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.
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
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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.
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?
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 EMA has accepted a MAA for Alvotech and Advanz Pharma’s AVT05, a proposed biosimilar to Johnson & Johnson’s (J&J) Simponi (golimumab).
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.
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
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
Ascendis Pharma will license its TransCon technology to Novo to develop therapies for metabolic and cardiovascular diseases.
pharmaphorum
NOVEMBER 5, 2024
AstraZeneca's shares have fallen more than 8% on speculation about an anti-corruption probe in China, its second-largest market, wiping around $14 billion off its value.The sell-off appears to have been prompted by an article in Chinese financial media outlet Yicai which suggested that "dozens of senior executives" at AZ's Chinese subsidiary have been implicated in an ongoing insurance fraud case.
Pharmaceutical Technology
NOVEMBER 5, 2024
Journey Medical's new rosacea treatment will rival industry giant Galderma's Oracea in the treatment of rosacea.
Fierce Pharma
NOVEMBER 5, 2024
With new approvals on the horizon and the closely watched Casgevy launch picking up steam in sickle cell disease and beta thalassemia, “there has never been a more exciting time to be at Vertex,” c | With its first Casgevy revenues in the books, Vertex lifted its full-year sales outlook as it turns its attention to two product launches in 2025, including an expected new entrant in the pain market.
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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
Syndax has entered into a synthetic royalty funding agreement with Royalty Pharma, focused on US net sales of Niktimvo.
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
Pharmaceutical Technology
NOVEMBER 5, 2024
Vertex is approaching two key PDUFA dates in January for new treatments in cystic fibrosis and pain respectively.
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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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
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%.
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.
Fierce Pharma
NOVEMBER 5, 2024
With its first FDA approval coming in August and a sec | With its first FDA approval coming in August and a second expected next month, these are exhilarating days for 19-year-old Syndax Pharmaceuticals as it transforms into a commercial enterprise. To help foot the bill to launch its approved graft-versus-host disease drug Niktimvo and the expected launch of its leukemia treatment revumenib, Syndax has struck a $350 million deal with Royalty Pharma.
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.
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.
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.
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.
Fierce Pharma
NOVEMBER 5, 2024
As the U.K. works to pump fresh cash into the local biopharma scene, London’s Accord Healthcare is capitalizing on the government’s renewed willingness to chip in. | Flush with a 50 million pound sterling ($65 million) joint investment deal from the U.K., Accord—one of Europe's top makers of generic chemotherapies—is embarking on an expansion of its Fawdon drug manufacturing facility in Newcastle upon Tyne, England.
Advertiser: FourKites
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.
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.
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.
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
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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