Bio Pharma Dive
JANUARY 11, 2023
Executives at the two pharmas talked up their rival autoimmune disease drugs at the J.P. Morgan Healthcare Conference, while Prime Medicine’s CEO pondered a busy future.
Pharmaceutical Technology
JANUARY 11, 2023
BioNTech has signed an agreement to buy UK-based artificial intelligence (AI) and machine learning (ML)-based products developer InstaDeep in a deal valued at about $440m (£362m) in cash and shares. InstaDeep shareholders will also receive up to $243.1m (£200m) in additional performance-based future milestone payments. The latest move follows an initial equity investment made by BioNTech as part of the Series B financing round of InstaDeep in January last year.
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Bio Pharma Dive
JANUARY 11, 2023
Airsupra joins a growing portfolio of new drugs that are helping the British drugmaker offset wilting sales of older respiratory medicines like Pulmicort.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 11, 2023
Inside your brain there is a map of every bedroom you’ve slept in. Every kitchen you’ve cooked in. Every city you’ve worked in, every country you’ve holidayed in. There’s even a threadbare map of every Universe you’ve dreamt in. Squeezing this vast trove of detailed information into a small tapestry of neurons is possible thanks […].
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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
Bio Pharma Dive
JANUARY 11, 2023
The agency will kick off discussions on how it will negotiate Medicare drug prices in the spring and publish a list of the first 10 drugs selected by Sept. 1, 2023.
Pharmaceutical Technology
JANUARY 11, 2023
AbbVie has collaborated with Anima Biotech for the discovery and development of mRNA biology modulators against three oncology and immunology targets. The collaboration will use the mRNA Lightning platform from Anima and AbbVie’s oncology and immunology expertise to discover new mRNA biology modulators against the targets. AbbVie will get exclusive rights to license and develop and market the programmes.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 11, 2023
The US Food and Drug Administration (FDA) has granted Fast Track designation for UNION therapeutics’ oral orismilast to treat moderate-to-severe hidradenitis suppurativa (HS). The company stated that the designation for orismilast highlights the urgent requirement to treat HS, a chronic, inflammatory, progressive, and scarring skin disease. Orismilast, a PDE4 inhibitor, targets the PDE4 subtypes which are connected to inflammation.
Bio Pharma Dive
JANUARY 11, 2023
The companies forecast that annual sales of two experimental anticoagulants they’re respectively developing could exceed $5 billion later this decade.
Pharmaceutical Technology
JANUARY 11, 2023
Avance Clinical is a full-service contract research organisation (CRO) that provides clinical research capabilities for biotech companies worldwide. The company specialises in offering high-touch clinical trial solutions tailored to clients’ individual needs. In this interview with Pharmaceutical Technology, Avance CEO Yvonne Lungershausen outlines the company’s services and what sets it apart from other CROs in the biotech sector, as well as its expansion plans for the near future.
Rethinking Clinical Trials
JANUARY 11, 2023
This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Emily Largent will present “Ethical Considerations When Vulnerable Populations are Subjects in Pragmatic Trials.” The Grand Rounds session will be held on Friday, January 13, 2023, at 1:00 pm eastern.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 11, 2023
Clinical Establishment (CE) Regulation should be adopted on priority basis because it stipulates eligibility and qualification of personnel running a lab, standards or guidelines on the infrastructure and testing facilities. This is taking a long time to progress, according to Dr. Arvind Lal, chairman, Dr. Lal PathLabs while revealing the fact that the country only […].
NPR Health - Shots
JANUARY 11, 2023
When first lady Jill Biden went for routine surgery for a small lesion above her right eye, doctors found two more lesions, and removed them, too, the White House said.
STAT News
JANUARY 11, 2023
The air in Mexico City was once so toxic that people watched as dead birds fell out of the sky. In 1992, the United Nations declared the city the most polluted in the world, with its unregulated diesel engines, factory production, fossil-fuel powered energy plants, and widespread use of internal-combustion engines, all trapped in a high-altitude, mountain-lined valley.
NPR Health - Shots
JANUARY 11, 2023
People who lose track of time aren't rude, researchers say — they may just be listening to their inner timekeeper instead of an external clock. Living according to "event time" has its benefits.
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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.
pharmaphorum
JANUARY 11, 2023
Over the past few decades, data generation has veritably exploded. However, the ‘Big Data paradigm’ is not so much concerned with the volume of that data, but how businesses and, indeed, industries can derive meaningful insights from what has become a glut of information. With the currently popular approach to artificial intelligence (AI) focussing on the Big Data paradigm, also, pharmaphorum spoke with Adityo Prakash, CEO of Verseon, about the whys and wherefores, delving deeper into the proces
NPR Health - Shots
JANUARY 11, 2023
Thousands of nurses at two New York hospitals are on strike for a third day. Their staffing shortages and other problems predate the pandemic, says the president of the American Nurses Association. (Image credit: Michael M.
