Thu.Mar 21, 2024

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The unique clinical trial challenges faced by digital therapeutics

pharmaphorum

On today’s podcast, host Jonah Comstock is joined by Meri Beckwith, co-founder of Lindus Health, a next-gen CRO that includes digital therapeutics among its specialties. They talk a little bit about the often unseen difficulties of validating a digital therapeutic through a clinical trial.

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NextCure to lay off 37% of staff, dial back research plans

Bio Pharma Dive

The job cuts at the cancer drug developer will primarily impact manufacturing roles, but will touch on several other parts of the organization, the company said.

Research 298
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Bionomics to advance non-SSRI PTSD candidate to Phase III

Pharmaceutical Technology

Bionomics plans to meet with the FDA following positive topline data from the Phase IIb ATTUNE trial of the post-traumatic stress disorder (PTSD) drug BNC210.

Trials 264
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Thermo Fisher, Bayer partner to develop companion diagnostics

Bio Pharma Dive

The companies aim to identify potential patients for Bayer’s precision cancer therapies and increase access to the treatments.

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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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Merck to invest €300m in South Korean bioprocessing centre

Pharmaceutical Technology

Merck KGaA has announced an investment of over €300m ($326.1m) to establish a new bioprocessing production centre in Daejeon, South Korea.

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Scientists Identify Speech Trait That Foreshadows Cognitive Decline

AuroBlog - Aurous Healthcare Clinical Trials blog

Can you pass me the whatchamacallit? It’s right over there next to the thingamajig. Many of us will experience “lethologica”, or difficulty finding words, in everyday life. And it usually becomes more prominent with age.

Scientist 238

More Trending

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Mirador debuts with $400M, picking up where immune drugmaker Prometheus left off

Bio Pharma Dive

The financing for the startup, which is led by former executives of a biotech Merck recently bought for nearly $11 billion, is the sector’s largest for a privately held company this year.

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Delivery tech remains challenging with gene therapies for brain disorders

Pharmaceutical Technology

Biotech executives discuss why developing gene therapies for central nervous system disorders remains difficult at a recent conference.

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Roche autoimmune disease drug disappoints in closely watched trial

Bio Pharma Dive

Though the medicine hit its goal in a Phase 3 study in myasthenia gravis, the results fell short of expectations in a boost to rival drug developers like Argenx and AstraZeneca.

Drugs 189
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Capstan secures $175m Series B funds for CAR-T therapy

Pharmaceutical Technology

Capstan Therapeutics has secured $175m Series B financing to advance its lead in vivo CAR-T candidate, CPTX2309, for autoimmune disorders.

In-Vivo 245
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Formation of IDRA will garner global recognition on par with US FDA & EMA: Dr BR Jagashetty

AuroBlog - Aurous Healthcare Clinical Trials blog

India must now move towards looking to merge its Central and state enforcement wings and form a single authority. This will be a significant administrative reform.

Licensing 179
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Bayer streamlines pharma leadership team amid company shakeup

Bio Pharma Dive

The executive team will reportedly shrink from 14 to eight in the latest step in new CEO Bill Anderson’s plan to slash management and reduce “bureaucracy” at the healthcare conglomerate.

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March 21, 2024: NINR Announces Funding Opportunity to Improve Health and Advance Equity in Rural Populations

Rethinking Clinical Trials

The National Institute of Nursing Research (NINR) published a funding opportunity for research to improve health outcomes and advance health equity in rural populations. Rural populations experience high rates of many causes of morbidity and disability, and high and increasing rates of premature death. Meaningful and sustained improvements in the health of rural populations require effective solutions to address the underlying causes.

Nurses 173
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Nouscom extends Series C round to $82m for cancer vaccine trials

Pharmaceutical Technology

Nouscom is part of a cancer vaccine landscape that has recently jump-started following years of dormancy.

