Thu.Aug 15, 2024

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Medicare reveals results of drug price negotiations

Bio Pharma Dive

The agency said the first round of pricing talks, which involved drugs like the blood thinners Eliquis and Xarelto, will result in $6 billion in savings for taxpayers.

Drugs 306
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How clinical trials can use AI responsibly and effectively

Pharmaceutical Technology

Strong measures must be in place to safeguard confidential patient data when deploying AI to optimise clinical trial translations.

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Lykos to cut 75% of staff after FDA rejection of MDMA-based therapy

Bio Pharma Dive

The layoffs are part of a larger reorganization that will also see the departure of Lykos’ founder, the psychedelics advocate Rick Doblin.

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Gilead’s PBC therapy Livdelzi bags accelerated approval

Pharmaceutical Technology

Livdelzi is said to be effective against primary biliary cholangitis (PBC) for patients unresponsive to standard-of-care therapy.

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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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Incyte builds out its arsenal of post-transplant drugs

Bio Pharma Dive

The approval of Niktimvo in graft-versus-host disease hands Incyte another immune system-regulating medicine that analysts see as valuable, especially if use is broadened through additional clearances.

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Evotec slashes workforce by 400 people in “difficult market” 

Pharmaceutical Technology

Evotec’s CEO Christian Wojczewski had previously announced a strategic reset after shutting down its gene therapy business earlier this year.

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Arrowhead announces push into obesity space with two gene therapies

Pharmaceutical Technology

Clinical trials for the two RNA interference (RNAi) programmes are slated to commence in early 2025.

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As mpox outbreak spreads across Africa, Siga's antiviral Tpoxx misses the bar in Congo study

Fierce Pharma

Just as a new strain of mpox spreads across Africa, results from a preliminary analysis of a study that began during the 2022 viral outbreak stands to provide more clarity on the clinical benefit o | Despite missing the trial's primary endpoint of time to lesion resolution, the study suggested that the treatment may be most beneficial for those treated early and those with severe disease.

Trials 124
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FDA greenlights Incyte and Syndax’s GvHD drug Niktimvo

Pharmaceutical Technology

The anti-CSF1R antibody, Nikitimvo, has been approved as a third-line treatment for chronic graft-versus-host disease (GvHD).

Antibody 130
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US court rules for AstraZeneca, erasing Pfizer's $107.5M jury award in patent infringement case

Fierce Pharma

Less than three months after a Delaware federal jury ordered AstraZeneca to pay $107.5 million to Pfizer in a patent infringement case, a Delaware judge has nullified the award and invalidated the | Less than three months after a Delaware federal jury ordered AstraZeneca to pay $107.5 million to Pfizer in a patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the original lawsuit.

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

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AI as an inventor: Defining ownership in the pharma sector

pharmaphorum

AI's role in inventing new drugs raises questions about ownership rights in the pharmaceutical sector. Explore the complexities of defining ownership in drug discovery with AI technology.

Drugs 117
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McMaster drug trial receives more than $6m to test smallpox vaccine against mpox

Pharma Times

Children accounted for the majority of mpox cases and deaths in the DRC since June 2023

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AstraZeneca said to be wavering on £450m UK vaccine plant

pharmaphorum

AstraZeneca's plan to invest £450m in a vaccines plant in the UK has been thrown into doubt by a bid to slash state aid, reports FT

Vaccine 115
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B. Braun, Baxter launch separate recalls over particulate concerns and excess endotoxin levels, respectively

Fierce Pharma

So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels. | So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels. While neither recall has resulted in any safety flags or side effect reports so far, the issues stemming from the faulty products could be severe, the drugmakers have w

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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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Incyte builds GvHD presence with Niktimvo approval

pharmaphorum

FDA clears Incyte's potential blockbuster Niktimvo as a treatment for chronic GvHD, making it a companion to the company's Jakafi for the disorder.

