Tue.Nov 05, 2024

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Cancer cell therapy from Arcellx, Gilead shows promise in early data

Bio Pharma Dive

The companies’ CAR-T seemed to cause fewer movement disorders in a multiple myeloma trial than J&J's Carvykti has in other tests, although Wall Street analysts were divided on how the two drugs compare.

Trials 297
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Novo Nordisk signs $285m deal with Ascendis to create once-monthly GLP-1RA

Pharmaceutical Technology

Ascendis Pharma will license its TransCon technology to Novo to develop therapies for metabolic and cardiovascular diseases.

Licensing 243
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Sickle cell patient dies in Beam study of base editing therapy

Bio Pharma Dive

The death, which investigators linked to a preparatory chemo treatment rather than Beam's medicine, highlights the risks of using decades-old transplant drugs alongside cutting-edge CRISPR medicines.

Medicine 296
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November 5, 2024: Study Snapshot and Updated Ethics Documentation Available for MOMs Chat and Care Study

Rethinking Clinical Trials

A new study snapshot and updated ethics and regulatory documentation are now available for the MOMs Chat and Care Study. One year into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The MOMs Chat and Care Study , and NIH Collaboratory Trial, is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce t

Nurses 162
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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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Sana to lay off staff, deepen autoimmune focus in latest retrenchment

Bio Pharma Dive

The company, which is only three years removed from one of biotech’s most lucrative IPOs, will cut jobs for a third time and invest more heavily in cell therapies for diabetes and lupus.

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Oxford Nanopore and UK to develop pathogen surveillance system

Pharmaceutical Technology

This initiative brings together UK Biobank, Genomics England, NHS England, and Oxford Nanopore to accelerate genomics-based research in the UK.

More Trending

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NLS and Kadimastem stocks soar following merger agreement

Pharmaceutical Technology

The stocks for both Swiss and Israeli biotechs were up over 20% after the companies signed a merger agreement.

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Intra-Cellular's unstoppable Caplyta nails another trial, this time for relapse prevention in schizophrenia

Fierce Pharma

Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial. | Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial.

Trials 122
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Vertex shares up after full-year product revenue guidance boost

Pharmaceutical Technology

Vertex is approaching two key PDUFA dates in January for new treatments in cystic fibrosis and pain respectively.

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AstraZeneca stock tanks over fears of expanding China fraud probe

Fierce Pharma

AstraZeneca’s stock price dropped by 8.4% during Tuesday’s trading in London after a local report fueled fears of a potentially escalating insurance fraud investigation in China. | AstraZeneca’s stock price dropped by 8.4% during Tuesday’s trading in London after a report fueled fears of a potentially escalating insurance fraud investigation in China.

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

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Nektar Therapeutics to sell Alabama facility to Ampersand

Pharmaceutical Technology

Nektar has signed a definitive agreement to divest its Huntsville facility and associated reagent supply business to Ampersand

Reagent 130
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Beam points to positive data with key base editing asset

pharmaphorum

Beam shines a light on phase 1/2 data with its base editing candidate for sickle cell disease ahead of a full presentation at ASH next month

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FDA approves Journey Medical’s rosacea treatment Emrosi

Pharmaceutical Technology

Journey Medical's new rosacea treatment will rival industry giant Galderma's Oracea in the treatment of rosacea.

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Sagimet’s Denifanstat Set to Enter Phase III Trials for MASH

XTalks

Sagimet Biosciences has announced that its experimental drug, denifanstat, will be heading into Phase III clinical trials for metabolic-associated steatohepatitis (MASH). The US Food and Drug Administration (FDA) has supported its advancement after the drug posted positive Phase II data. At the beginning of last month, the agency granted Breakthrough Therapy designation to denifanstat for the treatment of non-cirrhotic MASH.

Trials 104
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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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EMA accepts Alvotech and Advanz Pharma’s AVT05 MAA

Pharmaceutical Technology

The EMA has accepted a MAA for Alvotech and Advanz Pharma’s AVT05, a proposed biosimilar to Johnson & Johnson’s (J&J) Simponi (golimumab).

