Wed.Oct 19, 2022

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Lilly agrees to acquire gene therapy developer Akouos for $610m

Pharmaceutical Technology

Eli Lilly and Company has signed a definitive agreement for the acquisition of all outstanding shares of precision genetic medicine firm Akouos for a total deal value of up to nearly $610m or up to $15.50 for each share in cash. The deal comprises an acquisition value of $12.50 for each share in cash payable at closing along with one non-tradeable contingent value right per share (CVR) of up to another $3 in cash.

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A startup plans an IPO to give a shelved Lilly drug another shot

Bio Pharma Dive

Acrivon Therapeutics is looking to fund a development approach it claims could improve the prospects of a cancer drug Lilly scrapped after testing it in clinical trials.

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Mouse Study Reveals How to Help Speed Up The Liver’s Self-Regeneration Process

AuroBlog - Aurous Healthcare Clinical Trials blog

The liver is known for its ability to regenerate. It can completely regrow itself even after two-thirds of its mass has been surgically removed. But damage from medications, alcohol abuse, or obesity can eventually cause the liver to fail. Currently, the only effective treatment for end-stage liver disease is transplantation. However, there is a dearth […].

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FDA advisers back withdrawal of controversial drug for preterm birth

Bio Pharma Dive

A committee of independent experts voted 14-1 that the agency shouldn’t allow the treatment from Covis Pharma to remain on the market while further testing is conducted.

Drugs 208
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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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New dawn for the EU’s joint procurement crisis response

Pharmaceutical Technology

The European Union (EU) is on the cusp of approving clearer rules governing the joint procurement of medicines and medical devices by member states at the EU level. The imminent rule changes will apply to crisis-relevant supplies of medical countermeasures, including both vaccines and therapeutics, where the threshold of a 'serious cross-border threat to health' is met.

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Zymeworks strikes deal with Jazz as HER2 drug developers adjust their plans

Bio Pharma Dive

The high bar set by AstraZeneca and Daiichi Sankyo’s HER2-targeting drug Enhertu appears to have influenced Zymeworks’ decision, while leading to a restructuring at Ambrx Biopharma.

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Johnson & Johnson reports 1.9% rise in Q3 2022 sales

Pharmaceutical Technology

Johnson & Johnson (J&J) has reported sales of $23.79bn in the third quarter (Q3) of 2022, indicating an increase of 1.9% as against $23.33bn in the same quarter last year. For the quarter, net earnings stood at $4.46bn, signifying a surge of 21.6% from $3.67bn in the year-ago quarter. Diluted earnings per share (EPS) rose by 22.6% to $1.68 in the third quarter of this year compared to $1.37 in Q3 2021.

Sales 130
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October 19, 2022: This Week in PCT Grand Rounds: Protecting Patients and Research From Disinformation, Cyberthreat, and Choice

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Eric Perakslis of Duke University and Andrea Downing of The Light Collective will present “Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat.” The Grand Rounds session will be held on Friday, October 21, 2022, at 1:00 pm eastern. A professor of population health sciences at Duke University, Perakslis is the chief science and digital officer of the Duke Clinical Research Institute

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Syncromune and Eucure enter antibody licence deal

Pharmaceutical Technology

Syncromune and Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma have entered an exclusive global licence agreement for OX40 antibody YH002 and two other active ingredients. . According to the deal, the worldwide rights for developing and marketing intratumoral combination treatment containing Eucure’s YH002 and two additional active ingredients of the Syncrovax therapy will be acquired by Syncromune.

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October 19, 2022: Abstract Deadline Approaches for HCSRN 2023, Submissions Due Friday

Rethinking Clinical Trials

Abstract submissions and panel presentation submissions for the Health Care Systems Research Network (HCSRN) 2023 Annual Conference are due this Friday, October 21. The conference will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems.

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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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What it's like being an abortion doula in a state with restrictive laws

NPR Health - Shots

"I'm an abortion doula, I fund people's abortions, I make sure they can get to their appointments, period," said Ash Williams of North Carolina. "I can do that. I just need to keep doing that.

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Could monkeypox infections have long-term consequences?

STAT News

Since the world began confronting a global outbreak of monkeypox in the spring, the scientific community has had plenty of reasons to rue the fact that for decades this virus has been understudied. Here’s another one: Because of that oversight, doctors treating people who have been infected with monkeypox can’t answer with certainty whether some of them will face any long-term health consequences, referred to as sequelae in the field of medicine.

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Paying for mental health care leaves families in debt and isolated

NPR Health - Shots

A youth mental health crisis and a shortage of therapists and other care providers who take insurance are pushing many U.S. families into financial ruin. But it's rarely acknowledged as medical debt.

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Opinion: To learn lessons from pandemics, don’t listen to big pharma

STAT News

Early in the Covid-19 pandemic, the leaders of wealthy countries pledged to respond with “global solidarity.” But when vaccines to prevent the disease were developed, those same leaders pushed low and middle-income countries to the back of the queue, outbidding poorer countries, as well as COVAX, a worldwide initiative developed to achieve equitable vaccine access, to secure vaccines for themselves.

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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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How Black Death survivors gave their descendants an edge during pandemics

NPR Health - Shots

Up to 50% of Europeans died from the plague. Now a new study shows that those who lived had a protective gene mutation they passed on to bolster immunity — but it comes at a cost.

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October 19, 2022: Living Textbook Adds New Collection of Ethics and Regulatory Content

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory announced the addition of a new collection in the Living Textbook of Pragmatic Clinical Trials focused on ethical and regulatory aspects of pragmatic trials. “The Living Textbook is a dynamic, evolving collection of knowledge gained from 10 years of conducting pragmatic clinical trials within the NIH Collaboratory,” said Dr.

