Mon.Oct 24, 2022

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AstraZeneca’s persistence pays off with Imjudo approval

Bio Pharma Dive

After failing multiple studies, the company’s immunotherapy tremelimumab is cleared to treat liver cancer as part of a regimen that could challenge a similar drug combination from Bristol Myers Squibb.

Drugs 341
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Something Toxic Flourishes in Your Brain After Too Much Hard Work

AuroBlog - Aurous Healthcare Clinical Trials blog

A long day in the office can leave you empty of energy and overcome with desire for TV and a takeaway. But you’ve been sitting down all day. So why do you feel as tired as your friends who have physical jobs? Struggling through your list of essential tasks feels ever more grueling as the […].

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Myovant agrees to sell after buyer ups price

Bio Pharma Dive

Sumitomo Pharma, a Japanese drug company that already owns 52% of Myovant, is now offering to buy all the remaining shares for $27 apiece in a deal that values the biotech at $2.9 billion.

Drugs 317
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Pharma exports report 6.86% growth in September

AuroBlog - Aurous Healthcare Clinical Trials blog

Pharmaceutical export during the month of September has registered a 6.86 per cent growth as compared to the same month of previous year. The first six months of the fiscal year has also registered a growth of 6.04 per cent compared to the same period of previous year, with a significant improvement from the growth […].

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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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Astellas takes stake in gene therapy developer Taysha

Bio Pharma Dive

Already an investor in gene therapy, the Japanese pharma will buy 15% of the Texas biotech’s stock and gain options to two gene therapies for central nervous system disorders.

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October 24, 2022: NIH Pragmatic Trials Collaboratory Announces 2 New Core Working Groups

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory is pleased to announce the addition of 2 new Core Working Groups that will be focused on implementation science and health equity. From left, Devon Check, PhD, and Hayden Bosworth, PhD. The Implementation Science Core will provide technical support and pragmatic trial expertise for NIH Collaboratory Demonstration Projects with a specific focus on innovative dissemination and implementation science approaches.

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Abortion is on the California ballot. But does that mean at any point in pregnancy?

NPR Health - Shots

CA voters are expected to approve a constitutional amendment on abortion rights. But critics say it would actually expand abortion rights, because the amendment ignores the concept of fetal viability.

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‘I don’t feel safe.’ Abortion bans add new uncertainty to fertility treatment

Bio Pharma Dive

BioPharma Dive’s Delilah Alvarado worked with reporters from Healthcare Dive to examine the impact of state laws banning abortion on people trying to conceive via in vitro fertilization.

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Interview with Patty Spears, Patient Advocate at the Alliance for Clinical Trials in Oncology

XTalks

Patty Spears, the Chair of the Patient Advocate Committee at the Alliance for Clinical Trials in Oncology, shared insights about research advocacy for oncology trials, decentralized trials from the patient perspective and more. Patient advocates have made a big impact in the fight against cancer. One of them is Patty Spears, who is the recipient of the 2022 American Society for Clinical Oncology (ASCO) Patient Advocate Award.

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Novartis rival to AstraZeneca rare disease drugs succeeds in study

Bio Pharma Dive

The pharma said iptacopan, one of its top pipeline prospects, outperformed Alexion’s Soliris and Ultomiris in certain patients with a disease called PNH.

Drugs 183
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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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On the Horizon, Needle-Free Vaccines could Offer Better Protection and Access

BioSpace

In the near future, painful jabs and muscle soreness that persists for days could be replaced by new immunization approaches including intradermal delivery, edible and intranasal vaccines.

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Simplify IP for your gene therapy with OTS backbones, plasmids and enzymes

Bio Pharma Dive

Read how IP-simplified products can transform your speed to market without needing to reassess operations midway through to commercialization.

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The 5 Most Affordable Cities for Biopharma Jobs in the US

BioSpace

If you want to maximize your career earnings, it pays to consider which cities are the most affordable. Here are the top five most affordable cities for biopharma in the U.S.

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Vaxcyte rides investor enthusiasm for early pneumococcal vaccine data

Bio Pharma Dive

Encouraging study results for a vaccine with broader coverage than Pfizer’s Prevnar 20 sent Vaxcyte’s valuation soaring and could make the company a potential takeover target.

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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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Women and men are different, cardiovascular edition

STAT News

It’s quite the task to photograph someone’s heart while they’re exercising. They have to lie on their back in a pressure-controlled chamber, riding a suspended stationary bike while an ultrasound imager points at their pumping heart — at least that’s how one group of researchers from the University of Calgary and Hong Kong went about it.

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Novartis Axes NSCLC, Liver Transplant Programs in Q3 Report

BioSpace

Novartis' positive-third quarter growth report was slightly marred by several clinical setbacks that resulted in the termination of studies in liver transplant and non-small cell lung cancer.

