Fri.Mar 14, 2025

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FDA sets flu shot recommendations without input of outside advisers

Bio Pharma Dive

The agency formulated its advice to manufacturers after coordinating with the CDC and Defense Department. An advisory meeting that's typically held was canceled last month.

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MeiraGTx and Hologen launch AI-backed gene therapy venture

Pharmaceutical Technology

The venture aims to advance MeiraGTxs Parkinsons gene therapy through Phase III trials with up to $430m in funding from Hologen.

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CagriSema, Novo Nordisk’s Latest Obesity Drug Offering, Disappoints Investors with Trial Results

XTalks

Novo Nordisks investigational obesity combination drug, CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg), underperformed in its latest clinical trial, leading to a dip in the companys share price. In response to the trial outcomes, Novos shares declined by approximately 8% this week. Novo shared the latest data from the Phase III REDEFINE 2 trial evaluating the drug in overweight or obese patients with type 2 diabetes.

Trials 52
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Unsafe and unregulated cell therapies being sold in Europe

Pharmaceutical Technology

The EMA warns of products being sold as dendritic cell therapies with little evidence, but high health risks, in the European Union.

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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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Parents feel they are lacking information about bird flu, poll finds

Medical Xpress

Only 43% of parents report they are able to find accurate and current information on avian influenza A(H5N1), commonly known as bird flu, according to the University of Michigan Health C.S. Mott Children's Hospital National Poll on Children's Health.

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Boehringer Ingelheim and Salipro enter drug discovery partnership

Pharmaceutical Technology

Boehringer Ingelheim and Sweden-based Salipro Biotech have entered a research and licence agreement for drug targets' development.

Drugs 147

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AstraZeneca director says AI must be a “thought partner” in drug discovery

Pharmaceutical Technology

AstraZenecas senior director in oncology data science outlined how the company uses AI for drug discovery at a recent talk.

Drugs 147
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New members of the CDKL family of genes linked to neurodevelopmental disorders

Medical Xpress

CDKL5, one of the five members of the CDKL family of genes, is important for proper neurodevelopment and associated with seizures. However, the role the other four members of this family play in health and disease is unknown.

Gene 104
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EC approves Otsuka and Lundbeck’s Rxulti for schizophrenia

Pharmaceutical Technology

The EC has approved Otsuka Pharmaceutical and Lundbecks atypical oral antipsychotic, Rxulti (brexpiprazole), for treating schizophrenia.

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Photoacoustic imaging reveals new insights into how the brain learns new information

Medical Xpress

Wayne State University researchers are using photoacoustic imaging to observe brain activity and, in the process, discovering more about how it responds to different types of learning and experiences.

Research 104
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Insilico raises $110m to develop drug pipeline and AI platform

Pharmaceutical Technology

Insilico Medicine has completed a Series E round, raising $110m to progress the development of its pipeline of drugs and AI platform.

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Not knowing what to expect can make pain feel worse

Medical Xpress

When we accidentally touch something familiar, like a warm pan, our brains already know what feeling to expect and how much it might hurt. But if you were blindfolded and had no idea you were touching a warm pan, you'd feel more intense paineven if the pan wasn't warm enough to harm you. A new study from the Department of Clinical Medicine at Aarhus University shows that not knowing what to expect changes how the brain interprets pain, making it hurt worse even when there's no real danger.

Medicine 103
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FDA chooses flu vaccine strains despite cancelled meeting

pharmaphorum

The FDA has released its recommendations on the composition of influenza vaccines for the 2025-26 season, without the input of its external advisors

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How much sleep do you really need? Experts say it depends

Medical Xpress

Chances are, if you're reading this, you got some sleep last night. But are you feeling rested?

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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 England 'had lost control of health service', says BMA

pharmaphorum

As the news that NHS England is to be dismantled sinks in, the British Medical Association (BMA) and other bodies have weighed in on the decision

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COVID-19 vaccination not linked to major structural birth defects

Medical Xpress

COVID-19 vaccination in early pregnancy (20 weeks of gestation) is not associated with increased prevalence of major structural birth defects, according to a study published online March 14 in Pediatrics.

