Bio Pharma Dive
SEPTEMBER 28, 2021
Outside trial data reviewers have attributed three cases of severe muscle weakness to Pfizer’s treatment, causing the company to change the design of its closely watched Phase 3 study.
Pharma Times
SEPTEMBER 28, 2021
Informa Pharma Intelligence (IPI) has found that some drug firms may withdraw up to 90% of their products from Northern Ireland, once the Brexit grace period has passed.
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NY Times
OCTOBER 1, 2021
The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool against the virus.
pharmaphorum
SEPTEMBER 28, 2021
An app to support people with cognitive disabilities, developed with clinicians at Barts Health NHS Trust, has started to be made available more widely to patients. The Hear Me Now app developed with UCLPartners and software company Maldaba is designed to improve quality of care for people with cognitive impairment, specifically adults with a learning disability.
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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
SEPTEMBER 30, 2021
The acquisition is notable for Merck, which is under pressure to diversify its business beyond the cancer drug Keytruda and has typically favored smaller buyouts.
XTalks
SEPTEMBER 29, 2021
The world as we know it has changed because of the COVID-19 pandemic. We’ve adopted and embraced new technologies at a much faster pace in order to conform to these changes. Simple examples include the increased popularity of food delivery apps and at-home meal kits, but in the larger picture, the nature of working has changed entirely for many companies and people.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
SEPTEMBER 29, 2021
A research project between Bayer and digital health company Huma will use artificial intelligence to detect lung cancer in CT scans – and determine which type a patient has, in order to direct treatment. AI is already being applied by a number of groups, with some studies indicating it can even be more effective than trained radiologists in detecting subtle patterns that indicate the presence of tumours.
Bio Pharma Dive
OCTOBER 1, 2021
Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too.
Scienmag
SEPTEMBER 28, 2021
Niigata, Japan – Amyotrophic lateral sclerosis (ALS) is an intractable neurological disease. Aging is a risk factor for the accumulation of TDP-43 (transduction responsive region DNA-binding protein of 43kDa) in the motor cortex. TDP-43 is a protein that tends to accumulate in increasing amounts, and the amount is strictly controlled by the splicing of TDP-43. […].
BioSpace
SEPTEMBER 28, 2021
?Gene therapy research delivers breakthroughs this week with a CRISPR-edited droplet that could lead to a cure for heart disease and the possibility of turning glial brain cells into neurons.
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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
SEPTEMBER 29, 2021
Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. In this column he addresses the appropriate use of email and how to avoid nightmares in electronic communication. “My fiancée had bought me a string tanga birthday present.
Bio Pharma Dive
SEPTEMBER 29, 2021
Early study results offer some hopeful signs of efficacy, but the small number of patients treated and short follow-up limit firmer conclusions.
Pharma Times
OCTOBER 1, 2021
The European Patent Office (EPO) has granted a patent to specialist pharmaceutical company, N4 Pharma, for its Nuvec cancer treatment and vaccine delivery system.
BioSpace
SEPTEMBER 30, 2021
Noninvasive tests for colorectal cancer, prostate cancer and COVID-19 were among the highlights of the American Association for Clinical Chemistry meeting September 26-30.
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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.
pharmaphorum
SEPTEMBER 27, 2021
As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. The pharmaceutical industry is one of the most important industries in the world, providing lifesaving drugs and treatment to people who need it the most. This already significant industry is growing – it is estimated to be worth $1.27 trillion by end of 2020.
Bio Pharma Dive
SEPTEMBER 28, 2021
The Japanese pharma and Biogen partner is filing an application for accelerated OK of lecanemab, which works similarly to the companies' controversially cleared Aduhelm.
Scienmag
SEPTEMBER 30, 2021
A team of bioengineers at the UCLA Samueli School of Engineering has invented a novel soft and flexible self-powered bioelectronic device. The technology converts human body motions — from bending an elbow to subtle movements such as a pulse on one’s wrist — into electricity that could be used to power wearable and implantable diagnostic […].
BioSpace
SEPTEMBER 30, 2021
?This week, three global biopharmaceutical companies received over half a billion dollars to support research and development initiatives in the treatment of rare and deadly diseases.
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.
pharmaphorum
SEPTEMBER 28, 2021
Prospects for Valneva’s COVID-19 vaccine are up in the air, but another candidate partnered with Pfizer looks increasingly like it could fill the void of an effective shot for Lyme disease. New phase 2 data with their VLA15 vaccine shows that antibody responses from an initial three-dose regimen are initially high, although they start to decline after 18 months in adult subjects.
Bio Pharma Dive
OCTOBER 1, 2021
The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible.
NY Times
OCTOBER 1, 2021
The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool against the virus.
BioSpace
SEPTEMBER 27, 2021
Pfizer and BioNTech share data with FDA on COVID-19 vaccines for younger children as Sanofi pivot on its mRNA COVID-19 vaccine, shifting focus toward other infectious diseases instead.
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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.
pharmaphorum
SEPTEMBER 30, 2021
After days of speculation, Merck & Co confirmed today that it has agreed to acquire Acceleron Pharma $1.5 billion, setting up what could be one of the largest biopharma acquisitions of 2021 so far. The $180-per-share deal – if completed – will give Merck a pair of blockbuster drug candidates, one of which is already on the market, and help to reduce its reliance on $14.4 billion immuno-oncology blockbuster Keytruda (pembrolizumab).
Bio Pharma Dive
SEPTEMBER 29, 2021
The value of the biotech's growing gene therapy portfolio has been "unrecognized" by investors, said CEO John Crowley, leading to a sudden shift for an initiative that began just three years ago.
FDA Law Blog
SEPTEMBER 30, 2021
By Karla L. Palmer — The tale of “David versus Goliath” is never a dull skirmish. This time, “David” consists of a cast of seven compounding pharmacies and their amicus curiae supporters. And the “David” cast of characters has successfully challenged FDA’s promulgation of its final Memorandum of Understanding (“MOU”) intended to “address” shipments of compounded medications interstate.
BioSpace
SEPTEMBER 30, 2021
?The Phase III trial on a potential treatment for mild-to-moderate COVID-19 symptoms by Merck and Ridgeback Biotherapeutics showed promise in preventing hospitalizations and death.
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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.
pharmaphorum
SEPTEMBER 28, 2021
Sanofi has said that it won’t develop its mRNA-based vaccine for COVID-19 any further, even though it seemed to work in an early-stage trial, and will focus instead on another candidate partnered with GlaxoSmithKline. The French pharma group said it took the decision because mRNA vaccines from Pfizer/BioNTech and Moderna are already widely available today it will be too late to the market with its candidate, which was originated by its partner Translate Bio.
Bio Pharma Dive
SEPTEMBER 27, 2021
The hold, which was put in place by the FDA during the fourth quarter last year, came after five patients in an early trial experienced muscle weakness following treatment.
XTalks
SEPTEMBER 30, 2021
Of the many industries that have been negatively impacted by the COVID-19 pandemic, few have been hit harder than the foodservice industry. From labor shortages to lack of revenue, many restaurants were forced to lay off staff, adjust their operations or shut down entirely. But now, a decades-old technology is helping restaurants bounce back: quick response (QR) codes.
BioSpace
SEPTEMBER 26, 2021
With Pfizer expected to submit its COVID-19 vaccine data for children five to 11 years to regulators, a study showed just how damaging the pandemic has been to life expectancy. Here’s a look.
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