Fri.Feb 09, 2024

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US Senate committee interrogates big pharma on “outrageously high” drug prices

Pharmaceutical Technology

Pharma CEOs defended their high prescription drug costs, stating that the current prices are necessary for continued innovation.

Drugs 282
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Kyverna CEO Peter Maag on courting investors in a ‘volatile’ IPO market

Bio Pharma Dive

Shortly after Kyverna priced one of the sector’s largest IPOs in recent years, Maag spoke with BioPharma Dive about what it takes to go public now.

Marketing 189
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AstraZeneca posts 81% rise in FY 2023 profit after tax

Pharmaceutical Technology

AstraZeneca has reported a significant 81% rise in profit after tax, reaching $5.96bn for FY 2023 from $3.29bn in the previous year.

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Takeda speeds narcolepsy drug to late-stage testing

Bio Pharma Dive

New results have convinced Takeda to “rapidly” pursue a late-stage program for its drug TAK-861 in one type of narcolepsy, while in another the company opted not to continue.

Drugs 169
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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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Boehringer and CBmed partner to develop cancer therapies

Pharmaceutical Technology

Boehringer has entered a strategic collaboration with CBmed to expedite the translation of cancer treatment approaches into new therapies.

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A SMART way to efficiency and cost reduction in stem cell manufacturing

pharmaphorum

Learn how implementing a SMART approach in stem cell manufacturing can lead to improved efficiency and cost reduction for the production of mesenchymal stem cells (MSCs) used in the treatment of osteoarthritic and autoimmune conditions.

More Trending

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Drug/software combination improves blood pressure control

pharmaphorum

The combination of drugs for hypertension and software to personalise dosing to an individual patient has been shown to deliver improved blood pressure control and adherence to therapy in a pilot study.

Drugs 109
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Novo to buy Catalent: the backlash begins

Pharmaceutical Technology

Novo Nordisk’s plans to buy Catalent has raised objections related to the risk of drug shortages, manufacturing standards, and antitrust violations.

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Too many UK life sciences companies tolerate commercial failure – that has to change

pharmaphorum

Measuring the success or failure of UK MedTech companies is complex and multi-faceted, but it is undoubtedly influenced by two significant factors. Read on to learn more.

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BioNTech partners with Autolus to advance CAR-T therapies

Pharmaceutical Technology

BioNTech has entered into a strategic partnership with Autolus Therapeutics to progress the development of CAR-T cell therapy programmes.

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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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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ).

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Hemogenyx gets reprieve as FDA lifts clinical hold on AML CAR-T therapy

Pharmaceutical Technology

The Phase I trial for evaluating Hemogenyx’s CAR-T therapy to treat acute myeloid leukaemia has been cleared to begin in the US.

Trials 130
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Study Highlights the Value of Patient Support Programs

Pharmaceutical Commerce

Researchers explore the proportion of approved drugs in the Canadian marketplace that utilize manufacturer-sponsored patient support programs, along with the types of medications that are more likely to do so.

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Pharma and biotech concerned about the stability of large CROs, survey finds

Pharmaceutical Technology

The survey by CRO Worldwide Clinical Trials shows that pharma and biotechs favour midsize CROs due to the personalised service.

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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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Novo Nordisk settles with 2 Florida sellers of compounded Ozempic

Fierce Pharma

Novo Nordisk has reached confidential settlements with two Florida sellers of compounded versions of the mega-blockbuster semaglutide treatments Ozempic and Wegovy, the company said on Friday. | Novo Nordisk has reached confidential settlements with two Florida sellers of compounded versions of the mega-blockbuster semaglutide treatments Ozempic and Wegovy, the company said on Friday.

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Janssen seeks EMA approval of RYBREVANT for NSCLC

Pharmaceutical Technology

Janssen has filed a Type II extension of indication application with the EMA seeking approval for Rybrevant for NSCLC.

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Researchers identify new treatment target for genetic epilepsy

Pharma Times

The rare neurodevelopmental condition CDKL5 is characterised by early-onset epilepsy

Genetics 139
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Another recall: does Philips have a quality control problem?

Pharmaceutical Technology

Philips' has recalled a number of high profile medical devices in recent years, shaking investor confidence.

