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.
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.
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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.
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.
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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
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.
Fierce Pharma
DECEMBER 29, 2022
Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report. aarmstrong. Thu, 12/29/2022 - 14:42.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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 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 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
Medical Xpress
DECEMBER 29, 2022
Do you know the difference between Medicare and Medicaid? How about, in a pinch, how to find a nursing home and research which ones in your area might be good and others less so?
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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
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.
Medical Xpress
DECEMBER 29, 2022
Engineers at the University of Colorado Boulder have confirmed what the germ-phobic among us have long suspected: The flush of a commercial toilet releases a Vesuvius-like cloud of tiny droplets and aerosol particles that reaches more than 5 feet above the seat.
STAT News
DECEMBER 29, 2022
The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents. More than a year before Aduhelm’s June 2021 approval, Biogen surveyed insurance companies and doctors about how much the Alzheimer’s treatment should cost.
Medical Xpress
DECEMBER 29, 2022
Why do some people develop Alzheimer's disease and others don't? What makes one person's brain healthier than another's? And what can be done to improve, or at least slow, a brain's deterioration?
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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
DECEMBER 29, 2022
Congressional investigators sorted through more than 500,000 pages of documents from the Food and Drug Administration and Biogen to chronicle how a controversial Alzheimer’s disease drug was approved, and how it went from what was supposed to be the biggest drug launch in history to a financial catastrophe. The resulting report is filled with fresh details about how one of the most storied biotech companies plotted with the federal agency that is supposed to regulate it, and how Biogen de
Medical Xpress
DECEMBER 29, 2022
The U.S. Food and Drug Administration's approval process for the controversial Alzheimer's drug Aduhelm was "rife with irregularities," despite lingering doubts about the power of the pricey medication to slow the disease down, a Congressional report released Thursday claims.
STAT News
DECEMBER 29, 2022
For over two decades, a crisis of opioid overdoses has been one of the most urgent health care emergencies in the United States. Initially driven by the over-prescription of pharmaceutical opioids such as Oxycontin, a “second wave” of addiction deaths began as people transitioned from prescription opioids to heroin, a much riskier drug.
Medical Xpress
DECEMBER 29, 2022
The U.S. Food and Drug Administration has approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with HIV-1 whose HIV infection cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations.
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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 29, 2022
Pfizer said Thursday that its experimental gene therapy for hemophilia B significantly reduced the number of bleeds patients experienced over a year. Data from the 45-patient trial could set the stage for a second gene therapy to be approved for patients with the rare and serious bleeding disorder in as many years. In November, UniQure won approval for Hemgenix, the first hemophilia B gene therapy.
Medical Xpress
DECEMBER 29, 2022
Representation of women in academic medicine improved from 1990 to 2019, but representation of underrepresented minorities (URM) only modestly increased, according to a study published online Dec. 20 in JAMA Network Open.
STAT News
DECEMBER 29, 2022
WASHINGTON — The Food and Drug Administration’s review and approval of a controversial Alzheimer’s drug was “rife with irregularities,” including dozens of undisclosed calls and emails with Biogen and an “inappropriate” level of coordination between the drugmaker and regulators, a congressional investigation concluded.
pharmaphorum
DECEMBER 29, 2022
A new Data Protection and Digital Information Bill is currently being considered by UK ministers. The Bill has been created to update and simplify the UK’s data protection framework with a view to reducing burdens on organisations, providing them with greater flexibility on how to comply with certain aspects of the data protection legislation and improving the clarity of the framework.
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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 29, 2022
Dear Reader, From STAT’s first investigations in June 2021 revealing why the FDA gave the go-ahead for a marginally effective Alzheimer’s drug manufactured by Biogen, we have relentlessly stayed on the story. We’ve reported on the disastrous financial and leadership consequences for a one-time biopharma behemoth, as well as the dashed hopes of millions of people with dementia who had heard of a new drug called Aduhelm.
Medical Xpress
DECEMBER 29, 2022
After three years of quarantines pushed them close to shutting down, restaurant owner Li Meng and his wife are hoping for business to rebound after China rolled back severe anti-virus controls.
Fierce Pharma
DECEMBER 29, 2022
After FDA's Ukoniq pull, TG Therapeutics wins commercial mulligan with Briumvi to enter crowded MS arena. fkansteiner. Thu, 12/29/2022 - 09:30.
Medical Xpress
DECEMBER 29, 2022
Individuals with mpox infection ≥14 days after receipt of one JYNNEOS vaccine dose have less hospitalization, fever, headache, malaise, myalgia, and chills compared with unvaccinated individuals, according to research published in the Dec. 30 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.
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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.
Drug Patent Watch
DECEMBER 29, 2022
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Medical Xpress
DECEMBER 29, 2022
The United States has joined a growing number of countries in imposing restrictions on visitors from China after Beijing announced it would remove curbs on overseas travel as COVID cases surge at home.
Drug Patent Watch
DECEMBER 29, 2022
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Medical Xpress
DECEMBER 29, 2022
Diagnostic accuracy is high in the emergency department, with about 5.7 percent of patients misdiagnosed, according to a report published Dec. 15 by the Agency for Healthcare Research and Quality.
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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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