Bio Pharma Dive
JUNE 23, 2022
Two investment firms, Gurnet Point Capital and Patient Square Capital, have agreed to pay as much as $890 million for Radius, which has come under pressure amid share price declines.
Pharmaceutical Technology
JUNE 24, 2022
As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. In addition to providing protection against the Omicron BA.1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4 and BA.5.
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World of DTC Marketing
JUNE 22, 2022
Advanced economies typically spend about 10% of GDP on keeping their citizens in good health, a share that is rising as populations age. America’s profit-riddled healthcare-industrial complex consumes 17% of GDP, equivalent to $3.6trn a year. That is unsustainable. However, changes are slowly being implemented that could lower healthcare costs.
pharmaphorum
JUNE 23, 2022
Eisai’s digital tool to allow self-assessment of cognitive performance – NouKNOW – will be used in a Japanese project aimed at improving the management of dementia. The smartphone app – which uses a cognition-checking algorithm developed by Australian digital health company Cogstate – will be deployed in Bunkyo City, Tokyo in a dementia monitoring programme.
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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
Bio Pharma Dive
JUNE 21, 2022
A confirmatory study of PTC Therapeutics’ muscular dystrophy treatment Translarna missed its main goal, although the company highlighted the trial’s overall positive results.
Pharmaceutical Technology
JUNE 23, 2022
The European Commission (EC) has approved Novartis’ Tabrecta (capmatinib) as a monotherapy to treat advanced non-small cell lung cancer (NSCLC) in adults. The treatment is intended for patients with NSCLC harbouring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping and for those who need systemic therapy after previous treatment with immunotherapy and/or platinum-based chemotherapy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JUNE 20, 2022
Thousands more people with breast cancer in England look set to be eligible for routine treatment with Eli Lilly’s Verzenios, after new guidance from NICE backed use of the drug after surgery for early-stage tumours. The new advice means that around 4,000 people with hormone receptor-positive, HER2-negative, node-positive early breast cancer who are considered at high risk of recurrence after surgery can receive Verzenios (abemaciclib) in combination with standard hormone therapy, said the
Bio Pharma Dive
JUNE 22, 2022
The company says a recent coverage decision by Medicare has forced it to end an observational trial of the Alzheimer's drug after enrolling just 29 participants.
Pharmaceutical Technology
JUNE 24, 2022
Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. Developed utilising Novavax’s recombinant nanoparticle technology to generate antigen obtained from the coronavirus spike (S) protein, the vaccine is also formulated with the company’s saponin-
Scienmag
JUNE 23, 2022
WASHINGTON — Researchers have developed a new ultra-thin film that can create detailed 3D images viewable under normal illumination without any special reading devices. The images appear to float on top of the film and exhibit smooth parallax, which means they can be clearly viewed from all angles. With additional development, the new glass-free approach […].
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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
pharmaphorum
JUNE 21, 2022
Armed with new phase 3 data, AstraZeneca is preparing to file for regulatory approval of eplontersen, an antisense drug for one of the complications of the disease transthyretin amyloidosis (ATTR) it licensed from Ionis in a $3.6 billion deal last year. Eplontersen – previously known as IONIS-TTR-LRX – is designed to switch off the production of transthyretin (TTR), a protein which builds up in the disease to toxic levels causing heart problems (cardiomyopathy) and nerve damage (polyneuropathy).
Bio Pharma Dive
JUNE 22, 2022
The pharma will pay $75 million to access Precision’s gene editing technology, adding another program to the lengthening list of drug development efforts targeting the inherited blood condition.
Pharmaceutical Technology
JUNE 24, 2022
invoX Pharma has signed a definitive agreement for the acquisition of all issued and outstanding shares of clinical-stage biopharma firm F-star Therapeutics, in a deal valued at nearly $161m or $7.12 for each share in cash. invoX Pharma is a fully owned Sino Biopharmaceutical subsidiary. The latest deal will expedite the strategy of invoX to develop the International Biopharmaceutical R&D Platform of Sino Biopharm outside of China to transform the lives of patients globally.
Scienmag
JUNE 24, 2022
The Interactive Talk presentation, “Predicting Oral Cancer Risk using Machine Learning”, will take place on Saturday, June 25th, 2022 at 2 p.m. China Standard Time (UTC+08:00) during the “e-Oral Health Network I” session. The study, undertaken by John Adeoye of the University of Hong Kong, SAR China, aims to develop a machine learning-based platform to […].
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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.
