Tue.Dec 03, 2024

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All-in-one milling platforms: How to reduce your machinery footprint  

Pharmaceutical Technology

Many machines are required for pharmaceutical milling processes. Can you reduce that number, streamline operations and improve efficiency?

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Janux impresses Wall Street with new prostate cancer drug results

Bio Pharma Dive

While early and from a small trial, the findings suggest Janux’s method of “masking” T cell engagers could lead to differentiated results, some analysts said.

Drugs 282
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Novartis and Olema expand alliance with $250m to boost breast cancer trials

Pharmaceutical Technology

Olema Oncology and Novartis have signed a clinical trial collaboration and supply agreement for a Phase III trial in metastatic breast cancer.

Trials 246
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Coherus, sharpening immuno-oncology focus, sells another biosimilar for over $500M

Bio Pharma Dive

The company reached a deal to divest its third biosimilar this year, selling a copycat version of Amgen’s Neulasta for up to $558 million.

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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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December 3, 2024: Sharing Results With Research Participants Raises Special Considerations in Pragmatic Trials

Rethinking Clinical Trials

In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation. The article was published online ahead of print in Clinical Trials. There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants.

Trials 124
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Navigating medicine pricing in Turkiye: the pharmaceutical Euro exchange rate

Pharmaceutical Technology

Turkiye’s pharmaceutical industry has grappled with significant economic challenges such as the frequent upward revision of the pharmaceutical Euro exchange rate.

Medicine 147

More Trending

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From Cobenfy to Emraclidine: the muscarinic path to safer antipsychotics

Pharmaceutical Technology

Drugs such as Cobenfy could reshape the antipsychotic market, providing a more nuanced range of patient options.

Marketing 130
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Note from the Editor-in-Chief

Bio Pharma Dive

A change in ownership and what it means for our readers.

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Lundbeck acquires all outstanding shares of Longboard Pharma

Pharmaceutical Technology

Lundbeck has completed the acquisition of all outstanding shares of Longboard Pharmaceuticals, to bolster the neuro-rare disease sector.

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Eli Lilly's Zepbound defeats Novo Nordisk's Wegovy in head-to-head weight loss trial

Fierce Pharma

Over the last two-plus years, as Eli Lilly and Novo Nordisk have battled for their share of the massive weight loss market and patients wondered which company’s products were more effective, there | Eli Lilly revealed results from a study that showed its obesity drug Zepbound was 47% more effective than Novo’s Wegovy in helping patients lose weight.

Trials 115
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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J&J’s sBLAs seek FDA approval of TREMFYA for paediatric conditions

Pharmaceutical Technology

J&J is seeking approval of TREMFYA for paediatric conditions with the submission of two sBLA to the US Food and Drug Administration.

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Deadline looms for post-Brexit label changes for UK meds

pharmaphorum

The MHRA has reminded pharma companies that from 1st January all medicines sold in the UK will have to comply with new labelling requirements

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Novartis and PTC Therapeutics link to develop Huntington’s therapy

Pharmaceutical Technology

Novartis has entered a worldwide licence and partnership agreement with PTC Therapeutics for the development of PTC518.

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Orbit Discovery and Evergreen Theragnostics expand research collaboration

Pharma Times

Partnership aims to develop new radiopharmaceuticals for cancer treatment

Research 110
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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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The Role of Artificial Intelligence (AI) and Machine Learning (ML) in Drug Repurposing

Drug Patent Watch

In the ever-evolving landscape of pharmaceutical research and development, a revolutionary force is reshaping the way we approach drug discovery and repurposing. This force is none other than Artificial Intelligence (AI) and Machine Learning (ML).

Drugs 97
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KIMMTRAK recommended for funding by NICE for uveal melanoma patients

Pharma Times

Immunocore has announced that Kimmtrak (tebentafusp) has been recommended for funding in England by the National Institute for Health and Care Excellence (NICE) and is now available through the NHS.

