Thu.Nov 02, 2023

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Xtalks Clinical Edge Magazine: Bridging Innovations in Clinical Trials

XTalks

The clinical research landscape is witnessing a significant transformation. With rapid technological advancements, evolving regulatory environments and a growing need for collaborative knowledge exchange, it’s imperative for professionals within this space to stay abreast of the latest trends and insights. Xtalks has taken a monumental step to cater to this need by unveiling its pioneering publication, the Xtalks Clinical Edge magazine.

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Novo, Lilly buoyed by fast-growing GLP-1 drug sales

Bio Pharma Dive

The rival companies reported strong quarterly sales growth for their latest products, which could face off as weight loss treatments next year.

Sales 305
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Memo Therapeutics raises $27.67m for kidney transplant infection trial

Pharmaceutical Technology

Memo’s fast track-designated candidate is currently in a Phase II trial for BKV infection, with a data readout expected in 2024.

Trials 278
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Sangamo to cut jobs again with planned business overhaul

Bio Pharma Dive

The gene therapy company will move headquarters and reduce its workforce by 40%, while seeking partners for its Fabry and cell therapy research.

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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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MHRA authorises Pfizer’s Litfulo for alopecia areata

Pharmaceutical Technology

The UK MHRA authorises Pfizer’s Litfulo (ritlecitinib), to treat severe alopecia areata in people aged 12 years and above.

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BioMarin to replace CEO Bienaimé with Genentech veteran

Bio Pharma Dive

The rare disease drug developer is turning to former Genentech head Alexander Hardy as the launch of its Roctavian gene therapy stumbles.

More Trending

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You Can Stop a Sneeze, But Here’s Why You Never Should

AuroBlog - Aurous Healthcare Clinical Trials blog

If you have hay fever, you’ve probably been sneezing a lot lately. Sneezing is universal but also quite unique to each of us. It is a protective reflex action outside our conscious control, to remove irritants from inside our nose.

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The obesity drug effect: What medical device executives are saying

Bio Pharma Dive

Stock selloffs across the medical device sector have erased hundreds of billions of dollars in market value. But medtech executives argue GLP-1 drug demand will complement, not cannibalize, their sales.

Drugs 173
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India’s contract manufacturing gains momentum due to high quality & cost effectiveness: Expert

AuroBlog - Aurous Healthcare Clinical Trials blog

India is strengthening its scope in contract manufacturing as the global customers commend the strengths and dependability of its pharma and biotech sectors.

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Prelude and AbCellera jump on the ADC train with partnership

Pharmaceutical Technology

The companies will jointly develop up to five antibody-drug conjugates for treating cancer, with a focus on SMARCA degraders.

Antibody 162
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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UKHSA launches campaign for flu and COVID-19 vaccines

Pharma Times

The NHS has already delivered over 20 million winter vaccines this year - News - PharmaTimes

Vaccine 139
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Moderna takes hefty $1.3B COVID write-off, scales back manufacturing as sales shrink

Fierce Pharma

The days of booming COVID-19 vaccine sales, which sent Moderna into the ranks of pharma's top companies, have | The company is focusing on scaling back its manufacturing efforts to cope with the lack of COVID-19 vaccine demand.

Sales 131
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AI twice as accurate as a biopsy when grading severity of sarcomas

Pharma Times

The new AI model could potentially be applied to other cancers - News - PharmaTimes

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Sangamo tightens the belt, cutting staff and assets to advance product pipeline

Pharmaceutical Technology

As per the latest restructuring plan, Sangamo will advance its programs using AAV capsid delivery, Nav1.7 program, and Prion therapies.

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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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Sarepta enjoys early sales ramp for DMD gene therapy, maintains confidence in label expansion

Fierce Pharma

The third quarter marked a momentous one for Sarepta Therapeutics, bringing the long-anticipated launch of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. | Even before a potential label expansion, the gene therapy Elevidys has raked in around $69 million since its launch. Earlier this week, the company said that a pivotal trial on the medicine failed to reach its primary endpoint.

