Bio Pharma Dive
FEBRUARY 8, 2023
The company has begun enrolling patients in one of the largest Phase 3 programs in its history, a pair of trials that will test an anticoagulant it believes can be a future blockbuster.
Pharmaceutical Technology
FEBRUARY 8, 2023
The top 20 companies in the global biopharma industry saw 5.4%* aggregate market capitalization from $3.43 trillion to $3.61 trillion over the past year, according to GlobalData’s Pharma Intelligence Center Companies Database. The 13 top players experienced significant growth over 2022 despite the decline in demand for COVID-19 vaccines and therapeutics, as well as uncertainty surrounding pricing due to the newly passed Inflation Reduction Act in the US.
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Bio Pharma Dive
FEBRUARY 8, 2023
Anderson, who stepped down as Roche's pharmaceuticals chief in December, will replace Bayer's current head Werner Baumann on June 1.
Pharmaceutical Technology
FEBRUARY 8, 2023
Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science. Genenta already had an existing MSA with Molecular Medicine’s facility in Milan, which was acquired in 2020 by AGC Biologics.
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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
FEBRUARY 8, 2023
In a State of the Union address, Biden threatened to veto any efforts to repeal the legislation and chastised drugmakers for the current costs of insulin.
Pharmaceutical Technology
FEBRUARY 8, 2023
The US Food and Drug Administration (FDA) has accepted Aldeyra Therapeutics’ new drug application (NDA) for topical ocular reproxalap to treat signs and symptoms of dry eye disease. Reproxalap, a first-in-class investigational new drug candidate, is a small-molecule modulator of reactive aldehyde species (RASP) elevated in ocular and systemic inflammatory disease.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
FEBRUARY 8, 2023
Insurers, employers, taxpayers and other consumers will all be affected as drugmakers move these products to the commercial market in May. How much you'll pay depends on your health insurance.
Medical Xpress
FEBRUARY 8, 2023
As we age, the end caps of our chromosomes, called telomeres, gradually shorten. Now, Salk scientists have discovered that when telomeres become very short, they communicate with mitochondria, the cell's powerhouses. This communication triggers a complex set of signaling pathways and initiates an inflammatory response that destroys cells that could otherwise become cancerous.
STAT News
FEBRUARY 8, 2023
Veteran influenza epidemiologist Keiji Fukuda remembers vividly when he first became fearful that a virulent bird flu virus, H5N1, might be on the verge of triggering a devastating pandemic. The virus, seemingly out of nowhere, did something bird flu viruses were thought not to be able to do. It infected 18 people, killing six of them. That happened in 1997, in Hong Kong.
Medical Xpress
FEBRUARY 8, 2023
Two doses of mRNA COVID-19 vaccine during pregnancy are highly effective against delta and moderately effective against omicron infection, and are linked to a lower risk of hospital admission in infants under six months of age, finds a Canadian study published by The BMJ today.
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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
Rethinking Clinical Trials
FEBRUARY 8, 2023
This Friday’s PCT Grand Rounds will feature the next installment of our special series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Pearl O’Rourke, Dave Wendler, Miguel Vazquez, and Michael Ho will present “Informing and Consenting: What Are the Goals?” The Grand Rounds session will be held on Friday, February 10, 2023, at 1:00 pm eastern.
STAT News
FEBRUARY 8, 2023
Bayer named former Roche executive Bill Anderson as its new CEO on Wednesday, potentially ending a dramatic and difficult chapter during which its current chief executive, Werner Baumann, presided over the disastrous $63 billion purchase of the agriculture firm Monsanto. Anderson will take over April 1, becoming the first American to run the 160-year-old conglomerate, which invented aspirin and later played a major role in the development of hormonal contraceptives, hemophilia clotting factors,
Medical Xpress
FEBRUARY 8, 2023
Infants whose mothers have used snus (a moist oral tobacco product) during pregnancy run three times the risk of sudden infant death, according to a comprehensive registry study from Karolinska Institutet in Sweden, published in the journal Pediatric Research. The risk was much lower if the mother had stopped taking snus before the first antenatal visit.
STAT News
FEBRUARY 8, 2023
There’s been a surge in funding for health tech startups trying to treat or stave off the worst symptoms of chronic kidney disease, a costly and often deadly condition that affects 37 million people in the U.S. alone. Chronic kidney disease develops when the kidneys are so damaged they can’t filter blood as well as needed. People with diabetes, high blood pressure, and other metabolic conditions are at especially high risk of developing the condition.
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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.
Medical Xpress
FEBRUARY 8, 2023
Training the breathing muscles (primarily the diaphragm, which plays a vital role in breathing) could have longer lasting benefits than previously thought. The strength gains to the muscles from five weeks of inspiratory muscle training (a form of weight training to strengthen the muscles used to breathe) persist for five weeks after the training has stopped, according to new research published in Experimental Physiology.
