Wed.Jan 17, 2024

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Tr1x, a new biotech, joins ‘Treg’ chase with $75M fundraise

Bio Pharma Dive

The startup is focusing on immune cells called Tr1 cells, which it claims could be important in treating autoimmune conditions like graft-versus-host disease.

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Takeda gains US FDA approval for HYQVIA to treat CIDP

Pharmaceutical Technology

Takeda has gained approval from the US Food and Drug Administration for HYQVIA to treat chronic inflammatory demyelinating polyneuropathy.

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Kyverna sets plans for IPO in test of biotech market

Bio Pharma Dive

The offering is the fifth outlined by a biotech startup this month, suggesting companies are becoming more willing to gauge investors’ appetite for new stock offerings.

Marketing 319
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Coya stretches lead drug’s development to Parkinson’s and dementia

Pharmaceutical Technology

Coya plans to file investigational new drug applications for COYA 302 in amyotrophic lateral sclerosis and frontotemporal dementia later this year.

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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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Comanche Biopharma raises $75M to fund preeclampsia drug testing

Bio Pharma Dive

The biotech is developing an RNA-based therapy for what it describes as a root cause of the pregnancy-related complication, which affects millions of women.

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FDA approves Vertex’s gene-edited therapy for beta thalassemia

Pharmaceutical Technology

The US FDA has approved Vertex's CASGEVY, a gene-edited cell therapy, to treat transfusion-dependent beta thalassemia.

More Trending

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The evolving presence of AI in telemedicine for behavioural health

Pharmaceutical Technology

AI in telemedicine for behavioural health can revolutionise patient access to treatment, lower costs and identify urgent concerns.

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January 17, 2024: In This Friday’s PCT Grand Rounds, Why Are Imaging Trials Different?

Rethinking Clinical Trials

Dr. Pamela Douglas (Photo: Erin Roth, Duke Health) In this Friday's PCT Grand Rounds, Pamela Douglas of Duke University will present "Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials." The Grand Rounds session will be held on Friday, January 19, 2024, at 1:00 pm eastern. Douglas is the Ursula Geller Professor of Research in Cardiovascular Diseases at Duke University and a past president of both the American College of Cardiology and the American Society of Echocardiograp

Trials 147
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Bupa is leveraging its unique position to develop IoT and AI features

Pharmaceutical Technology

The British health insurance and coverage provider is well-placed to invest in new technology due to its payment structure.

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Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP)

Rethinking Clinical Trials

         Speaker Erin K. McCreary, PharmD, BCIDP Director of Infectious Diseases Improvement and Clinical Research Innovation, UPMC Clinical Assistant Professor of Medicine, University of Pittsburgh President-Elect, Society of Infectious Diseases Pharmacists (SIDP) Slides Keywords COVID-19, therapeutics, health equity, pragmatic clinical trial Key Points In April 2020, UPMC established a COVID Therapeutics Committee to determine a process for allocating experimental COVID-19 therapies.

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

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Avoid “narrow national interest” in fighting next pandemic, WHO chief says

Pharmaceutical Technology

Speaking at Davos, WHO chief Dr. Ghebreyesus said learning lessons from the Covid-19 pandemic is a priority in fighting Disease X.

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Women’s health gap estimated at $1trn in new report

pharmaphorum

The disparity in access to healthcare between women and men around the world is often talked about but has never been given a dollar value – until now.

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US PTO voids Seagen’s ADC patent infringement claims against Daiichi

Pharmaceutical Technology

The decision invalidates all claims of patent infringement, which has been central in litigation of breast cancer drug Enhertu.

Drugs 147
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Deadly ‘Zombie Drug’ Believed to Contain Human Bones Wreaks Havoc in West Africa

AuroBlog - Aurous Healthcare Clinical Trials blog

A new drug called kush is wreaking havoc in west Africa, particularly in Sierra Leone where it is estimated to kill around a dozen people each week and hospitalise thousands.

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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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Stalica raises $17.5m to advance neurology programmes

Pharmaceutical Technology

The Switzerland based company plans to use the Series B money to fund clinical trials for its three pipeline candidates.