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Opinion: Keeping families out of ICUs no longer makes sense as the pandemic eases

STAT News

On, December 9, 2020, my mom, brother, and I waited in a cold, wintery drizzle outside the local hospital in my hometown in southern Colorado, anxiously hoping to be allowed to see my dad for the last time. After contracting Covid-19, he had been in the intensive care unit (ICU) for nearly a month and his condition had deteriorated to the point that we were summoned to the hospital to say our goodbyes.

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AstraZeneca Sees Mixed Results in Phase III EoE Trial

BioSpace

???????AstraZeneca reported Tuesday that its Phase III MESSINA trial hit one primary endpoint but missed the other. The study was evaluating Fasenra in eosinophilic esophagitis.

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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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STAT+: Epic’s overhaul of a flawed algorithm shows why AI oversight is a life-or-death issue

STAT News

Epic, the nation’s dominant seller of electronic health records, was bracing for a catastrophe. It was June 2021, and a study about to be published in the Journal of the American Medical Association had found that Epic’s artificial intelligence tool to predict sepsis, a deadly complication of infection, was prone to missing cases and flooding clinicians with false alarms.

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Lieping Chen Founds Normunity to Take Pioneering PD-L1 Work to Next Level

BioSpace

Normunity is launching its creation of novel precision anti-cancer immunotherapies, backed by $65 million of Series A financing, the company announced Tuesday.

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RWE There Yet? FDA’s New Pilot Program Seeks to Help Usher in a New Era for Real World Evidence

FDA Law Blog

By Mark A. Tobolowsky — Making use of real-world data has long been of interest to stakeholders as having tremendous potential value. These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial.

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Novartis’ oral drug iptacopan tops injectables in head-to-head PNH trial

pharmaphorum

Novartis has chalked up another clinical trial win for its targeted factor B inhibitor iptacopan as it strives to position the drug as a patient-friendly, oral alternative to big-selling injectable rivals. The least positive readout comes from the APPLY-PNH study, which pitted iptacopan against AstraZeneca/Alexion’s anti-C5 antibodies Soliris (eculizumab) and Ultomiris (ravulizumab) in adults with paroxysmal nocturnal haemoglobinuria (PNH), a debilitating ultra-rare blood disorder in which

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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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Early Data Indicate Gritstone’s Self-Amplifying mRNA Vaccine could Fill COVID-19 Gaps - Updated

BioSpace

???????Data from two Phase I trials indicate Gritstone Bio's samRNA vaccine can safely induce a strong and durable immune response against COVID-19.

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Opinion: Better access to PET scans can help reduce racial inequities in Alzheimer’s disease

STAT News

While many Americans are familiar with the devastating impact of Alzheimer’s disease, few understand the cruel disparity with which it strikes. Black Americans are twice as likely to be diagnosed with this mind-robbing disease and bear the greatest costs of caring for loved ones suffering with it. Alzheimer’s was historically diagnosed based on symptoms, and only confirmed with an autopsy.

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GSK Abandons Cell Therapy Collaboration with Lyell

BioSpace

GSK terminated its cell therapy pact with Lyell Immunopharma. It's opting to advance its own programs without use of Lyell’s T-cell modulating technologies that were at the center of the partnership.

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STAT+: Pharmalittle: Merck suddenly finds Ebola vaccine doses in its freezers; drugs studied to combat women’s midlife mood swings

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 phone calls, online meetings, and deadlines has predictably returned. But what can you do? The world, such as it is, keeps spinning. So time to give it a nudge in a useful direction with a cup or three of stimulation.

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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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Trying to get clarity on CDF and VPAS and implications for the IMF

pharmaphorum

Companies who are thinking about seeking funding via England’s new Innovative Medicines Fund (IMF) need to think through all the commercial implications, including whether spending in the IMF counts towards rebates made against sales through the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). With the IMF not yet used, but based on the Cancer Drugs Fund (CDF), Leela Barham used a freedom of information request to find out how the CDF spend is treated, and speculates as to what

Sales 75
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Radioactive implant ‘completely eliminated’ tumours 

Drug Discovery World

Biomedical engineers at Duke University have demonstrated the most effective treatment for pancreatic cancer ever recorded in mouse models. . The new treatment completely eliminated tumours in 80% of mice across several model types, including those considered the most difficult to treat. . The approach combines traditional chemotherapy drugs with a new method for irradiating the tumour.

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NHS to offer epilepsy patients brain laser therapy

Pharma Times

The launch of the laser is part of the NHS’s Long Term Plan commitment

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Sumitomo ups ante and wins support for Myovant takeover

pharmaphorum

A sweetened offer from Sumitomo Pharma has convinced endocrinology specialist Myovant to agree to a takeover, after its first was rejected. Sumitomo and its subsidiary Sumitovant Biopharma initially offered $22.75 for Myovant – which develops hormonal therapies for conditions like uterine fibroids, endometriosis and prostate cancer – but that was deemed inadequate and was turned down earlier this month.

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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.