Bio Pharma Dive
NOVEMBER 5, 2024
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.
Pharmaceutical Technology
NOVEMBER 5, 2024
Ascendis Pharma will license its TransCon technology to Novo to develop therapies for metabolic and cardiovascular diseases.
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Bio Pharma Dive
NOVEMBER 5, 2024
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.
Rethinking Clinical Trials
NOVEMBER 5, 2024
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
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
Bio Pharma Dive
NOVEMBER 5, 2024
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.
Pharmaceutical Technology
NOVEMBER 5, 2024
This initiative brings together UK Biobank, Genomics England, NHS England, and Oxford Nanopore to accelerate genomics-based research in the UK.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 5, 2024
The stocks for both Swiss and Israeli biotechs were up over 20% after the companies signed a merger agreement.
Fierce Pharma
NOVEMBER 5, 2024
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.
Pharmaceutical Technology
NOVEMBER 5, 2024
Vertex is approaching two key PDUFA dates in January for new treatments in cystic fibrosis and pain respectively.
Fierce Pharma
NOVEMBER 5, 2024
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.
Pharmaceutical Technology
NOVEMBER 5, 2024
Nektar has signed a definitive agreement to divest its Huntsville facility and associated reagent supply business to Ampersand
Fierce Pharma
NOVEMBER 5, 2024
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%.
Pharmaceutical Technology
NOVEMBER 5, 2024
Journey Medical's new rosacea treatment will rival industry giant Galderma's Oracea in the treatment of rosacea.
pharmaphorum
NOVEMBER 5, 2024
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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharmaceutical Technology
NOVEMBER 5, 2024
The EMA has accepted a MAA for Alvotech and Advanz Pharma’s AVT05, a proposed biosimilar to Johnson & Johnson’s (J&J) Simponi (golimumab).
XTalks
NOVEMBER 5, 2024
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.
Pharmaceutical Technology
NOVEMBER 5, 2024
Syndax has entered into a synthetic royalty funding agreement with Royalty Pharma, focused on US net sales of Niktimvo.
pharmaphorum
NOVEMBER 5, 2024
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.
XTalks
NOVEMBER 5, 2024
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.
pharmaphorum
NOVEMBER 5, 2024
Cancer Research UK awards £5.
XTalks
NOVEMBER 5, 2024
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.
pharmaphorum
NOVEMBER 5, 2024
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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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.
XTalks
NOVEMBER 5, 2024
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.
Drug Patent Watch
NOVEMBER 5, 2024
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.
Worldwide Clinical Trials
NOVEMBER 5, 2024
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?
pharmaphorum
NOVEMBER 5, 2024
Learn about four key strategies for optimising your scientific medical congress strategy to maximise impact and engagement.
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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
Outsourcing Pharma
NOVEMBER 5, 2024
Innovative radiotherapy offers a precision treatment alternative.
pharmaphorum
NOVEMBER 5, 2024
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
Outsourcing Pharma
NOVEMBER 5, 2024
Clinical trial results have revealed that semaglutide treatment significantly reduced hospital admissions in overweight and obese adults with heart disease.
pharmaphorum
NOVEMBER 5, 2024
Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.The new capsule formulation of the antibiotic minocycline hydrochloride has been cleared by the US regulator to treat the inflammatory lesions caused by rosacea – which causes flushing or long-term redness and pustules on the face – in adults.
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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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