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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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.

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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.

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J&J focuses on newer meds to offset Stelara patent cliff

Bio Pharma Dive

Executives talked up the company’s cash position and incremental dealmaking as ways to buttress against incoming competition.

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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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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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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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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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Pharma at a critical crossroads in approach bringing new medicines to market, says OM1's CCO

Outsourcing Pharma

OM1 says it wants to stand at the helm of a healthcare revolution, fostering an integrated approach to generating and utilizing real-world evidence (RWE), reshaping the foundation of healthcare.

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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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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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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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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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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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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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Bridging the gap between the promise of technology and reality - Lokavant's hopes for SCOPE

Outsourcing Pharma

Andrew Mills, executive vice president of global commercial Lokavant and says the company can help businesses identify risk trends in trials much earlier than traditional methods.

Trials 105
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Johnson & Johnson reports 28% rise in Q4 2023 net earnings

Pharmaceutical Technology

Johnson & Johnson (J&J) has announced a robust financial performance for the fourth quarter (Q4) of 2023, with net earnings reaching $4.1bn.

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Advarra at SCOPE - excited to hear about site and sponsor technology coordination

Outsourcing Pharma

Elisa Cascade is chief product officer at Advarra, a business that says it aims to advance the way clinical research is conducted by bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration.

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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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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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SCOPE - the go-to destination for sharing innovative approaches in clinical operation

Outsourcing Pharma

Dawn Kaminski is vice president, of business development (BD) operations at eClinical Solutions and is responsible for working with the BD team as a subject matter expert for services and technology, strategically positioning the organization to acquire new business and expand the business offerings within current customers.

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Padeliporfin potassium by ImPact Biotech for Esophageal Cancer: Likelihood of Approval

Pharmaceutical Technology

Padeliporfin potassium is under clinical development by ImPact Biotech and currently in Phase I for Esophageal Cancer.

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Lightship's hopes for SCOPE 2024 - AI and tech in clinical trials creating the buzz

Outsourcing Pharma

Sepehr Shojaei serves as the vice president of design solutions at Lightship, using his 15 years of experience in clinical research operations to champion a patient-centric approach.

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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.

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ReciBioPharm: Enhancing gene therapies through flexible AAV platforms

BioPharma Reporter

We sat down with Xiaojun Liu, director of AAV process development at ReciBioPharm, to discuss the growing need for carefully designed platforms to deliver safe and cost-effective AAV therapies to patients at pace.

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SCOPE 2024 - a great place to hear best practice and move the needle for life sciences

Outsourcing Pharma

Veevaâs Jim Reilly, vice president is Veeva Development Cloud strategy and along with countless others is getting excited about SCOPE 2024.

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ReciBioPharm: Enhancing gene therapies through flexibile AAV platforms

BioPharma Reporter

We sat down with Xiaojun Liu, director of AAV process development at ReciBioPharm, to discuss the growing need for carefully designed platforms to deliver safe and cost-effective AAV therapies to patients at pace.

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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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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.