Fri.Oct 27, 2023

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Bristol Myers’ neuroscience research head explains the big pharma’s return to brain drugs

Bio Pharma Dive

In a wide-ranging interview, Bristol Myers’ Ken Rhodes talked biomarkers, diseases of interest and why the company is far from done with neuroscience-focused deals.

Research 316
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UK NICE recommends use of AbbVie’s Parkinson’s treatment 

Pharmaceutical Technology

The UK NICE has recommended the use of AbbVie’s foslevodopa–foscarbidopa (Produodopa) for the treatment of advanced Parkinson’s disease.

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Sanofi to divest consumer unit, joining pharma industry shift

Bio Pharma Dive

The restructuring came as the French company forecast an earnings drop in 2024, prompting a stock selloff that erased about $20 billion in market value.

Marketing 305
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(CST-2032 + nadolol) by CuraSen Therapeutics for Dementia: Likelihood of Approval

Pharmaceutical Technology

(CST-2032 + nadolol) is under clinical development by CuraSen Therapeutics and currently in Phase II for Dementia.

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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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FDA staff focus on ‘off-target’ risk in review of Vertex, CRISPR sickle cell therapy

Bio Pharma Dive

Documents released ahead of a Tuesday advisory meeting show agency scientists to be generally convinced by the treatment’s benefit, a sign analysts read as positive.

Scientist 211
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(CST-2032 + nadolol) by CuraSen Therapeutics for Dementia: Likelihood of Approval

Pharmaceutical Technology

(CST-2032 + nadolol) is under clinical development by CuraSen Therapeutics and currently in Phase II for Dementia.

More Trending

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FDA grants approval for Roche’s retinal vein occlusion therapy

Pharmaceutical Technology

The US FDA has granted approval for Roche’s Vabysmo (faricimab) to treat macular oedema following retinal vein occlusion.

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Regulators develop five principles for machine learning-enabled medical devices  

Pharma Times

The new principles will remove the regulatory burden for MLMD manufacturers - News - PharmaTimes

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PY-314 by Ikena Oncology for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval

Pharmaceutical Technology

PY-314 is under clinical development by Ikena Oncology and currently in Phase I for Triple-Negative Breast Cancer (TNBC).

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Sanofi CEO Hudson's new 'Play to Win' pivot sends stock plunging

Fierce Pharma

Sanofi acolytes are none too happy with the latest chapter of CEO Paul Hudson’s "Play to Win" strategy. | Sanofi acolytes are none too happy with the latest chapter of CEO Paul Hudson’s "Play to Win" strategy. After unveiling the pivot alongside third-quarter earnings Friday, Sanofi’s stock plunged nearly 20%, with one analyst group suggesting the plan came “at the wrong time.

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

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Eftozanermin alfa by AbbVie for Refractory Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

Eftozanermin alfa is under clinical development by AbbVie and currently in Phase I for Refractory Multiple Myeloma.

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CAR-TCR 2023 – Matt Lakelin

pharmaphorum

At CAR-TCR in Boston last month, pharmaphorum’s Jonah Comstock caught up with Matt Lakelin, co-founder of TrakCel, a software company that helps makers of advanced therapies manage their supply chain.

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Ibrutinib by AbbVie for Mantle Cell Lymphoma: Likelihood of Approval

Pharmaceutical Technology

Ibrutinib is under clinical development by AbbVie and currently in Phase III for Mantle Cell Lymphoma.

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Eli Lilly enters crowded ulcerative colitis market with delayed FDA approval for Omvoh

Fierce Pharma

Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too. | Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too.

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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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Georgiamune and Verily partner for cancer treatment

Pharmaceutical Technology

Verily's molecular and real-world evidence offerings will be leveraged to develop Georgiamune's drug candidates

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On a journey to diverse, inclusive, and more efficient rare disease trials

pharmaphorum

On a journey to diverse, inclusive, and more efficient rare disease trials Mike.