STAT News
FEBRUARY 8, 2023
The moment a donor heart is cut off from its blood supply, transplant teams are on a race against the clock to remove it, transport it, and sew it into the recipient, all within four hours. A new way of reprogramming donor hearts could give them more time. A study published Wednesday in Science Translational Medicine finds that when valproic acid, a medication to treat seizures, is infused in donor hearts, it could significantly extend — potentially double — the safe storage time o
Medical Xpress
FEBRUARY 8, 2023
Injury to the spinal cord often leads life changing disability, with decreased or complete loss of sensation and movement below the site of injury. From drugs to transplantation, there are many scientific advances aiming to restore function following spinal cord injury.
STAT News
FEBRUARY 8, 2023
Though it may be hard for many to fathom, even pregnant people and new parents can have active substance use disorders. They need support, not criminalization. The addiction and overdose crisis, which now claims more than 100,000 lives a year , shows little sign of abating, and emerging data highlight its startling impact on pregnant people: Overdose is now a leading cause of death during or shortly after pregnancy.
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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.
Antidote
FEBRUARY 8, 2023
Chronic obstructive pulmonary disease, known commonly as COPD, is a condition that impacts more than 16 million Americans. COPD is a chronic, inflammatory lung disease that obstructs the airflow to and from the lungs, and common symptoms include a continual cough, shortness of breath, excess mucus, and chest tightness.For those living with COPD, their loved ones, and their care partners, we’re sharing some helpful resources to gain information and build community.
STAT News
FEBRUARY 8, 2023
The newly-minted CEO of the Alphabet health tech spinout Verily is not a doctor or a Ph.D. scientist. He’s never run a top-flight lab or published a seminal paper in health care. His breakthrough executive job, far from the halls of science or medicine, was at Starbucks. But Stephen Gillett, 47, now finds himself in charge of one of the most ambitious (some would say overhyped) efforts to transform American health care with technology.
Medical Xpress
FEBRUARY 8, 2023
Surgery that removes only a portion of one of the five lobes that comprise a lung is as effective as the traditional surgery that removes an entire lobe for certain patients with early-stage lung cancer, according to results of a phase 3 multicenter clinical trial. The trial team was led by Dr. Nasser Altorki, chief of the Division of Thoracic Surgery at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center, and co-investigators from Duke University as well as investigator
STAT News
FEBRUARY 8, 2023
CVS Health’s $10.6 billion acquisition of Oak Street Health plants another flag in the latest era of health insurance industry consolidation — one defined by insurers moving beyond managing medical and drug benefits, and into directly providing care to people in a primary care office or at home. The financial benefits are immense for insurers that own those low-cost settings.
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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.
Medical Xpress
FEBRUARY 8, 2023
Early-life adversity—such as poverty, illness or family conflict—has long been linked to mental health difficulties and poorer cognitive functioning as children grow up. But how these factors interact and evolve over time has so far been unknown.
STAT News
FEBRUARY 8, 2023
Billionaire New York hedge fund manager Bill Ackman built a record of going against the grain and taking whatever flack or controversy came his way. True to form, Ackman announced last week that he and an anonymous donor had pledged $25 million over five years toward a new research lab for David Sabatini, a former star scientist from MIT and Whitehead Institute, whose career imploded in 2021 amid allegations of workplace misconduct and sexual harassment.
Medical Xpress
FEBRUARY 8, 2023
Universitätsmedizin Berlin, the Max Planck Institute for Molecular Genetics (MPIMG), and the University Hospital Schleswig-Holstein (UKSH) have investigated in detail how BPTA syndrome, an extremely rare hereditary condition, arises. A change in the charge of a protein disrupts cellular self-organization, resulting in a developmental disorder.
STAT News
FEBRUARY 8, 2023
Parents around the world want what’s best for their babies. Many have heard that breastfeeding is good for their babies’ health, and most expectant mothers want to breastfeed, but many can’t attain that goal. A new series of papers published in The Lancet — of which I am a co-author — makes clear that a key reason for this is the marketing tactics of companies selling formula.
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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.
Medical Xpress
FEBRUARY 8, 2023
Endocrine-disrupting chemicals (EDCs) in plastics may contribute to diabetes risk in women, according to a new study published in the Journal of Clinical Endocrinology & Metabolism.
Drug Discovery World
FEBRUARY 8, 2023
A diversity study has shown that clinical trials should use real world diseases epidemiology data, rather than US Census Bureau race and ethnicity data, to ensure enrolment reflects the populations affected by different diseases. GSK’s retrospective study looked at clinical trial demographic data from 495 GSK and ViiV clinical trials involving US-based participants from the period 2002 to 2019.
Medical Xpress
FEBRUARY 8, 2023
New research published in Clinical & Experimental Allergy indicates that the burden related to eczema in young individuals is substantial in most countries. A median of 6% of both children and adolescents experience some form of eczema while 0.6% and 1.1% of children and adolescents, respectively, report symptoms of severe eczema.
Pharma Times
FEBRUARY 8, 2023
The pathway is a programme designed to develop pharmacists’ knowledge of mental health among patients
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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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