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Pharma furious as UK Statutory Scheme rebate rate soars

pharmaphorum

The UK pharma sector has reacted with consternation to the government's proposal to raise the Statutory Scheme rate to 32.

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Study: Roflumilast cream 0.05% is safe, effective in young children with eczema

Medical Xpress

Once-daily roflumilast cream 0.05% is safe and effective for atopic dermatitis (AD) in patients ages 2 to 5years, according to a study published online Feb. 20 in Pediatric Dermatology.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Sutro puts lead ADC on hold, cuts staff and changes CEO

pharmaphorum

Sutro has shelved its lead drug for ovarian cancer and turned its attention to three preclinical candidates in a major shake-up of its business.

Drugs 59
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Decreased levels of TDP-43 gene may be contributing to neurodegenerative diseases like Alzheimer's and ALS

Medical Xpress

In Nature Neuroscience, UConn School of Medicine researchers have revealed a new scientific clue that could unlock the key cellular pathway leading to devastating neurodegenerative diseases like Alzheimer's disease, and the progressive damage to the brain's frontal and temporal lobes in frontotemporal degeneration (FTD) and the associated disease amyotrophic lateral sclerosis (ALS).

Gene 89
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Pharma Pulse 3/14/25: Pre-Launch Prep for Emerging Biopharmas, Using the Power of Three to Simplify the Business of Healthcare & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Immunotherapy may boost KRAS-targeted therapy in pancreatic cancer

Medical Xpress

Adding immunotherapy to a new type of inhibitor that targets multiple forms of the cancer-causing gene mutation KRAS kept pancreatic cancer at bay in preclinical models for significantly longer than the same targeted therapy by itself, according to researchers from the Perelman School of Medicine at the University of Pennsylvania and Penn Medicine's Abramson Cancer Center.

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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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Breaking Down Regulatory Challenges in Cell Therapy Production

Pharmaceutical Commerce

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jason C. Foster, CEO of Ori Biotech, discusses how regulatory hurdles are impacting the advancement of CGTs, along with the changes he would like to see along that front in order to accelerate patient access.

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Research highlights concerning rates of injecting-related injuries for drug users

Medical Xpress

New research from the University of Otago, Christchurchtakau Whakaihu Waka, tautahi, has exposed the large number of health-related injuries suffered by people who inject drugs in Aotearoa New Zealand, exacerbated by the significant barriers many face in accessing health care.

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Cold Chain Technologies Inks Deal for Global Cold Chain Solutions

Pharmaceutical Commerce

The thermal packaging company not only bolsters its APAC presenceit also grows its presence in the life sciences temperature-monitoring logistics sector.

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The fight against TB was frozen in time, until now. See its future.

Medical Xpress

Consumption, phthisis, the white plaguea killer by any other name, tuberculosis (TB) has stalked humanity since at least the ice age. Today, the diseasepassed from those who are actively sick to others through airborne dropletsis the leading infectious disease killer globally.

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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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5th Medical Device Software Development Summit

pharmaphorum

5th Medical Device Software Development Summit Sara.

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Study reveals emotional prediction deficits in individuals with high social anhedonia

Medical Xpress

A research team led by Dr. Raymond Chan from the Institute of Psychology of the Chinese Academy of Sciences, together with collaborators, has uncovered key differences in how individuals with high social anhedoniaa reduced ability to experience pleasure in social interactionspredict and experience emotions in real-life situations.

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NHS England 'has lost control of health service', says BMA

pharmaphorum

As the news that NHS England is to be dismantled sinks in, the British Medical Association (BMA) and other bodies have weighed in on the decision

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Maintenance of low eczema activity seen after about 80 days off tapinarof

Medical Xpress

Patients with atopic dermatitis (AD) who achieve completely clear skin with tapinarof (Vtama) cream maintain low disease activity after about 80 days off treatment, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 7 to 11 in Orlando, Florida.

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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.