Mon.Dec 11, 2023

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How Clario is improving clinical trials: 'Therapies that hold immense promise may never see the light of day'

BioPharma Reporter

Dr. Michael OâNeal, chief medical officer at Clario, believes that many drugs ultimately fail due to common operational and data challenges that could, and should, be corrected.

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Humira leads ICER’s latest list of ‘unsupported’ price hikes

Bio Pharma Dive

AbbVie’s blockbuster medicine topped a list of treatments that, combined, elevated U.S. healthcare spending by $1.3 billion in 2022, according to the price watchdog’s latest yearly report.

Medicine 306
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Quality and sustainability: The balancing act for pharma manufacturing  

Pharmaceutical Technology

Trends in sustainability and quality assurance were key themes discussed at the recent CPHI Europe 2023 meeting, although the data reveals a lack of implementation of sustainable solutions.

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ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

Bio Pharma Dive

Editas had the tall task Monday of convincing ASH attendees its gene therapy for sickle cell disease could improve on Casgevy and Lyfgenia.

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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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First gene therapies for sickle cell disease secure FDA approval

Pharmaceutical Technology

The FDA has approved Vertex/CRISPR’s Casgevy and bluebird bio’s Lyfgenia gene therapies for the red blood cell disorder.

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Profitable growth is on the horizon

Bio Pharma Dive

A return to profitable growth is on the horizon—organizations that take advantage of the following key trends can thrive in 2024 and beyond.

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More Trending

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Life sciences leaders invest in process mining to accelerate digital transformation

Bio Pharma Dive

Research from Everest Group shows how life sciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.

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UKHSA urges individuals from ethnic minority groups to get vaccinated

Pharma Times

New data highlights the inequalities in emergency hospital rates and vaccinations - News - PharmaTimes

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Signal: CAR-T study suggests cell therapy can treat autoimmune diseases

Pharmaceutical Technology

A study shared at ASH saw lupus and sclerosis patients make marked recoveries through CAR-T therapy initally targeted at blood cancers.

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NHS rolls out online GP registration to over 2,000 practices

Pharma Times

Around 2,100 GP surgeries had enrolled into the digital service by the end of November - News - PharmaTimes

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

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Novartis gears up for label expansion for Kisqali with Phase III results

Pharmaceutical Technology

Novartis is seeking approval for Kisqali as a treatment of early breast cancer, with an FDA application planned by the end of 2023.

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Predictive genetic testing offers the greatest promise and ethical challenge of our time

pharmaphorum

Predictive genetic testing offers the greatest promise and ethical challenge of our time Mike.

Genetics 126
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How to improve patient engagement and retention rates with mobile nurse visits

Pharmaceutical Technology

We analyse dropout data and speak to DCT expert, Ellen Weiss, to explore the power of mobile visits in improving patient engagement and retention rates.

Nurses 130
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How buying Canadian insulin aids Americans without medical coverage

pharmaphorum

How buying Canadian insulin aids Americans without medical coverage Mike.

Insulin 118
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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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InvaGen recalls seizure treatment due to leaking sachets

Pharmaceutical Technology

InvaGen Pharmaceuticals issued a voluntary recall of a single lot of its refractory complex partial seizure treatment due to leaking sachets.

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ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy

Fierce Pharma

ASH: Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy aliu Mon, 12/11/2023 - 14:51

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Ferring signs microbiome R&D partnership deal with PharmaBiome

Pharmaceutical Technology

Ferring Pharmaceuticals has signed an R&D partnership agreement with PharmaBiome to develop microbiome-based therapies in gastroenterology.

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MSD, Moderna take mRNA jab into phase 3 for lung cancer

pharmaphorum

MSD, Moderna take mRNA jab into phase 3 for lung cancer Phil.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Antimicrobial agents in pharmaceuticals: Important considerations for formulators

Pharmaceutical Technology

Thousands of over-the-counter (OTC) and prescription healthcare products contain antimicrobial agents. Here’s what you need to know when working with these ingredients.

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As ICER places a spotlight on pharma's price hikes, J&J, Roche and more hit back

Fierce Pharma

After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end u | The Institute for Clinical and Economic Review (ICER)’s fifth annual report on unsupported price increases (UPI) puts Humira in the top spot of offenders.

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FDA grants approval for Astellas Pharma’s antifungal therapy Cresemba

Pharmaceutical Technology

The US FDA has granted approval for Astellas Pharma’s Cresemba to treat children with invasive aspergillosis and invasive mucormycosis.

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ASH: Pfizer builds case for long-acting haemophilia drug

pharmaphorum

ASH: Pfizer builds case for long-acting haemophilia drug Phil.

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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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Nona Biosciences and Evive enter antibody discovery deal

Pharmaceutical Technology

Nona Biosciences has entered a partnership deal with biopharmaceutical company Evive Biotech to discover antibodies.

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Top 10 Fastest Growing Medical Device Companies in 2023

XTalks

Medical device companies continue to maintain a crucial role in enhancing patient care and diagnostic precision in 2023. Through the utilization of their state-of-the-art technology and substantial investments in research and development (R&D), these med tech/medical device companies persist in driving industry innovation beyond the pandemic, thereby laying the foundation for a more streamlined approach against diseases in the future.

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Trade & Channel Strategies 2023: A Dive into Pharmacy and the Distribution Channel

Pharmaceutical Commerce

Conference keynote offers an industry outlook, including new commercialization challenges.

Pharmacy 105
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Tome Biosciences Launches with $213M in Funding, Targets ‘New Era’ of Genomic Medicines

BioSpace

Backed by ARCH Venture Partners and Fujifilm, as well as technology licensed from MIT, Tome is looking to create curative cell and integrative gene therapies.

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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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Trade & Channel Strategies 2023: Aligning Patient Access

Pharmaceutical Commerce

Panel uncovers ways to handle the increasing complexities and risks surrounding commercialization.

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ASH: AZ’s danicopan shows long-term benefit in PNH

pharmaphorum

ASH: AZ’s danicopan shows long-term benefit in PNH Phil.

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Trade & Channel Strategies 2023: An Interview with Paul Chen of Lexicon Pharmaceuticals

Pharmaceutical Commerce

Lexicon Pharmaceuticals exec discusses upcoming Enable Holistic Hub and Provider Services panel.

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BMS Inks Potential $8.4B Deal for SystImmune’s ADC for Lung, Breast Cancer

BioSpace

Bristol Myers Squibb has bought the rights to develop and commercialize SystImmune’s potentially first-in-class, bi-specific antibody-drug conjugate for lung and breast cancer as well as other solid tumors.

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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.