Bio Pharma Dive
SEPTEMBER 8, 2022
Committee members voted 7-2 in support of the experimental medicine, which is under a closely watched FDA review. A decision on approval is expected by the end of the month.
Pharmaceutical Technology
SEPTEMBER 8, 2022
Roche has signed a definitive merger agreement for the acquisition of US-based biopharmaceutical company Good Therapeutics for an upfront payment of $250m in cash. Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 programme of Good Therapeutics.
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Bio Pharma Dive
SEPTEMBER 8, 2022
Fuller data from Alnylam’s APOLLO-B trial confirm the success reported by the company last month, but won’t end a debate on the degree of benefit offered by its drug.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 8, 2022
People with one of the type A blood groups are more likely to have a stroke before the age of 60 compared with people with other blood types, researchers have found. Blood types describe the rich variety of chemicals displayed on the surface of our red blood cells. Among the most familiar are those named […].
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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
SEPTEMBER 8, 2022
Updated data released ahead of the ESMO medical conference suggest Relay’s medicine could be more effective than others like it in treating a type of bile duct cancer.
Pharmaceutical Technology
SEPTEMBER 8, 2022
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AceLink Therapeutics’ AL01211 to treat Fabry disease. A glucosylceramide synthase (GCS) inhibitor, AL01211 has high potency, increased selectivity and other beneficial drug properties that support once-a-day oral dosing. Additionally, it provides a much-required oral small molecule treatment as a substitute to existing therapies for Fabry disease, which need repeated intravenous dosing. .
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
SEPTEMBER 8, 2022
Millions of New Yorkers embraced an "all in this together" motto during the pandemic — and many are roasting the city's transit agency over updated signs explaining its newly relaxed masking policy.
Bio Pharma Dive
SEPTEMBER 8, 2022
The data could help Trodelvy secure a place in treatment, although a rival drug from Daiichi Sankyo and AstraZeneca will offer strong competition.
STAT News
SEPTEMBER 8, 2022
At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals. The vote was 7-2, a substantial margin of support for the Amylyx drug called AMX0035 and a reversal of the same group’s vote against the drug last March.
Pharmaceutical Technology
SEPTEMBER 8, 2022
Speciality pharmacies play a crucial role in medication dosing, disease and side effects management, and patient care. The expert services rendered by them help in improving patient outcomes, minimising costs of the healthcare system, improving medicinal adherence and persistency and saving clinicians’ time. Speciality pharmacies provide comprehensive medications for individuals with serious medical conditions requiring complex treatments, including cancer, cystic fibrosis, haemophilia, hepatiti
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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
STAT News
SEPTEMBER 8, 2022
Gilead Sciences said Wednesday that its cancer drug Trodelvy prolonged the survival of women with the most common form of breast cancer by just under 30% — a clinical trial result that could lead to a better treatment option for patients with advanced disease and strengthen the drug’s commercial outlook. In the study, called TROPICS-02, Trodelvy showed a median overall survival of 14.4 months compared to 11.2 months for comparator chemotherapy.
Pharmaceutical Technology
SEPTEMBER 8, 2022
Pharmaceutical compounding is a method of preparing personalised medications for patients by mixing the individual ingredients in the exact strength and dosage form required by the patient. Increasing drug failure rates and essential drug shortages have driven the growth of the compounding pharmacies market, which has a high growth potential, especially in emerging economies.
STAT News
SEPTEMBER 8, 2022
A daily dose of Relay Therapeutics’ experimental drug for cholangiocarcinoma, a rare cancer of the bile ducts, led to tumor shrinkage of a third or more in 15 of 17 patients with metastatic disease, the company said Wednesday. The results were released in an abstract at the annual meeting of the European Society of Molecular Oncology, where they will be presented in full on Sunday.
Pharmaceutical Technology
SEPTEMBER 8, 2022
Pharmaceutical solid dose manufacturing companies in contract marketing segment have gained a vital position in pharmaceutical formulations. Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups. Streamlined development, flexibility in manufacturing, and improved product quality at reduced costs, while gaining access to capabilities and capacity are some of the factors fuelling the pharmaceut
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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
SEPTEMBER 8, 2022
Nothing has made the nation’s addiction epidemic more deadly than fentanyl’s infiltration of the drug supply. Yet in more than a dozen states, tools used to detect the ultra-potent synthetic opioid are still classified as drug paraphernalia — making it a crime to possess or distribute them. The practice of “drug-checking” — essentially, testing illicit drugs to see if they contain unknown toxins — has remained controversial even as the crisis of f
pharmaphorum
SEPTEMBER 8, 2022
Asking patients with chronic conditions to regularly inject themselves can be challenging, causing needle anxiety and worry that they may not carry out the procedure correctly, which can reduce compliance. Now, a partnership between Ypsomed and Sidekick Heath aims to tackle that problem. Ypsomed is a top developer of injection and infusion systems, so knows a lot about the difficulties that patients can face when getting to grips with these medical devices, particularly when they are just starti
STAT News
SEPTEMBER 8, 2022
As a woman of color who was fortunate to be accepted to medical school 29 years ago, I thought that if I had the intelligence, grit, and credentials, I would succeed. I thought that the profession of medicine operated within a system of meritocracy: work hard and you will be rewarded. I learned the hard way that it isn’t like that. My post-graduate professional journey has spanned a general surgery residency, fellowships in hospice and palliative medicine and clinical medical ethics, all
pharmaphorum
SEPTEMBER 8, 2022
Ben Hargreaves examines what advantages radiopharmaceuticals offer in the treatment of cancer and why there has been interest from big pharma in developing these types of therapies. The article also outlines some of the challenges remaining to be tackled. Radiotherapy dates back more than a hundred years, yet it still remains a core part of cancer treatment today.
