Pharmaceutical Technology
DECEMBER 27, 2022
The healthcare industry saw its share of ups and downs in 2022. Our response to the worldwide pandemic evolved over time, and so did the needs of the sector and the people relying on healthcare companies to deliver solutions. Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced.
Bio Pharma Dive
DECEMBER 30, 2022
An investigation by two House committees concluded the FDA failed to document all its meetings with Biogen, and shifted to consider an accelerated clearance on a “substantially abbreviated timeline.
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NPR Health - Shots
DECEMBER 25, 2022
China's National Health Commission said in a statement it would no longer publish daily data and that "from now on, the Chinese CDC will release relevant COVID information for reference and research.
STAT News
DECEMBER 27, 2022
People who study infectious diseases and who work in public health have long known a bad pandemic would one day come. They knew such an event would overwhelm hospitals, strain supply chains, and place stresses on society that we would be ill-equipped to meet. Countries like the United States have for decades prepared to respond to such a crisis.
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Pharmaceutical Technology
DECEMBER 27, 2022
Indian pharmaceutical company Hetero has received the World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its Nirmacom (nirmatrelvir). The company stated that Nirmacom is a generic version of Pfizer ’s Covid-19 oral antiviral drug, Paxlovid, a SARS-CoV-2 main protease (Mpro) inhibitor. Hetero’s Nirmacom combi-pack will contain nirmatrelvir 150 mg (two tablets) and ritonavir 100mg (one tablet).
Bio Pharma Dive
DECEMBER 29, 2022
The Phase 3 results showed the one-time treatment outperformed standard factor replacement in adults with the bleeding disorder, but suggest it may be less potent than CSL and UniQure’s rival therapy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
DECEMBER 30, 2022
The number of young people in the U.S. with type 2 diabetes could surge by about 700% over the next four decades, with a greater burden falling on minority groups, a new model predicts. If the recent acceleration of new diagnoses persists, then 220,000 people younger than 20 would have type 2 diabetes in 2060, compared with 28,000 in 2017, the latest year for which data is available, according to projections published this month in Diabetes Care.
Pharmaceutical Technology
DECEMBER 29, 2022
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved AstraZeneca ’s immunotherapies Imfinzi (durvalumab) and Imjudo (tremelimumab) to treat advanced liver, biliary tract, and lung cancers. The combination of Imfinzi and Imjudo has been approved to treat unresectable hepatocellular carcinoma (HCC) in adult patients. It has also been authorised to treat unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) along with chemotherapy.
pharmaphorum
DECEMBER 28, 2022
This year, the predicted flurry of merger and acquisition (M&A) activity might not have materialised. However, as we near the end of the year, there were some big moves. M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline.
NPR Health - Shots
DECEMBER 29, 2022
DOJ officials say the drug wholesaler could face "billions of dollars" in penalties for failing to report diversion of prescription opioid pain medications shipped to pharmacies across the U.S.
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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
Medical Xpress
DECEMBER 30, 2022
Ira Katz bustles at his pharmacy in Atlanta's Little Five Points neighborhood this cough season, serving patients who need medicine for respiratory viruses like COVID-19. He dispenses occasional packages of Paxlovid, a drug designed to nip COVID in the bud. But there aren't as many of those Paxlovid prescriptions as there might be.
STAT News
DECEMBER 30, 2022
Francesca Coleman, known to friends as “St. Louis,” has been unhoused since the age of 15. Now 24, Coleman sleeps in Tongva park, across from the famous Santa Monica pier in California. Like many unhoused people in the Los Angeles area, Coleman uses meth in an attempt to ease chronic pain, anxiety, and depression. On a Wednesday morning in July, physician Coley King checked in with Coleman in Tongva Park.
Fierce Pharma
DECEMBER 29, 2022
Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report. aarmstrong. Thu, 12/29/2022 - 14:42.
NPR Health - Shots
DECEMBER 30, 2022
The eye of the camera told the stories of kangaroo care for human babies, Angola's intrepid female de-miners, Ukrainian refugees who find a warm — and familiar — welcome in Brazil and more.
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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
DECEMBER 30, 2022
The Food and Drug Administration has approved Sunlenca, an injectable therapy to suppress HIV for patients who suffered drug resistance to other regimens.
