Sat.Jul 27, 2024 - Fri.Aug 02, 2024

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FDA fast-tracks first new fibromyalgia drug in 15 years

Drug Discovery World

The US Food and Drug Administration (FDA) has granted Fast Track designation to Tonix Pharmaceuticals’ Tonmya (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia. Tonmya is a non-opioid, centrally-acting analgesic drug under development for treating fibromyalgia, which is a common chronic pain condition affecting mostly women.

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Generation X and millennials in US have higher risk of developing 17 cancers compared to older generations

Science Daily: Pharmacology News

A new large study suggests incidence rates continued to rise in successively younger generations in 17 of the 34 cancer types, including breast, pancreatic, and gastric cancers. Mortality trends also increased in conjunction with the incidence of liver (female only), uterine corpus, gallbladder, testicular, and colorectal cancers.

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Talk of the Towne episode 11: American Kidney Fund

Antidote

In the latest installment of Talk of the Towne, we sat down with Melanie Paris, M.A., MPH, the Senior Director of Strategic Partnerships and Kidney Disease Education at the American Kidney Fund (AKF). In the discussion, we got her insights into the types of kidney disease, treatment disparities, and the importance of clinical research in the field. She also shared many valuable resources for individuals and their loved ones living with kidney disease, which are linked here.

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Pfizer quits Duchenne gene therapy, lays off staff following study setback

BioPharma Drive: Drug Pricing

The company is letting go of 150 staffers alongside a decision to officially terminate the high-profile program, which was acquired in 2016.

Therapies 135
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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.

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AI supercomputing speeds up chemistry calculations 80x

Drug Discovery World

Collaborators SandboxAQ and NVIDIA have reported a breakthrough that allows an 80-fold speed increase in computational chemistry calculations. SandboxAQ leverages Large Quantitative Models (LQMs) and the NVIDIA CUDA-accelerated Density Matrix Renormalization Group (DMRG) algorithm. Combining the CUDA-DMRG algorithm, the NVIDIA Quantum platform, and NVIDIA accelerated computing speeds up calculations more than 80x, compared with traditional 128-core CPU computations.

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Link between global warming and rising sea levels

Science Daily: Pharmacology News

A new study suggests that Earth's natural forces could substantially reduce Antarctica's impact on rising sea levels, but only if carbon emissions are swiftly reduced in the coming decades. By the same token, if emissions continue on the current trajectory, Antarctic ice loss could lead to more future sea level rise than previously thought.

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Lilly obesity drug shows heart benefit in late-stage trial

BioPharma Drive: Drug Pricing

The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.

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Why the UK needs to nurture a fit-to-fund life sciences sector 

Drug Discovery World

Professor Chris Molloy , CEO of Medicines Discovery Catapult (MDC), writes about the state of the UK’s drug discovery sector, exploring economic challenges and what is needed to support the country’s rich life sciences talent. We should all be proud of and inspired by the UK life sciences sector’s rich heritage. 25% of the world’s best-selling medicines have been discovered on British soil.

Science 162
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Virus that causes COVID-19 is widespread in wildlife, scientists find

Science Daily: Pharmacology News

SARS-CoV-2, the virus responsible for COVID-19, is widespread among wildlife species, according to new research. The virus was detected in six common backyard species, and antibodies indicating prior exposure to the virus were found in five species, with rates of exposure ranging from 40 to 60 percent depending on the species.

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Daily Aspirin Cuts Odds for Colon Cancer: Who Benefits Most?

Drugs.com

THURSDAY, Aug. 1, 2024 -- It's long been known that a daily dose of low-dose aspirin helps keep colon cancer at bay.But new research suggests that those who benefit most are folks whose lifestyles up their odds for the disease in the first.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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First-of-its-kind cell therapy approved by FDA for rare soft tissue cancer

BioPharma Drive: Drug Pricing

Adaptimmune’s Tecelra is the first TCR cell therapy to reach market and, at $727,000, is also the priciest cellular medicine for cancer in the U.S.

