Mon.Sep 19, 2022

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Back-to-back gene therapy approvals give Bluebird shot at survival

Bio Pharma Dive

The FDA's clearances of Zynteglo and Skysona are a boost to Bluebird, and could help lift the research field after a series of setbacks. But selling the high-priced therapies will be a challenge.

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EMA CHMP recommends authorisation of AstraZeneca’s Evusheld for Covid-19

Pharmaceutical Technology

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). This therapy is intended to treat adult and adolescent Covid-19 patients aged 12 years and above, who do not need additional oxygen and are at greater disease progression risk.

In-Vitro 279
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GenFit, continuing rebuild, buys startup Versantis

Bio Pharma Dive

The French company, still aiming to rebound from a Phase 3 study failure two years ago, will pay about $41 million for Versantis and its experimental liver disease drugs.

Drugs 208
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Beyond the Hype: Addressing Safety Challenges in Psychedelic Trials

Worldwide Clinical Trials

Emerging evidence showing therapeutic benefit of psychedelics for mental illnesses such as major depressive disorder , substance use disorder , and post-traumatic stress disorder , has captured the interest of clinical researchers, the general public, and Netflix-watchers. Researchers exploring psychedelic trials are faced with unique safety challenges for protecting patients and site staff because of the profound nature of the psychedelic experience and the requirements for psychotherapy that a

Trials 130
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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

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Optimizing pharmaceutical innovation

Bio Pharma Dive

Elevate pharma product development and marketing through collaboration with physician experts

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EC grants approval for BMS’ Opdualag to treat melanoma

Pharmaceutical Technology

The European Commission (EC) has granted approval for Bristol Myers Squibb ’s (BMS) fixed-dose combination, Opdualag (nivolumab and relatlimab), as first-line therapy to treat advanced (unresectable or metastatic) melanoma. The treatment is indicated for usage in adult and adolescent patients aged 12 years and above with tumour cell PD-L1 expression less than 1%.

Antibody 130

More Trending

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Musicians are back on the road, but every day is a gamble

NPR Health - Shots

For bands on tour, one positive COVID test can spell disaster. With audiences increasingly unmasked and institutional support drying up, safety is left mostly to the artists themselves.

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Opinion: FDA and USDA need to get on board with the CDC about reducing antibiotic use in raising animals for food

STAT News

The overuse of antibiotics and other antimicrobials in raising farm animals for food may not be equivalent to Covid-19 and climate change as threats to human health, but it is right up there. This practice contributes to antibiotic-resistant infections, which are now a leading cause of death worldwide. The annual death toll from antimicrobial resistance could reach 10 million by 2050 — more people than currently die from cancer.

Drugs 119
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Joe Biden says the COVID-19 pandemic is over. This is what the data tells us

NPR Health - Shots

While cases have decreased dramatically, there are still thousands of cases being reported across the world. (Image credit: Ted S.

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STAT+: Pfizer accused of running a fellowship program that discriminates on racial grounds

STAT News

In a move reflecting simmering controversy over diversity and equity, Pfizer has been accused of running a racially discriminatory fellowship program because it “categorically excludes” white and Asian American applicants, according to a lawsuit filed by an advocacy group that includes doctors, patients, and policymakers. But some legal experts question whether the argument can succeed.

Doctors 111
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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.

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Why Ryan Reynolds is telling people to get a colonoscopy

NPR Health - Shots

After he lost a bet, actor Ryan Reynolds had his colonoscopy filmed. His doctor detected a polyp, which can be a precursor to cancer. He's now urging others to get screened for colon cancer.

Doctors 105
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Medicare is using one of its biggest hammers to try to fix the dialysis system: how providers are paid

STAT News

Chronic kidney disease, already a problem affecting millions of Americans , is only expected to become more prevalent as the country ages. For those with the disease, a transplant is the ideal treatment, but dialysis is their reality. Hundreds of thousands of Americans flock to clinics three times a week to have their blood filtered through — in the absence of a functioning kidney — a machine or their abdomen.

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PHOTOS: The moms (and dads) of Ivory Coast are falling in love with kangaroo care

NPR Health - Shots

Can the warmth of a parent's chest be a boon to babies, especially premature births? In the 1970s, Colombian researchers found it did. The technique has gone global. Ivory Coast is the latest convert.

Research 105
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‘I’m deeply concerned’: Francis Collins on trust in science, how Covid communications failed, and his current obsession

STAT News

Former NIH director and current White House science adviser Francis Collins told a group of journalists late last week about his passion for both the Cancer Moonshot and the new biomedical research agency known as ARPA-H. But he also revealed his pain at seeing people spurn mRNA Covid vaccines developed with breathtaking speed and lamented that he and other health officials failed to communicate the ever-changing science behind Covid recommendations.

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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.

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Biden's remarks that the pandemic is over hurts efforts to save lives, experts say

NPR Health - Shots

President Biden says the pandemic "is over," but public health experts, epidemiologists, infectious disease researchers and others strongly disagree, saying his remarks endanger efforts to save lives.

