jenni Spinner

The drug discovery firm will work with the Dean Felsher Laboratory, using the company’s transomics platform to discover therapies for untreatable cancers.

Managing QC lab data is important part of research equation: Veeva

13-Jan-2022 By Jenni Spinner

A leader from the company discusses challenges in control labs and shares how a new solution aims to clear some key obstacles to greater effectiveness.

AI-based blood analysis tool geared toward decentralized diagnostics

01-Dec-2021 By Jenni Spinner

With the release of its new Sight OLO artificial intelligence based blood analyzer, Sight Diagnostics hopes to offer DCTs reliable, easy-to-use testing.

AstraZeneca opens new advanced therapeutics R&D facility in Cambridge

23-Nov-2021 By Jane Byrne

AstraZeneca has built a new R&D facility - The Discovery Centre (DISC) - in Cambridge in the UK.

Pharmaceutical packaging firm adds QC laboratory in Ireland

10-Nov-2021 By Jenni Spinner

Wasdell, a UK-based packaging and manufacturing provider in the UK, has opened a quality control laboratory in Dundalk to analyze products for its pharmaceutical clientele.

AAPS PharmSci 360

PharmSci 360 invites industry pros to ‘rethink and evolve’

14-Oct-2021 By Jenni Spinner

The conference (with online and in-person content) is slated to gather professionals for deep conversations and lively collaboration on important topics.

Tech Innovations: September 2021

16-Sep-2021 By Jenni Spinner

This month’s roundup of new technology, equipment, and industry partnerships includes news from IBM, IQVIA, Mediata, Labcorp, and other notable companies.

Cloud lab solution empowers access of research tech from miles away

26-Aug-2021 By Jenni Spinner

Emerald Cloud Lab’s remote, automated laboratory technology puts pieces of advanced scientific equipment within the reach of smaller research outfits.

Wave of acquisitions hits pharma industry this week

15-Jul-2021 By Jenni Spinner

The past several days have seen a relatively large number of industry acqusitions, with Lilly, Phillip Morris, WCG, CTI and others making notable buys.

Cryo-EM advancements lead to ‘resolution revolution’: Thermo Fisher

22-Jun-2021 By Jenni Spinner

An academic researcher and and company expert discuss on how evolving cryogenic electron microscopy has led to high resolutions and accelerated results.

Azzur opens new on-demand cleanroom facility in California

03-Jun-2021 By Jenni Spinner

The company’s Azzur Cleanrooms on Demand division has established another facility in Vista, a city in the San Diego Area, for life-sciences operations.

Lonza leader outlines small-molecule trends for 2021 and beyond

06-May-2021 By Jenni Spinner

The head of small-molecule business for the pharma solutions specialist talks about obstacles, and how companies can work to clear them for future success.

Latest FDA COVID-19-related advice and actions

04-May-2021 By Jenni Spinner

The US agency continues to keep a watchful eye over the nation’s pandemic response, issuing advice to professionals and taking action where appropriate.

PRA expands COVID-19 pharmacovigilance resources

04-May-2021 By Jenni Spinner

The CRO is offering an expanded range of post-authorization solutions designed to help developers with treatments and vaccines in their product pipeline

Study examines solution to gauge adverse drug event risk

26-Apr-2021 By Jenni Spinner

Published by Tabula Rasa Healthcare, the report looks at the MedWise Risk Score, technology designed to determine ADE risk rising from medication regimens.

Cancer detection tech uses AI, whole-genome sequencing

22-Apr-2021 By Jenni Spinner

An advanced cancer detection platform from C2i Genomics (reportedly capable of spotting miniscule traces of the disease) recently landed $100m in funding.

COVID-19 highlights need for digital lab connectivity: Waters

22-Apr-2021 By Jenni Spinner

A leader from the laboratory solutions provider talks about how the virus has created challenges for researchers, and how those obstacles might be cleared.

Immunomics firm reels in $14m to advance drug discovery

20-Apr-2021 By Jenni Spinner

ImmunoScape plans to use the investor funds to grow its Asia presence, expand into the US, and to further develop its Deep Immunomics platform technology.

Novartis, Artios cancer discovery deal worth up to $1.3bn

12-Apr-2021 By Jenni Spinner

The collaboration centers on development of precision cancer treatments, through discovery and validation of next-generation DNA damage response targets.

IQVIA completes acquisition of Q2 Diagnostics

05-Apr-2021 By Jenni Spinner

The clinical research tech specialists, which had held 60% of Q2 Diagnostics, will now wholly own the comprehensive clinical laboratory services company.

Vocal biomarkers enable unique diagnosis, monitoring capabilities

02-Mar-2021 By Jenni Spinner

A leader from Vocalis Health explains how health data can be culled from patient voice recordings to screen and monitor COVID-19 and other conditions.

