Bio Pharma Dive
MARCH 3, 2023
An experimental medicine from Praxis Precision Medicines missed the main goal of a Phase 2b trial. But there were also some positive findings, which have encouraged the company to press forward.
Pharmaceutical Technology
MARCH 3, 2023
Bristol Myers Squibb has secured complete marketing authorisation from the European Commission (EC) for Reblozyl (luspatercept) to treat anaemia in adult patients with non-transfusion dependent (NTD) beta-thalassemia. The regulatory approval enables the use of Reblozyl in all EU member states, as well as Liechtenstein, Iceland, and Norway. The first-in-class therapeutic option, Reblozyl is being developed and commercialised through an international partnership with Merck after the acquisition of
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Bio Pharma Dive
MARCH 3, 2023
The setback is the second for the pairing of Cabometyx and Roche’s immunotherapy Tecentriq, dimming Exelixis’ hopes of further expanding its drug’s use before a key patent expires.
Pharmaceutical Technology
MARCH 3, 2023
With over 18 years of experience, Alexander Dragitsch is a commercial customer service contract manufacturing (CSCM) manager at Baxter’s Halle/Westfalen facility in Germany. Alex and his team have the significant responsibility of managing various commercial programs for more than 40 marketed products. “The Halle customer service team is a “one-stop-shop” for client requests when it comes to commercial drug product manufacturing,” explains Dragitsch.
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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
MARCH 3, 2023
The company has struggled to maintain supply of its prostate cancer drug Pluvicto, hampered by production issues and higher-than-expected demand.
Pharmaceutical Technology
MARCH 3, 2023
French biopharmaceutical firm Ipsen has concluded the purchase of US-based Albireo Pharma , expanding its rare disease portfolio. In January, Ipsen signed a definitive merger agreement to acquire Albireo. Under the agreement terms, through a fully-owned subsidiary, Ipsen agreed to commence a tender offer to acquire Albireo’s outstanding shares for an initial estimated aggregate value of $952m and one contingent value right (CVR) per share.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
MARCH 3, 2023
Florida health officials are investigating the death and urging people to take precautions. Here's what to know if you're planning on breaking out your neti pot or swimming in a lake anytime soon.
Medical Xpress
MARCH 3, 2023
Cancer cells have an innate randomness in their ability to respond to chemotherapy, which is another tool in their arsenal of resisting treatment, new research led by the Garvan Institute of Medical Research shows.
NPR Health - Shots
MARCH 3, 2023
The Food and Drug Administration has new tools to hold drug companies accountable for promises they make about medications. But the agency has yet to show its hand in using this new power.
STAT News
MARCH 3, 2023
You’d think an irradiated wasteland would be a poor place to make a home, but some animals beg to differ. Since the Chernobyl nuclear meltdown 37 years ago, both wild animals and free-roaming domesticated dogs have, to the surprise and delight of environmentalists, flocked to and flourished in the evacuated,1,000 square mile zone surrounding the plant.
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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
MARCH 3, 2023
Shigella causes shigellosis, an inflammatory diarrhea. The extensively drug-resistant strain is relatively uncommon overall, but it's being seen in more cases among adults.
STAT News
MARCH 3, 2023
In a little-noticed move, the U.S. Fish and Wildlife Service recently began denying company requests to import certain monkeys from Cambodia for use in early-stage drug research. Now, the pharmaceutical industry is trying to push back by lobbying Congress. The National Association for Biomedical Research argues the situation is a “crisis,” with 60% of the supply of non-human primates “critical” to early-stage research now out of reach.
NPR Health - Shots
MARCH 3, 2023
Sick children overwhelmed hospitals this past fall and winter, exposing vulnerabilities in the nation's ability to care for its youngest during a crisis.
STAT News
MARCH 3, 2023
Next week, hundreds of scientists from around the world will convene in London for an international summit on genome editing. That technology, which enables scientists to easily excise, alter, or replace specific sections of DNA, was awarded the 2020 Nobel Prize for Chemistry. But the last time an event like this took place, in November 2018, carefully planned discussions about how it might be responsibly harnessed to treat genetic diseases were derailed by news that a team of researchers in Chi
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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
MARCH 3, 2023
When a grant for accessible playground equipment didn't cover all the costs, the students at a Minnesota elementary school launched a fundraising campaign.
