Wed.Jul 31, 2024

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Biotech startup Airna raises $60M for RNA editing medicines

Bio Pharma Dive

Launched last September, the company is working on a treatment for alpha-1 antitrypsin deficiency, which it said could enter the clinic in 2025.

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Magazine: Left in limbo: when pharma halts rare disease research

Pharmaceutical Technology

Gene therapy research is expensive. Biotechs invest millions of dollars in early research to develop therapies for conditions that might be rare. But when funds are limited and the market potential is dim, such programs are often abandoned by companies, leaving patients and investigators in a bind.

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GSK cuts vaccine forecasts, while predicting faster overall growth

Bio Pharma Dive

Several factors are slowing U.S. sales of Shingrix, the shingles vaccine that's become one of the British pharma's top sellers.

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One Diet Choice While Pregnant May Protect Your Child’s Heart For Life

AuroBlog - Aurous Healthcare Clinical Trials blog

The food consumed by a pregnant mother just got a little bit more important. According to a new study on pregnant mice, a diet rich in fiber improves the long-term heart health of developing offspring, significantly lowering their risk of cardiovascular disease later in life.

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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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FDA approves J&J’s multiple myeloma therapy

Pharmaceutical Technology

The US FDA has granted approval for Johnson & Johnson’s (J&J) DARZALEX FASPRO for treating newly diagnosed multiple myeloma (NDMM).

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Vertex’s pain drug gets speedy FDA review; Keytruda hits a sales milestone

Bio Pharma Dive

Elsewhere, Fibrogen plans to lay off three-quarters of its U.S. staff, while gene editing specialist Intellia is now cleared to start a U.K. study focused on AAT deficiency.

More Trending

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Merck shares slide as Gardasil sales drop in China

Bio Pharma Dive

The unexpected disclosure in Merck’s second quarter earnings prompted an investor sell-off that some analysts say may be overblown.

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Pfizer’s Q2 2024 net income attributable to shareholders down 98%

Pharmaceutical Technology

Pfizer has posted a 98% decrease in net income attributable to shareholders of $41m for Q2 2024, compared to $2.3bn in Q2 2023.

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July 31, 2024: Gene Editing Therapies and Population Health, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Adrian Hernandez In this Friday’s PCT Grand Rounds, Adrian Hernandez of Duke University will present “Precision Health to Population Health: Opportunities and Challenges for Gene Editing Therapies.” The Grand Rounds session will be held on Friday, August 2, 2024, at 1:00 pm eastern. Hernandez is a professor of medicine and vice dean in the Duke University School of Medicine and the executive director of the Duke Clinical Research Institute.

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ICMR calls for proposals to commercialize CRISPR Cas-Based TB detection system

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) has announced an Expression of Interest (EoI) inviting eligible organizations, companies, and manufacturers to participate in the ‘Transfer of Technology’ for a CRISPR Cas-based TB detection system.

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

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Vertex’s blockbuster-in-waiting painkiller suzetrigine set for FDA review next year

Pharmaceutical Technology

The FDA has set a PDUFA target action date of 30 January 2025 for Vertex’s acute pain treatment therapy that is a non-opioid alternative.

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Bayer lops off 70 more employees at New Jersey headquarters

Fierce Pharma

Four months after Bayer handed pink slips to 90 staffers at its U.S. headquarters in Whippany, New Jersey, the company is laying off 70 more workers at the site. | Four months after Bayer handed pink slips to 90 staffers at its U.S. headquarters in Whippany, New Jersey, the company is laying off 70 more at the site, according to a state Worker Adjustment and Retraining Notification.

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Revenue growth for 13 of top 20 biopharmas with obesity drug successes in 2023

Pharmaceutical Technology

The biopharmaceutical industry experienced varied revenue shifts in 2023, with significant success for companies with obesity drugs.

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Frontiers Health 2024: Connecting changemakers, cultivating health system change

pharmaphorum

Frontiers Health 2024 is a platform connecting innovators and changemakers in the life sciences industry to cultivate positive changes in health systems. Discover the latest trends and insights in healthcare innovation.

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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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Imunon’s shares soar after IL-12 therapy success in Phase II trial

Pharmaceutical Technology

In the intent-to-treat cohort, IMNN-001 plus chemotherapy offered a median 11.1-month increase in overall survival versus chemotherapy alone.

