Wed.Nov 06, 2024

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Who You Gonna Email? Digital Health Question Busters!

FDA Law Blog

By Jennifer D. Newberger — Though digital health is not new, it can still often be difficult to determine with precision the regulatory requirements applicable to a particular software product. Sometimes this is because FDA has not opined on a specific set of facts, but more often it is because FDA seems to take different approaches to the same technology offered by different companies.

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An RNAi renaissance is creating a new generation of startups

Bio Pharma Dive

Pioneers like Alnylam Pharmaceuticals have led the RNA interference field for years. Now, a crop of young biotechs is building on that foundation by taking the drugmaking technology in new directions.

RNA 348
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Top 20 biopharmas’ market cap rises 2% in Q3 2024 amid flurry of drug approvals

Pharmaceutical Technology

The top 20 biopharmaceutical companies demonstrated signs of recovery during the third quarter (Q3) of 2024 as investor optimism improved following the interest rate cuts by the US Federal Reserve in September 2024.

Marketing 263
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Moderna said to shuffle sales leadership; Vertex records first Casgevy sale

Bio Pharma Dive

Stephen Hoge will now oversee vaccine sales at Moderna, per a Bloomberg report. Elsewhere, Intra-Cellular unveiled an ambitious sales target and Syndax inked a lucrative royalty deal.

Sales 154
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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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Tevogen Bio partners Microsoft for HPV treatment

Pharmaceutical Technology

Tevogen Bio’s AI effort Tevogen.AI has partnered with Microsoft to advance the development of an HPV specific CTL treatment.

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Acadia sells speedy drug review voucher for $150M

Bio Pharma Dive

The selling price is an indication that the FDA’s planned sunsetting of the rare pediatric disease voucher program may be pushing values higher, according to one analyst.

Drugs 143

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Novo sees Wegovy sales rise as supply constraints ease

Bio Pharma Dive

Third quarter sales of Novo’s in-demand obesity drug totaled $2.5 billion, roughly 81% higher than the same period in 2023 and nearly doubling the total for Lilly’s Zepbound.

Sales 143
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November 6, 2024: Effects of Income Support on Health and Healthcare Use, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Sumit Agarwal of the University of Michigan will present “The Effect of Cash Benefits on Health Care Utilization and Health: A Randomized Study of an Income Support.” The Grand Rounds session will be held on Friday, November 8, 2024, at 1:00 pm eastern. Agarwal is an assistant professor of internal medicine and health management and policy at the University of Michigan.

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Novavax coughs up $123.8M to settle COVID vaccine supply dispute with UK

Fierce Pharma

Novavax has inked another settlement for a past COVID-19 vaccine supply deal. | Novavax has inked another settlement for a past COVID-19 vaccine supply deal. The Maryland biotech has agreed to pay $123.8 million to end a COVID vaccine supply pact with the U.K.

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Intra-Cellular bolsters Caplyta data with another Phase III win

Pharmaceutical Technology

The FDA-approved schizophrenia and bipolar disorder therapy met the primary and secondary endpoint in a Phase III “withdrawal trial”.

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

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Arcellx to present positive data on multiple myeloma treatments

Pharma Times

Phase 1 and 2 studies show promising results for anito-cel therapy

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Zentiva voices UWWTD concerns as EU grants approval

Pharmaceutical Technology

The UWWTD will require manufacturers to fund micropollutant removal, but Zentiva says the financial squeeze could mean shortages.

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MHRA grants approval for bladder cancer drug erdafitinib

Pharma Times

New therapy targets specific genetic alterations, promises extended survival

Genetics 121
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Strong Wegovy revenue growth for Novo Nordisk but shares dip

Pharmaceutical Technology

Sales of the GLP-1RA hit $2.5bn in Q3, a 79% increase over the same period last year.

Sales 130
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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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LumiThera’s Valeda Photobiomodulation System Gets FDA Authorization for Dry AMD

XTalks

LumiThera Inc. , a vision tech company focused on developing photobiomodulation (PBM) therapies for ocular diseases and disorders, has received US Food and Drug Administration (FDA) authorization for its Valeda Light Delivery System for patients with dry age-related macular degeneration (AMD), one of the most common causes of vision impairment in the aging population.

