Thu.Oct 24, 2024

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The Dangers Surrounding Bits and Bytes

Pharmaceutical Commerce

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jeffrey Bernstein, director of cybersecurity and data privacy for Kaufman Rossin’s risk advisory services, forecasts how cyber threats could potentially evolve over the next decade.

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Intellia data spark debate about CRISPR drug’s potential

Bio Pharma Dive

Newly published data show the therapy reduced the rate of swelling attacks in people with hereditary angioedema, but didn't silence questions about its commercial outlook.

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October 24, 2024: APA-SM Trial Joins the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory is pleased to welcome APA-SM (Personalized Auricular Point Acupressure for Chronic Pain Self-Management in Rural Populations) to its portfolio of innovative NIH Collaboratory Trials. The new project is supported by an award from the National Institute of Neurological Disorders and Stroke, with administrative oversight from the National Center for Complementary and Integrative Health.

Trials 147
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Lyell, in search of a turnaround, to buy cell therapy startup ImmPact

Bio Pharma Dive

The deal will give Lyell a dual-targeting CAR-T candidate for blood cancers. Relatedly, Lyell has opted to end development of two current pipeline programs.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva 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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How supervised machine learning optimizes AI use in clinical trials

Pharmaceutical Technology

In pharma, smaller-scale AI and supervised machine learning models could provide more effective solutions than large language models (LLM).

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GPCR drugmaker Septerna amasses $288M in IPO

Bio Pharma Dive

Septerna is the 23rd biotech to go public this year, raising funds to advance its lead candidate, a treatment for hypoparathyroidism now in Phase 1 testing.

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More Trending

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Merck, Pfizer lifted as CDC backs broader use of pneumococcal vaccines

Bio Pharma Dive

An agency panel recommended lowering the age for routine vaccination from 65 to 50, boosting the revenue outlook for multiple shots on the market and in development.

Vaccine 152
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Transforming CML patient monitoring with ICON’s innovative RNA-based NGS assay

Pharmaceutical Technology

Chronic myeloid leukaemia – CML – is difficult to monitor and manage using traditional solutions. New RNA-based assays are helping.

RNA 130
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Dengue is spreading and Sanofi is pulling the market’s only vaccine. What’s next?

Bio Pharma Dive

As Sanofi prepares to halt production on its dengue vaccine in 2026, locally acquired infections in the U.S. are raising the alarm.

Vaccine 141
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TreeFrog and University of Pittsburgh probe TLS role in immuno-oncology

Pharmaceutical Technology

TreeFrog has entered a research collaboration with the University of Pittsburgh to investigate the role of TLS in immuno-oncology.

Research 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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J&J’s Asish Xavier on biotech’s rebound in a volatile era

Bio Pharma Dive

Xavier, who leads biotech venture investing for the big drugmaker, expects an uptick in IPOs as well as renewed interest in the newer crop of gene and cell therapy companies.

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CPHI Europe: how AI can drive growth in the nutraceutical space

Pharmaceutical Technology

At CPHI Europe, an expert discussed the significance of implementing effective AI strategies to improve nutraceutical products.

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World Stroke Day 2024: Be Greater Than Stroke

XTalks

Every year on October 29, people around the globe come together to observe World Stroke Day , an event dedicated to raising awareness about stroke, its prevention and the impact it has on millions of lives. This annual observance is an opportunity to highlight the importance of recognizing stroke symptoms, understanding risk factors and taking steps to reduce your risk.

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Alpha-9 becomes latest radiopharma to secure funds with $175m Series C

Pharmaceutical Technology

The company will use the funds to advance its pipeline of cancer-targeting preclinical candidates to the “clinic-ready” stage.

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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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Hyntelo: AI solutions for improved customer engagement

pharmaphorum

Hyntelo offers cutting-edge AI solutions like GenAI for enhanced customer engagement. Learn how Hyntelo integrates as a Veeva AI Partner.

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DPV set to acquire Lumos Pharma for $38m

Pharmaceutical Technology

Double Point Ventures (DPV) has entered a definitive merger agreement to acquire all outstanding shares of Lumos for $38m.