BioPharma Reporter
JUNE 20, 2022
Following the adoption of a critical list of COVID-19 vaccines and treatments, European Union member states and pharma companies will communicate to ensure sufficient supply to meet evolving demand.
Bio Pharma Dive
JUNE 22, 2022
The Belgian drugmaker will spend more than $100 million to acquire two companies, CellPoint and AboundBio, in a move meant to “disrupt” CAR-T treatment.
Pharmaceutical Technology
JUNE 23, 2022
In the last year, well-known contract manufacturing organisations (CMOs) such as Agilent Technologies (Santa Clara, California) and Abzena (Cambridge, UK) have expanded their continuous manufacturing capabilities. US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals. As more drugs are approved with continuous manufacturing, this production method is becoming increasingly mainstream.
pharmaphorum
JUNE 20, 2022
Speculation that Merck & Co may be preparing a $30 billion takeover bid for Seagen – bolstering its oncology ambitions – has the biopharma community aflutter. The rumour was first published in the Wall Street Journal, which suggests that a takeover is just one option on the table, along with a marketing deal that would bind the two companies together without the risk of antitrust issues holding up or blocking a merger.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
BioSpace
JUNE 19, 2022
CVS Health has seen about 40% patient diversity in the work it has done so far, Josh Rose, VP and head of decentralized clinical trials, site solutions and strategy told BioSpace.
Bio Pharma Dive
JUNE 24, 2022
The decision brings what could be the first approved hemophilia gene therapy, Roctavian, closer to market, after a series of regulatory setbacks that have delayed its arrival.
Pharmaceutical Technology
JUNE 22, 2022
BioMarin Pharmaceutical has obtained Japan’s Ministry of Health, Labor and Welfare (MHLW) approval of the registration for its Voxzogo (vosoritide) for injection to treat achondroplasia in children whose growth plates are not closed. A modified C-type natriuretic peptide (CNP), Voxzogo acts on achondroplasia’s underlying pathophysiology. It works by down-regulating fibroblast growth factor receptor 3 (FGFR3) signalling and subsequently boosting endochondral bone formation.
pharmaphorum
JUNE 22, 2022
The pandemic highlighted how fragile the global manufacturing network is, as supply of certain products was limited and regulatory inspections became difficult to carry out. Ben Hargreaves finds out how the issue of foreign manufacturing has become a major US political talking point and how this could influence the pressures facing the industry. In a global economy, across a number of industries, low-margin products are often manufactured in countries where labour is cheap.
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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.
Pharma Times
JUNE 22, 2022
Novartis receives approval from the European Commission for Tabrecta for the treatment of non-small cell lung cancer
Bio Pharma Dive
JUNE 23, 2022
After one year, researchers detected important protein changes in patients who received a low dose of the experimental treatment. Further testing and functional data are needed to assess its potential, however.
Scienmag
JUNE 20, 2022
Throughout the middle of the 20th century, phosphorus inputs from detergents and fertilizers degraded the water quality of Switzerland’s Lake Geneva, spurring officials to take action to remediate pollution in the 1970s. Credit: Benoit Tissu Throughout the middle of the 20th century, phosphorus inputs from detergents and fertilizers degraded the water quality of Switzerland’s Lake […].
pharmaphorum
JUNE 22, 2022
Pfizer has harnessed the expertise of health data specialist Truveta to provide close monitoring of safety and other signals for its products, including COVID-19 vaccine Comirnaty, almost in real-time. Truveta’s platform is based on electronic medical record data – updated daily – for more than 50 million people in the US, harvesting anonymised patient care information from tens of thousands of clinical care sites across 42 states.
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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.
XTalks
JUNE 24, 2022
The US Food and Drug Administration (FDA) has authorized the use of Pfizer-BioNTech’s and Moderna’s COVID-19 vaccines for children as young as six months old, a much-awaited decision for some parents with young children. The amended authorization came after FDA advisors on the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously backed the use of the vaccines in young age groups.
Bio Pharma Dive
JUNE 21, 2022
A medicine at the center of a multibillion-dollar alliance between the two companies passed a major test in transthyretin amyloidosis. Full study details were not disclosed, however.
BioSpace
JUNE 20, 2022
Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.
BioPharma Reporter
JUNE 20, 2022
Pharma industry organizations say they are deeply disappointed by the decision taken by World Trade Organization (WTO) at its ministerial conference, MC12, to endorse a TRIPS waiver for COVID-19 vaccines.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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