Fri.Mar 15, 2024

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Madrigal, FDA approval in hand, outlines plan to sell MASH drug

Bio Pharma Dive

The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.

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With FDA greenlight, BMS Breyanzi brings CAR-T cell therapy to CLL and SLL

Pharmaceutical Technology

Amidst the many BTK inhibitors, Breyanzi will be the first and only CAR-T cell therapy available for the treatment of CLL and SLL.

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FDA panel backs broader use of J&J, Bristol Myers cell therapies for myeloma

Bio Pharma Dive

A majority of experts believed that the factors that may have led to an increased risk of early death in testing of Carvykti and Abecma aren’t as likely to occur outside of a clinical trial.

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Anocca signs licensing deal for EmendoBio’s gene-editing tech

Pharmaceutical Technology

Anocca has entered a licensing agreement with EmendoBio for the use of the latter’s OMNI-A4 nuclease, a gene editing technology.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bristol Myers cell therapy wins first-of-its-kind approval

Bio Pharma Dive

Sold as Breyanzi, the therapy is now cleared for use in certain adults with hard-to-treat forms of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

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FDA approves Madrigal’s Rezdiffra as the first NASH therapy

Pharmaceutical Technology

Madrigal’s Rezdiffra received an accelerated approval as a treatment for noncirrhotic NASH, also known as MASH.

More Trending

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Biotheus and Hansoh Pharmaceutical expand ADC collaboration

Pharmaceutical Technology

Biotheus has announced an expansion of its strategic partnership with Hansoh Pharmaceutical Group for antibody-drug conjugates (ADCs).

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Despite early death concerns, FDA advisers back J&J and Legend's Carvykti for earlier myeloma

Fierce Pharma

Even though the BCMA CAR-T therapy Carvykti showed a potential problem of early patient deaths in a trial, experts on the FDA’s Oncologic Drugs Advisory Committee (ODAC) still believe that the drug | Even though the BCMA CAR-T therapy Carvykti showed a potential problem of early patient deaths in a trial, experts on the FDA’s Oncologic Drugs Advisory Committee still believe that the drug’s long-term benefits outweigh its risks.

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FDA approves BeiGene’s TEVIMBRA for oesophageal cancer

Pharmaceutical Technology

The US FDA has approved BeiGene's TEVIMBRA for oesophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy.

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Novartis lays out $256M for antibody plant expansion in Singapore, plots 100 hires

Fierce Pharma

Over the years, Singapore has attracted a suite of biopharma majors, and Novartis is no exception. | Novartis broke ground on a $256 million expansion of its biopharmaceutical production facility in Singapore. The project will introduce digitalization and automation at the site in a bid to boost manufacturing productivity and to help upskill the company’s workforce.

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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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Q&A: Increasing awareness around digital therapeutics key to realising full potential

Pharmaceutical Technology

Andy Molnar, CEO of the Digital Therapeutics Alliance, discusses the latest trends and challenges in the digital therapeutics space.

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Navigating digital transformation in pharma: The rise of mobile messaging

pharmaphorum

Popular mobile messaging apps that offer end-to-end encryption for their users' communications means that the content of messages is only accessible to the sender and the recipient. However, like any software, they still have potential cybersecurity risks and compliance concerns that users should be aware of - especially in pharma.

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BeiGene spin-out Pi Health raises $30m to uptick cancer trial enrolment

Pharmaceutical Technology

Originally operating as a subsidiary under BeiGene, Pi Health has become an independent company with a Series A raise.

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Eli Lilly Partners with Amazon Pharmacy for Home Delivery of Drugs

XTalks

LillyDirect Pharmacy Solutions, Eli Lilly’s direct-to-consumer (DTC) drugs website, is teaming up with Amazon Pharmacy to deliver select medications to people’s homes. The drugs include Lilly’s newly approved GLP-1 obesity drug Zepbound (tirzepatide), around a dozen of the company’s insulins and migraine drug Emgality (galcanezumab). Prescriptions sent to LillyDirect Pharmacy Solutions will be delivered through third-party dispensers that include online pharmacy Truepill and now Amazon Pharmacy,

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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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FDA committee back Geron’s blood disorder drug

Pharmaceutical Technology

The committee ultimately backed the benefits of imetelstat based on data from the Phase III IMerge clinical trial.

