Sat.Nov 05, 2022 - Fri.Nov 11, 2022

article thumbnail

Amgen to test new way to lower heart risk with large drug trial

Bio Pharma Dive

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).

article thumbnail

Can gene therapies for haemophilia defend their high price tags?

Pharmaceutical Technology

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

From U.S. Air Force Captain to CRO Leader: Karl D. Kendall Shares His Story

Worldwide Clinical Trials

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?

article thumbnail

‘We’re sick of watching women die’: In Michigan, doctors rally to protect abortion access

STAT News

GRAND RAPIDS, Mich. — Doctors are on the frontlines of a political battle raging across the country, as abortion rights are added to the ballot in the first election since the Supreme Court overturned Roe v. Wade. Michigan is at the heart of the struggle. “Doctors fought hard for these rights because we’re sick of watching women die,” Melissa Bayne, an OB-GYN in Fremont, Mich., told the audience at a rally Saturday in Grand Rapids.

Doctors 145
article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

Centerview grows role as go-to adviser for biopharma dealmaking

Bio Pharma Dive

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.

356
356
article thumbnail

UK MHRA approves Pfizer-BioNTech’s bivalent Covid-19 booster

Pharmaceutical Technology

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.

More Trending

article thumbnail

U.S. set to face third Covid winter without key tools and treatments

STAT News

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.

article thumbnail

Pharma earnings outline drug law’s looming impact on sales, development

Bio Pharma Dive

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.

Sales 317
article thumbnail

EC grants approval for Sanofi-GSK’s Covid-19 booster

Pharmaceutical Technology

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.

article thumbnail

How a team of Black paramedics set the gold standard for emergency medical response

NPR Health - Shots

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.

144
144
article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

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.

article thumbnail

‘The tipping point is coming’: Unprecedented exodus of young life scientists is shaking up academia

STAT News

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.

Scientist 140
article thumbnail

Novavax details trial results for omicron-targeting booster shots

Bio Pharma Dive

A reformulated booster aimed at an earlier omicron subvariant outperformed Novavax’s current vaccine, but a bivalent version did not significantly raise antibody levels.

Trials 319
article thumbnail

AstraZeneca reports 9% rise in Q3 2022 total revenue

Pharmaceutical Technology

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.

article thumbnail

Statins vs. supplements: New study finds one is 'vastly superior' to cut cholesterol

NPR Health - Shots

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.

140
140
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.

article thumbnail

Cholesterol and diabetes drugs may lessen risk of degenerative eye disease associated with aging

Medical Xpress

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.

Drugs 136
article thumbnail

FDA halts Verve plans to test gene editing therapy for heart disease in US

Bio Pharma Dive

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.

article thumbnail

First human trials of lab-grown red blood cells start in UK

pharmaphorum

Blood cells grown in a laboratory have been given to people for the first time in a clinical trial being carried out by researchers in the UK, in the hope that plentiful supplies of rare blood groups can be manufactured to order. A team from the universities of Bristol and Cambridge, NHS trusts and NHS Blood and Transplant (NHSBT) have started giving small quantities of the lab-grown red blood cells – a couple of teaspoons full – to two healthy volunteers to see if they are safe.

Trials 126
article thumbnail

New VA study finds Paxlovid may cut the risk of long COVID

NPR Health - Shots

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.

Drugs 145
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

article thumbnail

Study points to potential new treatment for inflammatory bowel diseases

Medical Xpress

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.".

article thumbnail

Early data hint at benefit for Amgen’s obesity drug

Bio Pharma Dive

Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk.

Drugs 337
article thumbnail

STAT+: For its first two medicines, EQRx abandons its bold strategy to lower drug prices

STAT News

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.

Drugs 122
article thumbnail

A SCOTUS nursing home case could limit the rights of millions of patients

NPR Health - Shots

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.

Nurses 132
article thumbnail

The New Age of Decentralized Clinical Trials

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.

article thumbnail

'CAR pooling' screens identify most effective cancer immunotherapy cells

Medical Xpress

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.

Engineer 131
article thumbnail

Biogen names former Sanofi head Viehbacher to replace Vounatsos as CEO

Bio Pharma Dive

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.

337
337
article thumbnail

Opinion: Violence against health care workers is on the rise. They deserve protection

STAT News

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.

119
119
article thumbnail

Deli meats and cheeses have been linked to a listeria outbreak in 6 states

NPR Health - Shots

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.

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

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.

article thumbnail

New study illuminates why cancers caused by BRCA mutations recur

Medical Xpress

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.

Gene 119
article thumbnail

Ipsen drug shows benefit in pancreatic cancer, lifting shares of ghost company

Bio Pharma Dive

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.

Drugs 286
article thumbnail

STAT+: Jeff Jonas leaves Sage Therapeutics to launch biotech incubator

STAT News

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.

119
119
article thumbnail

New omicron subvariants now dominant in the U.S., raising fears of a winter surge

NPR Health - Shots

Step aside, BA.5. The new variants BQ.1 and BQ.1.1, appear to be among the most adept yet at evading immunity from previous infection and vaccination.

article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.