Mon.Nov 13, 2023

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Real-world evidence in pharmaceutical drug development – faster, safer and more relevant?

Bio Pharma Dive

Regulatory agencies have set the framework and use cases for RWE. How can these increase the probability of success or efficiency in a pre-clinical and clinical drug development program?

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FDA grants orphan drug designation to MAIA’s glioblastoma agent  

Pharmaceutical Technology

As per the company, the candidate THIO, is the only direct telomere-targeting agent currently in clinical development.

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Anthos blood thinner bests Xarelto on safety in mid-stage study

Bio Pharma Dive

Trial results add to evidence that so-called Factor XIa inhibitors could have less bleeding risk than currently available oral anticoagulants like Xarelto.

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BIO-Europe 2023: Barriers remain in the AI pharma revolution

Pharmaceutical Technology

At the BIO-Europe conference, experts discussed remaining challenges in AI healthcare interventions.

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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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Ajinomoto spices up its biopharma business with gene therapy deal

Bio Pharma Dive

Forge Biologics operates a contract manufacturing business as well as develops its own gene therapies, which appears to have attracted the Japan-based food and biotechnology company.

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UK announces $326.4m funding to improve drug and alcohol treatment

Pharmaceutical Technology

The UK government has announced £267m ($326.4m) funds for developing treatments for drug and alcohol misuse.

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More Trending

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Novartis licenses Legend cell therapy for lung cancer

Bio Pharma Dive

With the deal, the Swiss pharma is exploring a tumor target, DLL3, that’s thwarted past drugmaker efforts to attack it.

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Ministry of Ayush modifies eligibility criteria for National Dhanwantari Ayurveda Award

AuroBlog - Aurous Healthcare Clinical Trials blog

The Union Ministry of Ayush has come out with the revised guidelines governing the National Dhanwantari Ayurveda Award to be conferred to renowned ayurvedic practitioners, while celebrating the Ayurveda Day every year on the day of Dhanwantari Jayanti (Dhanteras).

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Wegovy study details revive debate over GLP-1 impact on devices

Bio Pharma Dive

Shares in several heart device makers, which have been battered over the perceived impact of obesity medicines, rose this week following AHA data on Novo’s therapy.

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CHMP provides positive opinion for Merck’s Keytruda

Pharmaceutical Technology

The EMA CHMP provided a positive opinion for granting approval to Merck’s Keytruda combination therapy to treat biliary tract cancer.

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

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3 ways decentralized clinical trials could help advance research on rare diseases

Bio Pharma Dive

Explore how decentralized clinical trials (DCTs) can enhance rare disease research in three key ways.

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Where old pathways to innovative cancer care fall short, a new model emerges

pharmaphorum

Where old pathways to innovative cancer care fall short, a new model emerges Mike.

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3 things manufacturers need to know about the new Annex 1 revision

Bio Pharma Dive

As biopharmaceutical organizations around the globe adjust to the new guidelines, Baroni shared insights on four things they need to know about Annex 1.

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Signal: Wegovy cuts cardiovascular risk by 20% for heart disease patients

Pharmaceutical Technology

Novo Nordisk announced this week that its weight loss drug Wegovy reduces the risk of major cardiovascular events by 20%.

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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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November 13, 2023: New Chapter of Living Textbook Explores Ethical Considerations for Artificial Intelligence and Machine Learning in Pragmatic Clinical Trials

Rethinking Clinical Trials

The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The chapter, “ Ethics and Equity for Artificial Intelligence and Machine Learning in Pragmatic Clinical Trials ,” describes key considerations and challenges with leveraging artificial intelligence and machine learning in pragmatic clinical trials.

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FDA approves Takeda’s targeted therapy for advanced colon cancer

Pharmaceutical Technology

On 8 November, Takeda announced it had received US Food and Drug Administration (FDA) approval for its oral Fruzaqla (fruquintinib) as a third-line treatment for adults with metastatic colorectal cancer (mCRC).

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Patient perspectives: Clinical trials and Diabetes Awareness Month

Antidote

Each November is designated as Diabetes Awareness Month , an event that highlights the importance of spreading awareness about diabetes and the health issues it can cause.

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Ethris and Heqet team up for RNA-based therapeutic development

Pharmaceutical Technology

Heqet Therapeutics and Ethris have collaborated to develop RNA-based therapeutics to treat cardiovascular conditions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Victoria Atkins replaces Barclay as UK health secretary

pharmaphorum

Victoria Atkins replaces Barclay as UK health secretary Phil.

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Victoria Atkins MP takes over UK’s department of Health and Social Care

Pharmaceutical Technology

The UK government has seen a cabinet reshuffle as the Prime Minister removed Steve Barclay as UK health secretary and replaced him with Victoria Atkins.

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Novo Nordisk says Wegovy can help heart disease patients—and not just because it produces weight loss

Fierce Pharma

Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. | Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack.

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FT Summit: AI and regulatory changes at the forefront of industry’s mind

Pharmaceutical Technology

At the FT Global Pharma and Biotech Summit in London, various industry players shared their thoughts on technological and regulatory advancements.

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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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Akili says OTC switch for ADHD DTx leads to sales rise

pharmaphorum

Akili says OTC switch for ADHD DTx leads to sales rise Phil.

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Mirati’s lung cancer treatment gains EMA CHMP’s positive opinion

Pharmaceutical Technology

Mirati Therapeutics has obtained EMA CHMP's positive opinion for Krazati to treat KRASG12C-mutated non-small cell lung cancer.

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UCB on course for approval of gMG drug Rystiggo in EU

pharmaphorum

UCB on course for approval of gMG drug Rystiggo in EU Phil.

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How can smaller biotechs navigate the landscape of oncology trials?

Pharmaceutical Technology

An upcoming two-day event will host talks on the impact of new technology on oncology trials and smaller biotechs.

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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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ADCs shine at ESMO ’23, as pharma makes case for early immunotherapy interventions

pharmaphorum

ADCs shine at ESMO ’23, as pharma makes case for early immunotherapy interventions Mike.

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Ajinomoto signs agreement to acquire Forge for $620m

Pharmaceutical Technology

Ajinomoto has signed a definitive agreement for the acquisition of Forge Biologics in an all-cash transaction totalling $620m.

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Half a year later, Teva's 'pivot to growth' strategy appears to be bearing fruit

Fierce Pharma

Six months on, Teva’s new “pivot to growth” strategy appears to be paying off. | In 2023’s third quarter, the Israeli-American generics giant reported global sales of $3.9 billion, up 7% from the same period in 2022. The company credited that growth to the strong momentum behind its branded meds Austedo and Ajovy, plus a “stable and sustainable generics business” in the U.S. that’s also seen “continued growth” in Europe and other international markets.

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Treatment innovation for healthier patients and a healthier planet  

Pharmaceutical Technology

Procaps studies show that by consuming Unigel® products, patients avoided the production and disposal of 27.5 million blister packs in 2022.

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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.