Bio Pharma Dive
NOVEMBER 9, 2022
While many companies are still unsure of the Inflation Reduction Act's effects, some have begun to warn investors about the likelihood of lower sales and reduced profitability.
Pharmaceutical Technology
NOVEMBER 9, 2022
Despite their potential multi-million-dollar sticker price, if haemophilia treatments by BioMarin and CSL Behring prove durable, they could help patients save money compared to current treatments, experts note. On November 2, the Institute for Clinical and Economic Review (ICER) released its updated evidence aimed at measuring the clinical effectiveness and cost of the two haemophilia gene therapies.
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Bio Pharma Dive
NOVEMBER 9, 2022
Adding Onivyde to chemotherapy helped patients live longer, a finding that could result in increased payouts to shareholders in the drug’s developer, Merrimack, which laid off all of its employees in 2019.
Pharmaceutical Technology
NOVEMBER 9, 2022
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 and BA.5 sub-variants. Indicated for usage as a booster in people aged 12 years and older, the modified vaccine is the second bivalent shot of the companies to obtain approval in the region.
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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
NOVEMBER 9, 2022
The biotech will sell its royalty interest in a heart disease drug Amgen is developing for $250 million, extending its operating runway by several quarters.
Pharmaceutical Technology
NOVEMBER 9, 2022
The proportion of pharmaceutical companies hiring for artificial intelligence related positions dropped in October 2022 compared with the equivalent month last year, with 37.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was lower than the 38.6% of companies who were hiring for artificial intelligence related jobs a year ago and a decrease compared to the figure of 39.8% in September 2022.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 9, 2022
According to a recent GlobalData report, healthcare professionals have – for the second year in a row – ranked artificial intelligence (AI) and Big Data as the top two technologies revolutionising the pharmaceutical sector. They are inextricably linked: data cannot be interpreted without cutting-edge algorithms, and algorithms cannot draw precise conclusions without data of sufficient quality and quantity.
Rethinking Clinical Trials
NOVEMBER 9, 2022
This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Stephanie Morain and Kayte Spector-Bagdady will present “Data Sharing and Pragmatic Clinical Trials: Law and Ethics Amidst a Changing Policy Landscape.” The Grand Rounds session will be held on Friday, November 11, 2022, at 1:00 pm eastern.
Pharmaceutical Technology
NOVEMBER 9, 2022
Personalised therapeutics company Unravel Biosciences and precision oncology company Spanios have collaborated to discover therapeutic targets for rare cancer. The collaboration combines Unravel Biosciences’ gene regulatory network and human health drug-gene interaction network model and drug response along with the patient-derived tumoroids (PDTs) from Spanios.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 9, 2022
The roll out of 5G services starting from the major cities in the country recently will benefit each of the key participants in the healthcare value chain, from the healthcare providers to the patients and the medical devices industry, said Pavan Choudary, chairman & director general, Medical Technology Association of India (MTaI).The Association is ready […].
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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
Pharmaceutical Technology
NOVEMBER 9, 2022
Novo Nordisk is maintaining a strong market position in the glucagon-like peptide-1 receptor agonist (GLP-1RA) market, despite the launch of the dual agonist GLP-1RA/gastric inhibitory peptide (GLP-1RA/GIP) from its main competitor in the diabetes market, Eli Lilly. Novo has been plagued with supply issues in the past year relating to its GLP-1 therapies, Wegovy and Ozempic (two versions of semaglutide), but despite this, its GLP-1 franchise—including Ozempic, Rybelsus, Wegovy, and Saxenda—has b
NPR Health - Shots
NOVEMBER 9, 2022
Researchers compared a practice of daily mindfulness meditation to taking Lexapro to control anxiety symptoms. The meditators got equivalent relief, without the side effects.
Pharmaceutical Technology
NOVEMBER 9, 2022
ProPhase Labs’ wholly owned subsidiary ProPhase BioPharma has entered a two-year collaboration agreement with Dana-Farber Cancer Institute for further research and development of Linebacker-1 (LB-1). The partnership deal provides for first and second-year research plans. It will also evaluate the tumoricidal effects of the flavonoid/polyphenol. LB-1, a small molecule, has been designed as an anti-cancer agent for use as a potential co-therapy that acts on the proviral integration site for molone
NPR Health - Shots
NOVEMBER 9, 2022
Nearly 75% of Americans with disabilities live with a family caregiver, many of them age 60 or older. Updating your care plan now, experts say, can help make sure everyone thrives.
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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.
