Bio Pharma Dive
FEBRUARY 14, 2023
Through social media, virtual meetings and mentorship programs, a growing group of entrepreneurs is looking for new ways to build drug companies.
Pharmaceutical Technology
FEBRUARY 17, 2023
In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The non-binding draft guidance gives insight into the agency’s current outlook and recommendations for standard and expedited programs in oncology.
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NPR Health - Shots
FEBRUARY 4, 2023
Gas utilities and cooking stove manufacturers knew for decades that burners could be made that emit less pollution in homes, but they chose not to. That may may be about to change.
STAT News
FEBRUARY 24, 2023
WASHINGTON — Nearly three weeks after a train derailed in East Palestine, Ohio, spewing toxic chemicals into the air, water and soil, Biden officials are racing to find answers on how the disaster happened. But it’s also unclear what happens next for thousands of Ohioans who could now be sick — and who covers their care. Ohio lawmakers from both parties have already demanded that Biden health officials step up their response and ensure health care through an obscure provisio
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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
FEBRUARY 17, 2023
Physicians routinely prescribe an infusion containing gadolinium to enhance MRI scans, but there is evidence that nanoparticles of the toxic rare earth metal infiltrate kidney cells, sometimes triggering severe side effects, University of New Mexico researchers have found.
Fierce Pharma
FEBRUARY 3, 2023
J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 3, 2023
Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.
NPR Health - Shots
FEBRUARY 28, 2023
Two U.S. intelligence agencies reportedly support the lab leak theory — with low-to-moderate confidence. No evidence has been shared. Scientists have strong evidence of animal spillover at a market.
STAT News
FEBRUARY 17, 2023
One day last fall, Kiran’s period cramps became so painful they woke her up from a nap. The 19-year-old took some ibuprofen, but found little relief. “The pain was so bad, it felt like someone was punching me,” said Kiran, who asked to be referred to by only her first name for privacy. It felt “like I was giving birth.
Medical Xpress
FEBRUARY 16, 2023
Whether we're night owls or morning larks, our body clocks are set by the sun. Theoretically, changing day length and light exposure over the course of the year could affect the duration and quality of our sleep. But figuring out how this applies in practice is difficult. Although studies where people assess their own sleep have suggested an increase in sleep duration during winter, objective measures are needed to determine how exactly the seasons affect sleep.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
BioPharma Reporter
FEBRUARY 21, 2023
The Danish-US biotech Hemab Therapeutics bags $135m to finance the clinical development of prophylactic treatments for genetic bleeding disorders including Glanzmann thrombasthenia and von Willebrand disease.
Bio Pharma Dive
FEBRUARY 13, 2023
The company said its modified contract with the federal government, which comes ahead of a planned transition to private market sales, will help it develop an updated version of its vaccine.
Pharmaceutical Technology
FEBRUARY 24, 2023
On December 20, 2022, the World Health Organization (WHO) updated its recommendations for cervical cancer vaccines in a bid to boost vaccination coverage. The WHO now says that a one-dose schedule for girls ages 9–14 years adequately protects against human papillomavirus (HPV), and more specifically, the HPV 16 and HPV 18 strains. The insights and amendments came following findings from a meeting held by WHO’s independent expert advisory group in April 2022.
NPR Health - Shots
FEBRUARY 20, 2023
Florida's medical boards have voted to ban gender-affirming care for transgender youth. Families with trans children and medical providers who care for them are worried about the impact.
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.
STAT News
FEBRUARY 15, 2023
In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution. The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage.
Medical Xpress
FEBRUARY 8, 2023
Over the past three years, the emergence of long-term effects associated with COVID-19 has led to increased focus on a disease with similar hallmarks and symptoms—myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Two studies publishing February 8 in the journal Cell Host & Microbe are taking a closer look at ME/CFS as it relates to the microbiome and the metabolites that microbial species produce.
Fierce Pharma
FEBRUARY 24, 2023
Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18
Bio Pharma Dive
FEBRUARY 17, 2023
Apellis’ Syfovre is the first marketed treatment for geographic atrophy, a common and irreversible eye condition. But questions linger about its benefit and safety.
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.
Pharmaceutical Technology
FEBRUARY 23, 2023
GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme. This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and R
NPR Health - Shots
FEBRUARY 16, 2023
Among the enacted changes, 16- and 17-year-olds will be allowed to undergo an abortion without parental consent. And workers suffering debilitating period pain can take paid time off.
STAT News
FEBRUARY 16, 2023
Matt Fitzgerald used to bike up and down 3,500 feet through the Santa Ana Mountains on three-hour rides just for fun. Now, nine months after being infected with SARS-CoV-2, the virus that causes Covid-19, he can’t muster walking on flat surfaces for 20 minutes without days of exhaustion. “My long Covid life remains terrifying,” he told me.
Medical Xpress
FEBRUARY 3, 2023
Cinnamon, the well-known aromatic spice that many of us use to bake cakes and cook savory dishes, is derived from the inner bark of Cinnamomum trees. These are evergreen trees found in the Himalayas and other mountain areas, as well as in rainforests and other forests in southern China, India and Southeast Asia.
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
Fierce Pharma
FEBRUARY 15, 2023
GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg esagonowsky Wed, 02/15/2023 - 09:02
Bio Pharma Dive
FEBRUARY 1, 2023
The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.
Pharmaceutical Technology
FEBRUARY 26, 2023
In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream. This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times.
NPR Health - Shots
FEBRUARY 18, 2023
A large study found that cutting down on alcohol is a good idea. People who quit drinking also had increased risk of dementia, but researchers cautioned about drawing conclusions from that.
Advertiser: Aggregage
New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!
STAT News
FEBRUARY 1, 2023
A recent study and accompanying news story in the preeminent journal Nature provocatively concludes that disruptive innovation in science has dramatically and mysteriously declined 90% since 1945. The study has prompted a wave of news coverage and tweets decrying the apparent languishing of modern science. We feel that the authors make interesting observations on publishing trends, but their conclusions seem to be quite disconnected from the valuable and transformative innovations that benefit h
Medical Xpress
FEBRUARY 8, 2023
As we age, the end caps of our chromosomes, called telomeres, gradually shorten. Now, Salk scientists have discovered that when telomeres become very short, they communicate with mitochondria, the cell's powerhouses. This communication triggers a complex set of signaling pathways and initiates an inflammatory response that destroys cells that could otherwise become cancerous.
Fierce Pharma
FEBRUARY 14, 2023
Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit kdunleavy Tue, 02/14/2023 - 10:29
Bio Pharma Dive
FEBRUARY 7, 2023
The health insurer’s national formulary considers Amylyx Pharmaceuticals’ Relyvrio to be "experimental, investigational or unproven for any use,” and now does not recommend covering it.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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