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Is the Covid-19 pandemic over? The answer is more art than science

STAT News

Is the Covid-19 pandemic over? President Biden told Scott Pelley of “ 60 Minutes” it was. The Sunday night interview aired just days after the director-general of the World Health Organization, Tedros Adhanom Ghebreyesus, said the end may be in sight — though Tedros clearly didn’t mean it was days away when he predicted it.

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Polyplus extends portfolio designed to support mRNA development

BioPharma Reporter

Polyplus, a French supplier focused on advanced biologic and cell and gene therapy production, is continuing to build out its mRNA support portfolio.

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A teaching hospital payout, Humana flirts with Wall Street, and new dialysis incentives

STAT News

You’re reading the web edition of Health Care Inc., STAT’s weekly newsletter following the flow of money through the health care system.  Sign up here  to get it in your inbox. The rise of the Medicare Advantage stock. If you ever needed evidence of just how much Wall Street salivates over the profitability of Medicare Advantage, look no further than Humana’s investor day last week.

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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.

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MeiraGTx unveils Ireland’s first commercial-scale gene therapy manufacturing site

BioPharma Reporter

MeiraGTx has formally opened its new GMP gene therapy manufacturing operations in Shannon, Ireland.

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Meta faces mounting questions from Congress on health data privacy as hospitals remove Facebook tracker

STAT News

Meta is facing mounting questions about its access to sensitive medical data following a Markup investigation that found the company’s pixel tracking tool collecting details about patients’ doctor’s appointments, prescriptions, and health conditions on hospital websites. During a Senate Homeland Security and Governmental Affairs Committee hearing on Sept. 14 , Sen.

Doctors 98
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Genfit builds rare liver disease pipeline with Versantis buy

pharmaphorum

French pharma company Genfit has reached a deal to buy Versantis of Switzerland, adding three development-stage drug candidates to its portfolio of experimental liver disease therapies and continuing a strategy change first unveiled in 2020. That change was forced by disappointing clinical trial results with Genfit’s lead drug elafibranor in non-alcoholic steatohepatitis (NASH), and included a pledge to build a pipeline in rare liver diseases behind elafibranor – now redirected at primary

Drugs 52
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STAT+: Have researchers hit a wall in the hunt for severe Covid drugs?

STAT News

It seemed interminably slow then, what with all the haze and fear of fresh plague, but in hindsight it was a medical marvel: From January 2020 to February 2021, researchers proved four different effective therapies for patients hospitalized with Covid-19 — a lightning pace for drug research, where progress is often measured in decades.  That picture has changed starkly.

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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.

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CTTI Welcomes Four New Members to its Executive Committee

CTTI (Clinical Trials Transformation Initiative)

Today, CTTI welcomed four new members to its Executive Committee, which is responsible for making decisions about the overall direction and strategy for the organization. The new Executive Committee members, whose three-year term runs from 2022-2025, include: . Barbara Bierer, The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard .

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Opinion: Surgery needs a new pay model, free from incentives to do more procedures

STAT News

How will my surgeon get paid? That’s a question few people ask as they think about having surgery. But it is worth asking, and the answer should factor into decision-making. For most surgeons, the answer is a compensation model that incentivizes more surgery — and bigger surgery — making it hard to ignore the dollar signs attached to these procedures.

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Exagen on why AVISE test can end the ‘diagnostic odyssey’

Outsourcing Pharma

Autoimmune diagnostics life sciences company Exagen is heralding the completion of the CAPSTONE study as evidence that its AVISE Lupus test is more clinically effective than traditional ANA methods (tANA), benefiting patients, providers and payers by enabling decisive clinical action and early treatment.

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STAT+: Pharmalittle: Advances in treating the sickest Covid patients have stalled; Moderna aids WHO effort to develop mRNA coronavirus shots

STAT News

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of calls, online meetings, and deadlines has predictably returned. But you knew this would happen, yes? To cope, we are firing up the coffee kettle and preparing to quaff our first cup of stimulation today.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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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GSK makes Medable its preferred partner for decentralized clinical trials in 4-year deal

Outsourcing Pharma

GSK has struck a four-year contract to make Medable its preferred partner for decentralized clinical trials (DCTs), positioning the companies to work together to improve access to research.

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bluebird bio gets green light for Skysona gene therapy in the US

BioPharma Reporter

The US Food and Drug Administration (FDA) has granted Accelerated Approval for bluebird bioâs Skysona (elivaldogene autotemcel), also known as eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD).

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A3921021

Pfizer

A3921021. vega. Mon, 09/19/2022 - 16:03. Xeljanz tofacitinib PHASE II Wed, 12/07/2005 - 12:00 Mon, 01/06/2014 - 12:00. NCT00263328 A3921021 Public Disclosure Synopsis.pdf. (4.36 MB).

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Evotec breaks ground on Toulouse biologics manufacturing facility

BioPharma Reporter

Evotec SE has officially launched the construction of its J.POD biologics manufacturing facility at its Campus Curie in Toulouse, France.

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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.