Wed.Oct 11, 2023

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A decade later, biotech’s CRISPR revolution is still going strong

Bio Pharma Dive

Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

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Why are haemophilia gene therapies so expensive?

Pharmaceutical Technology

Biomarin and CSL Behring’s haemophilia gene therapies have boosted innovation in the field, but assessing their cost effectiveness is less than straightforward.

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Novo Nordisk’s Ozempic shows kidney benefit in large study

Bio Pharma Dive

The finding from the study of its diabetes drug, which Novo didn’t detail, could help the company in its competition with rival drugmaker Eli Lilly.

Drugs 317
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Cybersecurity in pharma: Q&A with GlobalData thematic analyst

Pharmaceutical Technology

GlobalData analyst Wafaa Hasan discusses key topics around cybersecurity for the pharmaceutical industry.

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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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Cell therapy developer Sana turns again to layoffs

Bio Pharma Dive

The once high-flying biotech is cutting staff for the second time in a year and delaying some research to save cash.

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There’s One Critical Thing We Can Do to Keep Alzheimer’s Symptoms at Bay

AuroBlog - Aurous Healthcare Clinical Trials blog

Deep sleep could be key to forestalling slow declines in brain health that may one day lead to Alzheimer’s disease, the most common form of dementia.

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More Trending

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Advances in space technology to aid remote surgical care in healthcare industry: Dr. Mylswamy Annadurai

AuroBlog - Aurous Healthcare Clinical Trials blog

The advancements in space technology have given hope to the healthcare industry. An amalgamation of the two can provide high-quality surgical care to patients around the world without any geographic barriers, eventually leading to easy access, said Dr.

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SparX and Arovella partner to develop CAR-iNKT cell therapy

Pharmaceutical Technology

SparX’s monoclonal antibody was used to develop the Claudin 18.2 tumour-specific antigen targeting CAR-iNKT cell therapy.

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October 11, 2023: In This Friday’s PCT Grand Rounds, Incorporating Social Determinants of Health Into PCORnet

Rethinking Clinical Trials

Keith Marsolo, PhD In this Friday’s PCT Grand Rounds, Keith Marsolo of Duke University will present “Incorporating Social Determinants of Health Into PCORnet.” The Grand Rounds session will be held on Friday, October 13, 2023, at 1:00 pm eastern. Marsolo is an associate professor of population health sciences at Duke University and a cochair of the NIH Pragmatic Trials Collaboratory’s Electronic Health Records Core Working Group.

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Gritgen Therapeutics launches operations at GMP facility in China

Pharmaceutical Technology

Gritgen Therapeutics has launched operations at its commercial GMP facility in Suzhou Industrial Park, China.

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

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Kyowa Kirin to acquire Orchard Therapeutics in deal worth $477m

Pharma Times

The deal gives Kyowa access to a therapy for early-onset metachromatic leukodystrophy - News - PharmaTimes

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Astellas, BioLabs and Mitsui collaborate for Japanese life sciences hub

Pharmaceutical Technology

The collaboration aims to boost open innovation hub SakuLab-Tsukaba at Astellas’ Tsukuba Research Centre.

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SMC recommends Bayer’s cancer treatments for NHS Scotland use

Pharma Times

Eligible patients in Scotland will now have access to Nubeqa and Stivarga - News - PharmaTimes

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MinervaX raises $57m for Phase III trial of maternal strep vaccine

Pharmaceutical Technology

MinervaX is currently conducting Phase II trials of the prophylactic maternal vaccine against group B streptococcus bacterial infections.

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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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Novo Nordisk's unstoppable semaglutide clears kidney disease trial early on positive efficacy

Fierce Pharma

For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate. | For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate.

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Kanvas Biosciences strengthens therapeutics position with microbiome acquisition

Pharmaceutical Technology

Microbiome mapping technology company Kanvas Biosciences has announced the acquisition of assets from California-based Federation Bio, bringing with it two active therapeutics programmes.

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Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)

Rethinking Clinical Trials

       Speakers Speaker: David M. Murray, PhD NIH Associate Director for Prevention and Director, NIH Office of Disease Prevention Moderator: Jonathan C. Moyer, PhD Statistician, NIH Office of Disease Prevention Slides Keywords Implementation; Study design; Hybrid; Clustered; DECIPHeR Key Points People often contest that hybrid designs are not as rigorous as they should be.

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Agomab raises funding for fibrosis-focused pipeline development

Pharmaceutical Technology

Agomab Therapeutics has secured €94.9m ($100m) in its Series C funding round to advance the development of its fibrosis-focused pipeline.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novo Ends Semaglutide Kidney Study Early Due to Strong Efficacy Signals

BioSpace

Following the recommendations of an independent Data Monitoring Committee, Novo Nordisk has halted a Phase III kidney outcomes study of semaglutide ahead of schedule due to strong efficacy signals.

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Sellas wins FDA orphan drug designation for AML candidate

Pharmaceutical Technology

Topline results from an ongoing Phase IIa study with SLS009 are expected by the end of the year.

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Pfizer inks another EpiPen antitrust settlement, this one worth $50M

Fierce Pharma

Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief m | Pfizer has agreed to pay $50 million to resolve a class-action, antitrust case which alleged the company teamed up with others to delay the entry of a generic version of the EpiPen allergy relief medicine.

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BioMap and Sanofi to co-develop AI modules for biotherapeutic drug discovery

Pharmaceutical Technology

BioMap has entered into a strategic alliance with Sanofi to co-develop AI modules and expedite drug discovery for biotherapeutics.

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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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Economist Impact’s Future of Health Europe Summit: Day One

pharmaphorum

Economist Impact’s Future of Health Europe Summit: Day One Mike.

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Cellipont and Diakonos to develop cell therapy for glioblastoma

Pharmaceutical Technology

Cellipont Bioservices has signed an agreement with Diakonos Oncology to develop DOC1021, a cell therapy to treat glioblastoma multiforme.

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Biogen lays off staffers at newly acquired Reata, with 113 set to lose positions

Fierce Pharma

That didn't take long. | Just two weeks after Biogen completed its buyout of Reata Pharmaceuticals, the combined company is trimming its staff. Reata staffers who worked in roles that are already covered at Biogen are losing their jobs.

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Eversana acquires pharmaphorum owner Healthware Group

pharmaphorum

Eversana acquires pharmaphorum owner Healthware Group Phil.

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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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Biotech Bankruptcies Skyrocket

BioSpace

From Statera Biopharma and Sorrento Therapeutics to Aceragen and Infinity Pharmaceuticals, 2023 has seen a record high 28 bankruptcies in the biotech space so far. Here’s why.

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Mallinckrodt wins court go-ahead for 2nd bankruptcy, cutting $1B from opioid payout

Fierce Pharma

Mallinckrodt has essentially walked back its promise to pay $1.7 billion in an opioid settlement thanks to the company's second bankruptcy in just two years. | Mallinckrodt has essentially walked back its promise to pay $1.7 billion in an opioid settlement thanks to the company's second bankruptcy in just two years.

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Faron’s Clever-1 drug shows promise in blood cancers

pharmaphorum

Faron’s Clever-1 drug shows promise in blood cancers Phil.

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With Vtama's success in relieving itching, Dermavant eyes FDA filing in atopic dermatitis

Fierce Pharma

In the race to develop nonsteroidal topical treatments for autoimmune skin conditions, Dermavant is charging toward the finish line—again. | Dermavant has presented evidence that Vtama provides immediate and long-term relief from the severe itch condition pruritus, the most prevalent symptom of atopic dermatitis. The trial results bolster Dermavant's effort to win a label expansion for the drug.

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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.