August, 2024

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Era of ADCs: Pharma companies innovate to stand out in a buzzing market

Pharmaceutical Technology

As antibody drug conjugate (ADC)-centred deals dominate the oncology space, biotechs are using newer targets and linkers to differentiate themselves.

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Cell and gene therapy investment, once booming, is now in a slump

Bio Pharma Dive

Far fewer venture funding rounds were closed by cell and gene therapy developers over the first six months of 2024 than in prior years. Experts say there are several factors.

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New study suggesting suicidal ideation risk for Novo's Ozempic adds to ongoing safety debate

Fierce Pharma

Regulators in both the U.S. and Europe have looked into the potential link between suicidal thoughts and Novo Nordisk’s blockbuster semaglutide franchise after reports sounded the alarm last year. | Researchers found that users of Novo's semaglutide who were logged in a WHO database were more likely to report suicidal ideation.

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Embracing innovation to drive clinical change in UK stroke care

pharmaphorum

Discover how the innovative geko device is driving clinical change in UK stroke care. Learn how this technology is revolutionising the treatment and management of stroke patients.

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

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New Brain Tumor Drug Voranigo (Vorasidenib) Targets Grade 2 IDH-Mutant Glioma

XTalks

The US Food and Drug Administration (FDA) has approved Voranigo (vorasidenib) for Grade 2 IDH-mutant glioma, a challenging brain tumor that has seen limited effective treatments for nearly 25 years. Developed by Servier Pharmaceuticals, Voranigo offers the first targeted therapy for patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma that harbor isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation.

Drugs 111
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Breaking barriers in science: Thermo Fisher's Melanie Adams-Cioaba on innovation and inclusion

BioPharma Reporter

In the rapidly evolving field of drug discovery, Melanie Adams-Cioaba stands at the forefront, leading transformative advancements in cryo-electron microscopy (cryo-EM) at Thermo Fisher Scientific.

Drugs 121

More Trending

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Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs

Bio Pharma Dive

Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.

Licensing 332
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BioNTech posts €808M loss as company continues to come to grips with seasonal COVID vaccine market

Fierce Pharma

While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market. | While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market.

Vaccine 140
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Ask NAVLIN: The AI chatbot innovation driving a better global customer experience

pharmaphorum

Demonstrating EVERSANA's dedication to innovation, a novel artificial intelligence technology is set to enhance the NAVLIN experience for both current and prospective customers.

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AMR testing technology from QuantaMatrix backed by research paper in Nature

Pharma Times

The new test takes an average of 13 hours to identify the correct treatment compared to several days with current methods

Research 133
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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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Terran Biosciences - the difficulties of getting new schizophrenia treatments to market

BioPharma Reporter

Experience with severe mental health disorders in close friends and family gave Sam Clark the drive to found Terran Biosciences to explore new approaches to therapeutics in neuropsychiatry.

Marketing 119
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NICE recommends BeiGene’s MZL tablet for NHS use

Pharmaceutical Technology

The UK NICE has recommended BeiGene’s Zanubrutinib for marginal zone lymphoma (MZL) for use on the National Health Service (NHS).

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In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD

Bio Pharma Dive

The decision to turn down an application from Lykos Therapeutics comes at a pivotal time for psychedelics research, which, after decades of dismissal, has recently gained momentum.

Research 322
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Novartis and Viatris sued by estate of Henrietta Lacks, whose cells were extracted for research in 1951

Fierce Pharma

The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from | The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from the discoveries they made using her genetic material.

Research 136
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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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Not if, but when: Pandemic preparedness is crucial

pharmaphorum

On Wednesday, 14th August, the World Health Organization (WHO) announced the mpox outbreak in Africa as a public health emergency of international concern (PHEIC). By Thursday, 15th August, the first case of the severe variant was reported in Sweden, marking its emergence outside of Africa.

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H1 Connect links doctors to global humanitarian missions

Outsourcing Pharma

H1's decision to partner with GRM for this critical initiative in Ukraine was driven by a strong commitment to harness the power of global healthcare networks to provide humanitarian aid in regions that need it most.

Doctor 111
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Bateman Horne Center leads the way in ME/CFS and long COVID education

BioPharma Reporter

The Bateman Horne Center of Excellence (BHC) has established itself as a trusted leader in the clinical care, provider education, patient advocacy, and research of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID.

