Wed.Jan 24, 2024

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Lilly gene therapy finding puts focus on hearing loss treatment pipeline

Bio Pharma Dive

An 11-year-old boy born deaf can hear after receiving Lilly's genetic medicine. Others, including biotechs in China and Regeneron in the U.S., are taking aim at the same drug target.

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Accent Therapeutics secures funding to advance cancer therapies

Pharmaceutical Technology

Accent Therapeutics has raised $75m in a Series C financing round to progress the development of precision cancer therapies.

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Expert Reveals What Happens to Your Liver When You Quit Alcohol

AuroBlog - Aurous Healthcare Clinical Trials blog

According to Greek mythology, Zeus punished Prometheus for giving fire to humans. He chained Prometheus up and set an eagle to feast on his liver. Each night, the liver grew back and each day, the eagle returned for his feast. In reality, can a liver really grow back?

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4DMT secures rare paediatric designation for cystic fibrosis gene therapy

Pharmaceutical Technology

The company could be in line for a priority review voucher if 4D-710, currently in Phase I/II clinical trials, is approved.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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CG Oncology prices larger-than-expected $380M IPO in hopeful sign for biotech

Bio Pharma Dive

The sector’s first IPO of 2024 could be positive signal for the handful of other companies that have recently laid out plans for initial public offerings.

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Leveraging Genetic Testing for Enrolling Rare Disease Trials

Worldwide Clinical Trials

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. Many of the rare disease studies we support at Worldwide have a genetic etiology, and we discuss genetics and genetic testing with these sponsors.

Genetics 189

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January 24, 2024: In This Friday’s PCT Grand Rounds, Healthcare AI That’s Safe, Effective, and Equitable

Rethinking Clinical Trials

In this Friday's PCT Grand Rounds, Suresh Balu and Marc Sendak of Duke University will present "Advancing the Safe, Effective, and Equitable Use of AI in Healthcare." The Grand Rounds session will be held on Friday, January 26, 2024, at 1:00 pm eastern. Balu is the director of the Duke Institute for Health Innovation (DIHI) and the associate dean for innovation and partnership in the Duke University School of Medicine.

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Novo strikes another obesity drug deal

Bio Pharma Dive

The partnership with startup EraCal Therapeutics, a spinout of Harvard University and Zurich University, adds another prospect to Novo’s pipeline of weight-loss drugs.

Drugs 182
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Financial incentives & allocation of suitable plots for hospitals by govt to offset healthcare challenges

AuroBlog - Aurous Healthcare Clinical Trials blog

Challenges in the healthcare industry can be offset if the government takes several measures including land allotments for hospitals and introduce financial incentives and subsidies to healthcare providers to stimulate investments in infrastructure, medical technology, and workforce development, said Pritika Singh, CEO, Prayag Hospitals Group.

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CG Oncology is first biotech IPO of 2024, raising $380m

pharmaphorum

CG Oncology completes the first biotech IPO of 2024, raising $380 million for its oncolytic virus bladder cancer immunotherapy.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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HHS announces 2024 actions to protect contraceptive care

Pharmaceutical Technology

Amid increased restrictions on contraceptive care, HHS released plans pushing for full access to all FDA-approved contraceptives.

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The Omni Advantage: A concise roadmap for change, for the people

pharmaphorum

"The Omni Advantage: Accelerating the Behavioural Change with Omnichannel in Pharma Sales Engagement" is a game-changing book by businesswoman Merhnaz Campbell. Discover insights, strategies, and inspiration for pharma sales field team success.

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HHS reiterates plans to allow Paxlovid access regardless of insurance  

Pharmaceutical Technology

Pfizer will charge $1,400 per five-day course of Paxlovid when the drug moves over to commercial sales.

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Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

Fierce Pharma

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, it's adjusted the wording of a proposed boxed warning.

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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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Bristol Myers Squibb concludes Mirati acquisition for $5.8bn

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has concluded the acquisition of Mirati Therapeutics for $5.8bn, a move that bolsters its oncology portfolio.

