Bio Pharma Dive
JANUARY 28, 2021
So far, both Pfizer's and Moderna's vaccines appear to work against more transmissible variants, but preparation is underway for the day they don't.
BioSpace
JANUARY 28, 2021
The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
JANUARY 28, 2021
A small upfront payment gives Merck access to a program from Artiva Biotherapeutics that aims to create "off-the-shelf" CAR-NK cell therapies for solid tumors.
BioSpace
JANUARY 28, 2021
Regulators removed samples and records from the plant, which are being examined by experts from Belgium, the Netherlands, Italy, and Spain.
Advertisement
Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
JANUARY 28, 2021
Significant setbacks for pace-setting programs from BioMarin and UniQure have renewed questions about gene therapy’s promise, and its safety.
pharmaphorum
JANUARY 28, 2021
New findings from a digital study have challenged the belief that stress is a significant factor in triggering migraine attacks. Results came from a study by the digital health firm Curelator and the University of Calgary, who found that only 7.1% of patients had a majority of their attacks associated with increased levels of perceived stress. At the same time 76% of the total number of migraine attacks were associated with either flat or decreasing levels of perceived stress.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JANUARY 28, 2021
Study suggests that palbociclib could be used to treat around a fifth of people with TNBC
Bio Pharma Dive
JANUARY 28, 2021
The drugmaker is already discussing an authorization with health authorities in the U.K., and plans to begin talks with the FDA and other regulators, too.
BioSpace
JANUARY 28, 2021
The pharmaceutical industry continues to demonstrate its willingness to team up in the ongoing combat against the global COVID-19 pandemic.
Bio Pharma Dive
JANUARY 28, 2021
The experimental treatment from Asahi Kasei Pharma adds to Lilly's pipeline of drugs for pain, including a non-opioid medicine now under review at the FDA.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioSpace
JANUARY 28, 2021
Amgen announced data from the Phase II cohort of the CodeBreaK 100 trial of sotorasib (AMG 510) in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer.
BioPharma Reporter
JANUARY 28, 2021
In vitro studies found the Pfizer/BioNTech COVID-19 vaccine elicits antibodies against both the UK and South African virus strains.
pharmaphorum
JANUARY 28, 2021
It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. As we’ve seen over those five years, biosimilars are critical in continuing to provide doctors and patients choice in their care plans as well as continuing to decrease overall healthcare costs.
BioSpace
JANUARY 28, 2021
The Phase III analysis of its COVID-19 vaccine candidate shows the medication demonstrated 89.3% efficacy in a large-scale study conducted in the U.K. that included the most common strain of the virus, as well as variants.
Advertisement
When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
XTalks
JANUARY 28, 2021
Alpine Start, a Colorado-based company and makers of a premium instant coffee brand, announced their latest launch of functional beverages, called “With Benefits,” via Kickstarter. The brand was inspired by Mount Everest climbers Adrian Ballinger and Cory Richards. Alpine Start worked closely with athletes to develop and formulate the newest line of instant beverages that contain vitamins, adaptogens and medium-chain triglycerides (MCTs) to provide them with good-tasting drinks with the energy n
pharmaphorum
JANUARY 28, 2021
NHS patients in England with newly-diagnosed multiple myeloma can be treated with Celgene’s Revlimid as maintenance therapy after a stem cell transplant, after new guidance from NICE. The cost-effectiveness agency has backed interim funding for Revlimid (lenalidomide) in this setting via the Cancer Drugs Fund (CDF), which provides temporary reimbursement for medicines until further data can be gathered that can help NICE with its cost-effectiveness calculations.
BioPharma Reporter
JANUARY 28, 2021
German officials are not recommending the use of the AstraZeneca-Oxford University COVID-19 vaccine on people aged over 65, according to a report in the Financial Times.
BioSpace
JANUARY 28, 2021
While companies around the globe reduce staff amidst economic upheaval, there's at least one industry on the rise - life sciences. Here's who's breaking ground on expansion projects.
Advertisement
This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Pharma Times
JANUARY 28, 2021
The New Variant Assessment Platform will be led by Public Health England
BioSpace
JANUARY 28, 2021
Overall, against moderate-severe COVID-19 infection, the vaccine was 72% effective 28 days after vaccination in the U.S., 66% in hard-hit Latin America, and bottomed out at 57% in South Africa.
BioPharma Reporter
JANUARY 28, 2021
Belgian health authorities announced today that they visited Novasepâs plant in that country to determine if expected delays in the deliveries of AstraZenecaâs COVID-19 vaccine to the EU are related to production issues at that site.
BioSpace
JANUARY 28, 2021
There are severely limited therapeutic options for immuno-inflammatory diseases such as acute graft vs. host disease (aGVHD), lupus and asthma.
Advertisement
As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Scienmag
JANUARY 28, 2021
Credit: AlphaMed Press Durham, NC – Senquan Liu, Ph.D., is STEM CELLS‘s Young Investigator of 2020 for his work on human stem-cell derived extracellular vesicles (EVs). This award fosters advancements in the field of stem cell research by honoring a young researcher who is the principal author of an article published in STEM CELLS that […].
BioSpace
JANUARY 28, 2021
Janssen presented additional positive data from its phase I study of its bispecific antibody amivantamab in metastatic or unresectable non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
Scienmag
JANUARY 28, 2021
Credit: Institute of Industrial Science, the University of Tokyo Tokyo, Japan — In the marchland of Japan’s Oze National Park, keeping track of the deer population has been a difficult and time-consuming task for the park rangers. Now their lives could get much easier, thanks to a novel technique for tracking deer movements using unmanned […].
BioSpace
JANUARY 28, 2021
The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021.
Advertisement
Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
pharmaphorum
JANUARY 28, 2021
To be truly patient centric, do we need to turn the current model on its head and work within a more free-thinking, free-speaking framework? Amanda Barrell reports from Patients as Partners Europe. Despite huge progress over the last decade, patient involvement in research is still largely in the hands of the pharmaceutical companies. That is according to neuroscientist-turned-advocate, Dr Jonathan Stamford, who told this week’s virtual Patients as Partners Europe conference that patients – not
BioSpace
JANUARY 28, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Scienmag
JANUARY 28, 2021
ROCHESTER, Minn. — In a new study published in Circulation, Mayo Clinic researchers provide the first preclinical, proof-of-concept study for hybrid gene therapy in long QT syndrome, a potentially lethal heart rhythm condition. Researchers demonstrated its potential therapeutic efficacy in two in vitro model systems using beating heart cells reengineered from the blood samples of […].
BioSpace
JANUARY 28, 2021
While the ATLAS platform has the potential to lead to an effective vaccine in itself, its greatest impact in the field of immunotherapy may be that it offers a new way of understanding how a tumor evades the therapy’s boundaries by identifying bad Inhibigens that lead to suppressive, or inhibito.
Advertisement
The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
Expert insights. Personalized for you.
356 
Let's personalize your content