Bio Pharma Dive
DECEMBER 13, 2022
The positive data are the most significant findings for the mRNA developer’s pipeline of experimental treatments outside of infectious diseases, where it has reaped billions from COVID-19 vaccine sales.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 13, 2022
Research suggests there could be a “simple, safe, and economical” way to relieve pain: green light. And a new animal study reveals the biological underpinnings of how it might work. Scientists have been exploring the pain-relieving effects of green light for at least half a decade, uncovering an occasional clue on exactly how it happens. […].
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Bio Pharma Dive
DECEMBER 13, 2022
The Japanese pharma is paying $4 billion upfront, and potentially $2 billion more, for a medicine Nimbus claims can top Bristol Myers’ recently approved psoriasis drug Sotyktu.
Pharmaceutical Technology
DECEMBER 13, 2022
The US Food and Drug Administration (FDA) has granted accelerated approval for Mirati Therapeutics ’ Krazati (adagrasib) as a targeted therapy option to treat KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults. The therapy is indicated for such patients who have previously received a minimum of one systemic therapy.
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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
DECEMBER 13, 2022
Even with a shaky market for drug startups, the Apriori CEO and Alltrna cofounder said Flagship will continue its approach of betting on ambitious, and unproven, science.
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 13, 2022
The National Commission for Homoeopathy has prepared a regulation defining a structure to the Bachelor of Homoeopathic Medicine and Surgery (BHMS) course with changes including incorporation of a methodology to supplement modern advancement, research and technology in Homoeopathy (SMART-Homoeopathy). The regulation has come into force on the date of their publication in the Official Gazette.The […].
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Pharmaceutical Technology
DECEMBER 13, 2022
Amgen has signed an agreement for the acquisition of the complete issued and to-be-issued ordinary share capital of Horizon Therapeutics for $116.50 per share in cash or nearly $27.8bn on a fully diluted basis. The acquisition implies nearly $28.3bn enterprise value. Ireland-based international biotechnology firm Horizon discovers, develops and markets therapies for the critical needs of patients with rare, autoimmune and severe inflammatory ailments.
Bio Pharma Dive
DECEMBER 13, 2022
Months after restructuring and trimming its workforce, the company has teamed up with its original investors to form an antibody drug developer called Launchpad Therapeutics.
STAT News
DECEMBER 13, 2022
An experimental cancer vaccine being developed by the biotechnology firm Moderna and the drug giant Merck reduced the risk that melanoma would return after surgery or that patients would die by 44%, the company said. The data, made public in a press release, represent the first evidence of an effective individualized cancer vaccine based on mRNA, the technology used in the Covid shots.
Medical Xpress
DECEMBER 13, 2022
Females' propensity to deposit more fat in places like their hips, buttocks and the backs of their arms, so-called subcutaneous fat, is protective against brain inflammation, which can result in problems like dementia and stroke, at least until menopause, scientists report.
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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
NPR Health - Shots
DECEMBER 13, 2022
Using CRISPR to modify certain immune cells could make cancer-fighting immunotherapy more potent for a broader set of patients. Two people who went through the treatment share their stories.
STAT News
DECEMBER 13, 2022
Open the website of Workit Health, and the path to treatment starts with a simple intake form: Are you in danger of harming yourself or others? If not, what’s your current opioid and alcohol use? How much methadone do you use? Within minutes, patients looking for online treatment for opioid use and other addictions can complete the assessment and book a video visit with a provider licensed to prescribe suboxone and other drugs.
NPR Health - Shots
DECEMBER 13, 2022
Emergent BioSolutions has applied to the Food and Drug Administration to sell the opioid overdose-reversal drug over the counter. Addiction experts say it may be a key step to lower fentanyl deaths.
Medical Xpress
DECEMBER 13, 2022
New research led by scientists at the University of Colorado Boulder suggests that eyes may really be the window to the soul—or, at least, how humans dart their eyes may reveal valuable information about how they make decisions.
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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.
NPR Health - Shots
DECEMBER 13, 2022
CVS would pay about $5 billion and Walgreens more than $5.5 billion, though neither company has admitted wrongdoing. States have until the end of the year to accept the terms of the settlement.
Medical Xpress
DECEMBER 13, 2022
Two doctors at the Max Super Specialty Hospital in India has documented the filarial dance of scrotal worms on video. In the video, the undulations of live worms residing in a male patient's scrotum can be seen.
