Bio Pharma Dive
SEPTEMBER 28, 2022
The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s.
FDA Law Blog
SEPTEMBER 30, 2022
By Frank J. Sasinowski & James E. Valentine — On September 29, 2022, FDA approved Amylyx’s NDA for its drug, Relyvrio (sodium phenylbutyrate/taurursodiol), for treatment of patients with amyotrophic lateral sclerosis (ALS) (see FDA announcement here ). This approval decision charts a path for the exercise of appropriate flexibility in regulatory decisions for other rare conditions where there is a serious and/or life-threatening unmet medical need, as is very often the case.
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Pharmaceutical Technology
SEPTEMBER 13, 2022
Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI). Under the deal, Microsoft's computational services, Cloud and artificial intelligence (AI) will be merged with the drug discovery, development and data science expertise of Novo Nordisk.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 7, 2022
If you’ve ever had a urinary tract infection (UTI) before, you know what a pain it can be. Not just because of the physical pains it causes, but because it can also be such a pain to go to the doctor, provide a urine sample, and wait for your results. Skip advert UTIs are extremely […].
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
World of DTC Marketing
SEPTEMBER 7, 2022
Wall Street wants growth, as do investors, but that may be impossible for pharmaceutical companies. In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. Biogen’s failure should be a warning to other pharma companies. They relied so much on a new drug that they tried to market a product with bad science behind it.
Rethinking Clinical Trials
SEPTEMBER 20, 2022
The Johns Hopkins Berman Institute of Bioethics this week opened the application period for its 2023-2024 postdoctoral fellowships, including a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials. From the announcement: The Johns Hopkins Berman Institute of Bioethics invites applications for a Postdoctoral Fellowship in the Ethics and Regulatory Aspects of Pragmatic Clinical Trials.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
SEPTEMBER 30, 2022
For a while, scientists thought the trillions of microbes on our bodies lived in landscapes connected to the outside world — our skin, hair, and gut — but research in the last few years has shown that’s not so. When Ravid Straussman, a cancer biologist at the Weizmann Institute of Science in Israel, looked deeper, he and several other research groups around the world found bacteria in the milieu of tumors.
Pharmaceutical Technology
SEPTEMBER 22, 2022
It is the year 2030. You have just received the results from your whole genome sequencing test, offered through your public health provider, and discovered that you have a 75% chance of developing a rare form of cancer. But you are not panicking; your genomic data was automatically uploaded, with your permission, to your electronic health record (EHR), which is fully secured with blockchain technology.
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 […].
World of DTC Marketing
SEPTEMBER 12, 2022
Apple’s Health app gets new capabilities with iOS 16. The Health app adds Medications, allowing users to conveniently build and manage a medications list, create schedules and reminders, and track their medications, vitamins, or supplements. Will it matter? The health app will also tell users about potential interactions between medications, and it’s possible to connect with healthcare providers to see a list of past medications, get future updates, or add items to your schedule.
NPR Health - Shots
SEPTEMBER 22, 2022
Volunteers for the trial put an arm over a box with hundreds of mosquitoes carrying a genetically modified malaria parasite. Here's why they did it that way — and why the trial holds promise.
Bio Pharma Dive
SEPTEMBER 17, 2022
The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million.
STAT News
SEPTEMBER 27, 2022
The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.
Pharmaceutical Technology
SEPTEMBER 8, 2022
Tetra Bio-Pharma and Cellvera have entered an agreement to jointly develop ARDS-003 as an oral combination therapeutic candidate with 400mg Qifenda (Favipiravir) for Covid-19. A first-in-human drug product, ARDS-003 contains the active pharmaceutical agent, Onternabez. Onternabez is a selective full agonist of the type 2 cannabinoid receptor (CB2R).
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 5, 2022
The latest TikTok trend has us listening to brown noise. According to TikTok, this has multiple benefits including helping you relax and quickly fall into a deep sleep. Getting insufficient sleep, and insomnia are common. Skip advert So it’s no wonder many people are looking for ways to improve their sleep. But can brown noise […].
BioPharma Reporter
SEPTEMBER 1, 2022
Arcturus Therapeutics has obtained an award for up to $63.2m from the Biomedical Advanced Research and Development Authority (BARDA): allowing the company to expand its current influenza vaccine program to include development of a pandemic influenza vaccine based on its proprietary self-amplifying mRNA platform.
NPR Health - Shots
SEPTEMBER 20, 2022
Critics say a legal maneuver by one of the world's wealthiest corporations could set a precedent, allowing non-bankrupt companies and rich individuals to avoid liability for wrongdoing.
Bio Pharma Dive
SEPTEMBER 30, 2022
The application comes a year earlier than previously had been expected, as company says drug reviewers are open to accelerated review based on data from early-stage trials.
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STAT News
SEPTEMBER 28, 2022
BROWNSVILLE, Texas — Gladys Maestre is on a scouting mission. The Alzheimer’s disease researcher is driving through Southmost, a Mexican American neighborhood just north of looming sections of the border wall and a checkpoint that leads to Mexico. She passes barking dogs and “no trespassing” signs, but doesn’t see a single person outside, despite the comfortable stuffed recliners, refrigerators, and shade canopies that furnish many yards.
Pharmaceutical Technology
SEPTEMBER 30, 2022
After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 6, 2022
A previously unknown type of synapse appears to have been hiding in strange, hair-like appendages that can be found on the surfaces of neurons, new research reveals. A study in mice suggests that structures called primary cilia play a role in neuronal signaling; specifically, they act as a shortcut for transmitting signals directly into the […].
pharmaphorum
SEPTEMBER 5, 2022
Sam Crowther, founder and CEO of cybersecurity company Kasada, tells us about a recent discovery his company made that revealed tens of thousands of accounts with prescription drug attachments in major online pharmacies had been compromised. While performing analysis for a client of online accounts for sale, Kasada uncovered a new and illegal way bots are being used – to steal pharmacy customers’ accounts and resell prescriptions on a secondary market for in-demand substances, such as Oxyc
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.
NPR Health - Shots
SEPTEMBER 16, 2022
They argue the threat posed by COVID has lessened because of preexisting immunity and access to treatment. Plus, some deaths may be incorrectly blamed on COVID. Others caution it's too soon to tell.
Bio Pharma Dive
SEPTEMBER 2, 2022
Preliminary results from a Phase 1 study show Sangamo’s treatment to be safe and suggest it is working as intended, leading the biotech to move into the trial’s next phase.
STAT News
SEPTEMBER 28, 2022
HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside
Pharmaceutical Technology
SEPTEMBER 5, 2022
Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We want to be a sustainably growing company. Until 2025, we have strong growth ahead of us, but we also believe we can continue to grow very strongly post-2025 and it’s all about innovation in the pipeline.”.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 27, 2022
The US Food and Drug Administration (FDA) is now warning that breast implants filled with either silicone or saline may, on rare occasions, give rise to cancer in the scar tissue around breast implants. The safety notice was published this month and is based on an extensive review of the emerging literature on breast implants. […].
pharmaphorum
SEPTEMBER 28, 2022
The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.
NPR Health - Shots
SEPTEMBER 30, 2022
California Rep. Ami Bera was bitten by a rabid fox on Capitol Hill in April. He's OK, but now, he wants to make sure the cost of the lifesaving treatment isn't a burden for those who need it.
Bio Pharma Dive
SEPTEMBER 16, 2022
The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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