Trials 130
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How biometrics applications are contributing to clinical trial diversity

pharmaphorum

Ensuring equitable access to medications remains a fundamental commitment for many pharmaceutical companies to their customers, patients, and stakeholders. However, there has been a discernible shift recently in the timing of access discussions.

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FDA drug application costs set to rise to $4.3m from October

Pharmaceutical Technology

The US Food and Drug Administration application fees have increased by around $300,000 from 2024 and by $2 million compared to a decade ago.

Drugs 130
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J&J touts new 'foundational' frontline multiple myeloma treatment as Darzalex Faspro nabs quadruplet FDA nod

Fierce Pharma

On the heels of game-changing trial results presented at la | On the heels of game-changing trial results presented at last year's ASH meeting, J&J is introducing what it calls a "foundational frontline therapy" in multiple myeloma and at the same time expanding its already impressive presence in the field.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FibroGen axes 75% of staff after lead cancer therapy fails in Phase III trials

Pharmaceutical Technology

FibroGen’s pamrevlumab failed to prove its efficacy in two Phase III trials prompting the company to initiate cost-saving measures.

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Vertex eyes FDA decision on non-opioid pain drug in January

pharmaphorum

Vertex has filed for FDA approval of its non-opioid pain drug suzetrigine, starting the clock ticking on a review that should be completed early next year

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Novo faces growth challenges despite GLP-1 receptor agonist obesity boom

Pharmaceutical Technology

The industry is seeking to scale up and satisfy demand for diabetes and obesity treatments that are now chronically in shortage.

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Leqselvi Can Achieve Nearly 90% Scalp Hair Coverage in Severe Alopecia Areata Patients

XTalks

The US Food and Drug Administration (FDA) has just approved Leqselvi (deuruxolitinib), a new oral medication by Sun Pharmaceutical Industries Limited, offering significant hope for those suffering from severe alopecia areata, a condition causing sudden hair loss. This approval marks a significant milestone, bringing new possibilities to the estimated 300,000 people in the US who deal with severe forms of this autoimmune disease.

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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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Leveragen and Moderna link to advance therapeutics

Pharmaceutical Technology

Leveragen and Moderna have entered a research, option and licence agreement to advance the development of various therapeutics.

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National Immunization Awareness Month 2024: Stay Up to Date

XTalks

As August rolls around, it’s time to celebrate National Immunization Awareness Month 2024 (NIAM), a crucial time to highlight the importance of vaccines in protecting our communities. NIAM 2024 comes with the timely and important themes of strengthening community immunity and staying up to date on vaccines. These themes underscore the collective responsibility we share in safeguarding public health through vaccinations.

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Amgen in internet of things: theme innovation strategy

Pharmaceutical Technology

How many patents did Amgen submit related to internet of things last quarter, and how many were granted? Discover the latest information here.

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Lundbeck leaves Trintellix to partner Takeda in the US, opting for royalties as it focuses efforts on Rexulti

Fierce Pharma

The end of an era is nearing for Lundbeck. After a 17-year collaboration with Takeda on depression drug Trintellix, the Danish drugmaker is passing over its U.S. rights to its partner. | Lundbeck will collect only royalties on Takeda's U.S. sales of the partners' depression med as it reallocates resources to other growth drivers such as antipsychotic Rexulti.

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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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Bayer in batteries: theme innovation strategy

Pharmaceutical Technology

How many patents did Bayer submit related to batteries last quarter, and how many were granted? Discover the latest information here.

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Patients resist Novo Nordisk plan to stop making Levemir

pharmaphorum

Patient advocacy group APIC has started a campaign to stop Novo Nordisk from following through on a plan to stop making insulin product Levemir

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Bayer in ecommerce: theme innovation strategy

Pharmaceutical Technology

How many patents did Bayer submit related to ecommerce last quarter, and how many were granted? Discover the latest information here.

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GSK cuts vaccine sales outlook after RSV surprise, but CEO puts on bold front on peak potential

Fierce Pharma

The whole respiratory syncytial virus (RSV) vaccine field took a beating when the Centers for Disease Control and Prevention’s (CDC's) immunization committee doled out a limited recommendation last | The whole RSV vaccine field took a beating when the CDC’s immunization committee doled out a limited recommendation last month. And it’s showing in GSK’s forecast for 2024, just as the company’s Shingrix disappointed.

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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.