Thu.Feb 02, 2023

article thumbnail

Biotech startup Structure pulls off rare IPO, raising $161M

Bio Pharma Dive

The company’s lead drug could be an oral alternative to marketed diabetes and obesity drugs from Novo Nordisk and Eli Lilly.

Marketing 360
article thumbnail

US FDA approves GSK’s Jesduvroq to treat anaemia of CKD

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It is claimed to be the only HIF-PHI approved in the country that offers a new oral treatment option for adult patients on dialysis with anaemia of CKD.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Karuna, hoping to find new brain drugs, buys up a shuttering biotech’s pipeline

Bio Pharma Dive

Though Goldfinch Bio focused on kidney diseases, Karuna believes its experimental drugs may have potential treating psychiatric and neurological conditions.

Drugs 296
article thumbnail

Magazine: CRISPR gene therapies cut through in 2023

Pharmaceutical Technology

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. Having made significant advances in a relatively short period of time, CRISPR research is now edging closer to reaching the clinic , and this month’s cover story takes a look at the major players in this field and the big events that could break through this year.

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

GSK moves hepatitis B drug into late-stage testing

Bio Pharma Dive

The British drugmaker sees potential for the medicine to be a functional cure for chronic infections, and is beginning two Phase 3 trials to test its promise.

Drugs 287
article thumbnail

Inhaling Car Fumes Can Change a Brain’s Connectivity in Just 2 Hours, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

Breathing in air pollution could have an impact on the way your brain is wired, with scientists at the University of British Columbia (UBC) and the University of Victoria discovering that inhaling car exhaust can change a brain’s connectivity within two hours.

Scientist 200

More Trending

article thumbnail

Cidara Therapeutics expands partnership with WuXi XDC

Pharmaceutical Technology

Cidara Therapeutics has announced the expansion of its existing collaboration with WuXi XDC for advancing the CD73 oncology DFC programme. The deal builds on the existing partnership with WuXi XDC for chemistry, manufacturing, and controls (CMC) development and GMP manufacturing services for the CD388 influenza drug-Fc conjugate (DFC) programme of Cidara.

article thumbnail

Lilly reports fast sales for new diabetes drug

Bio Pharma Dive

Still, fourth quarter sales for Mounjaro were slightly below high Wall Street forecasts and didn’t offset falling revenue from Lilly’s COVID-19 antibodies.

Sales 164
article thumbnail

MD Anderson partners with Federation Bio to develop microbiome therapy

Pharmaceutical Technology

The University of Texas MD Anderson Cancer Center has announced a strategic collaboration with Federation Bio for the development of a new microbiome treatment for immunotherapy-resistant cancer patients. The collaboration is aimed at designing and developing a complex, synthetic microbial consortium to expand the number of cancer patients who respond to immunotherapy.

article thumbnail

Roche promotes from within to replace departing pharma head

Bio Pharma Dive

Teresa Graham, currently head of Roche Pharmaceuticals’ global product strategy, will succeed former chief Bill Anderson. The reshuffle is one of several recent changes in the pharma’s leadership.

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

SEC recommends waiver of local phase III and IV trials for Sanofi’s orphan drug to treat Pompe disease

AuroBlog - Aurous Healthcare Clinical Trials blog

The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The Committee recommended grant of permission to import and market the drug without these stages of studies.

Trials 140
article thumbnail

These blood-clot catching devices have been controversial for years. Why are doctors still relying on them?

STAT News

Inferior vena cava filters are supposed to save lives. The spider-like devices catch blood clots before they can travel up to the lung and cause deadly pulmonary embolisms. But for over a decade, these devices have been dogged by questions about how well they work and the serious complications they can cause for patients. The latest data make clear they’re still causing problems: Researchers examined a Food and Drug Administration database and found that adverse event reports related to t

Doctors 137
article thumbnail

SNAP recipients will lose their pandemic boost and may face other reductions by March

NPR Health - Shots

Congress ended the temporary benefit meant to help low-income households with pandemic-era hardships. A huge increase in Social Security benefits may mean some households see further SNAP reductions.

129
129
article thumbnail

Survey: A majority of Americans support banning all tobacco products

STAT News

WASHINGTON — A majority of Americans support banning all tobacco products, according to a new poll published by researchers at the Centers for Disease Control and Prevention. The survey , which was published Thursday in the peer-reviewed journal Preventing Chronic Disease, asked 6,455 people nationwide: “To what extent would you support a policy to prohibit the sale of all tobacco products?

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

Scientists create more efficient CAR immunotherapies using a molecular anchor

Medical Xpress

Adding a molecular anchor to the key protein used to recognize cancer in cellular immunotherapies can make the treatments significantly more effective. Scientists at St. Jude Children's Research Hospital found that immune cells with the anchored protein increased cancer killing, regardless of their cell type or the kind of cancer targeted.

Scientist 127
article thumbnail

Eye drops linked to U.S. drug-resistant bacteria outbreak

STAT News

NEW YORK — U.S. health officials are advising people to stop using over-the-counter eye drops that have been linked to an outbreak of drug-resistant infections. The Centers for Disease Control and Prevention on Wednesday night sent a health alert to physicians, saying the outbreak includes at least 55 people in 12 states. One died.