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Analysts point to Syfovre 'nadir' after Apellis discloses disappointing quarter

Fierce Pharma

Despite witnessing modest growth in demand over the past three months, Apellis Pharmaceuticals’ complement inhibitor for geographic atrophy (GA), Syfovre, may have hit a performance “nadir” in 2024 | Over the latest earnings stretch, Apellis' Syfovre saw sales down about 2% from the previous quarter despite an overall demand increase of about 7%.

Sales 103
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Syndax agrees funding with Royalty Pharma for Niktimvo US sales

Pharmaceutical Technology

Syndax has entered into a synthetic royalty funding agreement with Royalty Pharma, focused on US net sales of Niktimvo.

Sales 130
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Disc maps out US filing for porphyria drug bitopertin

pharmaphorum

Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.Shares in the company gained almost 24% after it announced that the end of phase 2 meeting with the US regulator had firmed up plans for a phase 3 trial of bitopertin in EPP, as well as the potential for accelerated approval.

Drugs 103
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Q&A with Worldwide’s Rare Disease Experts: The Latest Innovations and Hopes for 2025

Worldwide Clinical Trials

In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025. What was the biggest development in rare disease in 2024, and how has that impacted clinical research or patient outcomes?

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Seeking a single source of truth: Standardisation of the data model

pharmaphorum

Learn the importance of having a standardised data model as your single source of truth in this insightful video interview. Gain valuable insights on data management and standardisation processes.

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Novo Nordisk Takes Wegovy to MASH, Sharing Promising Data from First Part of Trial

XTalks

Novo Nordisk shared promising findings from the first part of its clinical trial evaluating semaglutide 2.4 mg (this dose commercially branded as Wegovy) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), previously known as non-alcoholic steatohepatitis (NASH). This marks the third major indication that Novo is pursuing for semaglutide.

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CRUK backs AI-powered, virtual radiotherapy trial projects

pharmaphorum

Cancer Research UK awards £5.

Trials 102
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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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Polyrizon IPO Strengthens Momentum in Non-Invasive Drug Delivery Solutions

XTalks

Polyrizon Ltd., an Israeli biotech company specializing in medical device hydrogels, recently closed its initial public offering (IPO), raising $4.2 million in gross proceeds. The IPO, priced at $4.38 per unit, included 958,903 units, each containing one ordinary share and three warrants to purchase additional shares at an exercise price of $4.38 per share.

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From neurosurgery to focused ultrasound: Not if, but when

pharmaphorum

Therapeutic or focused ultrasound began being applied to neurologic conditions less than a decade ago, but its potential in a wide spectrum of brain applications is high. In today’s podcast, web editor Nicole Raleigh speaks with Dr Neal Kassell, chair and founder of the Focused Ultrasound Foundation and previously a neurosurgeon, who created the Foundation in 2006 to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ult

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IPV Therapy Device Recall: Phasitron 5 Breathing Circuits Withdrawn

XTalks

Percussionaire has issued a Class I recall for certain lots of its Phasitron 5 breathing circuits, crucial components in intrapulmonary percussive ventilation (IPV) therapy, which aids breathing and keeps airways clear for patients on mechanical ventilation. The US Food and Drug Administration (FDA) marked this as a Class I recall, warning of a serious risk if affected devices are still in use.

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Starget Pharma’s AI-Driven Cancer Therapy Gains $5.1 Million Backing

Outsourcing Pharma

Innovative radiotherapy offers a precision treatment alternative.

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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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Strategies for effective biosimilar risk management plans

Drug Patent Watch

The development and approval of biosimilars have become increasingly important in the biopharmaceutical industry, offering cost-effective alternatives to original biological medicines. However, biosimilars pose unique challenges in terms of risk management due to their complex nature and potential for immunogenicity.

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FDA grants accelerated approval to Novartis’ Scemblix as a first-line leukemia therapy

Outsourcing Pharma

Scemblix is the first drug to show superiority over all standard of care therapies for a rare type of leukemia.

Drugs 75
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Four key strategies for optimising your medical congress strategy

pharmaphorum

Learn about four key strategies for optimising your scientific medical congress strategy to maximise impact and engagement.

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Palomar Health inspires youth with hands-on medical program

Outsourcing Pharma

Palomar Health Foundation ignites youth interest in healthcare with Middle School Medical Discoveries program.

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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.