STAT
OCTOBER 30, 2023
When the human body is exposed to extreme heat, it tries to fight back. To keep us from cooking, our hearts pump faster and harder to distribute the hot blood out to our fingers and toes, away from precious internal organs. We produce more sweat, and when it evaporates, the blood beneath the skin’s surface cools down, helping to lower our body temperature.
PharmaVoice
OCTOBER 30, 2023
Novavax scored a new COVID vaccine go-ahead for the 2023-24 season, but is it the boost the company needs?
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STAT
OCTOBER 30, 2023
Cassava Sciences has long claimed its experimental drug, called simufilam, slows the cognitive decline of people with Alzheimer’s. On Friday, we learned how: The company recruited a large number of people into its clinical trial who don’t have Alzheimer’s. People who almost certainly had Alzheimer’s were also included in the study, but in this group, a placebo outperformed Cassava’s drug.
ALiEM - Pharm Pearls
OCTOBER 30, 2023
Dr. Garcia is a freshly minted faculty member at Big Name University Medical Center. She’s excited to have finally finished residency and dive into her career as a full time (and fully paid) attending. After spending her first year acclimating to the new department and achieving board certification, Dr. Garcia finds herself at a bit of a crossroad.
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
STAT
OCTOBER 30, 2023
DENVER — On Jan. 1, it will be 10 years since customers lined up in the streets of the Mile High City to be the first in the United States to purchase legal recreational marijuana. In the succeeding decade, the sky has not fallen. The Colorado cannabis industry has generated over $2 billion in tax revenues that have funded building public schools and setting up bullying prevention programs.
The Pharmacist
OCTOBER 30, 2023
The General Pharmaceutical Council (GPhC) has extended the revalidation deadline, giving pharmacists due to submit their revalidation by 31 October an extra week to do so, following technical issues with its website. Pharmacists that were due to revalidate by the end of October now have until 11:59pm on Tuesday 7 November 2023 to submit their […] The post Revalidation deadline extended after GPhC technical issues appeared first on The Pharmacist.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
Drug Patent Watch
OCTOBER 30, 2023
Over the past two decades, Bayer Pharma has developed an in silico absorption, distribution, metabolism, and excretion (ADMET) platform with the aim of generating models for various pharmacokinetic and physicochemical… The post Advancements in In Silico ADMET Modeling: A 20-Year Journey of Machine Learning in Drug Discovery at Bayer Pharma appeared first on DrugPatentWatch - Make Better Decisions.
STAT
OCTOBER 30, 2023
In the next few weeks, Sarepta Therapeutics will release new data that could change the future of the company and the lives of thousands of patients with Duchenne muscular dystrophy. The Phase 3 trial is testing whether Sarepta’s gene therapy, Elevidys, can slow progression of the fatal, muscle-wasting disease significantly more than placebo.
Drug Patent Watch
OCTOBER 30, 2023
Annual Drug Patent Expirations for CALQUENCE Calquence is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are eight patents protecting… The post New patent for Astrazeneca drug CALQUENCE appeared first on DrugPatentWatch - Make Better Decisions.
STAT
OCTOBER 30, 2023
Physician staffing firms, flailing in the wake of a federal law banning surprise bills, are demanding extra payment from hospitals to stay afloat. Hospitals, desperate for doctors to staff their facilities, have little choice but to comply. It’s a big topic of conversation on for-profit hospital earnings calls. Just last week, major hospital chains said those expenses, known as physician subsidies, were up 20% to 40% from last year.
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Express Pharma
OCTOBER 30, 2023
Suven Life Sciences announced positive topline results from its Phase-2 proof-of-concept study assessing the safety and efficacy of Samelisant for the treatment of excessive daytime sleepiness (EDS) in adult narcolepsy patients with and without cataplexy. The study met primary endpoint, with Samelisant demonstrating statistically significant and clinically meaningful reduction in EDS measured by the ESS total score compared to placebo at Day 14 (p<0.05).
STAT
OCTOBER 30, 2023
Sarepta Therapeutics said Monday afternoon that its gene therapy for Duchenne muscular dystrophy failed to improve muscle function compared to a placebo in a large clinical trial — likely a major disappointment for patients and doctors who have been desperately awaiting the treatment for years. The company said all patients in the study improved and that secondary measurements indicated the drug was having an effect.
Drug Patent Watch
OCTOBER 30, 2023
Annual Drug Patent Expirations for REMODULIN Remodulin is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are ten patents… The post New patent for United Therap drug REMODULIN appeared first on DrugPatentWatch - Make Better Decisions.
STAT
OCTOBER 30, 2023
President Joe Biden ordered the nation’s leading health agencies on Monday to develop a plan for regulating artificial intelligence tools already widely in use within hospitals, insurance companies, and other health-related businesses. The order directs the US Department of Health and Human Services to establish a safety program to receive reports of AI-related harms and unsafe practices — and take actions to remedy them.
BioPharma Dive
OCTOBER 30, 2023
Yet Sarepta said it still plans to ask the FDA to expand regulatory clearance of Elevidys, which was granted an accelerated approval by the FDA in June.
STAT
OCTOBER 30, 2023
When patients go shopping today, they might find themselves checking out with more than the vitamins or bulk toilet paper on their list. Several retailers have recently launched telehealth programs that let patients pick their medical concern off a menu of options, from hair loss and erectile dysfunction to acne and ear infections. Then they pay cash — no insurance accepted — to have a text or video visit with a provider.