Trials 117
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China approves ViiV Healthcare’s Vocabria use with Rekambys for HIV-1

Pharmaceutical Technology

China’s NMPA has approved Vocabria used along with the Rekambys to treat human immunodeficiency virus type-1 (HIV-1) infection.

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Sanofi will exit consumer health and boost R&D investment

pharmaphorum

Sanofi will exit consumer health and boost R&D investment Phil.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA accepts BLA resubmission for ImmunityBio’s bladder cancer therapy

Pharmaceutical Technology

The FDA did not originally approve the therapy earlier this year; it will now go undergo a second review.

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Evolving with the patient: Optimising CAGT post-trial long-term follow-up

pharmaphorum

Evolving with the patient: Optimising CAGT post-trial long-term follow-up Mike.

Trials 115
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CpHI Europe: Taking the lessons of Covid-19 to the next frontier

Pharmaceutical Technology

Moderna's Senior Vice President of International Manufacturing discusses the impact of Covid-19 on mRNA applications and future trends in manufacturing.

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Lilly finally gets FDA OK for ulcerative colitis drug Omvoh

pharmaphorum

Lilly finally gets FDA OK for ulcerative colitis drug Omvoh Phil.

Drugs 111
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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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As Imbruvica loses steam, AbbVie takes $2.1B charge and points to CMS price negotiations

Fierce Pharma

Sales of AbbVie and Johnson & Johnson’s leukemia blockbuster Imbruvica are taking a hit from the introduction of BeiGene’s transformative oral treatment Brukinsa. | Sales of AbbVie and Johnson & Johnson’s leukemia blockbuster Imbruvica are taking a hit from BeiGene’s Brukinsa. But what about the impact of the Inflation Reduction Act? In August, Imbruvica was one of the 10 drugs identified by the CMS that will be subject to price negotiations in 2026.

Sales 111
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Early result backs Regeneron’s deafness gene therapy

pharmaphorum

Early result backs Regeneron’s deafness gene therapy Phil.

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Santhera, Catalyst score FDA nod for Duchenne drug. Can they gain more indications for Agamree?

Fierce Pharma

With the FDA approval of Agamree (vamorolone) to treat Duchenne | Thursday’s FDA approval of Santhera’s Agamree (vamorolone) to treat Duchenne muscular dystrophy (DMD) is just a start. The Swiss company is anxious to see how many disorders the first-in-class corticosteroid can treat.

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The Importance of Diversity, Equity, Inclusion, and Intersectionality in Clinical Research

WCG Clinical

Listen and Subscribe: Apple PodCASTs Spotify Google PoDCASTS About this episode: Listen to the latest episode of WCG Talks Trials to hear from experts on the importance of diversity, equity, and inclusion in clinical research and how intersectionality plays a role in promoting DE&I. We’ll discuss why diversity is pivotal for comprehending the full spectrum of clinical care mechanisms and review effective DE&I strategies being deployed today.

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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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Specialty injectables maker Exela issues recall after particles turn up in 3 different drugs

Fierce Pharma

Rogue particles turning up in drugs has caused a plethora of recalls in recent years, most recently affecting pharma giants Pfizer and GSK. | Exela is working with the FDA to recall three separate medications—injectable sodium bicarbonate, midazolam and the nutrition additive Elcys—after inspections of leftover samples flagged silicone matter in some vials.

Drugs 105
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FDA clears Roche’s Vabysmo for retinal vein occlusion

pharmaphorum

FDA clears Roche’s Vabysmo for retinal vein occlusion Phil.

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GSK's Jemperli prolongs life in endometrial cancer trial. Will FDA label expansion come next?

Fierce Pharma

After a quick FDA approval in a subgroup of endometrial cancer patients, GSK is trumpeting a win for its Jemperli that might help the PD-1 inhibitor expand to a broader population. | After a quick FDA approval in a subgroup of endometrial cancer patients, GSK is trumpeting a win for its Jemperli that might help the PD-1 inhibitor expand to a broader population.

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Aiolos $245m Series A heads latest crop of biotech rounds

pharmaphorum

Aiolos $245m Series A heads latest crop of biotech rounds Phil.

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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.