On-demand capabilities help drug developers in a pinch

18-Feb-2021 By Jenni Spinner

With demand for fast-tracking therapies, vaccines and other products increasing, companies like Azzur Group offer the ability to add capabilities quickly.

Clinical data shows BD COVID-19 antigen test might offer an edge

11-Feb-2021 By Jenni Spinner

A peer-reviewed study indicates that the company’s antigen test could be more selective in detecting contagious COVID-19 patients than PCR testing.

CELLINK launches all-in-one imager, single-cell dispenser

09-Feb-2021 By Jenni Spinner

The UP.SIGHT single-sell dispensing system is designed to boost efficiency in cell-line development workflows and offer double assurance of clonality.

COVID-19 tools from Cerba aim to save researchers time

28-Jan-2021 By Jenni Spinner

The company has released two products designed to help clinical researchers accelerate development of treatments and vaccines for the COVID-19 virus.

Calyx spins off medical imaging, eClinical solutions firm

19-Jan-2021 By Jenni Spinner

Formerly Parexel Informatics, the renamed clinical research technology company has broken off and will operate as an independent company going forward.

Lonza scientific team on the hunt for pharma fakery

13-Jan-2021 By Jenni Spinner

The company’s Forensic Chemistry Group comprises a collection of technical professionals using their respective talents to detect and thwart counterfeiting.

PRA Health Sciences expands COVID-19 monitoring program

11-Jan-2021 By Jenni Spinner

The CRO is working with PWNHealth and Fulgent Genetics to enhance its monitoring program, including the addition of at-home COVID-19 testing capabilities.

First FDA COVID-19 update of 2021

04-Jan-2021 By Jenni Spinner

As healthcare providers and other high-priority patients begin receiving the vaccines, the agency continues to act to help the national pandemic response.

DNA analysis could pinpoint ‘long haulers’ among COVID-19 patients

23-Dec-2020 By Jenni Spinner

The analytical tool, developed via Bionano Genomics, maps structural variations in DNA that are known to cause disease and are tied to symptom severity.

COVID-19 response platform expands reach across US

22-Dec-2020 By Jenni Spinner

The GoGetTested response operating system, to date used to administer more than 200,000 tests, now will scale to include health systems in more states.

Chicago life-sciences incubator to open in early 2021

14-Dec-2020 By Jenni Spinner

The resource—designed to provide seed capital, lab space, offices and management consulting to researchers—is opening its doors earlier than expected.

Ancestry study explores COVID-19 genetic risks

07-Dec-2020 By Jenni Spinner

The online DNA network has delved into self-reported data of more than 563,000 US adults to help identify genetic risk of infection and severe outcomes.

Scottish biotech outfit launches clinical trials division

24-Nov-2020 By Jenni Spinner

Intelligent Tissue Group has launched its Intelligent Clinical trials facility to help assess the effectiveness and safety of potential new treatments.

Phesi: protocol changes slow COVID-19 trial down

17-Nov-2020 By Jenni Spinner

A leader from the clinical services provider shares insights gained from comparing two COVID-19 vaccine trials, and tales told by the differences.

Metabolic-disease CRO poised for growth

02-Nov-2020 By Jenni Spinner

With an infusion of capital from investors 1315 Capital, ProSciento is setting its sights on expansion of its specialized clinical research services.

FDA COVID-19 advice and announcements this week

28-Oct-2020 By Jenni Spinner

The latest coming from the agency includes word of the first FDA-approved treatment for the virus, template for test developers and other resources.

ACD/Labs analytical platforms upgraded for COVID-19 age

15-Oct-2020 By Jenni Spinner

The company's Spectus and Percepta platforms offer features to help researchers meet challenges associated with working and collaborating in the pandemic.

Current FDA COVID-19 advice and actions

14-Oct-2020 By Jenni Spinner

The federal government continues to offer life-sciences professionals advice and resources as they pursue treatments to help fight the COVID-19 virus.

CPhI Festival of Pharma

Vetter to profile cleanroom concept at CPhI

30-Sep-2020 By Jenni Spinner

The aseptic technology specialist plans to discuss its V-CRT cleanroom technology at the upcoming CPhI Festival of Pharma online event in October.

Latest COVID-19 news from the FDA

17-Sep-2020 By Jenni Spinner

The US agency continues to issue advice for life-sciences professionals engaged in work related to the virus, and keep an eye out for fraudulent products.

Daxor research battles military injuries

10-Sep-2020 By Jenni Spinner

The company is delving into clinical research partnerships geared toward saving the lives of soldiers, eventually translating findings to civilian care.