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NICE recommendation for new Alexion PNH treatment

Pharma Times

danicopan shown to improve haemoglobin levels and reduce anaemia

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Opioid treatment market set to grow despite expected slump in US sale value

Pharmaceutical Technology

The opioid addiction treatment market will be worth $2.4bn by 2033, driven by diagnoses in the eight major world markets.

Marketing 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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World Psoriasis Day 2024: New Treatments and Research Trends

XTalks

World Psoriasis Day on October 29 shines a light on this chronic autoimmune condition, aiming to increase awareness and improve access to care. Hosted by the International Federation of Psoriasis Associations (IFPA), the World Psoriasis Day 2024 theme , “Psoriatic Disease and Family,” focuses on ensuring equal treatment opportunities worldwide, with an emphasis on improving diagnosis, treatment and support for psoriasis patients.

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Lilly’s Kisunla does not demonstrate “good value” for UK’s NHS

Pharmaceutical Technology

The UK’s National Institute of Health and Care Excellence (NICE) said the drug provided only a small benefit to patients.

Drugs 130
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Lundbeck planning for four novel drugs in phase 3 in 2026

pharmaphorum

Denmark's Lundbeck has said that efforts to build its R&D portfolio are on track to deliver four new molecular entities (NMEs) in phase 3 trials in 2026, including an epilepsy drug from its recently announced $2.6 billion takeover of Longboard Pharma.

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US CDC AdCom recommends lowering the age for pneumococcal vaccines

Pharmaceutical Technology

The committee voted to lower the recommended age for MSD’s Capvaxive and Pfizer’s Prevnar 20 to 50 years down from 65.

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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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Syneos Health Welcomes Costa Panagos as New CEO

XTalks

Biopharmaceutical solutions organization Syneos Health has announced the appointment of Costa Panagos as its new Chief Executive Officer (CEO). Panagos, an industry veteran with extensive experience in the healthcare and life sciences sector, takes over from Colin Shannon, who served as CEO for one year following the company’s acquisition by a consortium of private equity firms.

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MSD acquires cancer therapeutics developer Modifi Biosciences

Pharmaceutical Technology

MSD has acquired cancer therapeutics developer Modifi Biosciences, enhancing its portfolio with preclinical compounds.

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WhatsApp lands Moderna in hot water with PMCPA

pharmaphorum

WhatsApp message earns Moderna a reprimand under the ABPI Code, with Novo Nordisk, Otsuka, AstraZeneca and Daiichi Sankyo also breaching the rules

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CPHI Europe: strategies to navigate nitrosamines risk evaluation

Pharmaceutical Technology

Nitrosamines are organic compounds that have gained attention in the pharma industry as impurities in manufacturing.

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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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No More Delays: Accelerating Therapy Starts by Embedding Hub Services in Provider Workflows

Drug Channels

Today’s guest post comes from Shabbir Ahmed, Chief Commercial Officer at CareMetx. Shabbir explains the barriers that providers face when dealing with branded portals for multiple products. He then maintains that patients can access new therapies more quickly when the manufacturer relies on a brand-agnostic hub connected to a large network of providers and integrated with the systems those providers use daily.

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Be Bio raises $82m to advance haemophilia B gene therapy to Phase I/II trial

Pharmaceutical Technology

There are already two FDA-approved gene therapies for haemophilia B courtesy of Pfizer and CSL Behring.

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Marinus to trim workforce, weigh 'strategic alternatives' after another Ztalmy trial miss sends shares tumbling

Fierce Pharma

It’s déjà vu for Marnius Pharmaceuticals. | The recent trial flop for Ztalmy, this time in tuberous sclerosis complex (TSC)-associated seizures, leaves the company in a cost-cutting scramble as it moves to explore "strategic alternatives.

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How to Manage Regulatory Challenges in Generic Drugs

Drug Patent Watch

The generic drug industry faces significant regulatory challenges that can impact the quality and safety of these life-saving medications. With the majority of generic drugs manufactured overseas, ensuring compliance with regulatory standards is crucial. This article delves into the complexities of generic drug regulation, highlighting the challenges faced by the U.S.

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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.