Wed.Mar 01, 2023

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Amid industry turbulence, Chroma raises fresh funding to edit the epigenome

Bio Pharma Dive

At a time when many startups have struggled to gain cash, the biotech has raised another $135 million to back its research, a new twist on genetic medicine.

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US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals and Sanofi ’s Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients. Kevzara has been approved as the first and only biologic indicated for PMR adult patients who did not respond to corticosteroids or who cannot tolerate corticosteroid taper.

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Lilly to lower insulin prices by 70%

Bio Pharma Dive

The pharma company, along with its diabetes drug rivals Novo Nordisk and Sanofi, has long been under pressure over the high cost of insulin — scrutiny that has recently ramped up in the U.S.

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March 1, 2023: This Week’s PCT Grand Rounds Highlights Implementation Lessons From GGC4H

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Dr. Margaret Kuklinski and Dr. Stacy Sterling will present “Adoption, Implementation and Sustainment of Family-Focused Prevention in Health Care Systems: How Do We Get There?” Kuklinski and Sterling are the principal investigators of GGC4H , an NIH Pragmatic Trials Collaboratory Demonstration Project.

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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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Venture financing for APAC early-stage innovator drugs raises one-third less than US

Pharmaceutical Technology

Venture financing for early-stage innovator drugs for biotech companies based in the Asia-Pacific (APAC) region between 2018 to 2022 received three times less funding, at $23bn, than their US counterparts, at $72bn, according to GlobalData’s Pharma Intelligence Centre Deals Database. Although both regions experienced a surge in deal value and volume for early-stage venture financing for innovator drugs from 2020 to 2021, inflation and geopolitical factors such as the Russia-Ukraine war impacted

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Pfizer’s RSV vaccine gets lukewarm backing of FDA advisers

Bio Pharma Dive

The panel voted 7-4 in favor of Pfizer’s shot, but also expressed concerns over its safety profile and what they viewed as holes in the company’s data.

More Trending

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FDA approves Reata rare disease drug in controversial decision

Bio Pharma Dive

The clearance, the first for a medicine meant to treat Friedreich’s ataxia, comes after years of questions about its purported benefits and sent the drugmaker’s shares soaring.

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Magazine: ‘Right shoring’ API production in Europe

Pharmaceutical Technology

In the last few years, there have been growing calls to onshore the manufacturing of certain pharma products, including active pharmaceutical ingredients (API), to ensure a smooth supply and to minimise shortages in the European Union (EU). I n this month’s cover story , we explore what this ‘reshoring’ might look like amidst rising inflation and how to get these plans right in the EU.

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Cancer drug startup Cargo raises $200M to solve CAR-T relapse

Bio Pharma Dive

The biotech is developing a CAR-T therapy for lymphoma that targets a different protein flag than currently available cell treatments.

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Tevard Biosciences and Vertex partner to develop tRNA therapies for DMD

Pharmaceutical Technology

Tevard Biosciences and Vertex Pharmaceuticals have announced a four-year global research partnership to develop new tRNA-based therapies to treat Duchenne muscular dystrophy (DMD) patients. The deal offers access to the platforms of Tevard to discover and develop tRNA-based therapies. Under the agreement terms, Tevard will receive up-front, option-exercise, as well as milestone payments, along with royalties on any products that are approved.

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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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They could lose the house — to Medicaid

NPR Health - Shots

Depending on where they lived, demands for repayment can drain the assets that a patient on Medicaid leaves behind after they die. Iowa aggressively collects "clawback" funds.

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AI offers 'paradigm shift' in study of brain injury

Medical Xpress

From the gridiron to the battlefield, the study of traumatic brain injury has exploded in recent years. Crucial to understanding brain injury is the ability to model the mechanical forces that compress, stretch, and twist the brain tissue, causing damage that ranges from fleeting to fatal.

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Pandemic food assistance that held back hunger comes to an end

NPR Health - Shots

Millions of people who depend on the Supplemental Nutrition Assistance Program known as SNAP will see a cut of $90 a month or more. Some recipients say it will make it harder to buy healthy food.

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MP-0310 by Molecular Partners for Cervical Cancer: Likelihood of Approval

Pharmaceutical Technology

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Cervical Cancer. According to GlobalData, Phase I drugs for Cervical Cancer have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how MP-0310’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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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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3 abortion bans in Texas leave doctors 'talking in code' to pregnant patients

NPR Health - Shots

Some doctors in Texas are so worried about the abortion bans, they hint to patients with pregnancy complications, "I've heard traveling to Colorado is really nice this time of year.