European Pharmaceutical Review
OCTOBER 30, 2023
A large-scale study led by researchers at the University of Cincinnati and New York’s largest health care provider, Northwell Health, suggests that metformin can help prevent or reduce weight gain in youth taking second-generation antipsychotics (SGAs) to treat bipolar disorder. SGAs used to treat bipolar disorder are often effective at helping young patients’ mental health improve but can have significant side effects including elevated blood pressure and glucose, increased appetite, as w
STAT
OCTOBER 30, 2023
It’s changing of the guard time at pharmaceutical giant Bristol Myers Squibb. On Wednesday, CEO Giovanni Caforio will step down. He’ll be replaced by Christopher Boerner, who is currently chief operating officer. When Caforio took over in May 2015, Bristol was known as a big pharmaceutical firm with the high-flying stock of a biotechnology company, largely due to its role as the company that brought cancer immunotherapy to market.
Pharmaceutical Commerce
OCTOBER 30, 2023
Effort displays the diverse perspectives, skills, and people involved with the healthcare supply chain, as industry aims to continue to push DE&I forward.
STAT
OCTOBER 30, 2023
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hey there. Today, we discuss why Sanofi’s stock crashed, what Sarepta’s new Duchenne data will mean for the company and the space, and say goodbye to Bristol Myers Squibb’s chief executive.
BioPharma Dive
OCTOBER 30, 2023
The venture firm has supported a number of approved medicines with its co-development strategy, including Pfizer’s Besponsa and Apellis’ Empaveli.
STAT
OCTOBER 30, 2023
Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that oh-so familiar routine of online meetings and deadlines has predictably returned. After all, the world — such as it is — somehow continues to spin. To cope, we are brewing cups of stimulation. Our choice today is glazed doughnut.
Express Pharma
OCTOBER 30, 2023
The FDA recently rejected Eli Lilly’s biologic license application (BLA) for their anti-interleukin (IL) -13, lebrikizumab, which is in development for the treatment of atopic dermatitis (AD). This news will likely delay lebrikizumab’s entry into the US market and therefore affects the agent’s chances to compete directly with agents such as Sanofi and Regeneron’s first-to-market anti-IL-4/13 Dupixent (dupilumab) and LEO Pharma’s anti-IL-13 Adbry/Adtralza (tralokinumab), says GlobalData.
World Pharma News
OCTOBER 30, 2023
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced positive topline results from a Phase 1/2 study (NCT05596734) evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age.
European Pharmaceutical Review
OCTOBER 30, 2023
Echoes of the global health challenges we faced during the COVID-19 pandemic still linger as new variants emerge and COVID continues to make headlines. A question that continues to sit in the back of many people’s minds is what happens if there is another outbreak or global pandemic? Are we preparing and how ready are we for the next one? Vaccitech’s Chief Business Officer, Graham Griffiths, discusses key learnings in drug and vaccine development , the challenges of preparing for the unknown, an
Express Pharma
OCTOBER 30, 2023
Sun Pharmaceutical Industries and Zydus Lifesciences have entered into a licensing agreement to co-market Desidustat, an oral treatment for anemia associated with chronic kidney disease, (CKD) in India. Under the terms of this agreement, Zydus has granted Sun Pharma semi-exclusive rights to co-market the product in India. Sun Pharma will market the drug under the brand name RYTSTAT.
European Pharmaceutical Review
OCTOBER 30, 2023
Atamyo Therapeutics ’ one-time gene therapy for fukutin-related protein (FKRP) limb-girdle muscular dystrophy Type 2I/R9 (LGMD2I/R9) has enabled clinical trial patients to experience symptom relief, as well as a correction of centronucleation. LGMD2I/R9 is a rare genetic disease caused by mutations in the gene that produces fukutin-related protein (FKRP).
Pharma Times
OCTOBER 30, 2023
Over 600 commercial studies have been reviewed in the past 12 months - News - PharmaTimes
Express Pharma
OCTOBER 30, 2023
In response to the US Federal Government’s historic announcement regarding Medicare price negotiations for pharmaceuticals under the Inflation Reduction Act, the top 20 global biopharma firms experienced varied market capitalisation shifts in Q3 2023. These fluctuations highlight the industry’s response to evolving regulations, resulting in a slight 0.2 per cent increase in the aggregate market capitalization from $3.56 trillion in Q2 2023 to $3.57 trillion in Q3 2023, reveals Global
Pharma Times
OCTOBER 30, 2023
The NHS has been visiting at-risk communities to detect liver cancer earlier - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 30, 2023
The US FDA has issued a warning against the use of 26 over-the-counter eye drop products due to potential eye infection risks.
Outsourcing Pharma
OCTOBER 30, 2023
In the midst of International Gaucher Disease Awareness Month, GlobalData has highlighted a 'critical' issue within the Gaucher disease landscape: the significant lack of neuronopathic therapies.
Pharmaceutical Technology
OCTOBER 30, 2023
An EMA safety panel concluded that available evidence does not prove that GLP-1 receptor agonists cause thyroid cancer.
pharmaphorum
OCTOBER 30, 2023
Clinical trial disparities and how to build a more inclusive future Mike.
Pharmaceutical Technology
OCTOBER 30, 2023
A new study published by the Oxford Internet Institute has found that AI skills and knowledge can increase a worker’s salary as much as 40%.
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