Pharmaceutical Technology
MARCH 16, 2023
Talem Therapeutics, a subsidiary of Immunoprecise Antibodies, has entered a multi-target artificial intelligence (AI)-driven antibody discovery collaboration with Libera Bio. The partnership will use nanotechnology, which was proven in vivo, for providing antibodies inside tumour cells and provides a potential solution to address the medical challenge.
Bio Pharma Dive
MARCH 16, 2023
The guidance fills in details for one of the central pharmaceutical provisions of the Inflation Reduction Act, signaling how the agency will use its new authority.
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Pharmaceutical Technology
MARCH 16, 2023
Global biopharmaceutical firm UCB has entered an early drug discovery collaboration with Aitia. The collaboration is aimed at discovering and validating new drug targets and drug candidates that are linked to clinical endpoints causally in Huntington’s disease, a debilitating genetic disorder. It will combine the use of new drug targets for Huntington’s disease from Aitia’s Gemini Digital Twins with the expertise of UCB in preclinical model systems and drug research in neurodeg
Bio Pharma Dive
MARCH 16, 2023
The companies disagree over what qualifies for a payment of up to $300 million that’s associated with inclusion of heart data on the cholesterol drug’s label.
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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
Pharmaceutical Technology
MARCH 16, 2023
Silicon Valley Bank (SVB), the 16th largest bank in the US, collapsed on Friday 10 March. Its operations were seized by the Federal Deposit Insurance Corporation after a nearly two-day bank run that resulted in approximately $175bn of customer deposits being put at risk. News of the SVB crisis spread quickly from 8–10 March and into the weekend, and the US government finally announced on 12 March that commercial clients would be able to access all of their funds.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 16, 2023
The Central Drugs Standard Control Organisation (CDSCO) has approved two more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules (MDR), 2017.
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NPR Health - Shots
MARCH 16, 2023
A Mississippi woman's life has been transformed by a treatment for sickle cell disease with the gene-editing technique CRISPR. All her symptoms from a disease once thought incurable have disappeared.
Rethinking Clinical Trials
MARCH 16, 2023
In the latest episode of the NIH Collaboratory Grand Rounds podcast , Dr. Michael Gibson and Dr. Adrian Hernandez continue their discussion about The Heartline Trial and a new paradigm for virtual clinical trials. The full February 17 Grand Rounds webinar with Dr. Gibson is also available. The post March 16, 2023: Grand Rounds Podcast Returns, Featuring Dr.
STAT News
MARCH 16, 2023
Are you six months out from your Covid-19 bivalent booster and wondering when you’ll be able to get another shot? If you live in the United Kingdom or Canada, you already have your answer. The Canadian and U.K. governments, acting on recommendations from expert committees, plan to offer spring booster shots for people at highest risk of getting severely sick from Covid.
Medical Xpress
MARCH 16, 2023
In science, findings generated from studying small animals often are generalized and applied to humans, which are orders of magnitude larger. New research, which was led by Shirley Ryan AbilityLab and is published in the Journal of Physiology, not only is the first to directly measure human muscle contractile properties; it also is the first to show that extrapolating such information to humans based on animal measurements generates incorrect predictions.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
STAT News
MARCH 16, 2023
One of the largest operators of ketamine clinics in the country abruptly closed its facilities this week, leaving patients in the dark and out of treatment for depression and other chronic conditions. Ketamine Wellness Centers spanning nine states were shuttered, leaving laid-off employees and patients with more questions than answers. Interest in ketamine to treat depression and other conditions has grown in recent years.
Medical Xpress
MARCH 16, 2023
Elite male soccer players were 1.5 times more likely to develop neurodegenerative disease than population controls, according to an observational study published in The Lancet Public Health journal.
STAT News
MARCH 16, 2023
In a rare move, a U.K. pharmaceutical industry trade group suspended Novo Nordisk for two years due to “serious breaches” involving the promotion of a weight-loss drug that violated a code of practice and discredited the entire sector. The Association of the British Pharmaceutical Industry took this step after receiving a complaint alleging the company had sponsored courses on weight management on LinkedIn for health professionals, without making clear that it was involved in the s
Medical Xpress
MARCH 16, 2023
A new study published in the journal Human-Animal Interactions reveals that your lovable pet dog or cat may lead to you having more restless nights than those graced with long periods of peaceful sleep.
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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.
STAT News
MARCH 16, 2023
WASHINGTON — FDA Commissioner Robert Califf wants private insurers to chip in on doing post-approval clinical research on drugs. It’s a new request from the agency chief, who’s long pushed to find new ways to test drugs. “I’m not aware of a major effort by the insurance plans to help people get studies done,” he said at America’s Health Insurance Plans conference on Thursday.
