Tue.Oct 11, 2022

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BIO’s McMurry-Heath steps down as head of biotech lobby

Bio Pharma Dive

Her exit from the role follows reported disagreements over the group’s direction. Former GlycoMimetics CEO Rachel King will serve as interim CEO during the search for a successor.

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Stalicla signs licence deal for Evgen Pharma’s lead asset SFX-01

Pharmaceutical Technology

Swiss biotech company Stalicla has signed a licensing deal with Evgen Pharma for the latter’s lead asset, SFX-01, in neurodevelopmental disorders and schizophrenia. Under the deal, Stalicla will gain the global rights of SFX-01 as a potential treatment for autism spectrum disorder (ASD), while Evgen will retain SFX-01’s worldwide rights for all other indications.

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Brain disease startup Neumora draws more funding for ambitious research plan

Bio Pharma Dive

Launched last year to change how drugs for brain diseases are made, the biotech has now raised about $650 million to build a pipeline that includes two clinical-stage medicines.

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Ochre Bio raises funds to develop RNA therapies for liver diseases

Pharmaceutical Technology

Biotechnology company Ochre Bio has raised $30m in a Series A financing round to develop RNA therapies for chronic liver diseases. LifeLink, LifeForce Capital, Selvridge, Backed VC, Khosla Ventures, Hermes-Epitek, AixThera, EIT, along with individual investors, Verge Genomics CEO Alice Zhang, BioAge CEO Kristen Fortney, and Recursion Pharmaceuticals chairman Marty Chavez have participated in the funding round.

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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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Vertex, after setbacks, moves forward with second-generation rare disease drug

Bio Pharma Dive

The biotech is starting a trial of a new treatment for alpha-1 antitrypsin deficiency following disappointing study results for two earlier compounds.

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Is 'rainbow fentanyl' a threat to your kids this Halloween? Experts say no

NPR Health - Shots

The Drug Enforcement Administration is warning that drug dealers are marketing rainbow-colored fentanyl to kids. Many drug experts say that's likely not happening.

Drugs 145

More Trending

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On #dementia TikTok, family caregivers find support and bring the disease to light

NPR Health - Shots

On TikTok, the hashtag "dementia" has 3 billion views. Caregivers of people with Alzheimer's and other dementias have been using the site to swap tips and share the burdens of life with dementia.

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New TYK2 inhibitors: a growing race to top Bristol Myers

Bio Pharma Dive

The pharmaceutical company’s psoriasis drug Sotyktu was the first of its kind to win approval. A group of well-funded startups think they can do better.

Drugs 141
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Maternity care ‘deserts’ on the rise across the U.S., report finds

STAT News

The home birth had been going well, with the baby having been delivered safely, when midwife Lauren Genter noticed that the mother was losing more blood than normal. The family was Amish and didn’t have a phone in the house, so Genter took her cellphone to the one window where she had spotty service to call for an ambulance. She was able to keep the mother stable while they waited.

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October 11, 2022: AHRQ Announces Healthcare Systems Data Challenge

Rethinking Clinical Trials

The Agency for Healthcare Research and Quality (AHRQ) announced a new competition to explore the feasibility, resources, and infrastructure needed to integrate real-world healthcare system data into the agency’s systematic review findings to improve healthcare practice. The top award winner could earn up to $200,000. Learn more about AHRQ’s Challenge on Integrating Healthcare System Data With Systematic Review Findings.

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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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Opinion: Medicare’s cuts to home health are a step in the wrong direction

STAT News

My grandmother lived at the top of a hill overlooking the magical mountains and valleys of the Ozarks until the day we literally had to drag her off of it. Our family was spread out across Texas and California working full time, so no one was able to check in on her regularly. When she had home health workers, they helped with her medications and recovery after shoulder surgery.

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There's a spike in respiratory illness among children — and it's not just COVID

NPR Health - Shots

Sick kids are crowding emergency rooms in parts of the country and some pediatric hospitals say they're running out of beds.

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U.S. preventive health group recommends anxiety screening for kids 8 to 18

STAT News

An influential national panel of preventive health experts on Tuesday recommended for the first time that children and adolescents between 8 and 18 should be screened for anxiety, but said there was insufficient evidence to say that children 7 and under should be screened. The new recommendations, issued by the U.S. Preventive Services Task Force and published in JAMA, are for the screening of children and teens who are seen in primary care settings and have no symptoms.

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Innovative Sites and CROs Find Ways to Retain Top Talent

ACRP blog

Talent poaching. Aggressive recruiters. Signing bonuses. No, it’s not the National Football League draft. It’s actually the shocking state of play today in the world of clinical trial staffing, where clinical research coordinators (CRCs) and clinical research associates (CRAs) are being courted like star athletes, and sites and contract research organizations (CROs) are left reeling as they try to cobble together study teams amidst turnover, burnout, and rising demand for trials.

