Sat.Sep 09, 2023 - Fri.Sep 15, 2023

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FDA approves updated COVID boosters from Pfizer, Moderna

Bio Pharma Dive

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.

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Signal: Kroger to pay up to $1.4bn to settle opioid crisis lawsuits

Pharmaceutical Technology

Kroger's settlement, alongside the review of the Purdue Pharma bankruptcy case, is proof that the opioid reckoning isn't over yet.

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Eisai launches new digital business company for dementia

Pharma Times

Theoria technologies aims to empower those affected by dementia - News - PharmaTimes

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Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Fierce Pharma

Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

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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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Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

Bio Pharma Dive

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

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FDA approves Pfizer-BioNTech’s Omicron XBB.1.5-adapted Covid-19 vaccine

Pharmaceutical Technology

The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

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FTC fires shot across pharma's bows over 'improper' patents

pharmaphorum

FTC fires shot across pharma's bows over 'improper' patents Phil.

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Flagship-backed Generate raises $273M as its first drugs move to the clinic

Bio Pharma Dive

Since 2019, Generate has raised nearly $700 million in private financing and has now brought a monoclonal antibody into Phase 1 testing.

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SparingVision shares trial updates for rare eye disease gene therapies

Pharmaceutical Technology

The company is also planning to expand its Phase I/II PRODYGY lead candidate trial in retinitis pigmentosa to three more US sites.

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Orano Med and Orbit Discovery collaborate on radioligand therapies for cancer

Pharma Times

Both companies will work to advance the development of novel radiopharmaceuticals - News - PharmaTimes

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

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Oregon Project Extends Benefits of Clinical Trials to More Hispanics/Latinos

ACRP blog

With observations of National Hispanic Heritage Month kicking off on September 15, this year’s events will have special resonance for a team of Oregon Health & Science University (OHSU) researchers who are working to bring the benefits of clinical trials to more persons in underserved communities. Eneida R. Nemecek, MD, MS, MBA, an endowed professor of pediatrics and medical oncology and Medical Director of Clinical Research at the Knight Cancer Institute of OHSU, recently received a $625,00

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New startup Arialys takes aim at the immune system, hoping to create neuropsychiatry drugs

Bio Pharma Dive

Arialys Therapeutics launched Tuesday with $58 million in funding from a group of life sciences investors that includes Johnson & Johnson’s venture arm.

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FDA to start review of subcutaneous Entyvio for Crohn’s disease

Pharmaceutical Technology

The FDA is also reviewing a subcutaneous formulation of Takeda’s blockbuster drug for ulcerative colitis.

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Defibrillators should be given to high-risk heart failure patients sooner

Pharma Times

Around 2.

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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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CDC starts ‘Wild to Mild’ campaign to reverse falling flu vaccine use in key groups

Fierce Pharma

The CDC wants to reset expectations for flu vaccines to correct falling uptake. | The CDC wants to reset expectations for flu vaccines to correct falling uptake. After tracking declines in vaccine use in pregnant people and children, the health body has initiated its “Wild to Mild” campaign to raise awareness of the benefits of vaccination and encourage more people to get their shots.

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UK biotech AlveoGene launches with plans for inhaled gene therapy

Bio Pharma Dive

The company is working on a treatment of alpha-1 antitrypsin deficiency, which it claims it can deliver direct to lung cells via a nebulizer.

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CancerVAX joins forces with UCLA to develop a universal CAR-T cell therapy

Pharmaceutical Technology

CancerVAX plans to adapt its universal cancer vaccine platform to develop a universal CAR-T cell platform.

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MIT’s new technique to remotely evaluate cerebral palsy patients

Pharma Times

The method could also be beneficial for Parkinson’s disease and strokes - News - PharmaTimes

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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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Scientists find elusive cause of cell death in Alzheimer's

pharmaphorum

Scientists find elusive cause of cell death in Alzheimer's Phil.

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Moderna aims for the stars again with ambitious drug development plan

Bio Pharma Dive

The biotech is telling investors it expects to launch as many as 15 new products in five years, a bold goal that will require a lot to go right to pull off.

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Calibrating cold chain systems for cell and gene therapies in a post-pandemic world

Pharmaceutical Technology

Pharmaceutical supply chain partners are trying to create an efficient cold chain system to transport cell and gene therapies.

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UKRI report reveals impact of COVID-19 research and innovation funding

Pharma Times

The report highlights steps needed to ensure future pandemics are handled effectively - News - PharmaTimes

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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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AstraZeneca, working to grow Fasenra’s reach, touts positive trial against GSK's Nucala in new use

Fierce Pharma

Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala. | AstraZeneca's Fasenra has achieved its primary endpoint in a phase 3 trial, demonstrating noninferior rates of remission in a head-to-head battle against GSK's Nucala in patients with eosinophilic granulomatosis with polyangiitis.

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2Seventy CEO Leschly to step down as company cuts staff, spending

Bio Pharma Dive

Citing “near-term headwinds,” the cancer cell therapy developer will lay off 176 employees and pare back some of its research spending.

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Cure Genetics and Frametact seek gene cures for neurological ailments

Pharmaceutical Technology

Cure Genetics has entered a partnership and licensing deal with Frametact to develop gene therapy for familial neurological ailments.

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Salipro Biotech and Sumitomo Pharma collaborate for drug discovery

Pharma Times

The research will aim to reveal the mechanism of action of a drug target candidate - News - PharmaTimes

Drugs 137
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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It's unanimous: FDA panel says decongestant drug phenylephrine does not work

Fierce Pharma

For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.

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Actio, a precision medicine startup, launches with $55M and a mouse lab partnership

Bio Pharma Dive

The two-year-old San Diego biotech is allied with The Jackson Laboratory to engineer better mouse models of the rare diseases it plans to target.

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Eli Lilly’s Mounjaro approved on NHS for use in type 2 diabetes

Pharmaceutical Technology

Eli Lilly has had its therapy Mounjaro (tirzepatide) approved for patients in England with type 2 diabetes (T2D).

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UK government invests £200m to boost NHS resilience this winter

Pharma Times

The funding will reduce waiting lists and ease the demand on the NHS during Winter - News - PharmaTimes

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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.