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Japan's Ono pays $2.4B for Qinlock-maker Deciphera as biotech readies another approval run

Fierce Pharma

The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.

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AI in Precision Medicine: Transforming Obesity Treatment

Pharma IQ

Discover how artificial intelligence is revolutionizing the field of precision medicine. In this insightful article, Tim O’Connor, Chief Data Scientist at Phenomix Sciences, discusses the pivotal role.

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J.P. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer

MedCity News

Enlaza Therapeutics’ drugs form covalent bonds that lock the therapy onto its target. With cancer as its initial focus, the startup contends its approach could offer safety and efficacy advantages compared to currently available targeted therapies. The post J.P. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer appeared first on MedCity News.

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ESCMID 2024: Using AI in infection prevention and control

Pharmaceutical Technology

Artificial intelligence tools can be used for infection control through facial recognition systems designed to identify proper face mask use within hospitals.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Beyond discovery: AI and the future of the Web of Science

Clarivate

Learn about our generative AI-powered Web of Science Research Assistant, which will be available from September 2024. Last year, we announced our collaboration with the research community to bring a new generative-AI-powered capability to the Web of Science — the Web of Science Research Assistant. Since we released the beta to our development partners around the world, we have identified innovative ways to ensure the quality, strength and suitability of generative AI for academic researchers.

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Pfizer sets up DTC marketing platform as Q1 sales beat expectations

Fierce Pharma

Following the lead of Eli Lilly, Pfizer will establish a direct-to-consumer service, selling some of its medicines online and avoiding industry middlemen. | Following the lead of Eli Lilly, Pfizer will establish a direct-to-consumer service, selling some of its medicines online and avoiding industry middlemen. The company plans to sell products such as its COVID treatment Paxlovid and a migraine nasal spray in this way, it told the Financial Times.

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Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines

MedCity News

Regeneron Pharmaceuticals is collaborating with CRISPR technologies startup Mammoth Biosciences to develop in vivo gene-editing therapies. The deal marks the third pharmaceutical industry partnership for Mammoth, which initially focused on developing CRISPR-based diagnostics. The post Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines appeared first on MedCity News.

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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AbbVie breaks ground on new R&D centre

European Pharmaceutical Review

A new state-of-the-art research and laboratory building is being built on AbbVie’s main campus at its Rhineland-Palatinate site, the company ’s second largest research and development ( R&D ) location globally. The central research building LUdwighafens neue Arbeitswelt (LUnA) will benefit from an investment of approximately €150 million. Currently, the Rhineland-Palatinate site has over 2,000 employees, and LUnA will house over 300 researchers and scientists, according to AbbVie.

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GSK's Arexvy maintains its RSV market dominance, looks to key label expansion as Moderna's mRNA threat looms

Fierce Pharma

Even with the threat of a potential new competitor in the respiratory syncytial virus (RSV) vaccine race on the horizon, GSK and its leading Arexvy shot aren’t sweating. | The company's respiratory syncytial virus vaccine Arexvy takes some two-thirds of the RSV market share, GSK reported. Next up is a key FDA decision on the vaccine's use in the 50-to-59 age group, which would add another 50 million U.S. adults to its reach.

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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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The Relationship Between Cold Chain Logistics and Cell & Gene Therapies

Pharmaceutical Commerce

A one-on-one with Thermo Fisher’s Wilfredo Marin, who dives into the value of ultra-low temperature storage, the need for flexibility in the cold chain logistics space, and more.

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Experts Aren’t Surprised About Optum Closing Its Virtual Care Business

MedCity News

Optum is shutting down its virtual care unit after a three-year run. Industry experts agree that the closure reflects broader trends in the telehealth market, in which saturation and differentiation challenges are leading some providers to struggle. The post Experts Aren’t Surprised About Optum Closing Its Virtual Care Business appeared first on MedCity News.

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ESCMID 2024: The infectious consequences of climate change

Pharmaceutical Technology

Dengue fever is now found in over 120 countries compared to nine that experienced severe epidemics in the 1970s given the spread of infectious diseases due to climate change.

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California to sell state-branded Narcan generic to cut costs

pharmaphorum

California will start selling its own generic of overdose reversal agent naloxone in another example of the use of government-level purchasing power to reduce drug prices

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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FDA calls for adcomm to discuss Novo Nordisk's filing for weekly insulin

Fierce Pharma

For Novo Nordisk to gain approval in the United States for its groundbreaking Awiqli (insulin icodec), it will have to first pass muster with a panel of experts next month,

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Enhancing medicine manufacturing through digitalisation

European Pharmaceutical Review

By providing pharma companies with a real-life replicable model of a cloud-first manufacturing facility, we will drive forward the digital capability of pharma manufacturers” A new digital collaboration is set to take advantage of a manufacturing facility model featuring innovative technologies, accelerating how fast new medicines are made. The Centre for Process Innovation (CPI), academia, and the pharma industry will work together to develop the model which will harness artificial intell

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How Will Walgreens’ Expansion into Specialty Pharmacy Affect the Industry?

