Sat.Oct 26, 2024 - Fri.Nov 01, 2024

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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 271
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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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Will the tide turn for the wave of pharma layoffs?

Pharmaceutical Technology

Pharmaceutical management expert Kenneth Getz shares insights on broader trends in the pharma sector influencing the recent wave of layoffs.

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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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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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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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Roche weighs whether speedy approval path is open for latest Alzheimer’s drug

Bio Pharma Dive

In an investor presentation, executives hinted at the possibility of seeking an accelerated approval of trontinemab if it can significantly lower levels of amyloid in a Phase 3 trial.

Drugs 304

More Trending

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WHO report highlights resurgence of tuberculosis

Pharma Times

Approximately 8.

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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.

Trials 129
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Novo, with new results, to seek approval for obesity drug in MASH

Bio Pharma Dive

The Phase 3 findings position semaglutide to become the first drug of its kind for the liver disease. But they also confirm GLP-1s aren't a "silver bullet" for MASH, one analyst argued.

Drugs 297
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Biogen and Neomorph enter molecular glue degrader deal

Pharmaceutical Technology

Biogen and Neomorph have partnered to discover and develop molecular glue degraders for treating Alzheimer’s and other rare conditions.

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

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UK dementia clinical trial participation set to boost by ‘tens of thousands’

Pharma Times

The new Dementia Trials Accelerator is set to receive £20m of government funding

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Community Pharmacies in Crisis: Navigating the Challenges and Closures

Pharmaceutical Commerce

With today's pharmacy landscape shaken by unprecedented and wider disruption to healthcare support and delivery, community and independent entities strive to remain an integral cog in the mix.

Pharmacy 123
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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.

Protein 297
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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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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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NICE recommends remote monitoring technology for heart failure patients

Pharma Times

Heart failure accounted for approximately 90,000 hospital admissions in England in 2019 to 2020

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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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Biogen, Sage admit a defeat in major depression

Bio Pharma Dive

The partners no longer intend to develop Zurzuvae for one of the most common forms of depression, citing the time and cost of running new studies that would satisfy the FDA.

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For pharma companies, the possibilities of green chemistry are huge

Pharmaceutical Technology

Green chemistry has the potential to revolutionise the pharmaceutical 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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Novo Nordisk's semaglutide delivers in phase 3 MASH study, teeing up filings

Fierce Pharma

With a positive readout for metabolic dysfunction-associated steatohepatitis (MASH) now in the bag, Novo Nordisk is gearing up to pursue yet another indication for its star GLP-1 medicine semagluti | Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair.

Medicine 134
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Biogen shows its IgAN hand with felzartamab data

pharmaphorum

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.

Antibody 104
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Lilly shares fall as obesity drug sales miss forecasts

Bio Pharma Dive

Third quarter Mounjaro and Zepbound sales, while up substantially versus the same period last year, grew little compared to the second quarter amid inventory decreases in the U.S.

Sales 287
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FDA approves Iterum’s ORLYNVAH NDA for uUTI treatment

Pharmaceutical Technology

The US FDA has approved Iterum Therapeutics' NDA for ORLYNVAH to treat uncomplicated urinary tract infections (uUTIs).

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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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Regeneron's Eylea HD makes progress but doesn't dent the momentum of Roche's Vabysmo

Fierce Pharma

With U.S. | With U.S. sales of $392 million in the third quarter, Regeneron’s high-dose version of Eylea is closing in on blockbuster sales in its first full year on the market. The bad news for the company, however, is that while sales from Eylea HD increased by 29% sequentially, this didn't translate to a similar bump in overall U.S. revenue for the Eylea family of eye medications.

Sales 117
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Why language training is crucial for healthcare teams

pharmaphorum

Effective language training for healthcare teams within the NHS is crucial for providing quality care and communication with diverse patient populations. Learn why it is essential for healthcare professionals.

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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 281
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EU Critical Medicines Act: closer to ending overreliance on Asian manufacturers

Pharmaceutical Technology

China's virtual monopoly on the supply of many APIs could be dangerous for the security of medicine supply to Western countries.

Medicine 208
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Gardasil's China troubles haunt Merck in Q3, with execs warning of more obstacles ahead

Fierce Pharma

While Merck's oncology powerhouse Keytruda delivered another multibillion-dollar sales haul in the third quarter, regional fright surrounding another staple product took the spotlight during the co | Despite the China growth woes, Merck is still confident it can achieve its $11 billion sales goal for the HPV vaccine by 2030.

Sales 115
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Lexicon's type 1 diabetes drug voted down by FDA adcomm

pharmaphorum

FDA advisors vote against Lexicon Pharma's type 1 diabetes and chronic kidney disease therapy sotagliflozin ahead of December verdict

Drugs 114
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Biogen refreshes its C-suite; Novartis writes down MorphoSys assets

Bio Pharma Dive

Daniel Quirk, an immunology and neuroscience executive at Bristol Myers Squibb, will be Biogen’s next chief medical officer, while Robin Kramer will replace retiring CFO Michael McDonnell.

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US court upholds Avadel’s narcolepsy drug approval amid exclusivity battle 

Pharmaceutical Technology

The US District Court upholds the FDA’s approval of Avadel’s Lumryz, dismissing Jazz’s challenge over market exclusivity for its own drug.

Drugs 162
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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.