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Bayer CEO Bill Anderson makes his mark with major restructuring, 'significant' job cuts

Fierce Pharma

Bayer is launching a sweeping business overhaul as the German conglomerate sees “no viable alternative.” | Bayer is launching a sweeping business overhaul that will “come at the expense of many managerial employees,” as the German conglomerate sees “no viable alternative.

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EU access to oncology medicines lags behind in the Netherlands

Pharmaceutical Technology

In a report, findings suggested that cancer patients in the Netherlands will face longer waits to access new oncology medicines.

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What Are the Top Oncology Clinical Trial Trends Through the Lens of ESMO?

XTalks

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. There are many aspects of oncology drug development that are driven by the unique nature of the treatments being developed and the needs of the patients, their

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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KBI Biopharma and Argonaut form drug manufacturing alliance

Pharmaceutical Technology

KBI Biopharma and Argonaut have entered into a strategic partnership to provide biopharmaceutical clients with drug manufacturing solutions.

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StemSight and ERS Genomics focus on collaboration

Pharma Times

License agreement concerns development of cell therapies for corneal blindness

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EC grants orphan drug designation for Precigen’s PRGN-2012

Pharmaceutical Technology

The EC has granted orphan drug designation (ODD) for Precigen's PRGN-2012 aimed at treating recurrent respiratory papillomatosis (RRP).

Drugs 130
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New anti-smoking drug set for rapid NHS rollout

pharmaphorum

Oral cytisine therapy for smoking cessation from Consilient Health will launch in the UK next week, helping to alleviate a shortage of prescription drugs to help people quit

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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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Revolutionizing Orthopedic Joint Replacement — Interview with Ben Sexson, Co-Founder, CEO, Monogram Orthopedics – Xtalks Life Science Podcast Ep. 142

XTalks

This episode features an interview with Ben Sexson, CFA, Co-Founder, CEO, Monogram Orthopedics at Monogram Orthopedics , a company dedicated to revolutionizing orthopedic joint replacement through surgical robotics. Monogram is focused on developing patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging.

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First CRISPR drug Casgevy gets swift second approval

pharmaphorum

FDA has approved Vertex and CRISPR Therapeutics' Casgevy as first CRISPR based therapy for transfusion-dependent thalassaemia.

Drugs 116
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Poolbeg’s cytokine release syndrome candidate shows potential

Pharma Times

Data supports Poolbeg’s strategic expansion of POLB 001

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Why Scotland is well-positioned to lead in advanced therapies for complex diseases

pharmaphorum

Scotland's expertise in advanced therapies, combined with its robust healthcare system and strong research infrastructure, positions it as a leader in tackling complex diseases such as lung, liver, and vascular disorders. Discover why Scotland is at the forefront of innovation and advancements in this field.

Research 116
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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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US agency nixes Seagen patent, handing Daiichi Sankyo a win in long-running Enhertu entanglement

Fierce Pharma

After years of patent litigation between cancer drug developers Daiichi Sankyo and Seagen, the U.S. Patent and Trademark office (U.S. PTO) has handed Daiichi the latest win in the saga. | After a Texas jury sided with Seagen a patent spat, the U.S. Patent and Trademark Office has invalidated the patent in question.

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This week in clinical trials: 8th-12th January

pharmaphorum

Stay up to date on the latest clinical trials happening in the week of 8th-12th January. Get information on trials for Lytix Biopharma's Verrica, Celletcar, Ariceum, Dermavant, BI, and more.

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With $1.2B stock sale, GSK offloads more of its stake in consumer health spinoff Haleon

Fierce Pharma

GSK is sticking to its plan to gradually monetize its stake in Haleon, the consumer health business the British pharma giant spun off in 2022. | GSK is sticking to its plan to gradually monetize its stake in Haleon, the consumer health business the British pharma giant spun off in 2022.

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Seagen patent in Daiichi Sankyo ADC dispute nixed by USPTO

pharmaphorum

The US patent office has invalidated the only Seagen patent cited in a lawsuit claiming infringement by Daiichi Sankyo’s breast cancer therapy Enhertu.

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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.