Thu.Jun 13, 2024

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Versant debuts biotech working on ‘anger management for the immune system’

Bio Pharma Dive

Investor enthusiasm for precision immunology medicines is providing a tailwind for Santa Ana Therapeutics, a new startup backed by Versant, GV and a16z, among others.

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FDA approves AstraZeneca’s Farxiga for paediatric T2D patients

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's Farxiga for paediatric patients aged 10 years and above with type-2 diabetes.

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Pfizer setback brings questions for Duchenne gene therapy ahead of Sarepta decision

Bio Pharma Dive

The failure of another trial adds to uncertainty around the benefits of the gene-based treatments, though industry analysts still expect Sarepta’s Elevidys’ to be unaffected.

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Alzheon secures $100m to advance Alzheimer’s disease treatment

Pharmaceutical Technology

Alzheon has secured $100m in a Series E funding round to develop and commercialise ALZ-801 for Alzheimer's disease (AD).

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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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Moderna says next-gen COVID shot effective in study

Bio Pharma Dive

Trial data suggest the shot — an important component of an upcoming combination inoculation — has proven at least as effective, and in some cases superior, to the company’s initial COVID vaccine.

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Unlocking the Future of Personalized Medicine: Blood vs. Buccal Swab in Pharmacogenomics Testing

Worldwide Clinical Trials

Pharmacogenomics (PGx), the study of how genes affect a person’s response to drugs, has brought significant changes to the clinical trial industry. This groundbreaking approach can help tailor medical treatments to an individual’s genetic makeup, considerably enhancing drug efficacy and safety while minimizing adverse drug reactions. At Worldwide, our recent study delved into the intricacies of PGx, comparing two common methods of DNA sample collection: buccal swabs and blood samples.

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More Trending

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NHS and ABPI announce new guidelines ahead of UK elections

Pharmaceutical Technology

The new guidelines outline ways to develop NHS-industry partnerships and follow the ABPI’s manifesto.

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The Evolution of Oncology Trials: Project Optimus and Study Design Trends

Worldwide Clinical Trials

In the last few decades, oncology research has witnessed countless innovations and breakthroughs, significantly extending the lives of those affected by cancer and improving their quality of life. The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinical trials.

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Barinthus Bio slashes headcount by 25% and refocuses pipeline

Pharmaceutical Technology

Two Hepatitis B and coeliac disease candidates will be the priority for the company whilst a prostate cancer asset appears to be sidelined.

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LifeArc funds new projects to address and prevent global threat of dengue fever

Pharma Times

The mosquito-borne viral disease is responsible for an estimated 390 million cases globally

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

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Leo’s single-dose autoinjector secures FDA approval for atopic dermatitis

Pharmaceutical Technology

The autoinjector offers adults with moderate to severe atopic dermatitis an alternative administration method of Adbry.

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Launch Excellence: Moments of Truth

pharmaphorum

Explore the key moments of truth in launch excellence for MSLs and commercial teams in this informative white paper. Gain valuable insights and strategies for successful launches.

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NHS boss praises managers and leaders as Tories seek to scrap £1bn funding

Pharmaceutical Technology

NHS England chief executive Amanda Pritchard laid out a three-point plan to help support the future of the health service.

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The B2C prescription: Marketing lessons for B2B pharma companies

pharmaphorum

Learn valuable marketing lessons for B2B pharma companies by examining successful strategies used in the B2C prescription market, including over-the-counter (OTC) products and interactions with healthcare professionals (HCPs).

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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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GSK and Ochre Bio link to explore liver disease drivers

Pharmaceutical Technology

GSK has entered into a multi-year data licence agreement with Ochre Bio, aiming to advance the understanding of liver disease.

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Pfizer expects 8 blockbuster cancer drugs to come from each of 4 focus areas: exec

Fierce Pharma

Pfizer's oncology division plans to have eight blockbusters by 2030, with contributions from each of its four focused therapeutic areas.

Drugs 116
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Flagship Pioneering and ProFound link for obesity therapies

Pharmaceutical Technology

Flagship Pioneering and ProFound Therapeutics partnered to detect new therapeutics for the treatment of obesity.