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Tonix's trial results showing promise in fibromyalgia treatment

Outsourcing Pharma

Tonix Pharmaceuticals has announced promising phase 3 trial results for TNX-102 SL (sublingual cyclobenzaprine HCl), a treatment targeting fibromyalgia.

Trials 103
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AI chatbots struggle to interpret patient descriptions

pharmaphorum

Large language models (LLMs) find it hard to identify genetic conditions based on patient-written descriptions, say NIH researchers.

Genetics 111
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Study identifies new disease-inducing mechanism for inflammatory bowel disease

Pharma Times

Combined, Crohn’s disease and ulcerative colitis affect over 500,000 people in the UK

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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PBC drug choices rise in US with OK for Gilead's seladelpar

pharmaphorum

FDA approves Gilead's Livdelzi for primary biliary cholangitis, setting up a contest with Ipsen's recent launch Iqirvo in the second-line setting

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August 15, 2024: Application Process Opens for HEAL K12 Career Development Award

Rethinking Clinical Trials

The Chronic Pain and Fatigue Research Center at the University of Michigan is requesting applications for the HEAL National K12 Clinical Pain Career Development Award (HEAL K12). The HEAL K12 is a mentored career development program designed to provide protected time for clinicians and scientists to focus on training in and conducting clinical pain research.

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Why Over 300 Clinical Professionals are Heading to the Fierce Clinical Summit 2024

Fierce Pharma

The clinical operations and trial management community is buzzing with anticipation as the most influential leaders in the field prepare to convene at the

Trials 98
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Lonza boosts clinical services with new bottling capabilities

Outsourcing Pharma

Lonza, a global leader in the pharmaceutical, biotech, and nutraceutical markets, has announced a significant expansion of its clinical manufacturing services at its small molecules site in Bend, Oregon.

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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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Advice for young women in science - stay curious and inquisitive the rest will follow

BioPharma Reporter

Katarina Wikstrom has worked for over 20 years in the field of translational molecular oncology and holds the position of VP global product development at Almac Diagnostic Services.

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Theramex's uterine fibroid drug Yselty backed for NHS use

pharmaphorum

A daily oral therapy for uterine fibroids has been recommended for NHS by NICE, providing a new option for around 30,000 women in England and Wales.

Drugs 81
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The TROP2 race for supremacy

Fierce Pharma

The TROP2 antibody-drug conjugate race has heated up among three Big Pharma companies: Gi | In this week’s episode of “The Top Line,” Fierce executive editor Eric Sagonowsky chats with Angus Liu about his feature story on the three TROP2 front-runners.

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Intelliguard, Cencora Collaborate on Boosting RFID-Tagged Medication Compatibility

Pharmaceutical Commerce

Partnership adds supply chain efficiencies, while prioritizing patient safety.

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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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Recursion, Exscientia, and AI drug discovery’s moment of truth

pharmaphorum

Recently, two leading and long-established firms in the expanding AI drug discovery sector revealed an unexpected merger. In an approximate 75-25 agreement, Recursion Bio and Exscientia are set to unite, pending approval, into a single entity that will merge Recursion's biological proficiency with Exscientia's chemical specialisation.

Drugs 59
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Maximizing ROI in Medical and Disease Education Programs: A Marketing Analytics Perspective

Intouch Solutions

In the ever-evolving landscape of healthcare marketing, understanding audience engagement and measuring success is paramount. In a recent PM360 Think Tank article , Iyiola Obayomi, SVP, Managing Director of Analytics, shared his expertise on mastering metrics. Let’s explore key insights from his perspective. Audience-Centric Metrics: Historically, marketers relied on superficial metrics like likes and shares.

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Which pharmaceutical drugs have the most drug patents in European Patent Office?

Drug Patent Watch

This chart shows the drugs with the most patents in European Patent Office. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.

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Gilead gains accelerated FDA approval for rare liver disease treatment

BioPharma Reporter

Gilead wins on new company acquisition with accelerated approval for autoimmune liver disease drug

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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.