Bio Pharma Dive
OCTOBER 30, 2024
All doses of the two drugs are now listed as available in the U.S., per an FDA database, although the company cautioned patients may still experience "variability" filling their prescriptions.
Pharmaceutical Technology
OCTOBER 31, 2024
Reeves' budget promised investment for innovation and R&D with a view to "harnessing the full potential of the UK’s science base”.
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Pharmaceutical Technology
OCTOBER 25, 2024
At the Outsourcing in Clinical Trials Conference, key opinion leaders shared predictions for workflow changes due to AI.
Rethinking Clinical Trials
OCTOBER 30, 2024
Dr. Thomas Carton and Dr. Anitha John In this Friday’s PCT Grand Rounds, Thomas Carton of the Louisiana Public Health Institute and Anitha John of George Washington University and the Children’s National Hospital will present “Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult Centered Care (CHI-RON) Study.” The Grand Rounds session will be held on Friday, November 1, 2024, at 1:00 pm eastern.
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
Worldwide Clinical Trials
OCTOBER 29, 2024
By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.
Fierce Pharma
OCTOBER 28, 2024
Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. | Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy. While Apellis' drug seems to have an efficacy edge based on a cross-trial comparison, Novartis may have gotten the jump by filing for approvals ahead of its competitor.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
OCTOBER 29, 2024
The EC has approved AstraZeneca's Fasenra as an add-on therapy for adults with relapsing or refractory EGPA.
Rethinking Clinical Trials
OCTOBER 24, 2024
The NIH Pragmatic Trials Collaboratory is pleased to welcome APA-SM (Personalized Auricular Point Acupressure for Chronic Pain Self-Management in Rural Populations) to its portfolio of innovative NIH Collaboratory Trials. The new project is supported by an award from the National Institute of Neurological Disorders and Stroke, with administrative oversight from the National Center for Complementary and Integrative Health.
pharmaphorum
OCTOBER 30, 2024
Eli Lilly says a new starting dose regimen for its Alzheimer's disease therapy Kisunla reduces the risk of side effects that have stood in the way of approvals and reimbursement decisions for drugs in its class.Simply shifting one vial of the anti-amyloid antibody from the first infusion to the third infusion of the titration phase of dosing – the period used to achieve therapeutic levels in the body – is enough to lower the incidence of a potentially serious side effect known as ARIA-E, accordi
Fierce Pharma
OCTOBER 29, 2024
Exactly three years after an initial FDA green light for the third-line treatment of leukemia, Novartis’ Scemblix has won an accelerated approval to treat newly diagnosed patients. | Exactly three years after an initial FDA green light for the third-line treatment of leukemia, Novartis’ Scemblix has won an accelerated approval to treat newly diagnosed patients.
Bio Pharma Dive
OCTOBER 30, 2024
The British pharma’s experience during the third quarter mirrored that of rival Pfizer, which also reported lower sales of its competing RSV shot.
Pharmaceutical Technology
OCTOBER 25, 2024
A new vaccines drug substance facility and R&D pilot plant, completed by the end of 2028, will create over 200 new jobs.
XTalks
OCTOBER 28, 2024
November is National Diabetes Month. This year’s theme of National Diabetes Month 2024, “Take Charge of Tomorrow: Preventing Diabetes Health Problems,” highlights how today’s actions can shape healthier futures. On National Diabetes Month 2024, healthcare organizations, policymakers and community programs are raising awareness for the nearly 29.3 million Americans with diagnosed diabetes, alongside 9.7 million undiagnosed and 115.9 million at risk with prediabetes, based on the Ameri
pharmaphorum
OCTOBER 30, 2024
Novartis says FDA approval for frontline use of its leukaemia drug Scemblix will boost the number of eligible patients four-fold, as it hunts blockbuster sales
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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
Fierce Pharma
OCTOBER 29, 2024
Incyte’s blockbuster JAK inhibitor Jakafi has been driving the company’s sales for years now, with this quarter being no different. | Meanwhile, the company also scrapped plans to expand its topical JAK Opzelura into two other skin disorders.