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Mahana’s DTx for IBS gets permanent reimbursement in Germany

pharmaphorum

Mahana Therapeutics has granted permanent reimbursement in Germany for its Cara Care digital therapeutic for irritable bowel syndrome

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog

By Sara W. Koblitz — As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy statements, challenged patent listings, tapped Congress, appeared on talk shows, and filed amicus briefs all in the span of the last 8 months. It seems like all that work is paying off.

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Future of Pfizer’s Duchenne gene therapy in doubt

pharmaphorum

Pfizer is “evaluating next steps” for its Duchenne muscular dystrophy (DMD) gene candidate after it failed a phase 3 trial

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With phase 3 miss, Pfizer's DMD candidate is no threat to Sarepta's Elevidys ahead of key label expansion: analysts

Fierce Pharma

With a phase 3 miss following a fatality in a related study and marking what analysts are calling the “final nail” in Pfizer’s Duchenne muscular dystrophy (DMD) gene therapy coffin, Sarepta Therape | With a phase 3 miss and severe safety signals, Pfizer's Duchenne muscular dystrophy gene therapy candidate is no competition to Sarepta's established Elevidys, according to analysts.

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AbbVie licenses FutureGen IBD drug in $1.7bn deal

pharmaphorum

AbbVie agrees $1.

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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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NIH Invests $30 Million in a Community-Based Primary Care Network to Promote Health Equity

XTalks

As reported by Statista, in 2021, the US allocated 17.8 percent of its gross domestic product (GDP) to healthcare, amounting to a whopping 4.4 trillion US dollars in 2022. The burden of chronic diseases and obesity is particularly severe in the US; the 2020 Commonwealth Fund International Health Policy Survey revealed that 30.4 percent of adults reported having two or more chronic conditions such as heart disease, diabetes and depression.

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Four takeaways from ASCO24

pharmaphorum

Last weekend, editor-in-chief Jonah Comstock attended the annual conference of the American Society of Clinical Oncologists in Chicago, an event renowned for announcing significant advancements in cancer treatment.

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GLP-1 Global Obesity Market to Reach $111B by 2033, Despite Headwinds: GlobalData

BioSpace

While GLP-1 drugs remain wildly popular and are a highly lucrative sector, data analytics firm GlobalData contends manufacturing and cost will remain overhangs on the obesity market.

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WuXi buoyed as BIOSECURE Act is left out of US spending bill

pharmaphorum

Shares in WuXi Biologics and WuXi AppTec rose after the BIOSECURE Act was omitted from legislation due to be followed up in congress.

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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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Sysmex receives Longitude Prize on AMR for antimicrobial testing system

Pharma Times

AMR is designated as one of the top ten global public health threats facing humanity by WHO

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Flagship, ProFound set off on obesity drug hunt for Pfizer

pharmaphorum

Pfizer has had some setbacks in its efforts to develop drugs for the lucrative obesity market, but could see its pipeline swell thanks to its $7 billion partnership with venture capital firm Flagship Pioneering. Flagship has just announced that it will work with biotech startup ProFound Therapeutics to find first-in-class protein therapeutics with potential in obesity, confirming this is the first programme in the alliance with Pfizer signed last July.

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Setrusumab by Ultragenyx Pharmaceutical for Osteogenesis Imperfecta: Likelihood of Approval

Pharmaceutical Technology

Setrusumab is under clinical development by Ultragenyx Pharmaceutical and currently in Phase III for Osteogenesis Imperfecta.

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Talc plaintiffs file for restraining order to block Johnson & Johnson's 3rd bankruptcy attempt

Fierce Pharma

As Johnson & Johnson has tried to resolve talcum powder lawsuits that have been consolidated in a multidistrict litigation in New Jersey, the company has had to deal with two groups of plaintif | J&J has had to deal with two groups of plaintiffs in its talc lawsuits—one that wants to accept a settlement and the other that doesn’t. Now, the latter group has asked a New Jersey federal court to issue a restraining order to block a J&J subsidiary from filing for bankruptcy.

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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.