Sat.Sep 23, 2023 - Fri.Sep 29, 2023

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Generative AI-focused biotech startup Evozyne raises $81m

Pharmaceutical Technology

The company’s algorithms put proteins through millions of years of simulated evolution to identify potential functional candidates.

Protein 317
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FDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show

Bio Pharma Dive

Agency scientists flagged numerous issues with Brainstorm’s stem cell treatment ahead of a high-profile Wednesday meeting of expert FDA advisers.

Scientist 310
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Grand Rounds September 22, 2023: Integrating Community Health Workers into Team-Based, Early Childhood Preventative Care (Tumaini Rucker Coker, MD, MBA)

Rethinking Clinical Trials

    Speaker Tumaini Rucker Coker, MD, MBA Professor of Pediatrics Division Head for General Pediatrics University of Washington Department of Pediatrics Seattle Children’s Hospital Slides Keywords Pediatrics, Preventive Medicine, Community Health, Well Child Care Key Points There are 10 preventive care visits from ages 0-3, usually scheduled as 15-20 minute visits with a pediatrician.

Trials 210
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NHS Confederation research supports investment in NHS services

Pharma Times

Report shows that if the health service invests in community services hospital admissions will reduce - News - PharmaTimes

Research 162
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Karuna Therapeutics files for FDA approval for schizophrenia treatment

Pharmaceutical Technology

Karuna Therapeutics has announced the submission of a NDA to the FDA for KarXT (xanomeline-trospium) for the treatment of schizophrenia.

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PTC to lay off more staff following drug setback in Europe

Bio Pharma Dive

The biotech is expanding cuts it announced a few months ago after the EMA decided against renewing a conditional clearance for its drug Translarna.

Drugs 308

More Trending

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Oxford Biodynamics launches prostate screening test

Pharma Times

EpiSwitch is designed for men with prostate cancer risk in the UK and is 94% accurate - News - PharmaTimes

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Generics expected to improve access for patients with idiopathic pulmonary fibrosis

Pharmaceutical Technology

The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments approved by the FDA in 2014.

Licensing 264
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Roche bets on Ionis RNA medicines with neuroscience deal

Bio Pharma Dive

The Swiss drugmaker is restocking its pipeline by buying into preclinical Ionis medicines for Alzheimer’s and Huntington’s diseases.

Medicine 303
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Ann Marie Hall, SR Clinical Trial Manager, Site Management, shares her story about why World Alzheimer’s month is so important to her.

Worldwide Clinical Trials

In September, as we observe World Alzheimer’s month and focus attention on how far we have come in raising awareness of the disease and research being done to find more effective treatments, I think back to when my grandmother was first diagnosed and how heart wrenching it was to watch her loose herself over the years. When my mother was diagnosed, it was not a surprise, as I had already been witnessing those early changes and knew what was coming.

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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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AstraZeneca and SAS link up on AI and analytics

Pharma Times

Collaboration will enable teams across the organisation to increase clinical research innovation - News - PharmaTimes

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New Alzheimer’s disease medication approved in Japan

Pharmaceutical Technology

Eisai and BioArctic’s Leqembi is the only approved treatment that slows cognitive and functional decline in adults with Alzheimer’s.

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ProQR sale of eye drugs comes undone over employment contracts

Bio Pharma Dive

Laboratoires Théa terminated its planned purchase of ProQR’s sepofarsen after certain ProQR personnel opted against working for the French company.

Sales 295
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Post-pandemic reality hits digital health hard

pharmaphorum

Post-pandemic reality hits digital health hard Mike.

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

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NICE nod for Darzalex with lenalidomide and dexamethasone

Pharma Times

Therapy has been developed to treat adult patients with newly diagnosed multiple myeloma - News - PharmaTimes

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AI is a pillar of tomorrow’s healthcare system, but limitations remain

Pharmaceutical Technology

At the industry crossroads of healthcare and pharmaceuticals at the Life Sciences Baltics 2023 conference, all signs pointed towards an AI-based future.

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BrainStorm’s ALS therapy not effective, FDA panel finds

Bio Pharma Dive

Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment was effective for treating ALS.

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Clinical trial phases: What’s the difference?

Antidote

Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed. Before any new treatment becomes available on the market, it must go through this process, as required by the FDA.

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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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NHS medicines access in jeopardy says ABPI

Pharma Times

Review raises concerns about approach taken by the DHSC regarding changes to Statutory Scheme - News - PharmaTimes

Medicine 159
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ModeX wins $168m BARDA contract to develop viral antibody therapies

Pharmaceutical Technology

BARDA in the US has awarded a $168m Project NextGen grant to ModeX Therapeutics to develop anti-viral therapies.

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Intercept, after biotech rollercoaster ride, agrees to buyout by Alfasigma

Bio Pharma Dive

Once valued at more than $7 billion, the liver drug company couldn’t secure a long-sought FDA approval in NASH and last month said it would abandon that research.

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Psycheceutical Q&A: Could topical ketamine transform PTSD treatment?

BioPharma Reporter

Psychedelics have re-emerged in the world of medicine as promising treatments for various mental health conditions, particularly post-traumatic stress disorder (PTSD).

Medicine 126
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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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Women in Life Science Denmark launches leadership drive

Pharma Times

Initiative has been designed to support career advancement for women across the life sciences - News - PharmaTimes

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Pharmaceutical Technology Excellence Awards 2023: Apprentice.io

Pharmaceutical Technology

Apprentice provides cloud-based software solutions and is a Category Award Winner in the 2023 Pharmaceutical Technology Excellence Awards

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Structure boosted by early data for experimental obesity drug

Bio Pharma Dive

Shares in the biotech surged on Phase 1 trial results for an oral GLP-1 drug Structure is developing, reflecting investor enthusiasm for the weight loss medicines.

Drugs 286
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Four Neurodegenerative Trials to Watch in Q4

BioSpace

Pivotal clinical trials in Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis and multiple sclerosis are expected to read out this fall. Here's a closer look.

Trials 122
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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UKHSA reaches vaccine deal with CSL Seqirus

Pharma Times

Agreement will provide timely boost to pandemic preparedness against influenza - News - PharmaTimes

Vaccine 159
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Pfizer gains FDA approval for rare childhood leukaemia drug

Pharmaceutical Technology

Bosutinib has been approved for adult use for 10 years, but the FDA has given the green light for use in children.

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Former Novartis executive Tsai to lead UK heart drug startup

Bio Pharma Dive

John Tsai, previously Novartis’ chief medical officer, has been named CEO of Forcefield Therapeutics, an 18-month-old biotech working on a treatment for heart attacks.

Drugs 286
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How AI is propelling pharma into the modern age

pharmaphorum

How AI is propelling pharma into the modern age Mike.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time