Bio Pharma Dive
OCTOBER 30, 2024
Archon Biosciences, co-founded by the winner of the 2024 Nobel Prize in Chemistry, emerged from stealth Wednesday with $20 million in seed capital.
Pharmaceutical Technology
OCTOBER 30, 2024
GlaxoSmithKline (GSK) has entered an agreement to acquire Chimagen Biosciences’ CMG1A46 for $300m upfront.
BioPharma Reporter
OCTOBER 29, 2024
Anu Codaty, VP of global marketing and strategy at Aldevron, is blazing trails in biotech, inspired by a family legacy in medicine and driven to create life-changing therapies.
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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.
pharmaphorum
OCTOBER 28, 2024
Biogen has revealed encouraging phase 2 results with its anti-CD38 antibody felzartamab in rare kidney disease IgA nephropathy (IgAN), which it hopes could join a series of first-in-class therapies for the disorder.Data reported at the Kidney Week 2024 congress in San Diego showed that felzartamab was able to achieve "substantial" reductions in proteinuria and stabilised kidney function in the 54-subject IGNAZ study that extended for 18 months after the last dose of the antibody.
Fierce Pharma
OCTOBER 30, 2024
Following reports of an ex-AstraZeneca executive being detained in China, the company acknowledged that its current president in the country, Leon Wang, "is cooperating with an ongoing investigatio | Following a report of an ex-AstraZeneca executive being detained in China, the company acknowledged that its current president in the country, Leon Wang, "is cooperating with an ongoing investigation.
Bio Pharma Dive
OCTOBER 24, 2024
Newly published data show the therapy reduced the rate of swelling attacks in people with hereditary angioedema, but didn't silence questions about its commercial outlook.
Pharmaceutical Technology
OCTOBER 28, 2024
The US FDA has approved Iterum Therapeutics' NDA for ORLYNVAH to treat uncomplicated urinary tract infections (uUTIs).
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.
BioPharma Reporter
OCTOBER 29, 2024
In a move set to transform drug discovery, CRO NovAliX has partnered with Bruker, a leader in scientific instruments, through a strategic investment aimed at enhancing drug development success rates.
pharmaphorum
OCTOBER 31, 2024
Septerna's protracted IPO on the Nasdaq has finally reached its conclusion, with the final amount raised by the GPCR-focused biotech above $331m
Fierce Pharma
OCTOBER 29, 2024
Amid a looming standoff with activist investor Starboard Value, Pfizer fought back against accusations of underperforming by delivering double digit revenue growth over the third quarter and notchi | The company is projecting yearly sales of $61 billion to $64 billion in a $1.5 billion boost from previous forecasts.
Bio Pharma Dive
OCTOBER 28, 2024
Buying Aliada Therapeutics would hand AbbVie a clinical-stage Alzheimer’s medicine and a drugmaking technology that may be useful for a variety of brain diseases.
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
OCTOBER 29, 2024
Iterum Therapeutics has won approval from the US Food and Drug Administration (FDA) for Orlynvah (oral sulopenem) to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli , Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative antibacterial treatment options. The FDA nod marks the first approved product for Iterum and the first approved indication for Orlynvah.
pharmaphorum
OCTOBER 29, 2024
Patients in England and Wales with multiple myeloma are celebrating a decision by NICE to relax strict restrictions on eligibility to receive Pfizer's Elrexfio.In June, the cost-effectiveness agency cleared the use of the BCMAxCD3 bispecific antibody with 'optimised guidance' that allowed it to be used for a narrower range of patients than was covered by the approved label for the drug.
Fierce Pharma
OCTOBER 29, 2024
As expected, Novartis’ radioligand therapy Pluvicto crossed the blockbuster sales threshold with one quarter still left of 2024. | Novartis didn't use a priority review voucher for Pluvicto's key application in an earlier treatment setting of prostate cancer. The company made the decision in response to the FDA's request for "flexibility" in its review timeline, Novartis CEO Vas Narasimhan explained.
Bio Pharma Dive
OCTOBER 30, 2024
The funding for Axonis, which is developing novel medicines for pain and epilepsy, reflects growing confidence in precision therapies for neurological diseases, one investor told BioPharma Dive.
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