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Changing Faces: Digital and supplier hires from February 2024

pharmaphorum

Explore the latest digital and supplier hires in the pharmaceutical industry, including Campbell, EMS Healthcare, PhRMA, and Exscientia in February 2024. Stay updated on the changing faces in industry.

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Noramco launches North American pharma supply chain services provider

Pharmaceutical Technology

Noramco has announced the launch of Noramco Group, a North American pharmaceutical supply chain services provider.

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The Case for Domestic Sourcing to Establish Reliable Pharmaceutical Supply Chains in the United States

Pharmaceutical Commerce

Reliance on foreign imports means that disruptions in the supply chain can profoundly impact the ability of individuals in the United States to get access to the medications they need.

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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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The Power of Co-Creation in Cultivating Authenticity

Intouch Solutions

In a recent article published by Med Ad News and PharmaLive.com , Hattie Stearns, Senior Director of Experience DesignOps, provides five key takeaways she observed as a brand and design lead at SXSW 2024. In the article, Hattie expands on each takeaway and highlights the responsibility we have as marketers to co-create and cultivate authentically. Art meets tech for healing and community Brands getting real Designing with heart and inclusivity Learning through stories AI with a human touch “Co-c

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DP World launches 100 worldwide freight forwarding offices to boost healthcare logistics

BioPharma Reporter

DP World, a global leader in supply chain solutions, has launched over 100 freight forwarding offices worldwide in a bold move aimed at bolstering support for the global healthcare sector.

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ALS body takes digital approach to clinical trials access

pharmaphorum

The ALS Association is partnering with myTomorrows to connect patients and physicians with clinical trials using a digital platform.

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NIHR reveals phase 1/2 trial to evaluate an investigational vaccine for mpox in the UK

Pharma Times

More than 3,700 cases of mpox have been identified in the UK since May 2022

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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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Healthee heads latest crop of digital health financings

pharmaphorum

Our latest round-up of funding rounds in the digital health category features updates from Healthee, Aktiia, Moxe Health, Eleanor Health, Tava Health, BrainCheck, and Redi Health.

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Fierce Pharma Asia—BIO-WuXi break-off; Takeda's site closure; FDA's concern over Carvykti

Fierce Pharma

WuXi AppTec left the Biotechnology Industry Organization amid increasing pressure on the trade group stemming from a draft U.S. bill targeting certain Chinese biotechs. | WuXi AppTec left BIO amid alleged biosecurity concerns and as U.S. lawmakers target certain Chinese biotechs. Takeda will shut down a gene therapy manufacturing and R&D facility in Austria.

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Future medicine makers will get VR training at new UK centre

pharmaphorum

Consortium led by Birmingham University unveils a centre of excellence for medicines manufacturing training using VR, to answer a UK skills shortage.

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BioDesign: Accelerating the Momentum of Bioconjugate Therapeutics

Fierce Pharma

Over the last several decades, mounting interest has positioned bioconjugate therapeutics as one of the most promising biopharmaceutical modalities. | Antibody-drug conjugates are a promising biopharma modality but specialized expertise is instrumental for successfully bringing drugs to the clinic.

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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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Madrigal Pharma is first over the MASH finish line

pharmaphorum

Madrigal Pharma is first pharma company to get FDA approval for a drug to treat metabolic dysfunction-associated steatohepatitis (MASH)

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The Four Key Factors to Evaluate When Insourcing vs. Outsourcing Patient Support Programs

Drug Channels

Today’s guest post comes from Josh Marsh, Vice President and General Manager of Sonexus™ Access and Patient Support at Cardinal Health. Josh discusses factors that drive manufacturers to insource versus outsource patient support services. He shares data from a Cardinal Health survey of biopharmaceutical companies and offers four factors to consider when evaluating your patient support program.

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Getting the Lay of the Land After a Banner Year for Biosimilars

Pharmaceutical Commerce

Biosimilars market experiences massive growth, but regulatory and adoption challenges remain.

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NHS to roll out AI to improve waiting times and reduce missed appointments

Pharma Times

Every year, missed hospital appointments are estimated to cost the NHS £1.

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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.