Medical Xpress
MARCH 16, 2023
In virtually all persons with amyotrophic lateral sclerosis (ALS) and in up to half of all cases of Alzheimer's disease (AD) and frontotemporal dementia, a protein called TDP-43 is lost from its normal location in the nucleus of the cell. In turn, this triggers the loss of stathmin-2, a protein crucial to regeneration of neurons and the maintenance of their connections to muscle fibers, essential to contraction and movement.
STAT News
MARCH 16, 2023
In a sudden about-face, the Food and Drug Administration will hold a meeting of outside experts to consider whether or not to approve Sarepta’s experimental gene therapy for Duchenne muscular dystrophy. The announcement Thursday comes just weeks after the company said the FDA had told it an advisory panel meeting to review the treatment, called SRP-9001, would not be necessary.
Medical Xpress
MARCH 16, 2023
In the late 1980s, when smoking was still allowed on some airline flights, California boosted its tax on cigarettes from 10 to 35 cents a pack, devoting 5 cents to programs to prevent smoking.
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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.
STAT News
MARCH 16, 2023
U.S. regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products. The paltry outcome was largely blamed on steps that brand-name manufacturers take to forestall would-be competitors, as well as the high bar for regulatory approval.
Medical Xpress
MARCH 16, 2023
A new paper published in the Journal of Medical Internet Research describes how generative models such as DALL-E 2, a novel deep learning model for text-to-image generation, could represent a promising future tool for image generation, augmentation, and manipulation in health care. Do generative models have sufficient medical domain knowledge to provide accurate and useful results?
STAT News
MARCH 16, 2023
NEW YORK — Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests. More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.
Medical Xpress
MARCH 16, 2023
In Quebec, colorectal cancer is the second leading cause of cancer deaths in men and the third in women. The appearance and progression of this cancer has been linked to the composition of the gut microbiome. It appears that certain bacteria found in the gut can promote its development.
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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.
STAT News
MARCH 16, 2023
Following the lead of its rivals, Sanofi will cut the price of its most widely prescribed insulin in the U.S. by 78% and also place a $35 cap on out-of-pocket costs for commercially insured patients who take the treatment, which is called Lantus. The moves will go into effect on Jan. 1, 2024. The change comes after Eli Lilly and then Novo Nordisk announced plans this month to reduce list prices for some of their own insulin products by similar amounts.
Medical Xpress
MARCH 16, 2023
The human immunodeficiency virus HIV-1 is able to infect various tissues in humans. Once inside the cells, the virus integrates its genome into the cellular genome and establishes persistent infections. The role of the structure and organization of the host genome in HIV-1 infection is not well understood.
STAT News
MARCH 16, 2023
Before there was CRISPR, aspiring genome editors relied on an island of misfit, less elegantly named enzymes: Zinc-finger nucleases, TALENs, recombinases. Many of these once beloved tools were tossed aside when CRISPR came along, having helped few actual patients but driven plenty of graduate students to exhaustion. They were stubborn, inflexible enzymes, requiring endless engineering.
Medical Xpress
MARCH 16, 2023
An animal tranquilizer has flooded the illicit drug market in Maryland, according to a new study by the National Institute of Standards and Technology (NIST) and the Maryland Department of Health. When injected, the tranquilizer, xylazine, causes wounds at the injection site, in some cases so severe that people need to have their arms or legs amputated.
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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.
STAT News
MARCH 16, 2023
It’s the gold standard in medicine: taking a treatment, and putting it head-to-head against a placebo to confidently declare whether it actually works. But for most medical devices, placebo trials have never been done. The most basic argument for this, put forth by medical device makers and regulators, is that mimicking an invasive procedure is far more difficult than handing patients a sugar pill.
Medical Xpress
MARCH 16, 2023
The nation's opioid crisis, which kills thousands of Americans annually, is best viewed as an ecosystem where all parts of the vexing problem are interconnected, underscoring the need for holistic solutions that address the broad needs of those battling addiction, their families and the communities where they live, according to a new report from the nonprofit RAND Corporation.
STAT News
MARCH 16, 2023
Good morning, everyone, and how are you today? Hazy skies are enveloping the frosty Pharmalot campus, where the official mascot is running about watering the weeds and the short person is sleeping in. As for us, we are busy firing up the trusty coffee kettle and brewing cups of stimulation. Our choice today is roasted coconut, for those who track this sort of thing.
Drug Discovery World
MARCH 16, 2023
There was some good news for the UK life sciences sector in the government’s Spring Budget, but did it go far enough? DDW’s Diana Spencer takes a look at the industry’s reaction. There wasn’t much to write home about in the UK government’s Spring Budget, described by Bloomberg UK’s Marcus Ashworth as a “minimalist masterclass”. However, there was some positive news for what the Chancellor Jeremy Hunt referred to as the “largest life sciences sector in Europe”, and some measures that could assist
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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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