Fri.Dec 02, 2022

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FDA lifts pause on Beam plans to test base editing cancer therapy

Bio Pharma Dive

The FDA’s decision is a step forward for a type of drugmaking known as “multiplex editing,” which involves editing several genes simultaneously.

Gene 316
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India’s CDSCO approves Bharat Biotech’s intra-nasal vaccine for Covid-19

Pharmaceutical Technology

India’s Central Drugs Standard Control Organisation (CDSCO) has granted approval for Bharat Biotech’s BBV154 vaccine for treating Covid-19. BBV154 is claimed to be the first intra-nasal vaccine for Covid-19 in the world. It has been approved for restricted use in emergencies for people aged 18 and above in India for the first two-dose schedule and homologous booster doses.

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Rigel wins US approval of rival drug to Servier leukemia treatment

Bio Pharma Dive

The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo.

Medicine 315
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PTC Therapeutics’ Waylivra receives Brazilian regulatory approval

Pharmaceutical Technology

PTC Therapeutics has received approval from the Brazilian health regulatory agency, ANVISA, for Waylivra (volanesorsen) to treat familial partial lipodystrophy (FPL). This is marked as the first approval for Waylivra for the indication worldwide. In 2018, the company in-licensed regional rights to the therapy from Ionis Pharmaceuticals’ wholly owned subsidiary Akcea Therapeutics to commercialise in Latin America.

Licensing 130
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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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J&J’s Duato to replace departing Gorsky as board chair

Bio Pharma Dive

The board reshuffling will consolidate Duato’s leadership of J&J as the company absorbs a big medtech acquisition and nears a planned spin out of its consumer health division.

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STAT+: Alzheimer’s researchers try out an unfamiliar sensation: optimism

STAT News

SAN FRANCISCO — Scientific meetings about Alzheimer’s disease can be funereal affairs, with researchers from around the world gathering in hopes that the latest in a long line of negative clinical trials might light the path to a long-awaited success. This year was different. Nearly 2,000 people showed up to the Clinical Trials in Alzheimer’s Disease meeting, a conference record, to hear about lecanemab, a drug from Eisai and Biogen that appears to have broken the decades-lo

Research 145

More Trending

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Opinion: Congress: Close the gap between funding for nutrition research and the toll diet-related disease takes on Americans

STAT News

You are what you eat. Every year, new scientific discoveries make clear that food is critical to health. In recent years, nutrition research trials have shown that a Mediterranean diet reduces cardiovascular disease; ultra-processed foods increase weight gain; omega-3 fatty acids improve IQ in preterm babies; cocoa prevents heart attacks; and vitamin D supplements do — well, almost nothing.

Research 141
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Short term memory problems can be improved with laser therapy, according to new study

Medical Xpress

Laser light therapy has been shown to be effective in improving short term memory in a study published in Science Advances.

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Opinion: Breakthrough Therapies Act: Good idea, wrong solution

STAT News

The Breakthrough Therapies Act , recently proposed by Senators Rand Paul (R-Ky.) and Cory Booker (D-N.J.) as a way to expand access for therapeutic purposes to potentially beneficial but highly regulated Schedule I substances like psilocybin and LSD, has the right underlying idea but provides a solution that is wrong. The act would automatically reclassify to Schedule II any experimental medicine designated by the Drug Enforcement Agency as a Schedule I controlled substance — defined as a

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Studies into video telemedicine diagnostic accuracy and patient satisfaction find positive trends

Medical Xpress

During the first months of the COVID-19 pandemic, clinicians across Mayo Clinic transitioned to virtual modes of care to continue to treat patients safely—resulting in an increase of over 10,000% in video telemedicine visits between patients and clinical care team members across the organization. These monumental shifts in care delivery also made for an opportunity to conduct some of the largest video telemedicine studies to date.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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STAT+: AAM’s Dan Leonard, president of generic drug lobby, ousted

STAT News

The generic drug industry’s lobbying group, the Association for Accessible Medicines, fired its president Dan Leonard, two sources familiar with the decision said Friday evening. It was not immediately clear why Leonard was fired, and AAM didn’t immediately respond to a request for comment. The sources said its members were frustrated that it was late to engage when Congress was debating the Inflation Reduction Act, which gives Medicare the power to negotiate drug prices.

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Prostate cancer: Getting ever closer to diagnosis using an 'electronic nose'

Medical Xpress

The diagnosis of prostate cancer using a non-invasive method and with greater accuracy than traditional diagnostic procedures is ever closer to becoming a reality.

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In Philadelphia, ‘tranq’ is leaving drug users with horrific wounds. Other communities are bracing for the same

STAT News

PHILADELPHIA — The volunteers were handing out the staples of harm reduction: safe injection and smoking kits, condoms, and Narcan, the opioid overdose reversal medication. Down the line, they were distributing hats, socks, coats, and blankets to the people who use drugs who came to this outreach event on a recent Saturday, a bright, cold morning a few days before Thanksgiving.