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NPT-2042 by NeuroPro Therapeutics for Seizures: Likelihood of Approval

Pharmaceutical Technology

NPT-2042 is under clinical development by NeuroPro Therapeutics and currently in Phase I for Seizures. According to GlobalData, Phase I drugs for Seizures have a 94% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how NPT-2042’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

Rethinking Clinical Trials

                                           Speakers Konstantin Dragnev, MD Professor of Medicine, Hematology/Oncology Irene Heinz Given Professor in Pharmacology Associate Director for Clinical ResearchPrincipal Investigator – Dartmouth Lead Academic Participating Site for NCTN Dartmouth Cancer Center Dartmouth Health Karen Reckamp, MD, MS Director, Division of Medical Oncology Associate Director, Clinical Research Clinical Professor, Department of Medi

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Nedisertib by Merck for Neuroendocrine Tumors: Likelihood of Approval

Pharmaceutical Technology

Nedisertib is under clinical development by Merck and currently in Phase I for Neuroendocrine Tumors. According to GlobalData, Phase I drugs for Neuroendocrine Tumors have a 74% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Nedisertib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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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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LGBTQ+ youth are less likely to feel depressed with parental support, study says

NPR Health - Shots

Participants were asked questions about their parents' general parenting style and how that affected how their thoughts and feelings in the last two weeks.

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MP-0310 by Molecular Partners for Colorectal Cancer: Likelihood of Approval

Pharmaceutical Technology

MP-0310 is under clinical development by Molecular Partners and currently in Phase I for Colorectal Cancer. According to GlobalData, Phase I drugs for Colorectal Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how MP-0310’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit

Fierce Pharma

Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit aliu Wed, 03/01/2023 - 10:03

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Orvacabtagene autoleucel by Bristol-Myers Squibb for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

Orvacabtagene autoleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Relapsed Multiple Myeloma. According to GlobalData, Phase II drugs for Relapsed Multiple Myeloma have a 38% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Orvacabtagene autoleucel’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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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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U.S. Intelligence: foreign rivals didn't cause Havana Syndrome

NPR Health - Shots

The U.S. intelligence community concludes it's "very unlikely" a foreign country is responsible for the so-called Havana Syndrome ailments involving U.S. officials working abroad.

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Nedisertib by Merck for Head And Neck Cancer Squamous Cell Carcinoma: Likelihood of Approval

Pharmaceutical Technology

Nedisertib is under clinical development by Merck and currently in Phase I for Head And Neck Cancer Squamous Cell Carcinoma. According to GlobalData, Phase I drugs for Head And Neck Cancer Squamous Cell Carcinoma have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Nedisertib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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STAT+: CRISPR patent fight redux? A new battle is brewing among biotechs over next-gen gene-editing tools

STAT News

Genome editing summits are generally friendly, nerdy affairs, but for a moment at a Lisbon hotel last June, the conversation at the FASEB genome engineering conference grew tense. Tessera Therapeutics chief scientist Michael Holmes had just finished presenting a much-anticipated peek at a technology the company had previously said could “ revolutionize genetic medicine ” and “cure nearly any genetic disease.

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COVID-19 conspiracies soar after latest report on origins

Medical Xpress

COVID-19's origins remain hazy. Three years after the start of the pandemic, it's still unclear whether the coronavirus that causes the disease leaked from a lab or spread to humans from an animal.

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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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STAT+: Bell Labs for biology: Why Salesforce, Meta, and ByteDance are betting on AI protein design

STAT News

It’s an author affiliation that would make even the most seasoned scientist do a double take: New research on artificial intelligence-powered protein design, written by researchers at, of all places, Salesforce. From Meta to TikTok’s parent company ByteDance, nearly every tech company has research programs on large language models, the foundational technology behind text-generating AI tools like ChatGPT.

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Long COVID linked to lower brain oxygen levels, cognitive problems and psychiatric symptoms

Medical Xpress

Long COVID is associated with reduced brain oxygen levels, worse performance on cognitive tests and increased psychiatric symptoms such as depression and anxiety, according to new research studying the impacts of the disease.

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Eli Lilly cuts the price of insulin, capping drug at $35 per month out-of-pocket

NPR Health - Shots

The moves announced Wednesday promise critical relief to some people with diabetes who can face annual costs of more than $1,000 for insulin they need in order to live.

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Researchers reveal how oxygen is delivered to tissues, opening the door to a new class of drugs

Medical Xpress

Cardiovascular medicine, hematology and pulmonary medicine may soon have the first-ever therapies to correct poor tissue oxygenation, a key driver of disease in millions, including peripheral artery disease, sickle cell disease, heart failure, stroke, emphysema and many others.

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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.