Therapies 123
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The untapped potential of the transcriptome  

Drug Discovery World

Serna Bio was founded by Rabia Khan , who is also the CEO, to unlock the transcriptome as a drug discovery target. DDW’s Megan Thomas speaks to Khan about the work her team is doing to create the first map of the druggable transcriptome, which involves understanding RNA biology to discover small molecule drugs. MT: Why is the transcriptome important for drug discovery?

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Retreat of tropical glaciers foreshadows changing climate's effect on the global ice

Science Daily: Pharmacology News

As they are in many places around the globe, glaciers perched high in the Andes Mountains are shrinking. Now, researchers have uncovered evidence that the high-altitude tropical ice fields are likely smaller than they've been at any time since the last ice age ended 11,700 years ago.

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FDA Warns of Danger From At-Home Chemical Peels

Drugs.com

THURSDAY, Aug. 1, 2024 -- Don't use a chemical peel to help rejuvenate your skin unless it's done under the supervision of a trained professional, the U.S. Food and Drug Administration has advised. "FDA is warning consumers not to purchase or use.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Moderna shares fall amid lower sales outlook for RSV, COVID shots

BioPharma Drive: Drug Pricing

The biotech cited competitive pressure and “very low” expected sales in Europe for its latest guidance cut, which sent shares down by nearly 20%.

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Obesity drug competition expected to intensify by 2030

Drug Discovery World

Viking Therapeutics’ dual GLP-1/GIP receptor agonist VK2735 could become a direct competitor to Eli Lilly’s Mounjaro/Zepbound (tirzepatide), predicts data analytics company GlobalData. In February 2024, Viking Therapeutics published Phase IIa results for its VK2735 candidate, which is being investigated both as a weekly subcutaneous injection and as an oral tablet to treat obesity.

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Key to rapid planet formation

Science Daily: Pharmacology News

Researchers have developed a new model to explain the formation of giant planets such as Jupiter, which furnishes deeper insights into the processes of planet formation and could expand our understanding of planetary systems.

Research 137
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Mpox Has Surged in Africa Amid Shortages of Vaccines and Treatments

Drugs.com

FRIDAY, Aug. 2, 2024 -- Mpox cases have soared by 160% in Africa this year, as a lack of both vaccines and treatments hamper efforts to slow the spread of the virus.In a report released by the Africa Centers for Disease Control and Prevention on.

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Perficient Included In Forrester’s Modern Application Development Services Landscape, Q3 2024

Perficient: Drug Development

Imagine a world where your business can effortlessly keep pace with technological advancements and continuously changing customer expectations. The ability to swiftly develop new technology products and applications is crucial to staying competitive. However, relying solely on in-house development capabilities is not always feasible for many organizations.

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Six start-ups move to Phase II of CRUK’s Tech Accelerator

Drug Discovery World

Six teams have been accepted onto Phase II of the Cancer Tech Accelerator, the entrepreneur training programme from Capital Enterprise dedicated to supporting cutting-edge oncology technology commercialisation. Selected from the 25 teams that took part in Phase I, three of the Phase II project teams will receive a £70,000 grant to continue the development of their technology, while three more Rising Stars will benefit from four months of mentorship and training.

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Breaking MAD: Generative AI could break the internet, researchers find

Science Daily: Pharmacology News

Researchers have found that training successive generations of generative artificial intelligence models on synthetic data gives rise to self-consuming feedback loops.

Research 134
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FDA Approves Another Blood Test for Colon Cancer Screening

Drugs.com

MONDAY, July 29, 2024 -- The U.S. Food and Drug Administration on Monday approved a new blood test that can spot colon cancer.In late May, an FDA advisory panel had voted 7-2 that the benefits outweigh the risks when using the Guardant Health's.

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Real-World Evidence in Clinical Drug Development

Quanticate

Real-world evidence (RWE) is changing clinical drug development, bridging the gap between controlled clinical trial environments and the complexities of everyday patient experiences. By using Real-World Data (RWD) from various sources like electronic health records (EHRs), insurance claims, and digital health tools, researchers can gather valuable insights into how drugs work in a wide range of populations.