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NHS to test new blood group genotyping test on inherited blood disorder patients

Pharma Times

Patients living with sickle cell disease and thalassaemia will be eligible for the test

Genotype 115
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EraCal and Novo Nordisk partner on obesity treatment

Pharmaceutical Technology

EraCal Therapeutics and Novo Nordisk partner on the development and marketing of an oral, small molecule programme for obesity treatment.

Marketing 130
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A year of major M&A ahead?

pharmaphorum

Is the upcoming year set to be a year of major expansion, acquisitions, and deal-making in the business world? Stay informed about the potential trends and opportunities that await in the M&A landscape.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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NAYA buys gene therapy company Florida Biotech for $20m 

Pharmaceutical Technology

NAYA’s acquisition includes Florida Biotechnologies’ AAV gene therapy for the treatment of a rare genetic disorder.

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Calluna Pharma announces €75m series A financing for immunological diseases

Pharma Times

The new company will develop novel therapies to benefit the body’s immune system

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LEO says chronic hand eczema drug bests its only rival

pharmaphorum

LEO Pharma's chronic hand eczema drug delgocitinib has outperformed the only approved drug for the condition in a phase 3 trial.

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SCOPE - first-hand insights from experts at the forefront of the industry

Outsourcing Pharma

Medable says its mission is to get effective therapies to patients faster.

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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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BARDA backs Locus phage therapy for resistant E coli

pharmaphorum

BARDA has given $24 million to Locus Bio to support a mid-stage trial of bacteriophage therapy LBP-EC01 for resistant E coli infections.

Trials 105
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AUR-105 by Aurigene Oncology for Leukemia: Likelihood of Approval

Pharmaceutical Technology

AUR-105 is under clinical development by Aurigene Oncology and currently in Phase I for Leukemia.

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BenevolentAI names pharma vet Jörg Möller as its new CEO

pharmaphorum

BenevolentAI’s search for a new chief executive has concluded with the appointment of industry bigwig Dr Jörg Möller to the role, four months after Joanna Shields stepped down and as the company emerges from a restructuring drive. The UK artificial intelligence specialist said in a statement that Möller is “an accomplished R&D leader and champion of the application of AI to drug discovery.

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PXS-4728 by Syntara for Sleep Disorders: Likelihood of Approval

Pharmaceutical Technology

PXS-4728 is under clinical development by Syntara and currently in Phase II for Sleep Disorders.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Leo scores again in hand eczema with its JAK inhibitor cream

Fierce Pharma

It’s been four years since Japan Tobacco snagged approval in its home country for its topical JAK inhibitor delgoci | It’s been four years since Japan Tobacco snagged approval in its home country for its topical JAK inhibitor delgocitinib to treat atopic dermatitis. Slowly but surely, Denmark’s Leo Pharma—which gained the rights to develop and commercialize delgocitinib in the rest of the world a decade ago—is working toward its first green light for the topical cream.

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Aldesleukin by Iovance Biotherapeutics for Graft Versus Host Disease (GVHD): Likelihood of Approval

Pharmaceutical Technology

Aldesleukin is under clinical development by Iovance Biotherapeutics and currently in Phase II for Graft Versus Host Disease (GVHD).

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3D Printed Fish: Steakholder Foods Unveils Plant-Based Shrimp

XTalks

Steakholder Foods marks a pivotal moment in the seafood industry with its latest innovation: 3D printed fish in the form of plant-based shrimp. This breakthrough, developed by a leader in cultivated meat and 3D bioprinting technology, is set to transform the $60 billion shrimp market. The company’s use of cutting-edge technology not only showcases a technological triumph but also positions it as a major disruptor in the seafood sector.

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Birch triterpenes by Chiesi Farmaceutici for Radiodermatitis: Likelihood of Approval

Pharmaceutical Technology

Birch triterpenes is under clinical development by Chiesi Farmaceutici and currently in Phase II for Radiodermatitis.

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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.