STAT News
DECEMBER 13, 2022
Long Covid has begun appearing on death certificates for a small percentage of people who have died during the pandemic, but that tiny fraction of records only hints at the whole story, two experts told STAT, while another has doubts about drawing any conclusions from it at all. Death certificates listing long Covid as a cause of death numbered 3,544, representing 0.3% of the 1,021,487 Covid deaths in the United States from January 2020 through June 2022, according to an analysis issued Wednesda
NPR Health - Shots
DECEMBER 13, 2022
Winter can be hard, especially in the halls of healing. A doctor shares how this year's World Cup has become the holiday event she and others didn't know they needed.
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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
DECEMBER 13, 2022
In his assessment of governments’ work to provide sufficient mental health resources to their citizens, Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, warned that “good intentions are not being met with investment.” Though many countries have implemented policies, plans, and laws to improve mental health care, they haven’t offered enough leadership and governance for community-based mental health resources and sufficient promotion a
Medical Xpress
DECEMBER 13, 2022
Researchers of the Faculty of Psychology, the Institute of Neurosciences (UBNeuro) and the Institute of Complex Systems (UBICS) of the University of Barcelona have identified, using functional magnetic resonance techniques, differences in the spontaneous activity of the brain in a resting state in people with Down syndrome (DS) compared to the general population.
STAT News
DECEMBER 13, 2022
Medicines that reshape or tamp down immune responses may be life-changing for patients with cancer and autoimmune disorders, but in some cases they can awaken a dormant virus and unleash a deadly brain disease. A new study suggests that the root of the problem is buried in our genetic code. Researchers uncovered four gene variants connected with the immune system that significantly increase a person’s risk of developing the disease, known as progressive multifocal leukoencephalopathy or P
NPR Health - Shots
DECEMBER 13, 2022
Although the study authors say the results can't be used to gauge drug use on the roads nationwide, the high number of drivers, passengers and others with drugs in their systems is concerning.
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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
DECEMBER 13, 2022
Jeremy Farrar , director of the Wellcome Trust, the world’s second largest private funder of biomedical research, has been named the new chief scientist of the World Health Organization. The appointment was announced Tuesday by the global health agency, which also revealed the appointment of Amelia Latu Afuhaamango Tuipulotu as WHO’s chief nursing officer.
BioSpace
DECEMBER 13, 2022
Kymera and Sanofi shared positive results for an IRAK4 degrader for hidradenitis suppurativa and atopic dermatitis.
STAT News
DECEMBER 13, 2022
In May of 2017, Samira Kiani found herself in a San Diego hotel ballroom surrounded by some of the CRISPR field’s brightest shining stars. Jennifer Doudna , George Church , and others were all there at the behest of the Defense Advanced Research Projects Agency to talk about gene drives — a CRISPR-enabled technology that forces a genetic trait through a population at evolutionary warp speed — and what they as scientists could do to build guardrails around them.
pharmaphorum
DECEMBER 13, 2022
A new initiative to boost research and development into rare and paediatric diseases launched last week, on Thursday 8 th December, at the European Health Summit. The Rare Disease Moonshot is a collaborative commitment between seven organisations, seeking to break down barriers to finding new treatments and cures for some of the world’s rarest and most severe conditions.
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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
DECEMBER 13, 2022
More than 155,000 Americans who shared their DNA for science are about to learn something in return: Do they have some particularly worrisome genes? It’s part of a massive project to unravel how people’s genetics, environments, and habits interact to determine their overall health. The National Institutes of Health said Tuesday it’s now starting to notify participants about some early findings — if they carry variants that can cause any of 59 inherited diseases
Fierce Pharma
DECEMBER 13, 2022
Cancer center leaders lay bare CAR-T makers' struggles—and an unexpected laggard. aliu. Tue, 12/13/2022 - 20:12.
Medical Xpress
DECEMBER 13, 2022
The reason your three-pound brain doesn't feel heavy is because it floats in a reservoir of cerebrospinal fluid (CSF), which flows in and around your brain and spinal cord. This liquid barrier between your brain and skull protects it from a hit to your head and bathes your brain in nutrients.
STAT News
DECEMBER 13, 2022
My colleague, Skip, was the kind of primary care doctor I always wanted to be. He could riff on the evaluation of a patient with new joint or liver inflammation like an improvising jazz musician. He could discern a familiar rash in the most puzzling plumes of hot, angry bumps. When I had lab results that flummoxed me, I’d go see Skip. He’d tip back in his chair, swivel a bit in thought, and make sense of the findings.
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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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