Research 119
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AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting

Pharmaceutical Technology

The FDA approval of Imfinzi in this indication comes a month after the agency called for an overhaul of perioperative lung cancer trials.

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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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With pharma in ‘catbird seat,’ biotechs get less upfront in drug partnerships

Bio Pharma Dive

Recent data from J.P. Morgan indicates early-stage startups are getting smaller upfront payments in alliances than a few years ago, a trend industry insiders attribute to weaker leverage in deal talks.

Drugs 325
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Bavarian Nordic scores $157M contract to replenish US supplies of smallpox/mpox vaccine Jynneos

Fierce Pharma

Following the commercial launch of Bavarian Nordic’s smallpox/mpox vaccine Jynneos earlier this year, the Danish company has locked up yet another supply agreement with the U.S. government. | The Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic $156.8 million to “partly replenish” Jynneos vaccine stocks in response to the 2022 outbreak of mpox, the disease formerly known as monkeypox.

Vaccine 134
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mRNA technologies: Looking beyond COVID vaccines

pharmaphorum

Explore the innovative applications of mRNA technologies beyond COVID-19 vaccines. Learn about the potential and future developments in this groundbreaking field.

Vaccine 126
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Gilead’s Livdelzi (Seladelpar) for Primary Biliary Cholangitis Promises Pruritus Reduction

XTalks

The US Food and Drug Administration (FDA) has given the nod to Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC), a rare autoimmune disease that primarily affects women. PBC gradually destroys the bile ducts in the liver, leading to inflammation, scarring and, if untreated, potentially liver failure. For the 130,000 Americans living with this condition, many find existing treatments either ineffective or hard to tolerate.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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The future of drug discovery: Using AI to optimise the hit-to-lead process

Drug Discovery World

Mirit Eldor , Managing Director, Life Sciences Solutions, Elsevier, looks at how artificial intelligence (AI) can improve the hit-to-lead process for small molecules. Early drug discovery takes an average of three-to-six years and accounts for 42% of total costs 1 in the development of a new drug. It’s therefore no surprise that pharmaceutical companies are increasingly interested in using artificial intelligence (AI) to accelerate development and reduce costs.

Drugs 110
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How clinical trials can use AI responsibly and effectively

Pharmaceutical Technology

Strong measures must be in place to safeguard confidential patient data when deploying AI to optimise clinical trial translations.

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Biotech Red Queen launches with $55M to build versatile antivirals

Bio Pharma Dive

The funding from Apple Tree Partners will help the startup advance an antiviral drug pipeline that includes a COVID treatment nearing mid-stage testing.

Drugs 332
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FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumor

Fierce Pharma

Adaptimmune has won accelerated FDA approval | Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma which becomes the first engineered cell therapy for a solid tumor and the first new treatment in the indication in more than a decade.

Engineer 132
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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People need to know how to use AI now

pharmaphorum

With the implementation of advancing technologies in industry comes the parallel need for suitable upskilling of the workforce – but this doesn’t as yet always pan out, and in today’s pharmaphorum podcast COO of Enthought Mike Connell discusses the growing skills gap in R&D in life sciences and the 80/20 rule with web editor Nicole Raleigh, as well as the need for correct education of people and machines, both.

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GLP-1 Drugs Mounjaro, Zepbound, Wegovy Back in Stock After Extended Shortages

XTalks

After a nearly two-year-long shortage, the US Food and Drug Administration (FDA) announced earlier this month that Eli Lilly’s GLP-1 diabetes drug Mounjaro (tirzepatide) is back on shelves along with weight loss version Zepbound. A few days later, GLP-1 drug rival Novo Nordisk announced that four out of five dose strengths of its GLP-1 obesity drug Wegovy (0.5 mg, 1 mg, 1.7 mg and 2.4 mg) are now available in the US.

Drugs 111
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Study reveals AI insights can predict development of disease a decade in advance

Pharma Times

The study predicted the development of conditions including Alzheimer’s and heart disease

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Eli Lilly acquires Morphic in IBD portfolio expansion

Pharmaceutical Technology

Eli Lilly has concluded the acquisition of Morphic Holding at $57 per share, bolstering its inflammatory bowel disease portfolio.

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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.