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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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Novo Holdings acquires Catalent for $16.5 billion 

Drug Discovery World

Catalent and Novo Holdings, a holding and investment company that manages the assets and wealth of the Novo Nordisk Foundation, have entered into a merger agreement under which Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5 billion. Novo Holdings will acquire all outstanding shares of Catalent for $63.50 per share in cash.

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As cancer drug shortages persist, ASCO official urges congressional action at hearing

Fierce Pharma

A year into a dire shortage of essential cancer medicines in the U.S., the American Society of Clinical Oncologists (ASCO) is again pushing Congress to act to end the crisis. | The oncology drug supply crisis has entered its second year, and doctors still face "impossible choices" without access to standard-of-care therapies, ASCO's chief medical officer, Dr.

Drugs 99
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What Goes into Planning LogiPharma Europe?

Pharmaceutical Commerce

A dive into the intricacies of how to ensure a long-running event stays fresh and relevant to the needs of the pharmaceutical industry.

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JP Morgan 2024 – Trevor Martin

pharmaphorum

Discover insights from Trevor Martin, the co-founder and CEO of Mammoth Biosciences, in an exclusive interview from JP Morgan for 2024. Gain valuable knowledge about Mammoth Biosciences and the future of biotech innovation.

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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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As Catalent prepares to join Novo family, CDMO's sales continue to slide

Fierce Pharma

As Catalent gets ready to join the Novo fold, the contract manufacturing juggernaut continues to slide on its diminishing COVID-19 business. | Despite some turbulence at Catalent, including an 11% sales drop for the quarter, investors still seem to be buzzed about the stock after this week’s announcement that Novo Holdings is buying out the CDMO for $16.5 billion.

Sales 90
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Royal Marsden to implement RaySearch’s online adaptive radiation therapy system

Pharma Times

OART is increasingly emerging to assess and adapt treatment for cancer patients

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New Survey Reveals Manufacturers’ Patient Services Priorities for 2024

Drug Channels

Today’s guest post comes from Nasir Ali, Chief Product Officer at CareMetx. Nasir shares findings from CareMetx’s new 2024 Patient Services Report research study: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage. As he explains, manufacturers want hub partners that can take a holistic approach and address each patient’s individual needs.

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Novo Nordisk Fends Calls About Ozempic from “Scared” Junk Food Makers

XTalks

With the frenzy around Ozempic (semaglutide) not stopping any time soon, maker Novo Nordisk has been fielding calls from junk food suppliers with concerns about how the blockbuster diabetes and weight loss version of the drug, Wegovy (semaglutide), could potentially make a dent in their businesses. Novo CEO Lars Fruergaard Jørgensen told Bloomberg that he’s been receiving calls from the “scared” bosses of food companies who are feeling threatened by the current new weight loss culture driven by

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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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New patent for Intra-cellular drug CAPLYTA

Drug Patent Watch

Annual Drug Patent Expirations for CAPLYTA Caplyta is a drug marketed by Intra-cellular and is included in one NDA. It is available from two suppliers. There are eighteen patents protecting… The post New patent for Intra-cellular drug CAPLYTA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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International Epilepsy Day 2024: New and Promising Treatments for Epilepsy

XTalks

International Epilepsy Day, observed annually on the second Monday of February, serves as a pivotal occasion to increase awareness of epilepsy. This global initiative, coordinated by the International Bureau for Epilepsy (IBE) and the International League Against Epilepsy (ILAE), offers a platform for individuals with epilepsy to share their stories and experiences with a worldwide audience.

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Synlogic shuts down after PKU drug fails phase 3 trial

pharmaphorum

Synlogic has slashed nearly all its staff and launched a strategic review after its lead drug for rare disease phenylketonuria failed a phase 3 trial

Trials 58
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Valentine’s Day Food Offers: A Complete Guide to National Deals

XTalks

Each year, restaurants and food companies across the US roll out special Valentine’s Day food offers to celebrate this day of love. From cherished dinners at high-end restaurants to cozy meals at home with takeout, the variety of Valentine’s Day food offers ensures there’s something for everyone. Reflecting on past celebrations, we’ve seen an evolving trend of heart-shaped pizzas, themed desserts and prix fixe menus designed to make the day memorable.

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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.