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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
SEPTEMBER 8, 2022
UnitedHealth Group is poised to widen its lead in the Medicare Advantage market through a partnership with the retail giant Walmart. The two companies announced a multifaceted, 10-year partnership Wednesday that will kick off in January with a co-branded Medicare Advantage plan in Georgia. UnitedHealth will also help Walmart Health clinics manage care for all of their Medicare Advantage patients, regardless of insurer, starting with 15 locations in Georgia and Florida and growing from there.
NPR Health - Shots
SEPTEMBER 8, 2022
The health care industry is obsessed with consumer satisfaction. But national patient surveys still don't get at an important question: Are hospitals delivering culturally competent care?
STAT News
SEPTEMBER 8, 2022
The passage of the Inflation Reduction Act brings a new era to drug pricing in the United States. After decades of being an outlier, it now joins every other developed nation in having the federal government engaged in negotiating drug pricing. The pharmaceutical industry will continue its fight to blunt the implementation of the law, but in coming years Medicare prices for a limited number of high-cost medications will be lowered, with new prices established either through steep discounts off t
NPR Health - Shots
SEPTEMBER 8, 2022
Forehead thermometers were significantly less likely to have accurate readings for Black patients compared to oral thermometers. There could be two reasons for this.
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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
SEPTEMBER 8, 2022
WASHINGTON – On Tuesday, a group of more than 30 attorneys general announced they had reached a “landmark” $438.5 million settlement with the e-cigarette maker Juul over its alleged marketing toward children. Tobacco control advocates had hoped the settlement would compare to the historic one reached two decades earlier between states and cigarette companies, a multi-billion dollar deal that changed the way tobacco companies marketed their products forever.
JAMA Internal Medicine
SEPTEMBER 8, 2022
This cross-sectional study examines characteristics of COVID-19–associated hospitalizations among vaccinated persons and comparative hospitalization rates in unvaccinated and vaccinated persons.
STAT News
SEPTEMBER 8, 2022
WASHINGTON — Washington’s attempts to permanently lock in telehealth coverage have been hobbled by a fear that virtual care could drive up Medicare fraud and spending. But a new watchdog report offers early evidence that only a small portion of providers are billing for virtual care in a potentially fraudulent way, suggesting that targeted interventions could crack down on abuse.
Pharma Times
SEPTEMBER 8, 2022
Collaboration involves the marketing and distribution of PreHevbri across Europe
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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
SEPTEMBER 8, 2022
Amid ongoing controversy over clinical trial transparency, a new analysis found that just 3% of the more than 3,700 studies run exclusively in Canada over a recent 10-year period were registered prospectively, reported results, and published the findings. More specifically, 47% of those trials, or more than 1,770, were registered in advance, while only 12% reported results in a registry and 48% published their findings.
NPR Health - Shots
SEPTEMBER 8, 2022
NPR's Ari Shapiro talks with Dr. Tomás Aragón, director of the California Department of Public Health, about how the state is responding to its recent heatwave.
STAT News
SEPTEMBER 8, 2022
Running clinical trials remotely or virtually can provide substantial financial savings for pharmaceutical companies, according to a new pilot study. And the findings may prompt still further use of such techniques, which have been increasingly adopted during the Covid-19 pandemic. Specifically, remote or virtual methods — such as telemedicine and the use of other mobile devices — yielded a five-fold return on investment of $8.6 million, on average, for Phase 2 clinical trials.
pharmaphorum
SEPTEMBER 8, 2022
A malaria vaccine developed by members of the University of Oxford team behind the AstraZeneca COVID-19 jab has been hailed as a possible game-changer in the fight against the deadly parasitic infection. Hopes were already running high for the R21/Matrix-M vaccine after it showed 77% protective efficacy over 12 months in a phase 2b trial involving young west African children that was reported last year – meeting the World Health Organisation’s efficacy goal of 75% – after an initial three-
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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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