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Immunocore's rare eye cancer drug backed by NICE

pharmaphorum

Patients in England with a rare form of eye cancer will be able to access Kimmtrak, a TCR therapy from Immunocore, after NICE changes its position

Drugs 105
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Novocure’s TTFields Therapy Shows Survival Benefit in Pancreatic Cancer

XTalks

Novocure, a global leader in oncology innovation, has long been at the forefront of advancing tumor treating fields (TTFields) therapy. This technology, already approved by the US Food and Drug Administration (FDA) for glioblastoma and mesothelioma , and most recently for metastatic non-small cell lung cancer (NSCLC), harnesses electric fields to disrupt cancer cell division.

Trials 90
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Gilead looks beyond Trodelvy with Tubulis alliance

pharmaphorum

Gilead Sciences has shored up its antibody-drug conjugate pipeline by licensing a candidate from German biotech Tubulis in a deal worth up to $415m.

Licensing 103
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Körber absorbs Wilhelm Bähren to expand pharma packaging toolbox

Outsourcing Pharma

Discover how a strategic acquisition in pharma packaging is set to drive growth as the market aims to double by 2028

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FDA kicks off review of Cytokinetics' aficamten for HCM

pharmaphorum

Cytokinetics should hear back from the FDA next September about its application for Camzyos rival aficamten in obstructive hypertrophic cardiomyopathy

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Novocure reports positive phase 3 results for tumor treating fields therapy

Outsourcing Pharma

Novocure's PANOVA-3 trial shows TTFields therapy with chemotherapy improves survival in pancreatic cancer, marking a significant breakthrough in treatment

Trials 66
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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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Ipsen doubles up in TCEs for cancer, adding Biomunex drug

pharmaphorum

Ipsen has expanded its oncology pipeline by licensing a T cell engager (TCE) therapy from Paris-based startup Biomunex for up to $610m

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PTC Therapeutics, Novartis Sign License and Collab Deal for Huntington’s Disease Program

Pharmaceutical Commerce

The agreement provides PTC with $1 billion in cash once deal closes, and is centered around PTC518's development, manufacturing and commercialization.

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Seeking effective, safe treatment for all with precision dosing

pharmaphorum

Tune in to the podcast interview with Dr Sharmeen Roy to learn more about precision dosing and how DoseMe is providing effective and safe treatment for all through personalised dosing solutions.

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Pharma Pulse 12/3/24: Early Access for Innovative Therapies, AI-Powered Drug Response Prediction Technology & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Drugs 59
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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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12 Questions with Jackie Marchington

pharmaphorum

Get to know Jackie Marchington, an expert in IPG Health Medical Communications, through this exclusive interview. Learn about her insights, experiences, and perspectives on the industry.

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New CTTI Project Aims to Identify Challenges and Solutions to Facilitate Successful Implementation of Diversity Action Plans for Clinical Trials

CTTI (Clinical Trials Transformation Initiative)

In December 2022, Congress passed the Food and Drug Omnibus Reform Act (FDORA) requiring drug and device manufacturers to develop and submit diversity action plans (DAPs) for Phase III and other pivotal trials outlining how they plan to recruit, enroll, and retain a population that reflects the patient population with the disease or condition in the US that is expected to use the medical product if approved, licensed, authorized, cleared, or classified.

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Youth in Belgium meets guidelines for physical behaviour less and less

Sciensano

Ten years ago, children were more active than they are now. That is according to the Food Consumption Survey by Sciensano, which assessed and measured the physical activity and sedentary behaviour of the Belgian population in 2022-2023. Only 31% of children aged 3 to 9 and 19% of adolescents aged 10 to 17 engage in sufficient physical activity. However, 46% of children and 41% of adolescents walk, bike or use a non-electrical scooter to get to school.

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The 3rd Medical Device Software Development Summit Europe

pharmaphorum

Integrating Expertise from Software Development, Quality Assurance, Regulatory Affairs, & Product Teams to Drive Innovation in Alignment with Global Regulatory Guidelines, AI & ML Enabled Software, Cybersecurity, & Agile Methodologies

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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.