Fri.Sep 16, 2022

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FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases

Bio Pharma Dive

The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments.

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Gilead’s Veklury receives WHO recommendation to treat severe Covid-19

Pharmaceutical Technology

Gilead Sciences has received expanded recommendation under the World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline for the use of Veklury (remdesivir) to treat severe Covid-19 patients. The guideline update comes after the treatment received recommendation from the health agency for treating non-severe Covid-19 in patients at increased risk of hospitalisation.

Allergies 277
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Third Harmonic boosts biotech with sector’s top IPO in four months

Bio Pharma Dive

The startup’s $185 million initial public offering is the largest for the sector since early May and potentially a sign of renewed investor interest in young biotechs.

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FDA and NIH partner for neurodegenerative disease treatment development

Pharmaceutical Technology

The US Food and Drug Administration (FDA) and the US National Institutes of Health (NIH) have unveiled a public-private partnership (PPP) to understand and develop treatments for neurodegenerative diseases. Named the Critical Path for Rare Neurodegenerative Diseases (CP-RND), the partnership will be convened by the Critical Path Institute (C-Path). It will focus on developing therapies for amyotrophic lateral sclerosis (ALS) and various other rare neurodegenerative diseases.

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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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Intellia offers first look at CRISPR drug for rare swelling disorder

Bio Pharma Dive

Preliminary study results show the biotech’s gene editing treatment could reduce markers and symptoms of hereditary angioedema, though the data come from few patients and follow-up remains limited.

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IPO refuses patent to Mitsubishi for diabetes drug teneligliptin following pre-grant opposition by Glenmark Pharma

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Patent Office (IPO) has refused the patent application of Japanese drug maker Mitsubishi Tanabe Pharma Corporation for exclusive rights for its innovation related to type 2 diabetes drug teneligliptin, in favour of a pre-grant opposition filed by Mumbai-based pharma major Glenmark Pharmaceuticals Ltd. The company filed the patent application on July 11, 2012 […].

Drugs 165

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Almirall:Tildrakizumab is the first and only IL-23p19 inhibitor to demonstrate meaningful sleep improvement in people living with psoriasis

Pharma Mirror

Barcelon, a global biopharmaceutical company focused on skin health, announced at the 31st EADV (European Association of Dermatology and Venereology) Congress the results from TRIBUTE, an interventional phase IV clinical study, which resembled real-life clinical practice. In this study, Ilumetri®? (tildrakizumab) is the first IL-23p19 inhibitor to demonstrate improvement on sleep impairment in patients with moderate-to-severe chronic plaque psoriasis.

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Alnylam, Regeneron to advance NASH drug after early signs of potential

Bio Pharma Dive

A gene discovery four years ago led to a partnership between the companies, which plan to start a Phase 2 study later this year after encouraging early data.

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Syntegon Group appoints Dr. Peter Hackel as Chief Financial Officer

Pharma Mirror

Waiblingen/Germany, The Syntegon Group, a globally leadingsupplier of processing and packaging technology, intends to appoint Dr. Peter Hackelas member of the Executive Board at the beginning of 2023. In his new position, asChief Financial Officer (CFO) Peter Hackel will be responsible for Finance &Controlling, Foreign Trade and IT of Syntegon. He will be located at Beringen,Switzerland.Peter Hackel is a well-rounded, highly accomplished executive, experienced withinSales as well as in Finan

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Sanofi, AstraZeneca win EMA support for RSV drug in babies

Bio Pharma Dive

If authorized by the European Commission, the companies’ antibody medicine would become the first cleared for broad use in newborns and infants.

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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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How Berlinger’s climate-focused innovation is helping to reduce, remove and offset emissions from the pharmaceutical supply

Pharmaceutical Technology

There is no getting away from the need for action on the climate crisis. The importance of sufficiently eliminating harmful greenhouse gas (GHG) emissions to limit global temperature to the 1.5-degree rise proposed in the Paris Climate Agreement is well understood by leaders in the pharmaceutical industry. And despite the recent pandemic that forced the industry to develop and deliver treatments and vaccines all over the world, the issue of reducing emissions has remained high on industry leader

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Pfizer reports success in trial of all-in-one meningitis vaccine

Bio Pharma Dive

The company is planning an FDA submission as it works to expand its vaccine business beyond top-selling shots for COVID-19 and pneumonia.

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Australia TGA approves Specialised Therapeutics bile duct cancer therapy

Pharmaceutical Technology

The Australian Therapeutic Goods Administration (TGA) has granted provisional approval for Specialised Therapeutics’ targeted therapy, Pemazyre (pemigatinib), for the treatment of cholangiocarcinoma, a rare bile duct cancer. The therapy is indicated for locally advanced or metastatic cholangiocarcinoma in adults who have a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has advanced following a minimum of one previous line of systemic therapy.

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Scientists debate how lethal COVID is. Some say it's now less risky than flu

NPR Health - Shots

They argue the threat posed by COVID has lessened because of preexisting immunity and access to treatment. Plus, some deaths may be incorrectly blamed on COVID. Others caution it's too soon to tell.

Scientist 145
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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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US FDA grants fast track designation for Jasper’s antibody to treat SCID

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast track designation to Jasper Therapeutics’ antibody, JSP191, for the treatment of severe combined immunodeficiency (SCID) patients who undergo allogeneic hematopoietic stem cell transplant. . A humanised anti-CD117 monoclonal antibody, JSP191 hinders stem cell factor receptor signalling, resulting in hematopoietic stem and progenitor cell clearance from the bone marrow.