MedCity News

Walgreens announced that it is expanding its specialty pharmacy offerings. Experts think that this move could yield several strategic benefits, given the higher profit margins associated with specialty medications compared to traditional drugs. They also think Walgreens’ move could lead to greater competition, consolidation and innovation within the broader pharmacy industry.

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Pfizer receives FDA approval for haemophilia B gene therapy

Pharmaceutical Technology

Pfizer has received approval from the US Food and Drug Administration (FDA) for its one-time gene therapy BEQVEZ for haemophilia B.

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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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X4 Pharma gets first FDA okay for WHIM syndrome drug

pharmaphorum

Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light by the FDA. Oral CXCR4 antagonist Xolremdi (mavorixafor) can be used in patients aged 12 and over with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a congenital immunodeficiency characterised by low neutrophil counts that affects fewer than 1,000 people in the US.

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Lilly cranks up outlook, banking on GLP-1 production expansions despite continuing supply squeeze

Fierce Pharma

While an ongoing production expansion push for Eli Lilly's popular tirezeptide-based medicines Mounjaro and Zepbound should help out with perpetual supply strains later this year, the expected | While Eli Lilly's supply for Mounjaro and Zepbound is scheduled to increase during the second half of the year, demand is still expected to outpace supply through 2024 and possibly into 2025, executives said.

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European Pharmaceutical Review Issue 2 2024

European Pharmaceutical Review

Articles included in Issue 2 of European Pharmaceutical Review – our cell and gene therapy focus – include: CELL & GENE THERAPY Proper planning prevents CMC disasters for cell and gene therapies Drew Hope, Ryan Guest and Clare Blue eXmoor Pharma SUPPLY CHAIN Fresh or frozen? Navigating the cryopreservation dilemma for CGT Priya Baraniak OrganaBio GUIDE TO TESTING LoD requirements of qualitative microbiological methods for short shelf-life products Edwin van den Heuvel Eindhoven U

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Ono Pharma’s Plan to Become a Global Player Picks Up a New Piece With $2.4B Deciphera Acquisition

MedCity News

Ono Pharmaceutical’s acquisition of Deciphera Pharmaceuticals adds to a cancer drug pipeline that already spans multiple modalities. Deciphera develops drugs that target the on-off switch of enzymes that drive cancer cell growth. The post Ono Pharma’s Plan to Become a Global Player Picks Up a New Piece With $2.4B Deciphera Acquisition appeared first on MedCity News.

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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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Cell and gene therapy companies trip at scalability hurdle

Pharmaceutical Technology

Experts hold scalability challenges and high costs accountable for market failures within the cell and gene therapy landscape.

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Owlstone secures $6.5M for breath-based diagnostics for infectious disease

pharmaphorum

Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development of breath-based diagnostic solutions to improve outcomes in the developing world.

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Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

Fierce Pharma

After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. | After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on the antibody-drug conjugate Trodelvy. With a busy year ahead across therapeutic areas, CEO Dan O'Day emphasized a "time of focused execution.

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CHMP meeting highlights: April 2024

European Pharmaceutical Review

The Committee for Human Medicinal Products (CHMP) has recommended the approval of new eight medicines. A positive opinion of a marketing authorisation was granted for Altuvoct (efanesoctocog alfa), as a treatment and prophylaxis of bleeding in patients with the rare blood disorder haemophilia A. Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Johns Hopkins Is Teaming Up With Healthy.io to Improve Diabetic Patients’ Wound Care

MedCity News

Johns Hopkins Hospital teamed up with Healthy.io, a company that offers smartphone-based technology to improve wound care management for diabetic patients. The partners are conducting a 120-person study to measure the impact of the startup’s technology. The post Johns Hopkins Is Teaming Up With Healthy.io to Improve Diabetic Patients’ Wound Care appeared first on MedCity News.

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Cambridge study finds AI more accurately assesses eye problems compared to doctors

PharmaTimes

GPT-4 is trained on datasets to offer eye-related advice, diagnosis and management suggestions

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Ono swoops on Deciphera in $2.4 billion takeover

pharmaphorum

Japan’s Ono Pharma has bolstered its cancer pipeline with a $2.4 billion agreement to buy Deciphera Pharma of the US and its fast-growing gastrointestinal stromal tumour (GIST) therapy Qinlock. Ono is offering $26.50 per share in cash for the Waltham, Massachusetts-based company, saying the deal will enable it to “build a robust presence in oncology,” one of the group’s key priority areas.

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Bristol Myers, Johnson & Johnson plot appeal after US judge dismisses IRA lawsuits

Fierce Pharma

Biopharma companies and industry lobbying groups are striking out in their legal efforts to challenge price-cutting measures in the Inflation Reduction Act. | A federal judge tossed lawsuits by Bristol Myers Squibb and Johnson & Johnson, which questioned the constitutionality of the U.S. government requiring drugmakers to negotiate with Medicare on drug pricing.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.