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Bacteria destroys head and neck cancer tumours

Drug Discovery World

Researchers at Guy’s and St Thomas’, and King’s College London in the UK have found that a bacteria is toxic for head and neck cancer and could lead to better treatments for patients. Fusobacterium is usually associated with the progression of bowel cancer. However, new research published in Cancer Communications shows that in the most common type of head and neck cancer, Fusobacterium actually destroys tumour cells.

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Cannabinoid CBG reduces anxiety and stress in first human clinical trial

Science Daily: Pharmacology News

A lesser-known cannabinoid that is gaining in popularity Cannabigerol (CBG) effectively reduced anxiety in a clinical trial without the intoxication typically associated with whole plant cannabis. It may even have some memory enhancing effects, according to a new study. For the study, researchers conducted the first human clinical trial investigating the acute effects of CBG on anxiety, stress and mood.

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Some Americans Lost Trust in Medical Profession During Pandemic

Drugs.com

WEDNESDAY, July 31, 2024 -- The number of people who trust doctors dropped steeply during the COVID-19 pandemic, a new study says.Worse, those who lost their faith in medicine are less likely to get vaccinated against COVID or the flu, researchers.

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Benefits of Drug Patent Licensing Agreements

Drug Patent Watch

The Power of Patent Licensing: Unlocking Innovation and Access to Medicines Patent licensing agreements have become a crucial tool in the pharmaceutical industry, allowing companies to collaborate and…

Licensing 105
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Improving the standard of biological drugs

Drug Discovery World

DDW Editor Reece Armstrong speaks to Dr Steven Powell , co-founder of Glen Clova Scientific (GCS), about the company’s approach of using virus-like particles (VLPs) to treat conditions such as eczema and asthma, and what the current market looks like for this therapy area. Spun-out of the Univeristy of Dundee in 2022, Glen Clova Scientific is developing a new class of active biologic drugs for chronic inflammatory and autoimmune disorders.

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NASA data shows July 22, 2024 was Earth's hottest day on record

Science Daily: Pharmacology News

July 22, 2024, was the hottest day on record, according to a NASA analysis of global daily temperature data. July 21 and 23 of this year also exceeded the previous daily record, set in July 2023. These record-breaking temperatures are part of a long-term warming trend driven by human activities, primarily the emission of greenhouse gases.

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FDA Warns of Accidental Overdoses from Compounded Versions of Ozempic

Drugs.com

TUESDAY, July 30, 2024 -- People taking compounded versions of Ozempic have been overdosing on the drug, the U.S. Food and Drug Administration warns.These ODs typically are due to miscommunications or miscalculations regarding dosage, the FDA.

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Biotech startup Airna raises $60M for RNA editing medicines

BioPharma Drive: Drug Pricing

Launched last September, the company is working on a treatment for alpha-1 antitrypsin deficiency, which it said could enter the clinic in 2025.

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MHRA approves semaglutide to reduce risk of cardiovascular events

Drug Discovery World

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for semaglutide (Wegovy) to reduce the risk of overweight and obese adults suffering from heart attacks or stroke. The GLP-1 receptor agonist is already approved for use in the treatment of obesity and for weight management, to be used alongside diet, physical activity and behavioural support.

Disease 147
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What no one has seen before -- simulation of gravitational waves from failing warp drive

Science Daily: Pharmacology News

Physicists have been exploring the theoretical possibility of spaceships driven by compressing the four-dimensional spacetime for decades. Although this so-called 'warp drive' originates from the realm of science fiction, it is based on concrete descriptions in general relativity. A new study takes things a step further -- simulating the gravitational waves such a drive might emit if it broke down.

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Many Women Don't Know This Warning Sign of Endometrial Cancer

Drugs.com

FRIDAY, Aug. 2, 2024 -- Too many women don’t know a key warning sign of endometrial cancer, the most common cancer of the female reproductive organs, a new study shows.More than one-third (37%) of women surveyed did not know that postmenopausal b.

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