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Moderna posts reported net loss of $3.6bn in Q3 earnings 

Pharmaceutical Technology

Revenues saw a decline of 32% to $3.4bn from $5bn in the same quarter of the previous year, but the company is projecting a profit in 2024.

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Eli Lilly 'aggressively planning' manufacturing expansions, CEO says, as Mounjaro soars

Fierce Pharma

Supply problems for Eli Lilly’s diabetes med Mounjaro were no secret. But strong demand continues to push sales of the GLP-1/GIP agonist to new highs ahead of an FDA decision on weight loss. | As strong demand continues to push Mounjaro sales to new highs, Eli Lilly CEO David Ricks said the company is "not done with" manufacturing expansions.

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Aldeyra and AbbVie partner for reproxalap development

Pharmaceutical Technology

Aldeyra Therapeutics and AbbVie have signed an agreement for the development, manufacture and commercialisation of reproxalap.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Buoyed by GLP-1 stars, Novo's sales soar in Q3. Will manufacturing prove a long-term hurdle?

Fierce Pharma

Ever since Novo Nordisk won FDA approval for its GLP-1 weight-loss med Wegovy more than 2 years ago, analysts and investors have been keeping a close eye on the blockbuster drug launch. | Ever since Novo Nordisk won FDA approval for its GLP-1 weight-loss med Wegovy more than 2 years ago, analysts and investors have been keeping a close eye on the blockbuster drug launch.

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GSK reports 64% increase in operating profit for Q3 2023

Pharmaceutical Technology

GSK has reported a total operating profit of £1.

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12 Questions with Jenny Reid-Young

pharmaphorum

12 Questions with Jenny Reid-Young Mike.

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Scaling up RNA-LNPs: Strategies for successful and consistent clinical manufacturing

Pharmaceutical Technology

While things may have slowed down a little since the rapid approvals of the COVID-19 vaccines, the excitement around RNA-LNP is still going strong. We spoke to nanomedicine experts at Precision NanoSystems to understand the process development and manufacturing challenges that lie ahead of companies approaching the clinical phase, and how the right partnerships can work wonders.

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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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Sangamo sheds staff once again in another retreat

pharmaphorum

Sangamo sheds staff once again in another retreat Phil.

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Rani cuts workforce by 25% and reprioritises drug pipeline

Pharmaceutical Technology

The company terminated the RT-101 programme while pausing the development of the RT-105 and RT-110 compounds.

Drugs 130
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Phathom passes acid tests, capturing 2 FDA approvals for Voquezna after impurity setback

Fierce Pharma

In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna (vonoprazan). | In a span of three days, Phathom Pharmaceuticals has scored two green lights from the FDA for its first-in-class heartburn drug Voquezna. The first came on Monday when the regulator signed off on Phathom’s reformulation of Voquezna to treat Helicobacter pylori infection.

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Novo Nordisk shrugs off supply issues with record sales

pharmaphorum

Novo Nordisk shrugs off supply issues with record sales Phil.

Sales 105
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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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Regeneron touts launch of high-dose Eylea in battle with Roche's Vabysmo

Fierce Pharma

Roche’s surge in sales for its long-acting macular degeneration drug Vabysmo showed that patients in the market are open to switching to another treatment. | After gaining FDA approval for its high-dose Eylea, Regeneron racked up $43 million in sales in the U.S. over the final six weeks of the third quarter for the new formulation. Regeneron and partner Bayer are battling Roche's Vabysmo in the treatment of multiple eye diseases.

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Samay’s AI-enabled wearable ‘can diagnose COPD’

pharmaphorum

Samay’s AI-enabled wearable ‘can diagnose COPD’ Phil.

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November 2, 2023: NIH Pragmatic Trials Collaboratory Launches New Online Training Resources

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory has launched an enhanced training section of rethinkingclinicialtrials.org that includes a new series of video learning modules and reorganized and refreshed pragmatic clinical trials training resources. The new training section features a series of 8 self-paced, guided video modules on topics that cover every phase of a pragmatic clinical trial.

Trials 100
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Change at the top at BioMarin as CEO Bienaimé steps down

pharmaphorum

Change at the top at BioMarin as CEO Bienaimé steps down Phil.

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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.