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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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AstraZeneca’s intranasal COVID vaccine fails first clinical test

pharmaphorum

An intranasal formulation of AstraZeneca’s widely-used COVID-19 vaccine Vaxzevria has failed at the first hurdle, after results from a phase 1 trial found it was unable to stimulate a strong immune response to the virus. The 30-subject study – funded by AZ and published in the Lancet journal eBioMedicine – tested two strengths of the current formulation of the vaccine administered as a nasal spray, with half the group receiving a second intranasal dose 28 days later, and half getting a reg

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Intranasal delivery of AstraZeneca COVID-19 vaccine fails to generate strong immune response

BioPharma Reporter

Intranasal delivery of ChAdOx1 nCoV-19 failed to induce either a consistent mucosal antibody response or a strong systemic immune response, according to results from a Phase 1 clinical trial released today. However, researchers say delivery of vaccines to the nose and lungs remains a promising approach: hoping their findings will help inform future research.

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Wellcome funds work on regulating digital mental health tools

pharmaphorum

An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy? Wellcome has provided funding in the UK to help answer that question. The healthcare charity is providing £1.8 million (around $2 million) in financial support for UK health technology assessment (HTA) agency NICE and medicines regulator MHRA to develop guidance on “appropriate, risk-proportionate regulation of digit

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STAT+: For Swedish professor and his tiny biotech, Alzheimer’s drug means vindication and a fortune

STAT News

Last month, word spread that a drug was finally shown to slow Alzheimer’s disease, and overnight a 73-year-old Swedish professor made $350 million. The lucky man, Lars Lannfelt, was not particularly famous. He had done pioneering work on the disease, but it was in the 90s and belonged to a sub-field that, after a litany of failures and one disastrous approval, had fallen from grace.

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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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Miami's Little Haiti joins global effort to end cervical cancer

NPR Health - Shots

As a first step to early treatment, health workers who speak Haitian Creole are teaching people in Little Haiti how to test themselves for HPV, the virus that causes half of all cervical cancers.

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Positive results from trial of Arecor’s insulin candidate AT247

Pharma Times

Therapy demonstrates significantly accelerated insulin absorption and early exposure

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A minuscule new HHS office has a mammoth goal: tackling environmental justice

STAT News

WASHINGTON — Ask 10 people how a federal health care agency might tackle “environmental justice,” and you’ll get 10 answers. For Jackson, Miss., residents, it is ensuring potable water after weeks of risk from a damaged sanitation system. For people in “asthma alley,” northern New York City’s communities astride major highways, it is slowing the flow of emissions-related respiratory problems, even as new laws could divert more traffic their way.

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AlzeCure demonstrates disease-modifying effects of NeuroRestore ACD856

Pharma Times

Data from the study shows that ACD856 has a potential neuroprotective effect in a cellular mode

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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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It's a bleak 'Day of the Girl' because of the pandemic. But no one's giving up hope

NPR Health - Shots

The United Nations established the Day of the Girl a decade ago to address issues that affect girls' rights: education, teen pregnancy, child marriage. Steady progress has been made. Then came COVID.

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STAT+: Even as large health systems bleed money, children’s hospitals are faring well

STAT News

Children’s hospitals were spared from the worst ravages of the pandemic, putting them in a much stronger financial position than their acute-care peers. At their January 2022 peak, Covid-19 hospitalizations were more than five times higher across all age groups compared with kids, even though kids have far lower Covid-19 vaccination rates than adults.

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Frontiers Health Steering Committee spotlight – Paul Tunnah

pharmaphorum

As the Frontiers Health 2022 conference in Milan on 20th to 21st October draws ever nearer, pharmaphorum has been catching up with members of the event’s Steering Committee to find out more about what drives both them and the event itself. This time, Paul Tunnah – pharmaphorum’s very own founder and chief content officer and managing director UK at Healthware Group – discussed healthcare’s digital transformation (this year’s guiding theme) and his own journey into the digital space.

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STAT+: Bright exits ACA health insurance marketplaces to stay afloat

STAT News

Bright Health Group is drastically cutting back its health insurance offerings for next year, including a full exit of the individual Affordable Care Act marketplaces, and is attempting to raise $175 million to keep the company afloat. The financially troubled company’s new strategy is an abrupt turn from its recent public intentions. Over the summer, Bright filed documents with states like Alabama , Florida , and Georgia , anticipating it would continue to sell ACA plans next year even a

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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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Merck and Moderna Move Forward with Personalized Cancer Vaccine

BioSpace

Merck and Moderna are moving forward with a personalized cancer vaccine as Merck exercised its option to develop and commercialize mRNA-4157/V940, the companies announced Wednesday.

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STAT+: Pharmalittle: BIO CEO resigns amid board disagreements; Pfizer exec denies allegations over EU Covid-vaccine deal

STAT News

Good morning, everyone, and how are you today? We are doing just fine thank you, especially since we had an extended weekend break due to a holiday on this side of the pond. Now, though, we are returning to the usual routine of online meetings, phone calls, and deadlines. This calls for — you guessed it — a cup or two of stimulation. Our choice today is butter pecan, for those tracking this sort of thing.

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Ascidian Nets $50M to Rewrite RNA in Stargardt Disease and Beyond

BioSpace

With $50 million in backing from Apple Tree Partners, Ascidian Therapeutics launches Tuesday with technology that allows for the treatment of some diseases through rewriting of RNA.

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How ClinLife reaches 6 times more patients in Germany, than leading sponsor portals and databases

Clairnes

The post How ClinLife reaches 6 times more patients in Germany, than leading sponsor portals and databases appeared first on Clinical Trial Recruitment & Management Services.

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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.