STAT News
JANUARY 11, 2023
The last two decades have been a period of declining economic influence for practicing physicians. Independent medical practice has been steadily eroded by hospital employment, as well as by private equity and corporate acquisitions, to the point where less than half of physicians in the U.S. work in private practices. I have argued that the emerging scarcity of practitioners will eventually reverse this erosion.
pharmaphorum
JANUARY 11, 2023
AbbVie and Anima Biotech have announced that they are collaborating in a deal worth up to over $580 million to discover and develop drugs that modulate mRNA biology for three targets in cancer and immunology. Anima uses its mRNA Lightning platform to discover small molecules and determine their mechanisms of action for diseases previously deemed undruggable, with scientists searching for compounds that target proteins with roles in regulating mRNA, so as to affect disease states through post-tra
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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
JANUARY 11, 2023
WASHINGTON — After 9/11, Congress created an entirely new government agency to address the threat of terrorism, and Americans are still taking off their shoes in airports more than 20 years later. After a pandemic that killed more than 1 million people in the United States alone, very little about the federal government has changed at all, and it may not for a long time.
NPR Health - Shots
JANUARY 11, 2023
Before being flown to Buffalo, N.Y., Hamlin had been treated for nearly a week at the University of Cincinnati Medical Center after going into cardiac arrest on the field during Monday Night Football.
STAT News
JANUARY 11, 2023
Three years after news of the first cases of Covid-19 infections and deaths began to appear, the global response to pandemics remains in a sluggish, reactive mode, waiting until dire threats emerge before initiating action. Take the latest Ebola outbreak in central Uganda. It’s been more than a month since the last case has been found, and a two-month lockdown of two districts west of the capital, Kampala, ended in mid-December.
XTalks
JANUARY 11, 2023
XBB.1.5 is the newest Omicron subvariant that appears to be quickly taking a strong foothold in the US, making up almost a third of new COVID-19 cases nationally as of January 7, according to the Centers for Disease Prevention and Control ( CDC ). In the northeast of the country, XBB.1.5 made up 72 percent of COVID infections as of last week. The new Omicron offshoot appears to be the most transmissible variant of SARS-CoV-2 to date.
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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
JANUARY 11, 2023
When case counts suggest Covid-19 is in check, the truth is in the toilets. The pandemic has long been in its fatigue phase , making it hard for public health departments to have the return on investment to keep testing clinics open — and making it all but impossible to know, in real time, how many people in a certain area are sick. And while hospitalizations are fairly reliable, that indicator lags behind cases.
NPR Health - Shots
JANUARY 11, 2023
A small study shows pharmacists could play a key role in getting addiction medication directly into the hands of more people who need it, but there are a lot of barriers to expanding the project.
STAT News
JANUARY 11, 2023
Verily, a health technology company spun out of tech giant Alphabet, announced Wednesday that it is restructuring its management team and business and cutting 15% of its workforce. According to a memo exclusively obtained by STAT, Amy Abernethy , the former Food and Drug Administration official that Verily brought on to advance the use of technology in speeding up clinical trials, will be elevated to president of product development and chief medical officer.
NPR Health - Shots
JANUARY 11, 2023
Grant Wahl's death at the Qatar World Cup set off conspiracy theories that persisted long after they were disproven.
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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
JANUARY 11, 2023
A physicians group is urging the Food and Drug Administration to hold an expert panel meeting to review an experimental Alzheimer’s treatment before issuing a full-blown approval, a move that reflects nagging safety issues surrounding the medication. The appeal follows a step announced last week by the FDA to grant accelerated approval for the medicine, which is called Leqembi.
Pharma Times
JANUARY 11, 2023
Candidate will go through the development programme, which includes safety and tolerability studies
STAT News
JANUARY 11, 2023
SAN FRANCISCO — Decoding the billions of chemical letters that help shape who we are once cost a fortune. But genomics startup Element Biosciences on Wednesday announced it can now read a whole human genome for as little as $200 — the cost of a couple trips to the grocery store. Element’s announcement, made during the J.P. Morgan Healthcare Conference , comes after Illumina and Ultima made commitments to bring the cost of reading a whole genome down to $200 and $100, respect
Fierce Pharma
JANUARY 11, 2023
AstraZeneca's first-in-class rescue inhaler Airsupra wins FDA nod—but only for adult use. esagonowsky. Wed, 01/11/2023 - 09:03.
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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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