Fri.Nov 22, 2024

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BridgeBio heart drug approved by FDA, setting up battle with Pfizer

Bio Pharma Dive

The approval of Attruby for transthyretin amyloidosis with cardiomyopathy begins a battle for control of a lucrative market that investors have been skeptical BridgeBio can win.

Drugs 310
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Health Canada issues NOC to J&J’s CARVYKTI for multiple myeloma

Pharmaceutical Technology

Health Canada has issued a Notice of Compliance (NOC) for Johnson & Johnson’s (J&J) CARVYKTI for multiple myeloma treatment.

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Lexicon to disband sales team, lay off 60% of staff

Bio Pharma Dive

The restructuring follows the company's receipt of a letter from the FDA citing "deficiencies" in its approval application for diabetes drug Zynquista.

Sales 263
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“No magic wand” for Novo Nordisk, as CagriSema pen supply rumours swirl

Pharmaceutical Technology

Novo Nordisk and Ypsomed’s 2023 deal is rumoured to include an autoinjector supply for potential Wegovy successor CagriSema.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Will Walgreens’ store closures disrupt its clinical trial aims?

Bio Pharma Dive

Despite plans to shutter 1,200 stores, the company’s chief clinical trials officer said the pharmacy giant remains committed to aiding drug research.

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Enveda raises $130m to advance AI-driven plant based drug development

Pharmaceutical Technology

The biotech uses its AI platform to discover the therapeutic potential of plant-based molecules, advancing ten candidates with the funds.

More Trending

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Zai Lab and Pfizer to commercialise XACDURO in China

Pharmaceutical Technology

Zai Lab and Pfizer have entered a strategic collaboration for the commercialisation of XACDURO in mainland China.

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Cloudbyz Recognized in Everest Group’s 2024 PEAK Matrix® for Life Sciences CTMS Solution

Cloudbyz

Cloudbyz Achieves Key Recognition in Everest Group’s 2024 PEAK Matrix® for Life Sciences Clinical Trial Management System (CTMS) Products Naperville, IL, November 22, 2024 – Cloudbyz, a leader in cloud-based clinical trial management solutions, proudly announces its recognition in the 2024 Everest Group PEAK Matrix® for Life Sciences Clinical Trial Management System (CTMS) solutions.

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Novartis acquires Kate Therapeutics to advance gene therapies

Pharmaceutical Technology

Novartis has announced the acquisition of Kate Therapeutics to enhance its portfolio of gene therapies for inherited neuromuscular diseases.

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Printable organic X-ray sensors may transform treatment for cancer patients

Medical Xpress

An international research team, led by the University of Wollongong (UOW), has found wearable organic X-ray sensors could offer safer radiotherapy protocols for cancer patients.

Research 125
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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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J&J eyes FDA approval for injection-based Tremfya in ulcerative colitis

Pharmaceutical Technology

Johnson & Johnson Innovation Medicine has submitted a request to the FDA to approve Tremfya as a treatment for ulcerative colitis.

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Scientists identify key mechanism in development of skin cancer

Medical Xpress

LMU researchers have discovered how the interplay between a key protein and an endolysosomal ion channel promotes tumor development in skin cancer.

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UK point-of-care production of cell therapies could arrive in 2025

Pharmaceutical Technology

The UK’s proposed regulations would provide the legal framework for POC manufacturing of cell therapies, including quality assurance.

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Neurogene drops high-dose arm in Rett study after death

pharmaphorum

The patient affected by a serious adverse event in Neurogene's clinical trial of Rett syndrome gene therapy has now died

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

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Magazine: Pharma’s green shift with dry powder inhalers

Pharmaceutical Technology

Several pharmaceutical companies are advancing dry powder inhalers (DPIs) for respiratory conditions in an effort to cut down on greenhouse emissions and create a solution that is more eco-friendly than traditional pressurised metered-dose inhalers (pMDIs).

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Woman receives world's first robotic double-lung transplant

Medical Xpress

A 57-year-old woman with COPD has received the world's first fully robotic double lung transplant.