Antibody 130
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STAT+: Intellia says CRISPR treatment safely corrects DNA of six patients with rare disease

STAT News

Intellia Therapeutics said Friday the first six patients to receive its CRISPR-based treatment for a genetic swelling disorder have safely had small, corrective changes made to dysfunctional DNA inside their liver cells. Preliminary results from the study — just the second to show that CRISPR-based gene editing can be delivered systemically and performed in vivo, or inside the body — found that the treatment, NTLA-2002, reduced levels of the disease-causing protein, kallikrein, by

DNA 142
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The future of AI drug discovery & development in immunology and GPCR research

pharmaphorum

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”.

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Borrowing CAR-T tool from cancer therapy, lupus patients go into remission

STAT News

Rheumatology — the study of immune-system-driven diseases of the bones, joints, muscles, and in-betweens — has inherited plenty of hand-me-downs from cancer research. For example, there are ways of squelching an immune system in order to shrink certain kinds of cancerous tumors. And scientists have found that, when retrofitted, those strategies can also alleviate some symptoms of autoimmune conditions.

Scientist 140
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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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Grand Rounds Ethics and Regulatory Series September 9, 2022: Building An Academic Learning Health System: Why Is It So Hard? (Steven Joffe, MD, MPH)

Rethinking Clinical Trials

Speakers. Steven Joffe, MD, MPH. Art and Ilene Penn Professor and Chair. Department of Medical Ethics & Health Policy. University of Pennsylvania Perelman School of Medicine. Keywords. Ethics, Learning Health System. Key Points. Academic medical institutions may seem like the natural setting to build Learning Health Systems (LHS), but they face unique structural barriers that require leadership, focus, and intentionality to overcome.

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At a fashion show for people with spinal muscular atrophy, models take back their own stories

STAT News

NEW YORK — The scene: a fashion show on Fifth Avenue. The catwalk was not elevated, as it usually would be. People were packed tightly on benches alongside it in the dark. The first person to walk it was a singer/songwriter, James Ian, dressed in a flashy suit with a howling wolf embroidered in beadwork on the back. Ian walked with a slight limp.

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A boil-water notice has been lifted in Jackson, Miss., after nearly 7 weeks

NPR Health - Shots

But a state health department official said concerns remain about copper and lead levels in the city water. The official said people should continue to avoid using it to prepare baby formula.

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Opinion: The White House has a major chance to improve coordination of federal nutrition efforts

STAT News

At the end of September, the White House will host a Conference on Hunger, Nutrition and Health , the first such conference in more than 50 years. Its goal is to accelerate progress toward ending hunger, improving nutrition and physical activity, and reducing diet-related disease. Given the ubiquity of contradictory and headline-grabbing information that can lead to confusion about what to eat or drink, progress on improving diets and the science underlying dietary recommendations is needed now

Research 105
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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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Legal fights and loopholes could blunt Medicare's new power to control drug prices

NPR Health - Shots

The Inflation Reduction Act gives Medicare historic new powers to limit prescription drug prices. But the pharmaceutical industry is already lobbying to dull their impact.

Drugs 115
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The meth crisis is worse than ever, but new treatments might be around the corner

STAT News

When it comes to meth addiction, Thomas Robey has long been at a loss. As an emergency room doctor, he treats a steady stream of patients who show up at Providence Regional Medical Center in Everett, Wash., after experiencing a methamphetamine overdose.

Doctors 98
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What are your chances of catching monkeypox?

NPR Health - Shots

We crunch the current numbers for high-risk and low-risk groups. We also look at how the risk of monkeypox compares with chances of catching COVID, of being in a fatal car crash and of a shark attack.

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STAT+: Humana appeases Wall Street with big projections of Medicare Advantage growth

STAT News

Humana is targeting ambitious growth of its Medicare Advantage plans and primary care clinics over the next three years, which executives said Thursday will significantly propel Humana’s profitability. Humana’s stock price ended the day up 8%, valuing the company at $63 billion. The main purpose of Humana’s messaging was to comfort Wall Street over concerns the company was losing ground in the booming Medicare Advantage market.

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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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Opdivo set to take on Keytruda in adjuvant melanoma

pharmaphorum

Bristol-Myers Squibb’s Opdivo has shown efficacy when used as a post-surgery (adjuvant) treatment for patients with melanoma, extending the time before the disease recurrence or patient death in a phase 3 trial. The positive readout from the CheckMate-76K study means that Opdivo (nivolumab) has a chance to draw level again with Merck & Co’s rival cancer immunotherapy Keytruda (pembrolizumab), which was approved for adjuvant treatment of melanoma last December.

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STAT+: Up and down the ladder: The latest comings and goings

STAT News

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right.  Send us your changes, and we’ll find a home for them.  Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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New Research Reveals How Air Pollution May Trigger Lung Cancer

XTalks

Researchers at the Francis Crick Institute and University College London in the UK have found how air pollution can trigger the activation of cells with existing genetic mutations to form cancer. While it has long been known that pollution can lead to an increased risk of lung cancer in people who don’t smoke, the exact reasons have remained unknown.

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Listen: Pharma’s telehealth gold mine, the return of the biotech IPO, & a merger deferred

STAT News

Is online prescribing a good idea? When is $2 billion not a lot of money? And what’s going to happen at J.P. Morgan 2023? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Katie Palmer joins us to explain a burgeoning trend in pharmaceutical advertising that has health policy experts alarmed.

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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.