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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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Parkinson’s UK grants funding of up to nearly £450,000 to four new research projects

Pharma Times

The globally fast-growing progressive neurological condition affects around 153,000 people in the UK

Research 145
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Molecular glues are the latest craze in pharma research, but what are they?

Pharmaceutical Technology

Deals involving research into molecular glues have skyrocketed this year as big pharma bets on their revolutionary potential.

Research 130
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AI in Drug Discovery: Day One

pharmaphorum

There is no denying that artificial intelligence (AI) has captured the imagination of innovators working across the pharmaceutical sector. The drug discovery space is no different, with myriad applications promising to revolutionise the way that researchers and sponsors approach identifying and progressing new drug candidates.

Drugs 126
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Keytruda combination treatment for NSCLC falls short in Phase III

Pharmaceutical Technology

The Phase III KEYLYNK-006 study evaluating a Keytruda/Lynparza combination treatment failed to meet its primary endpoints.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Approves Third Duchenne Muscular Dystrophy Treatment in Nine Months

BioSpace

Duvyzat, which will be sold in the U.S. by ITF Therapeutics, joins a growing market that includes recently approved gene therapy Elevidys and corticosteroid Agamree.

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Early AMR pipeline looks beyond traditional antibiotics

Pharmaceutical Technology

Different therapeutic approaches against antibiotic-resistant bacteria were highlighted throughout day two of the ELRIG UK conference.

Bacteria 130
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Despite positive trial, Roche says Enspryng fell short of expectations in myasthenia gravis

Fierce Pharma

Drug developers often try to spot tidbits of positive information from a failed clinical trial. | Drug developers often try to spot tidbits of positive information from a failed clinical trial. But Roche is doing the opposite for its positive Enspryng study in the competitive autoimmune disorder of myasthenia gravis.

Trials 119
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Donanemab: FDA AdCom will put spotlight on tau enrolment and ARIA concerns

Pharmaceutical Technology

Lilly says that the FDA wants to look closer at efficacy implications of the Phase III donanemab trial design before giving the green light.

Trials 130
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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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MS research network taps Seqster for data sharing

pharmaphorum

Novartis-supported multiple research project will use Seqster's data-sharing platform to support R&D and evidence-based care

Research 115
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Delivery and manufacturing hurdles remain in the cell and gene therapy

Pharmaceutical Technology

Panellists discuss opportunities and challenges in cell and gene therapies at the Advanced Therapies conference in London, UK.

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How will rising demand for mono-material packaging affect pharma?

pharmaphorum

The rising demand for mono-material packaging in the pharmaceutical industry due to its sustainability benefits will have a significant impact. Learn more about how this trend is shaping the future of pharmaceutical packaging.

Packaging 115
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Lonza to acquire Roche biologics manufacturing site for $1.2bn

Pharmaceutical Technology

Lonza has agreed to acquire the Genentech large-scale biologics manufacturing facility in the US from Roche in a deal totalling $1.2bn.

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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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Clasp emerges with $150m for safer T cell engagers

pharmaphorum

Clasp Therapeutics has burst onto the T-cell engager (TCE) scene with $150 million in funding for a platform that aims to improve the safety of the class, which is currently gaining traction in cancer immunotherapy.

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Researchers reveal protein found in human sweat could protect against Lyme disease

Pharma Times

The bacterial infection transmitted by ticks affects nearly half a million people in the US every year

Protein 107
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Eisai backs Leqembi’s Japan rollout with insurance policy

pharmaphorum

A partnership between Eisai and Lifenet that aims to improve insurance cover for people with early dementia has generated its first policy, part of an effort by the pharma group to develop an ‘ecosystem’ to support patients.

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GSK joins AstraZeneca, Boehringer in capping US out-of-pocket inhaler prices at $35 per month

Fierce Pharma

Amid congressional scrutiny on U.S. | The drugmaker's commitment will start by January 1, 2025, and follows similar moves by peers Boehringer Ingelheim and AstraZeneca. Before the pledges, the companies—and Teva—caught Senate heat over high U.S. inhaler prices.

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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.