STAT News
MARCH 3, 2023
“But aren’t you grateful to be alive”? That’s a question adoptees like me are often asked when we speak out against the Supreme Court’s decision to overturn Roe v. Wade. Like other adoptees, I hesitate to answer, feeling the pressure to respond as we’ve been trained to by society, “Yes, I’m grateful, so very grateful.
Medical Xpress
MARCH 3, 2023
A preclinical study evaluating a Kiwi-made COVID-19 vaccine—Kiwi Vax—has shown its unique formulation induces a safe and highly effective immune response to SARS-CoV-2 variants of concern, making it a promising booster vaccine candidate.
STAT News
MARCH 3, 2023
Just over two weeks ago, President Biden had skin cancer, but today, he doesn’t. According to a White House physician’s memo on Friday, doctors at Walter Reed National Military Medical Center removed a lesion off his chest on Feb. 16, treated the area around the tumor site, and that was that. The president’s cancer might be cause for more concern were it not for the type: basal cell carcinoma.
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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
MARCH 3, 2023
A team of researchers has developed a machine learning model that draws from the contents of news articles to effectively predict locations that face risks of food insecurity. The model, which could be used to help prioritize the allocation of emergency food assistance across vulnerable regions, marks an improvement over existing measurements.
STAT News
MARCH 3, 2023
WASHINGTON — A new approach to paying doctors and hospitals — originally billed as a way to bolster traditional Medicare — might be speeding the public health insurance program’s privatization. Medicare Advantage typically gets credited, or blamed, for moving beneficiaries into a system run by private health insurers. The program has grown rapidly since its inception ; nearly half of people on Medicare are now in a private plan.
Medical Xpress
MARCH 3, 2023
Human papillomavirus (HPV) vaccination rates among eligible veterans and active-duty military are half that of their civilian peers, putting them at greater risk of HPV-related cancers. That's according to a new study published today in JAMA Oncology that provides the first national estimate of HPV vaccination rates in this population.
STAT News
MARCH 3, 2023
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is a decidedly low-key affair. We look forward to promenading with the official mascot, binge-watching in front of the telly, and holding our weekly listening party (the rotation includes this , this and 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.
Medical Xpress
MARCH 3, 2023
Researchers at Tohoku University have shown that astrocytes—star-shaped glial cells that control the local ionic and metabotropic environment of the brain—exhibit an acid response with REM sleep in mice. They theorize that the acid response could be the underlying drive for specific information processing and generating plasticity during sleep.
STAT News
MARCH 3, 2023
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
Drug Patent Watch
MARCH 3, 2023
Annual Drug Patent Expirations for NORMOCARB+HF+25 Normocarb Hf 25 is a drug marketed by Dialysis Sups and is included in one NDA. There is one patent protecting this drug. This… The post New patent expiration for Dialysis Sups drug NORMOCARB HF 25 appeared first on DrugPatentWatch - Make Better Decisions.
STAT News
MARCH 3, 2023
File this under: “What were they thinking?” Cipla, which is one of the world’s largest generic drug manufacturers, was recently cited by inspectors from the U.S. Food and Drug Administration for a litany of violations at a plant in India. But one problem stood out: the company failed to properly keep important manufacturing records and, instead had loaded bags paper scraps onto a truck and stored other bags that were earmarked for shredding.
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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
MARCH 3, 2023
Rates of mental health-related emergency department visits are highest among non-Hispanic Black adults, according to research published online March 1 in the National Health Statistics Reports, a publication from the U.S. Centers for Disease Control and Prevention.
Pharma Times
MARCH 3, 2023
Treatment is a lung-specific stem cell therapy designed for hospitalised patients with respiratory infections
Medical Xpress
MARCH 3, 2023
There's no cure, yet, for Alzheimer's disease. But dozens of programs developed in the past 20 years can improve the lives of both people living with dementia and their caregivers.
Cloudbyz
MARCH 3, 2023
Mid-size Clinical Research Organizations (CROs) play a significant role in the pharmaceutical and biotech industry by providing various services such as study design, clinical trial management, data management, and biostatistics. However, mid-size CROs face unique challenges in offering differentiated services and value to their customers to stay competitive against larger CROs.
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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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