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Kyverna Files First IND to Leverage CAR-T Therapy for Lupus

BioSpace

Kyverna Therapeutics filed its first IND application this week to test the efficacy and tolerability of KYV-101, a CAR-T therapy for lupus nephritis.

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Black Death may have influenced evolution of genes involved in immune responses, study finds

STAT News

The phrase “Black Death mass burial site” tends to evoke images of haphazard piles of diseased deceased like the “bring out your dead” Monty Python scene. But Hendrik Poinar, anthropology professor at McMaster University, said the East Smithfield graveyard in London, a mass burial site that dates back to the height of the bubonic plague pandemic, is the exact opposite.

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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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Frontiers Health 2022 – day 1

pharmaphorum

Frontiers Health 2022 in Milan is LIVE! Opening Day One will be Healthware Group’s CEO and founder Roberto Ascione and WTF Health’s founder and host Jessica DaMassa. The day’s keynote addresses will include ‘The H is for humanity’ by MD of Taliossa Tony Estrella and founder and trustee of Rachel’s House Lynna Chandra, as well as ‘Creative disruption in delivering novel VR solutions in pain: evidence, teamwork, and delivery’ by Christopher Eccleston, professor of medical psychology at the U

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FDA authorizes booster shot for Novavax’s Covid-19 vaccine

STAT News

The Food and Drug Administration announced Wednesday that it has authorized a booster shot for Novavax’s Covid-19 vaccine. Unlike the latest boosters from Pfizer-BioNTech and Moderna, which target both the original strain of SARS-CoV-2 and the Omicron BA.4/5 variants, the Novavax booster only targets the original strain. The company announced in late May that it was studying an Omicron-targeting strain, as well as a bivalent booster.

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Grifols’ Tavlesse receives NICE recommendation

Pharma Times

Therapy treats refractory chronic immune thrombocytopenia and is available across UK

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STAT+: Large insurer’s decision to cover some prescription digital therapies may be a milestone for app makers

STAT News

A large commercial insurer’s decision to cover a controversial class of software-based treatments for psychiatric and other conditions could prove to be a landmark moment in the development of these so-called prescription digital therapeutics, which until now had been unable to secure coverage from insurers skeptical that the new technologies are as effective as their makers claim.

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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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How to Weather the Clinical Research Talent Recruitment Storm

ACRP blog

Experienced boaters know how to handle a storm at sea: They steer straight into it while maintaining enough power to avoid being tossed around by waves and wind. It may sound counter-intuitive, but by confronting the bad weather directly they improve their chances of seeing better days ahead. In the turbulent waters of the clinical research workforce, with high turnover and burnout circling like relentless sharks, several leading organizations have found ways to navigate their way through and ar

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Opinion: STAT+: How digital health innovators can successfully navigate evolving FDA regulations

STAT News

In the rapidly changing landscape of digital health, innovation has often outpaced regulations , especially for novel technologies and emerging industries. To narrow the gap, the Food and Drug Administration has acknowledged that new regulatory policies and frameworks are necessary. To this end, the FDA has been testing new regulatory paradigms , modernizing submission approaches , updating policies , and urging legislative actions to keep up with new developments.

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How the Digital Patient Experience is Shaping the Future of Pharma

pharmaphorum

From diagnosis to treatment and ongoing condition management, the patient journey is becoming an increasingly digitised one – a process which has been massively accelerated by the Covid pandemic and has significant implications for pharma & their patients vs. their customers. Join us on Monday 7 th November at 12:30 GMT / 13:30 CET / 7:30 am EDT as panellists focus on how this new paradigm is shaping both the industry’s omnichannel engagement and the patient care journey, from patient identi

Sales 98
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STAT+: FDA panel votes that a controversial premature birth medication should be withdrawn

STAT News

After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted on Wednesday to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births. The 14-to-1 vote came after the agency and Covis Pharma, the manufacturer of the drug, offered highly contrasting views of reams of clinical evidence — which they parsed in excruciating detail — in order to settle the fate of the treatment, known as Mak

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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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Every scientific message has a story. Medical communications must adapt to effectively bring these to life.

pharmaphorum

Medical communications are in a state of transition. Due to the combined impact of emerging technologies, changing provider preferences, and an evolving post-pandemic world, pharma must navigate new ways to engage providers with relevant, science-driven, digital content. Delivering these materials in the proper format, however, requires a keen understanding of providers’ educational needs, learning science, and creative storytelling.

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Opinion: What the Makena vote means about accelerated approval, trust, and the FDA

STAT News

On Wednesday, the FDA advisory committee that oversees obstetrics, reproductive, and urologic drugs voted 14-1 that the drug Makena was not effective at reducing the risk of preterm birth, and that it should be removed from the market. We’ve been here before. In 2011, the same year that Makena received accelerated approval from the FDA, I was a member of a similar FDA advisory committee hearing in which we considered withdrawing the breast cancer indication for the drug Avastin.

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¿Cómo ha afectado su vida la ley de aborto estatal? Comparta su historia

NPR Health - Shots

Las leyes que restringen el aborto están afectando la vida de las personas en formas grandes y pequeñas. Si han tenido un impacto en su vida o en la vida de su familia, NPR quiere oir de usted.

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STAT+: Pharmalittle: Merck KGaA probed by French court for misleading info; former Genentech scientists given prison terms over trade-secret theft

STAT News

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is green apple caramel — a new addition to our pantry.

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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.