Trending Articles

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Novo takes big step toward ending Ozempic, Wegovy shortages

Bio Pharma Dive

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.

Drugs 269
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EC approves AstraZeneca’s Fasenra for EGPA treatment

Pharmaceutical Technology

The EC has approved AstraZeneca's Fasenra as an add-on therapy for adults with relapsing or refractory EGPA.

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Pharma companies must adapt to keep pace with AI developments, say experts

Pharmaceutical Technology

At the Outsourcing in Clinical Trials Conference, key opinion leaders shared predictions for workflow changes due to AI.

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October 30, 2024: In This Week’s PCT Grand Rounds, the CHI-RON Study of Adults With Congenital Heart Defects

Rethinking Clinical Trials

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.

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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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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Worldwide Clinical Trials

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.

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Novartis' Scemblix leaps into newly diagnosed leukemia—where winning over doctors may take time

Fierce Pharma

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.

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October 24, 2024: APA-SM Trial Joins the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

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.

Trials 147
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Lilly touts new Kisunla regimen that reduces side effects

pharmaphorum

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

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With Jakafi's patent cliff looming, Incyte looks to 2025 launches to bulk up revenue by decade's end

Fierce Pharma

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.

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GSK vaccine sales sink on lower demand for RSV, shingles shots

Bio Pharma Dive

The British pharma’s experience during the third quarter mirrored that of rival Pfizer, which also reported lower sales of its competing RSV shot.

Sales 277
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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GSK pumps up to $800m for US manufacturing site upgrade

Pharmaceutical Technology

A new vaccines drug substance facility and R&D pilot plant, completed by the end of 2028, will create over 200 new jobs.

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Aldevron’s Anu Codaty on passion, leadership, and innovation

BioPharma Reporter

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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Novartis gets FDA okay for frontline use of Scemblix in CML

pharmaphorum

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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AstraZeneca's China president faces 'ongoing investigation' by authorities in the country

Fierce Pharma

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.

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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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A new biotech, built around protein design, springs from David Baker’s lab

Bio Pharma Dive

Archon Biosciences, co-founded by the winner of the 2024 Nobel Prize in Chemistry, emerged from stealth Wednesday with $20 million in seed capital.

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GSK to acquire Chimagen’s CMG1A46 for autoimmune disease

Pharmaceutical Technology

GlaxoSmithKline (GSK) has entered an agreement to acquire Chimagen Biosciences’ CMG1A46 for $300m upfront.

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National Diabetes Month 2024: Take Charge of Tomorrow — Preventing Diabetes Health Problems

XTalks

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

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Harnessing AI to future-proof biopharma

pharmaphorum

Discover how leveraging AI can help biopharma companies future-proof their operations and strategies. Learn about innovative AI strategies that can drive success in the biopharma industry.

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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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Novartis, Apellis drop dueling datasets as they race for approval in rare form of kidney disease

Fierce Pharma

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.

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Intellia data spark debate about CRISPR drug’s potential

Bio Pharma Dive

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.

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Transforming pharmaceutical R&D: the impact of digital technologies on drug discovery and development

Pharmaceutical Technology

The Pharmaceutical Automation and Digitalisation Congress (AUTOMA+) 2024 is a strategic platform for discussion and collaboration among decision makers, researchers and technologists who understand and follow this tendency.

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CRO NovAliX teams with Bruker to advance drug development

BioPharma Reporter

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.

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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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Joy as NICE lifts restrictions on myeloma drug Elrexfio

pharmaphorum

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.

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Pfizer bumps up revenue outlook by $1.5B in Paxlovid rebound amid criticism from activist investor Starboard

Fierce Pharma

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.

Sales 113
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AbbVie to acquire a J&J-backed brain drugmaker for $1.4B

Bio Pharma Dive

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.

Medicine 224
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How a patient helped shape a treatment for rare skin disorder  

Pharmaceutical Technology

Barman-Aksӧzen shared her experience of guiding treatment research for her own ultra rare disorder, erythropoietic protoporphyria (EPP).

Research 147
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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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Orlynvah Approved for Uncomplicated UTIs After Initial FDA Rejection and Amid Concerns of Antimicrobial Resistance

XTalks

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.

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GSK plans $800m US manufacturing investment

pharmaphorum

GSK has made another investment in its manufacturing network, setting aside $800 million to build two plants at its Marietta site in the US.The programme represents the largest capital spend by the UK drugmaker on production capacity to date and will double the size and capacity of GSK's existing medicines and vaccines facility in Marietta, Pennsylvania, creating around 200 new jobs.

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Novartis' Pluvicto enters FDA orbit for expansion bid as agency requests 'flexibility'

Fierce Pharma

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.

Sales 113
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Investors put $115M into Axonis amid revived interest in brain drugs

Bio Pharma Dive

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.

Medicine 177
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time