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Nxera Pharma and Antiverse to design antibodies targeting GPCRs

Pharmaceutical Technology

Nxera Pharma has entered a collaboration and licensing agreement with Antiverse to design antibodies for GPCRs.

Antibody 130
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XRHealth buys NeuroReality in health XR marriage

pharmaphorum

Two players in medical extended reality (XR) – XRHealth and NeuroReality – have come together in a quest to build the biggest company in the sector.Boston, US-based XRHealth is leading the deal, acquiring NeuroReality of the Netherlands for an undisclosed sum, combining their products and expertise in the use of XR and virtual reality software for healthcare applications.

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GSK’s RSV vaccine approved in Canada for adults aged 50 to 59

Pharmaceutical Technology

GSK has received approval for its vaccine, AREXVY, in Canada to prevent LRTD caused by RSV in adults aged 50 to 59 years.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Alligator pancreatic cancer drug 'nearly doubles' survival

pharmaphorum

New results with Alligator's CD40 agonist mitazalimab show it nearly doubled survival in pancreatic cancer, ahead of phase 3 trial next year.

Drugs 104
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Drugs for unmet needs and those from experienced companies had the best chance for successful launches in 2023: report

Fierce Pharma

Drugs for unmet needs and those from experienced companies had the best chance for successful launches in 2023: report kdunleavy Wed, 11/06/2024 - 09:23

Drugs 98
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Progress with the UK’s VPAG

pharmaphorum

Get the latest updates on progress with the UK's VPAG (Voluntary scheme for branded medicines Pricing, Access and Growth), including the latest recommendations from the National Institute for Health and Care Excellence (NICE).

Branding 103
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After Lilly's GLP-1 sales fumble, Novo reports mixed results on Ozempic, Wegovy

Fierce Pharma

Following a disappointing earnings showing from Eli Lilly last week, Novo Nordisk’s latest report on the performance of its GLP-1 stalwarts Ozempic and Wegovy is more of a mixed bag. | Among Novo’s semaglutide-based drugs, diabetes blockbuster Ozempic fell short of analysts' expectations during the third quarter while weight-loss med Wegovy came above a consensus estimate.

Sales 86
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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.

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Company Profile: HCG

pharmaphorum

HCG’s drive to transform is motivated by industry-leading perspective on the emerging trend of “impact”, and recognition that understanding that the impact of medical communications efforts is more critical than ever.

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Gelteq IPO: Supporting Gel Technology for Oral Drug Delivery

XTalks

Gelteq Limited, a biotechnology innovator in ingestible gel delivery solutions, recently completed its initial public offering (IPO), raising gross proceeds of $5.2 million. Priced at $4.0 per share, the offering included 1,300,000 ordinary shares, which began trading on the Nasdaq Global Market under the ticker symbol GELS on October 29, 2024. Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceutica

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Cassava’s Alzheimer’s drug nears P3 readout, but SEC scandal casts long shadow

pharmaphorum

Cassava Sciences is nearing a Phase 3 readout for its Alzheimer's drug, lecanemab, despite facing a scandal involving the SEC. Learn more about the latest updates on donanemab and the company's progress in the field of Alzheimer's research.

Drugs 90
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Streamlining eCOA: From complex setup to simplified solutions

Outsourcing Pharma

As clinical trials evolve, electronic Clinical Outcome Assessments (eCOA) remain central to data quality but often lag in adoption due to complex setup and deployment challenges.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Wegovy romps ahead after key rival sees slowdown

pharmaphorum

Novo Nordisk's sales of blockbuster obesity drug Wegovy grew by a massive 79% in the third quarter, in a relief to investors after disappointing results three months ago.

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The Future of Temperature-Controlled Technology

Pharmaceutical Commerce

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Delphine Perridy, chief commercial officer, Envirotainer, forecasts the future of the pharma cold chain regarding technological advancements and changes in market dynamics.

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How to Develop a Risk Management Plan for Generic Drugs

Drug Patent Watch

Developing a Risk Management Plan (RMP) for generic drugs is a crucial step in ensuring the safety and efficacy of these medications. An RMP provides detailed information on a medicine’s safety profile, measures to prevent or minimize risks, and plans for ongoing safety monitoring and evaluation.

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Pharma Pulse 11/6/24: Balancing Personalized Targeting with Protecting Consumers, What Do SMA Caregivers Want? & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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.