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Amneal files again for FDA approval of first dihydroergotamine autoinjector

Pharmaceutical Technology

Amneal Pharmaceuticals has submitted another NDA for its DHE prefilled syringe autoinjector to treat tough-to-treat headaches.

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Animal characters can boost young children's psychological development, study suggests

Medical Xpress

Children's books are full of animal characters whose antics capture the hearts and inspire the imaginations of their young readers.

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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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Europe’s TCR immunotherapy licensing deals surge 123% above US in 2024

Pharmaceutical Technology

TCR immunotherapy is emerging as a promising, targeted approach for treating solid tumours and other indications.

Licensing 130
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Empowering community pharmacies: The key to bridging health inequalities

pharmaphorum

Community pharmacies play a crucial role in bridging health inequalities and empowering communities. Learn how the NHS and community pharmacies work together to improve health outcomes for all.

Pharmacy 106
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Clinical trial: Monoclonal antibody may be an effective alternative to cisplatin in treatment of head and neck cancers

Medical Xpress

Head and neck cancers are the seventh most common type of cancer worldwide, according to the 2020 World Cancer Report. Smokers and drinkers, as well as those with HPV infections, are disproportionately affected.

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FDA experts lukewarm on AZ's anticoagulant antidote Andexxa

pharmaphorum

AstraZeneca is facing some pushback as it tries to upgrade anticoagulant antidote drug Andexaa to full approval in the US.

Drugs 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Researchers link snoring to behavioral problems in adolescents without declines in cognition

Medical Xpress

Adolescents who snore frequently were more likely to exhibit behavior problems such as inattention, rule-breaking, and aggression, but they do not have any decline in their cognitive abilities, according to a new study conducted by researchers at the University of Maryland School of Medicine (UMSOM).

Research 104
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Jazz gets first FDA nod for HER2 bispecific Ziihera

pharmaphorum

Jazz Pharma has claimed FDA approval for its HER2-directed bispecific antibody Ziihera as a treatment for biliary tract cancer

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How ovarian cancer cells adapt while moving across tissues

Medical Xpress

The spread of tumor from the primary cancer site to distant organs, called metastasis, has puzzled scientists for many years—they are only now beginning to pinpoint triggers and mechanisms that drive this process.

Scientist 102
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Pfizer led industrywide sales surge in Q3 after several quarters of dominance by Eli Lilly, Novo Nordisk

Fierce Pharma

After six straight quarters in which Eli Lilly or Novo Nordisk achieved the highest year-over-year revenue growth among the top companies in the biopharma industry, there was a new champion in the | After six straight quarters in which Eli Lilly or Novo Nordisk achieved the highest year-over-year revenue increases among the top companies in the biopharma industry, there was a new growth champion in the third quarter.

Sales 90
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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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Flu, COVID vaccination rates remain low as winter nears

Medical Xpress

Worn down by pandemic-era vaccine overload, many Americans are ignoring pleas by health officials to get immunized against the flu and COVID-19, new data shows.

Vaccine 98
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As other Big Pharmas face local headwinds, Pfizer doubles down on China commitment with Zai Lab antimicrobial marketing pact

Fierce Pharma

As other Big Pharmas face local headwinds, Pfizer doubles down on China commitment with Zai Lab antimicrobial marketing pact fkansteiner Fri, 11/22/2024 - 09:04

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Cardiology collaboration advances machine learning predictions for AFib after stroke

Medical Xpress

Researchers at Penn State are using machine learning and existing electrocardiogram (ECG) data to help doctors make more accurate predictions. A team of artificial intelligence engineers, in collaboration with a team of physicians from Penn State Heart and Vascular Institute, is working to develop novel algorithms for point-of-care, in-house use and for technology licensing.

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After FDA setbacks, Lexicon slashes commercial operations in transition back to clinical-stage outfit

Fierce Pharma

For many biopharmas, it takes years of hard work to transition from being a clinical-stage drugmaker to a commercial one. Companies rarely want to make the shift back. | The pivot comes after the FDA issued a notice that the deficiencies in the company's approval bid for type 1 diabetes med Zynquista are too great to proceed for further discussion.

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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