STAT News
NOVEMBER 9, 2022
To protect this child from the same genetic disease that killed two older siblings, treating her as soon as she was born might only work so well, the doctors knew. So they dialed back the therapeutic clock, delivering the medication to her as a fetus. Now 16 months old, Ayla appears totally healthy. She still requires weekly doses of the medication, an enzyme that she can’t produce on her own, but she has no symptoms of the condition she inherited, the most serious form of the rare Pompe
NPR Health - Shots
NOVEMBER 9, 2022
The vote effectively scraps a 1931 state ban on the procedure that could have taken effect following the U.S. Supreme Court's overturning of Roe v. Wade.
STAT News
NOVEMBER 9, 2022
An FDA advisory panel voted 5-to-8 to recommend rejecting a new drug for patients hospitalized with Covid-19, ruling that a glimmer of potential life-saving benefit couldn’t make up for a long list of questions around the company’s main trial. The debate centered around sabizabulin, a molecule originally put in development for cancer but repurposed during the pandemic.
NPR Health - Shots
NOVEMBER 9, 2022
The suspension comes after reports of several students drugged between September and November and a sexual assault reported over the weekend.
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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.
Medical Xpress
NOVEMBER 9, 2022
Tuberculosis is usually encountered as a disease of the lungs, but in 2% of cases in the U.S. it can also be found in the bones. The 9,000-year-old skeletons of some Egyptian mummies show signs of having tuberculosis infection in their bones, a painful condition that leaves the bones looking like they've been gnawed.
STAT News
NOVEMBER 9, 2022
Innovative health tech startups with big ideas will not get very far if they cannot convince the turtles in the traditional health care system to give them a shot. To that end, Silicon Valley venture capital giant Andreessen Horowitz has partnered with rural health system Bassett Healthcare Network to serve as a sort of preferred testing ground for its portfolio companies.
Medical Xpress
NOVEMBER 9, 2022
In Alzheimer's disease, the degeneration of brain cells is linked to formation of toxic protein aggregates and deposits known as amyloid plaques. Similar processes also play an important role in type 2 diabetes. A research team under the lead of the Technical University of Munich has now developed "mini-proteins," so-called peptides, which are able to bind the proteins that form amyloids and prevent their aggregation into cytotoxic amyloids.
STAT News
NOVEMBER 9, 2022
Ask most Americans to name a victim of polio and they’ll say President Franklin Delano Roosevelt. Ask me the name of a polio victim and I would offer two: my father’s older sister and his youngest brother. My dad’s sister was a medical student in India when she died of polio in 1950. She contracted it from their younger brother, my uncle, who was five years old at the time and became permanently paralyzed in his right leg.
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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.
NPR Health - Shots
NOVEMBER 9, 2022
Several crises in the country — including political instability, COVID and financial collapse — have created deteriorating conditions that have allowed the bacteria to spread.
STAT News
NOVEMBER 9, 2022
Clovis Oncology, a maker of cancer drugs, warned Wednesday that it will likely file for bankruptcy protection due to dwindling sales of its sole product, mounting financial losses, and a crushing debt load. Based on its current operating plan, Clovis does not have the resources to remain financially solvent beyond January 2023, the company said in its quarterly filing with the Securities and Exchange Commission.
BioSpace
NOVEMBER 9, 2022
BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.
STAT News
NOVEMBER 9, 2022
Shares of Merrimack Pharmaceuticals, a shuttered drug company with no employees or any active research programs, more than doubled Wednesday because of a $225 million windfall that it will receive due to the success of a treatment for pancreatic cancer. The approved cancer drug, called Onivyde, was once owned by Merrimack, but was sold in 2017 to the French drugmaker Ipsen.
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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.
Medical Xpress
NOVEMBER 9, 2022
A team of medical professionals, clinicians, epidemiologists and political scientists recently published the results of a study that revealed new information about the prevalence of post-acute sequelae of SARS CoV-2 infection, otherwise known as "long COVID.".
STAT News
NOVEMBER 9, 2022
The idea that the narrowing gap between Covid-19 deaths among white Americans and Americans of color represents a racial equity success story is being bandied about. Not so fast, says Nathan T. Chomilo, a pediatrician and internist at the University of Minnesota Medical School. To be sure, it’s worth celebrating the tenacity of community champions who relentlessly fought for equitable access to vaccines and the subsequent reduction in deaths among Black and Hispanic people.
Medical Xpress
NOVEMBER 9, 2022
US park officials have asked visitors to stop licking psychedelic toads, warning that anyone seeking a hallucinogenic high from the wart-covered amphibians is more likely to end up seriously ill.
pharmaphorum
NOVEMBER 9, 2022
GSK has revealed updated results from its phase 2b trial of its antisense drug for hepatitis B virus (HBV) infections, which reveal a sharp decline in the proportion of patients with undetectable levels of the virus compared to an earlier readout. In the latest results from the 457-patient B-Clear study, published in the New England Journal of Medicine, bepirovirsen at a dose of 300 mg per week over 24 weeks resulted in sustained hepatitis B surface antigen (HBsAg) and HBV DNA loss to below the
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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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