Drugs 136
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New position statement explicitly supports family, career ambitions

Medical Xpress

The Society of NeuroInterventional Surgery (SNIS), a scientific and educational association with more than 1,000 members dedicated to advancing the specialty of neurointerventional surgery, has made a statement in support of pregnancy and parental leave policies for those in the field who are birthing or non-birthing parents including those who adopt, foster, and the like.

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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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Image manipulation in science is suddenly in the news. But these cases are hardly rare

STAT News

In 2004, Mike Rossner and Kenneth Yamada, two top editors at the Journal of Cell Biology, wrote an editorial alerting readers to what they saw as an emerging problem in science: Thanks to Photoshop, researchers could prettify the images in their manuscripts in ways that might cross the line into deception in an effort to clear the bar of peer review.

Research 122
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UK approval for CBD pain treatment

Drug Discovery World

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a CBD/THC combination treatment under its Named Patient programme and other compassionate areas. Medlab’s NanaBis, to be used under NanaDol, a botanical version of NanaBis, has previously shown encouraging Phase I/II data for the treatment of cancer-induced bone pain and could be a potential alternative to opioids. .

Doctors 98
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STAT+: An Anavex study spin job sullies an otherwise spectacular Alzheimer’s conference

STAT News

Anavex Life Sciences said Thursday that its experimental treatment for Alzheimer’s disease slowed the rate of cognitive decline in a clinical trial — but only by changing the study’s primary efficacy goals, omitting patients from the analysis, randomly altering data, making basic math errors, whistling past safety concerns, and using nonsensical statistical tests.

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Improving trial predictability: leveraging AI-powered analytics to guide trial design, strategy, and operations

pharmaphorum

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. This emphasises sponsors’ need for enrolment predictability. The challenge the industry faces, however, is that operational certainty is exacerbated by the impact of global disruptions, such as the effect of COVID-19, natural disasters, and regional conflicts.

Trials 98
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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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STAT+: Inside one startup’s quest to build proteins from scratch using artificial intelligence

STAT News

A Somerville startup and an academic lab in Seattle say they have developed a way to use artificial intelligence to design proteins that don’t exist in nature. Proteins help people move, digest food, and fight infections — to name a few of their numerous functions. They’re also the basis of a nearly  $300 billion  drug industry for treating cancer, immune diseases, and other conditions.

Protein 111
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Breast implants after mastectomy associated with very low risk of lymphoma

Medical Xpress

The incidence of a rare cancer, anaplastic large-cell lymphoma (ALCL), has surged in recent years, possibly because of the growing use of textured breast implants. Considering this trend, some breast cancer patients who undergo mastectomy may wonder if the benefits of getting reconstructive implants are worth the risk of developing a second cancer.

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STAT+: Up and down the ladder: The latest comings and goings

STAT News

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Batteryless and wireless device detects coronavirus with magnetostrictive composite plates

Medical Xpress

What if you could tell if your surroundings contained COVID-19 particles or droplets the moment they or you entered the vicinity? This is now closer to reality. A research group has engineered a batteryless, self-powering device that can wirelessly transmit the detection of coronavirus in the air.

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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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STAT+: Pharmalittle: Private equity moving to buy clinical trials firms; data provider limits media access to drug prices

STAT News

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda, for now, appears rather modest. We plan to promenade extensively with the official mascot, catch up on our reading, and have a listening party with Mrs. Pharmalot. And what about you?

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Mapping the hidden connections between diseases

Medical Xpress

A new study led by UCL researchers has identified patterns in how common health conditions occur together in the same individuals, using data from 4 million patients in England.

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Healthcare leaders warn about unsustainable pressure on mental health services

Pharma Times

Patients and service users routinely struggle to access mental healthcare across the NHS

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EU bans cough syrup chemical over severe allergies

Medical Xpress

Cough medicines containing the chemical pholcodine should be banned due to the risk of potentially deadly allergic reactions in people under general anaesthetic, the European Union's drug regulator said Friday.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker

Fierce Pharma

With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker. fkansteiner. Fri, 12/02/2022 - 09:51.

Drugs 108
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How parents can play a key role in the prevention and treatment of teen mental health problems

Medical Xpress

More than 44% of teens reported persistent feelings of sadness and hopelessness in the first half of 2021, according to a report from the Centers for Disease Control and Prevention. The early 2022 report, which was based on an online survey, also found that nearly 20% had seriously considered suicide, and 9% attempted suicide.

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Merck KGaA’s arpraziquantel validated by European Medicines Agency

Pharma Times

Positive scientific opinion by EMA would create pathway for arpraziquantel in African endemic countries

Medicine 119
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Seizures seem tied to faster decline in people with dementia

Medical Xpress

Dementia patients who suffer from seizures tend to decline faster and die younger, according to a new study that urges caregivers to watch for these sudden brain changes.

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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.