Fri.Oct 06, 2023

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NIH funds research for three experimental ALS drugs

Bio Pharma Dive

The funding, which is part of ACT for ALS, will support expanded access studies of drugs developed by Prilenia Therapeutics, Clene Nanomedicine and Rapa Therapeutics.

Drugs 321
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Ocular launches ocular implant trial to combat macular degeneration

Pharmaceutical Technology

Ocular Therapeutix has confirmed the launch of a trial of an intravitreal eye implant intended to combat macular degeneration.

Trials 246
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FDA panel finds KRAS drug data unreliable, in blow to Amgen

Bio Pharma Dive

The negative panel vote likely means Amgen will need more data to support a full approval for its conditionally cleared lung cancer drug Lumakras.

Drugs 162
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AstraZeneca reveals new research to improve drug discovery

Pharma Times

The study used data from 50,000 people in the UK Biobank - News - PharmaTimes

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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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Amgen completes $28B Horizon buyout that was challenged by FTC

Bio Pharma Dive

Regulators’ holdup of the deal had stoked investor fears of greater scrutiny on M&A. In the end, Amgen agreed to requirements meant to guard against product “bundling.

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Biologics emerge as dominating molecule type in solid tumour indication

Pharmaceutical Technology

Biologics are poised to overtake innovative small molecules in terms of sales revenue by 2027, with forecast sales of $120bn.

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'Extremely concerning' chemo shortage persists despite FDA's efforts, national cancer group reports

Fierce Pharma

While the White House recently touted the FDA’s efforts to mitigate the ongoin | The National Comprehensive Cancer Network found that 72% of centers are still experiencing a carboplatin shortage, while 59% remain low on cisplatin. The survey follows a June report which found that nearly all centers had short supply of the chemotherapies.

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EASD 2023: Effectiveness of GLP-1 Agonists vs. DPP-4Is in Patients with T2D and CKD

Pharmaceutical Technology

Tuttle and colleagues recognized that patients with T2D and CKD are limited in their therapeutic use because their low eGFR.

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After short FTC fight, Amgen wraps up $27.8B Horizon buyout

Fierce Pharma

Amgen has completed its $27.8 billion acquisition of Horizon Therapeutics after fending off a legal challenge by the U.S. antitrust watchdog. | Amgen has completed its $27.8 billion acquisition of Horizon Therapeutics after fending off a legal challenge by the U.S. antitrust watchdog.

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TREAT California embarks on plan to earn $5bn for psychedelic research

Pharmaceutical Technology

TREAT California started collecting signatures for a 5 November ballot measure that aims to raise money for psychedelic therapy research.

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

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Novo Nordisk's weight-loss drugs pose small risk of severe stomach complications: study

Fierce Pharma

People who use Novo Nordisk’s popular weight-loss drugs are taking on a small risk of developing severe stomach problems, according to research conducted by the University of British Columbia and < | People who use Novo Nordisk’s popular weight-loss drugs are taking on a small risk of developing severe stomach problems, according to research conducted by the University of British Columbia.

Drugs 122
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Signal: Serum Institute of India plans to increase global reach

Pharmaceutical Technology

Serum is already India's most valuable unlisted company, and it is looking to expand its offering into wealthier nations.

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UK launches total-body PET drive to support drug discovery

pharmaphorum

UK launches total-body PET drive to support drug discovery Phil.

Drugs 118
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Thermo Fisher expands US manufacturing plant to support biologics

Pharmaceutical Technology

The expansion at the St. Louis (Missouri) would include up to four bioreactors to accommodate the production of biologic therapies.

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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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Korean CDMO Lotte Biologics buys land, sets out to build 3 new plants by 2030

Fierce Pharma

Aiming to hit a corporate value of around $15 billion by the end of the decade, Korean CDMO Lotte Biologics has laid out plans to stand up three new manufacturing facilities in the same time frame. | Lotte this week unveiled a land purchase agreement with the Incheon Free Economic Zone Authority in Incheon, Korea. With the new real estate, Lotte plans to build out three separate bio plants by 2030.

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FDA panel says Amgen’s Phase III lung cancer KRAS drug data is unreliable

Pharmaceutical Technology

The panel identified several issues with the trial including study organisation and loss of follow-up data from patients who withdrew consent.

Trials 130
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What AI really means for biology and the pharmaceutical industry

pharmaphorum

What AI really means for biology and the pharmaceutical industry Mike.

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Emergex and VIC to develop infectious disease therapies in the Gulf

Pharmaceutical Technology

Emergex and Saudi Vaccine Industrial Company (VIC) will develop T cell-priming immune set-point candidates against infectious diseases.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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CAR-TCR 2023 – Josh Ludwig

pharmaphorum

CAR-TCR 2023 – Josh Ludwig Mike.

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Agomab’s FSCD therapy gains fast track designation from US FDA

Pharmaceutical Technology

Agomab Therapeutics FSCD therapy has received the US Food and Drug Administration (FDA)'s fast track designation

Drugs 130
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Empowering health through innovation: Smartwatches as diagnostic aids

pharmaphorum

Empowering health through innovation: Smartwatches as diagnostic aids Mike.

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GSK to divest 2.9% stake in consumer healthcare company Haleon

Pharmaceutical Technology

GSK has announced plans to divest its 2.9% stake in consumer healthcare company Haleon for £885.6m ($1.07bn).

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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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Orchard will help Kyowa Kirin grow in gene therapy

pharmaphorum

Orchard will help Kyowa Kirin grow in gene therapy Phil.

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AbbVie to bolster neuroscience pipeline with Mitokinin acquisition

Pharmaceutical Technology

AbbVie has acquired discovery-stage biotechnology company Mitokinin in a deal totalling $655m, to bolster its neuroscience pipeline.

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FDA panel sceptical on Lumakras confirmatory data

pharmaphorum

FDA panel sceptical on Lumakras confirmatory data Phil.

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Twist Bioscience and Bayer partner for antibody discovery

Pharmaceutical Technology

Genomics company Twist Bioscience has entered into an antibody discovery, option and licence agreement with German drug manufacturer Bayer.

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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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LogiPharma USA 2023: Impactful Roundtable Discussions

Pharmaceutical Commerce

Conference hosts roundtable chats, with topics ranging from data-driven decision making to cold chain logistics.

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Boehringer moves obesity therapy into phase 3

pharmaphorum

Boehringer moves obesity therapy into phase 3 Phil.

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LogiPharma USA 2023: Tracy Nasarenko Discusses the GS1 US Addendum Guidance and XML Examples for GS1 US DSCSA Implementation Guideline R1.3

Pharmaceutical Commerce

Sr. Director of Community Engagement for Pharmaceuticals at GS1 US explains what the implementation guidelines are meant to accomplish.

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Brainspo: Bring Your Brain, Perspective and Curiosity

Intouch Solutions

Working at EVERSANA INTOUCH means being surrounded by forward-thinking, highly innovative and creative individuals who strive to think differently. Recently, a group of EVERSANA INTOUCHers began a new internal series called “Brainspo.” The idea for Brainspo began as an internal pilot within the EVERSANA INTOUCH Oxygen affiliate and came out of wanting to get people out of their day-to-day and spend 15 minutes of thought-provoking conversation together, once a week, to open minds and ultimately g

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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.