Bio Pharma Dive
SEPTEMBER 16, 2021
Combining Amen's Lumakras with its drug Vectibix appeared to work better in treating colorectal cancer than Lumakras alone, spurring the biotech to unveil plans for a new Phase 3 trial.
Pharma Mirror
SEPTEMBER 16, 2021
What is a health coach? A health coach is someone with expertise in wellness who assists people achieve good health by being a mentor and educator on lifestyle and nutritional changes. It is important to understand that health coaching is not only about nutrition, but instead, health coaches offer people a holistic approach to creating and sustaining healthy habits.
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Bio Pharma Dive
SEPTEMBER 16, 2021
Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally.
pharmaphorum
SEPTEMBER 16, 2021
Given the rising cost of medicines as a share of the NHS budget in England, the establishment of ICSs provides a timely opportunity to take stock on delivering medicines optimisation at local level, says NHS Gloucestershire CCG’s Ellen Rule. Medicines optimisation aims to improve health outcomes, service quality, and sustainability by ensuring patients are taking their prescribed medicines as recommended to derive the intended benefits and avoid incurring harms.
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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
Pharma Times
SEPTEMBER 16, 2021
Through Entia’s virtual oncology platform, patients are able to perform their own blood tests
pharmaphorum
SEPTEMBER 16, 2021
Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The US regulator has cleared the tyrosine kinase inhibitor (TKI) as a second-line treatment for locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients whose tumours have EGFR exon20 insertion mutations, after first-line chemotherapy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 16, 2021
The COVID-19 pandemic has changed science journalism. Semantics aside, though, science and health care have taken a new position in the hierarchy of top news priorities.
BioPharma Reporter
SEPTEMBER 16, 2021
AGC Biologics is expanding its Heidelberg facility to create new capacity for messenger RNA (mRNA) projects, and to boost its plasmid-DNA (pDNA) manufacturing capabilities.
BioSpace
SEPTEMBER 16, 2021
In a late-breaking presentation on Saturday, EQRx and partner CStone Pharmaceuticals will report data from the phase III GEMSTONE-301 study of its anti-PD-L1 antibody sugemalimab.
pharmaphorum
SEPTEMBER 16, 2021
Tobacco giant Philip Morris International (PMI) has won the shareholder vote it needed for its controversial £1.1 billion takeover of respiratory drugmaker Vectura, despite mobilised opposition to the deal. PMI said it had won support from enough shareholders that – when added to its own holding in Vectura – meant it had a 75% position in the firm, well ahead of the 50% needed to get the transaction accepted.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioPharma Reporter
SEPTEMBER 16, 2021
Pfizerâs mRNA flu vaccine joins candidates from Moderna and Sanofi in hoping to provide greater protection against influenza than existing vaccines.
BioSpace
SEPTEMBER 16, 2021
?COVID-19 remains relentless in challenging the community as it continues to evolve. Here are some of the top news for the week.
Scienmag
SEPTEMBER 16, 2021
Results of a new study led by the University of Maryland School of Public Health show that people infected with the virus that causes COVID-19 exhale infectious virus in their breath – and those infected with the Alpha variant (the dominant strain circulating at the time this study was conducted) put 43 to 100 times […].
BioSpace
SEPTEMBER 16, 2021
A trustee with the DOJ filed a request for an “expedited stay” in order to prevent the initiation of the bankruptcy plan.
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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.
Outsourcing Pharma
SEPTEMBER 16, 2021
Stakeholders in the Rare Disease Cures Accelerator-Data and Analytics Platform initiative are partnering in hopes of bringing treatments to patients faster.
BioSpace
SEPTEMBER 16, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
Delveinsight
SEPTEMBER 16, 2021
FDA’s Go-Ahead to Amylyx New Drug Application for ALS Drug. Amylyx Pharmaceuticals has announced its plan to submit a New Drug Application (NDA) to the U.S. FDA for its drug, AMX0035 (sodium phenylbutyrate (PB) and Taurursodiol (TURSO)), for the treatment of Amyotrophic lateral sclerosis (ALS). A few months ago, the company had decided to file for a marketing application to the different regulatory agencies seeking approval on the basis of the Phase II CENTAUR trial, which has shown that the dru
BioSpace
SEPTEMBER 16, 2021
Biopharma companies big and small are presenting exciting clinical studies at the European Society for Medical Oncology Congress 2021.
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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.
JAMA Internal Medicine
SEPTEMBER 16, 2021
This cohort study examines the association between the incidence of peripheral intravenous catheter bloodstream infections and a change in hospital policy from routine catheter replacement to clinically indicated catheter replacement.
BioSpace
SEPTEMBER 16, 2021
Gilead announced its plans to replant some roots back in North Carolina’s Research Triangle. The new site is expected to bring in 275 jobs to the North Hills innovation district.
Scienmag
SEPTEMBER 16, 2021
A?UCLA-led?team of?engineers and chemists has taken a major step forward in the development of?microbial?fuel cells — a technology that?utilizes?natural bacteria to extract electrons from organic matter in wastewater to generate electrical currents.?A study detailing the breakthrough was recently published in?Science.? Credit: Image created by AKang, Sphere Studio.
BioSpace
SEPTEMBER 16, 2021
The massive genetic data mining project aims to gain deeper insight into how human genetic variants affect risk for common complex diseases.
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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.
Drug Discovery Today
SEPTEMBER 16, 2021
A drug already used to treat high blood pressure could be re-purposed as the first treatment to tackle a type of vascular dementia caused by damaged and ‘leaky’ small blood vessels in the brain, according to research part-funded by the British Heart Foundation and published today in the Journal of Clinical Investigation.
BioSpace
SEPTEMBER 16, 2021
Vifor Pharma Group and Travere Therapeutics inked a collaborationfor the commercialization of sparsentan for the treatment rare progressive kidney diseases.
Pharma Times
SEPTEMBER 16, 2021
Partnership aims to develop mRNA-encoded antibody therapeutics
pharmaphorum
SEPTEMBER 16, 2021
BioCryst Pharma’s Orladeyo has been recommended by NICE as a treatment for the rare disease hereditary angioedema (HAE) in England, Wales and Northern Ireland. Orladeyo (berotralstat) – which was approved by the EMA and MHRA in April and May, respectively – is set to become the first oral, once-daily therapy that can be used to prevent HAE attacks in NHS patients aged 12 and over, according to the drugmaker.
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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.
Pharma Times
SEPTEMBER 16, 2021
NICE has recommended the treatment for people who have at least two attacks per month
Outsourcing Pharma
SEPTEMBER 16, 2021
This monthâs roundup of new technology, equipment, and industry partnerships includes news from IBM, IQVIA, Mediata, Labcorp, and other notable companies.
Cloudbyz
SEPTEMBER 16, 2021
Cloudbyz, a fast-growing integrated Clinical Research and development solution provider in Healthcare & Life Science, has recently executed a CSR drive at the Samarthanam Trust for the Disabled showcasing its commitment to social responsibility by giving back to the community. Samarthanam Trust for the Disabled is a non-profit organization catering to the needs of specially-abled and underprivileged children and women, with early phase education for specially-abled children.
Scienmag
SEPTEMBER 16, 2021
It’s the rare engineer who gets to conduct experiments in space. But Lehigh University now has three who will be doing just that. Credit: Lehigh University It’s the rare engineer who gets to conduct experiments in space. But Lehigh University now has three who will be doing just that. A multidisciplinary trio from Lehigh’s P.C. […].
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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.
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