STAT News
DECEMBER 29, 2022
The very term “chronic disease” might imply that little changes — or improves — over time. But there is a lot percolating on the chronic disease front, from the mysterious (long Covid) to well-known problems. For the millions of people in the United States who have one or more chronic conditions, a small scientific stir can lead to a huge impact.
pharmaphorum
DECEMBER 29, 2022
The turbulence of the last three years can make it seem as though pharma manufacturers have been operating in an atmosphere of non-stop crisis. COVID-19 erupted, mutated, and was supplemented by the challenges of monkeypox and the need to catch up with major treatment and immunisation backlogs accumulated during the pandemic. At the same time, the industry must address the long-term difficulty of providing essential medicines and health services to the high percentage of global population that c
NPR Health - Shots
DECEMBER 27, 2022
The nation has the highest rate of maternal mortality among wealthy countries. A long-standing program, Nurse-Family Partnership, which supports new parents, works to address this deadly trend.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Medical Xpress
DECEMBER 30, 2022
An international team of researchers including Sofya Kulikova, Senior Research Fellow at the HSE University-Perm, found that ketamine, being an NMDA receptor inhibitor, increases the brain's background noise, causing higher entropy of incoming sensory signals and disrupting their transmission between the thalamus and the cortex. This finding may contribute to a better understanding of the causes of psychosis in schizophrenia.
STAT News
DECEMBER 28, 2022
When Eric Xu fell sick and tested positive with Covid this month, he took pills of his own invention. Paxlovid, the primary oral antiviral available in the U.S., is in short supply in China. But Xu, a prominent biochemist at the Chinese Academy of Sciences, had helped devise his own in 2021 and, as the drug’s inventor, could legally take it even as it went through clinical trials.
Antidote
DECEMBER 29, 2022
Generally, a doctor’s visit is intended to provide clarity and insight into a patient’s concerns — but many people are all too familiar with the feeling of walking out of a clinic more confused than when they arrived. In fact, many Americans find themselves searching for health literacy tips after becoming confused by a doctor’s instructions or the directions on a prescription label.
NPR Health - Shots
DECEMBER 30, 2022
As case counts surge in China, rumors circulate about the effectiveness and safety of the made-in-China vaccines in use there. Here's what we know about CoronaVac and Sinopharm.
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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
DECEMBER 29, 2022
A high-fat diet may combat low platelet counts in the blood caused by chemotherapy, according to preliminary research, which suggests that a ketogenic eating plan may be a nontoxic, low-cost and high-benefit addition to cancer therapy.
STAT News
DECEMBER 30, 2022
This year, STAT deepened its footholds in a number of coverage areas, from hospitals and insurance to reproductive health to health tech. Our staff also looked with admiration — and some envy — to many other journalists doing great reporting in these spaces. Below is our annual list of STAT staffers’ favorite stories of the year, and that we wish we had written.
ProRelix Research
DECEMBER 27, 2022
Clinical trials form the crux of all regulatory decisions regarding any new health intervention such as drugs and medical devices and thus require to be performed with the utmost care […]. The post USA Clinical Trial Market Size and Opportunities appeared first on ProRelix Research.
NPR Health - Shots
DECEMBER 27, 2022
Psychedelic drugs were a hot topic at this year's Society for Neuroscience meeting. Researchers hope the drugs can help people with disorders like depression and PTSD.
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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.
Medical Xpress
DECEMBER 28, 2022
In a first-of-its-kind study, researchers at Tel Aviv University equipped close to 5,000 Israelis with smartwatches and monitored their physiological parameters over two years. Of those monitored, 2,038 received the booster dose of the coronavirus vaccine, allowing the researchers to objectively compare measures before and after the participants took the vaccine, and confirm the safety of the vaccine.
STAT News
DECEMBER 29, 2022
The 22nd year of the 21st century, like most years before it, had its share of turbulence, offering opinion/perspective authors a wealth of topics to write about. STAT published nearly 500 First Opinion essays in 2022, written by more than 700 authors from the biopharmaceutical industry, health care, academia, government, and private life in the United States and beyond.
pharmaphorum
DECEMBER 30, 2022
The vast majority of GPs are persuaded of the benefits of moving diagnostic services from the hospital to the community, according to a new survey of 200 GPs in the UK. Just 4% of would choose the hospital as the preferred location of testing, compared to 46% for the GP surgery, 18% for a community hub, 15% for a patient’s home and 12% for the pharmacy.
NPR Health - Shots
DECEMBER 29, 2022
When she was pregnant, Kaitlyn Joshua struggled to get medical care — and answers — in post-Roe Louisiana, where abortion is banned.
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