Bio Pharma Dive
NOVEMBER 7, 2022
Buoyed by strong mid-stage study results, the biotech will soon start a cardiovascular outcomes trial of a drug designed to target a genetic risk factor called lipoprotein(a).
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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Worldwide Clinical Trials
NOVEMBER 8, 2022
At Worldwide, we are committed to a cause that extends beyond ourselves. Our mission is to work with passion and purpose every day to improve lives. Our study teams are committed to working collaboratively with our sponsors, united in purpose. Worldwide aims to become an employer of choice?for veterans, military members, and?their families, by creating an?
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 10, 2022
For some years now, scientists have been investigating how psilocybin, the psychedelic compound in magic mushrooms, can ease the symptoms of depression. More evidence of the link has arrived with a phase 2, double-blind trial involving 233 participants, the largest study on this subject carried out so far in terms of sample size. The volunteers […].
Bio Pharma Dive
NOVEMBER 8, 2022
Over the past several years, the investment firm has served as a financial adviser on biopharma acquisitions worth more than $200 billion in total, with the latest announced Monday.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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 11, 2022
The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. It is indicated as a booster in people of this age group who were earlier inoculated with a Covid-19 vaccine. The latest development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on vaccine use.
STAT News
NOVEMBER 10, 2022
The country is heading into its third Covid winter without crucial tools we’ve relied on at previous points in the pandemic, both as governments roll back their responses and as the virus outruns some of our most important medicine-cabinet defenses. Free at-home tests are no longer showing up at people’s doorsteps. States are reporting outbreak data less frequently, and globally, testing and surveillance programs have been curtailed.
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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
NPR Health - Shots
NOVEMBER 5, 2022
In American Sirens, writer Kevin Hazzard recounts how a group of Black paramedics in Pittsburgh in the 1970s pioneered and professionalized the modern day ambulance service.
Bio Pharma Dive
NOVEMBER 8, 2022
A reformulated booster aimed at an earlier omicron subvariant outperformed Novavax’s current vaccine, but a bivalent version did not significantly raise antibody levels.
Pharmaceutical Technology
NOVEMBER 11, 2022
AstraZeneca has reported an 11% rise in total revenue to $10.98bn in the third quarter (Q3) 2022 as against $9.87bn in the year-ago quarter. For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In the third quarter of 2022, core earnings per share (EPS) were recorded to be $1.67, signifying a 55% increase while reported EPS was $1.06.
STAT News
NOVEMBER 10, 2022
SAN DIEGO — Rayyan Gorashi is keeping her options open. After all, she’s still a second-year bioengineering Ph.D. student at UC San Diego, and there are so many careers to explore. Patent law has been high up on her list ever since a class she took in college. There’s also regulatory affairs. Oh, and science publishing sounds interesting, too.
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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.
NPR Health - Shots
NOVEMBER 6, 2022
Millions of people are prescribed statins to lower cholesterol and reduce the risk of heart disease, but many would rather take supplements instead. A new study shows statins are much more effective.
Bio Pharma Dive
NOVEMBER 8, 2022
Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk.
Medical Xpress
NOVEMBER 7, 2022
Regular use of drugs to lower cholesterol and control type 2 diabetes may lessen the risk of the degenerative eye disease associated with aging, known as AMD, finds a pooled data analysis of the available evidence, published online in the British Journal of Ophthalmology.
STAT News
NOVEMBER 10, 2022
Changing the way cancer drugs are priced in the U.S. is apparently even harder than it sounds. EQRx, a company founded to upend the costly U.S. system for pricing new drugs, said Thursday it would abandon that goal for the two products that are closest to the market.
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.
NPR Health - Shots
NOVEMBER 8, 2022
For those at high risk, Pfizer's antiviral drug helps stave off severe COVID-19. Now research suggests it may also reduce their chances of long COVID.
Bio Pharma Dive
NOVEMBER 7, 2022
Verve didn’t say what led to the FDA’s decision, but claimed it hasn’t observed any safety issues in an ongoing trial in New Zealand and the U.K, where enrollment will continue.
Medical Xpress
NOVEMBER 7, 2022
People with inflammatory bowel diseases develop inflammation of the intestine that can cause thickening of the gut wall and life-threatening blockage of the intestinal tube. Twenty to 50 percent of people with Crohn's disease and ulcerative colitis are affected over their lifetime by this poorly understood condition, called "fibrosis.".
STAT News
NOVEMBER 11, 2022
There is no place for violence in civil society. Yet stabbings, shootings, threats and other violent attacks have become frighteningly common, including in America’s hospitals and other health care settings. As leaders of national associations representing hospitals and emergency physicians, we know the intimidation and violence endured by medical professionals every day.
NPR Health - Shots
NOVEMBER 6, 2022
An Indiana man's family sued a state-owned nursing home for alleged mistreatment. A U.S. Supreme Court decision in the case could determine the right of many Americans to sue government agencies.
Bio Pharma Dive
NOVEMBER 10, 2022
Viehbacher, who ran Sanofi from 2008 to 2014, will take over as CEO on Nov. 14, more than six months after Biogen began its search for a new leader.
Medical Xpress
NOVEMBER 10, 2022
In recent years, genetically re-engineered immune cells—armed with molecular weaponry to recognize and destroy tumor cells—have changed the landscape of cancer treatment. Now, UC San Francisco researchers have developed a new method for comparing massive numbers of these CAR-T cells, each with slightly different molecular features, to determine which is most effective and long-lasting against cancer.
STAT News
NOVEMBER 10, 2022
Longtime Sage Therapeutics executive Jeff Jonas is leaving the biotech company to launch a biotech incubator with global investment giant CBC Group. Sage announced this week that Jonas would leave the company to join a private equity firm. He has been part of the C-suite at Sage Therapeutics since 2013. He helped the company go public, build a pipeline of new antidepressants and other psychiatric medications, and sign a $1.5 billion deal with Biogen.
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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.
NPR Health - Shots
NOVEMBER 10, 2022
A listeria outbreak has led to 16 infections and one death across six states, with New York having the most cases. The CDC has not yet pinpointed specific products that could be causing the outbreak.
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.
Medical Xpress
NOVEMBER 10, 2022
Researchers at the University of Pennsylvania's Basser Center for BRCA at the Abramson Cancer Center have discovered factors that may make breast and ovarian cancers associated with BRCA1/2 gene mutations more likely to recur.
STAT News
NOVEMBER 8, 2022
WASHINGTON – On Tuesday, Californians overwhelmingly voted to ban all flavored tobacco products in the state. The move makes California by far the largest state to ban such products, which are already illegal in a smattering of smaller states, including Rhode Island, New Jersey, and Massachusetts.
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