Bacteria 126
article thumbnail

Possible new way to reduce pain inspired by chickens

Medical Xpress

Stanford Medicine researchers have discovered a possible new way to treat pain without the use of opioids. By targeting a specific area of a well-known pain receptor, they were able to reduce pain sensitivity in mice without affecting the receptor's other functions, such as sensitivity to heat.

Medicine 124
article thumbnail

STAT+: Teva quits brand lobby PhRMA, in line to lead generic lobby AAM

STAT News

WASHINGTON  — Teva Pharmaceuticals has quit the Pharmaceutical Research and Manufacturers of America, STAT has learned.   “ Teva has decided not to renew its membership with PhRMA in 2023,” PhRMA spokesperson Brian Newell confirmed.

Branding 126
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

Small molecule inhibitors show early-stage promise against YAP fusion-driven cancers

Medical Xpress

An unexpected discovery made by experts at the Brain Tumor Center at Cincinnati Children's while studying a rare-but-deadly type of brain tumor may also lead to improved treatments for several other forms of cancer that share a common influencing factor called a YAP fusion protein.

Protein 124
article thumbnail

February 2, 2023: New Tool Developed to Assess Intervention Complexity

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory has developed an online tool to evaluate the complexity of delivery of a trial intervention. To develop the tool, principal investigators of embedded pragmatic clinical trials (ePCTs) shared critical drivers of complexity that affected their ability to implement an intervention and discern treatment effects. A manuscript describing the tool and its development was published today in Contemporary Clinical Trials.

article thumbnail

Opinion: Invasive strep A: bad in affluent countries, far worse in low-income nations

STAT News

The deaths of nearly 30 children under the age of 15 years from invasive strep A infections in the United Kingdom between September 2022 and January 2023, together with a rise in new invasive strep A infections in that country, made headlines around the world. In Kenya, about 100 children aged 5 and younger died from invasive strep A infections over the same period — which did not make headlines.

Bacteria 119
article thumbnail

Clinical Research as a Career Path and the Need for Deliberate Site Action

ACRP blog

Changing ‘I fell into this’ into ‘This was my career of choice.’ Many clinical research professionals “fell into” this career pathway rather than choosing it deliberately from the outset. With today’s well-known workforce challenges, it is more important than ever for sites to address workforce development in a meaningful way, reimagining how clinical research departments perform in an organizational context.

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

Listen: Pharma blockbusters, pandemic policy, & legal chicanery

STAT News

Is the next Lipitor on the way? When is a pandemic over-over? And what’s a Texas two-step? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. STAT Washington correspondent Rachel Cohrs joins us to explain the looming end of Covid-19’s status as a federal emergency and what that does and doesn’t mean for public health.

111
111
article thumbnail

Study links adoption of electric vehicles to less air pollution and improved health

Medical Xpress

Electric vehicles are widely hailed as a key way to mitigate climate change through reduced emissions, but research on the dual benefits of reduced air pollution and improved health has been largely hypothetical.

Research 108
article thumbnail

Venture capital is investing little in new treatment for addiction, report finds

STAT News

There are about as many Americans living with addiction as there are Americans living with cancer — but you wouldn’t know it based on the world of venture capital. In the past decade, investment firms have poured roughly 270 times more money into developing cancer drugs than addiction cures, according to a new report from BIO, the biotechnology industry trade group.

article thumbnail

Podcast: The impact of synthetic biology and collaboration in pharma

Drug Discovery World

This is the latest episode of the free DDW podcast. It covers two articles written for Volume 23, Issue 1 – Winter 2021/22 of DDW. They are called “ Why synthetic biology is the next big thing for biopharma ” and “ Collaborative spirit helps drive innovation ”. ‘Can synthetic biology save us?’ and ‘Synthetic biology can benefit us all’, are just some of the headlines this emerging scientific field has recently elicited.

Drugs 98
article thumbnail

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.

article thumbnail

Opinion: Generics: a missing piece in China’s Covid-19 crisis response

STAT News

China’s massive Covid-19 crisis, sparked in part by the country’s rolling back its strict zero-Covid policies in early December, has seen millions of people infected with SARS-CoV-2. Making the problem worse is that supplies of name-brand Covid-19 drugs are few and far between, and generics of these drugs won’t be available in China due to failed manufacturer negotiations.

Branding 105
article thumbnail

World Cancer Day cancer research roundup

Antidote

The statistics about the prevalence of cancer can be disheartening. Over 10 million people die each year from cancer , making it one of the leading causes of death — and unfortunately, researchers have yet to find a cure for many cancers.

article thumbnail

Rare polio case highlights how hard it will be to keep polio gone once it’s eradicated

STAT News

An incident that took place at a Dutch polio vaccine production facility late last year is a critical reminder of a major challenge the world faces if and when polio eradication is completed: How do we keep polio from re-establishing itself, given that laboratories and vaccine manufacturers in numerous countries will need to continue to work with the viruses?

article thumbnail

Processes to collect information from electrical signals in the skin to make inferences about mental activity

Medical Xpress

Wearable monitoring is likely to play a key role in the future of health care. In many cases, wearable devices may monitor our physiological signals that can indicate mental states, such as emotions.

98
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.