First Oral Antiviral Treatment For COVID-19 Gets FDA Approval
Drug Topics
MAY 26, 2023
More than 11.6 million treatment courses of the medication have been prescribed in the U.S. to date.
Fri.May 26, 2023
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Five Trends Transforming Pharmacies into Wellness Centers of the Future
Pharmacy Times
MAY 26, 2023
With so many radical developments in medicine and technology unfolding at once, the role and potential of the pharmacy as we know it is evolving at breakneck speed.
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Johnson & Johnson cites rebates and discounts for drug price increases
Fierce Pharma
MAY 26, 2023
Johnson & Johnson cites rebates and discounts for drug price increases kdunleavy Fri, 05/26/2023 - 07:36
Incorporating FMT Treatment Into Clinical Practice
Pharmacy Times
MAY 26, 2023
Candace Cotto, RN, reviews the process of incorporating fecal microbiota, live-jslm treatment into clinical practice, what patients can expect, and the room sanitation process after the procedure.
Position Your Pharmacy for Expansion
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.
Some hoped a new oral vaccine would solve all the polio campaign’s problems. Reality is settling in
STAT
MAY 26, 2023
When a new and hoped-to-be safer oral polio vaccine started to make its way into use in March 2021, there was huge optimism that this long-needed tool would help the polio eradication campaign quell a growing problem that was — and is still — complicating efforts to stamp out polio forever. Two years later, expectations surrounding the new vaccine, known as novel oral polio vaccine type 2, or nOPV2 for short, are moderating a bit.
Phase 2a Trial Showed Peresolimab Reduced Joint Swelling, Tenderness in Patients With Rheumatoid Arthritis
Pharmacy Times
MAY 26, 2023
This is the first clinical evidence to show that stimulating the programmed cell death protein 1 (PD1) inhibitory pathway is beneficial for rheumatologic disease.
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Incidence of C. diff Infection Increased Significantly in Some Countries During the Pandemic
Pharmacy Times
MAY 26, 2023
In Greece, the stark increase in Clostridioides difficile (C. diff) incidence cannot be explained by a rise of antimicrobial use during the pandemic.
Immuno-oncology market set to grow in billions, but access concerns remain
Pharmaceutical Technology
MAY 26, 2023
The immuno-oncology market continues to evolve as treatments establish their presence across different types of cancer, having seen approvals in multiple indications in the past decade. While the market was worth over $6 billion in 2012, this has now grown to nearly $48 billion only a decade later, said Avigayil Chalk, PhD, GlobalData’s Senior Oncology and Haematology analyst, at an immuno-oncology webinar held on May 23.
Pharmacoscopy Platform Creates Automated, Personalized Selection of Treatment Options for Patients With Multiple Myeloma
Pharmacy Times
MAY 26, 2023
Multiple myeloma treatment selection is critical due to the potential for developing treatment resistance over time to the currently prescribed drugs.
Krystal Biotech receives FDA approval for DEB topical gene therapy
Pharmaceutical Technology
MAY 26, 2023
Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. VYJUVEK is designed to address the underlying genetic cause of the disease. An excipient gel applied topically is a key component of the therapy, which is supplied by Krystal’s client, Berkshire Sterile Manufacturing (BSM).
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Oncology Pharmacists Connect Meeting Promises Focus on Changing Treatment Paradigms, Implementation Challenges for Pharmacists
Pharmacy Times
MAY 26, 2023
Program Chair Ryan Haumschild, PharmD, MS, MBA, discussed what attendees can look forward to at the inaugural Oncology Pharmacists Connect meeting.
Life sciences sector to receive £650 million funding
European Pharmaceutical Review
MAY 26, 2023
The UK Chancellor has announced a £650 million life sciences growth package (Life Sci for Growth) to help deliver the Science and Technology framework through reforming regulation, boosting investment and driving up talent and skills. Bringing together 10 different policies, the package includes: A total of £121 million to improve commercial clinical trials to bring new medicines to patients faster Up to £48 million of new money for scientific innovation to prepare for any future health emergenc
How the Decentralization of Clinical Trials Can Transform Health Care
Pharmacy Times
MAY 26, 2023
Decentralization has already been shown to streamline clinical trials, but it also has the potential to improve the broader health care ecosystem.
While Pfizer, BioNTech agree to cut COVID vaccine supply to Europe, Moderna sets up shop in China
Fierce Pharma
MAY 26, 2023
While Pfizer, BioNTech agree to cut COVID vaccine supply to Europe, Moderna sets up shop in China kdunleavy Fri, 05/26/2023 - 10:03
5 Reasons to Upgrade Your Pharmacy Management Software
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Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.
Overweight, Obese BMI Associated With Increased Risk of Gastrointestinal Cancer
Pharmacy Times
MAY 26, 2023
Overweight or obesity between middle and later adulthood had a statistically significant risk for noncolorectal gastrointestinal cancer.
Opinion: STAT+: An overlooked way to make participants in clinical trials look more like America
STAT
MAY 26, 2023
A recent report from the National Academies of Sciences, Engineering and Medicine (of which one of us, GC, is an author) shows that underrepresentation of population subgroups in clinical research is bad for the health of Americans. For instance, recent research showed that appropriate dosing for an often- prescribed blood thinner, warfarin, differs due to genetic variants.
Migraine: Much Progress Made, Significantly More Needed
Pharmacy Times
MAY 26, 2023
Although an established standard of care for migraine prophylaxis exists, the current protocol is not without significant shortcomings.
Texas wants to wean trans youth off meds in a ‘safe and medically appropriate’ way. Doctors say that’s impossible
STAT
MAY 26, 2023
In a wave of anti-LGBTQ legislation , 19 U.S. states thus far have banned at least some gender-affirming health care for minors — care that is evidence-based and supported by the major medical and professional organizations. The state of Texas may soon add to that count, with legislators passing a bill last week that Governor Greg Abbott has promised to sign when it comes across his desk.
5-Year Follow-Up Studies Support B/F/TAF Regimen As Long-lasting, Effective Treatment for Patients With HIV-1
Pharmacy Times
MAY 26, 2023
Bictegravir/emtricitabine/ tenofovir alafenamide tablets (B/F/TAF) provides long-term virologic suppression for nearly 100% of patients.
Science finally figured out how to make effective RSV vaccines. Will seniors care?
STAT
MAY 26, 2023
The world has waited decades for vaccines to protect older adults against RSV. One, made by GSK, was approved by the Food and Drug Administration earlier this month. A second, made by Pfizer, is expected to follow by the end of May. Both will likely be in use this fall, in time to protect seniors going into the next RSV season. So it’s tempting to think the fight against respiratory syncytial virus in older adults is about to kick into high gear, that as early as next winter the United St
Study: Mifepristone Does Not Statistically Improve Symptoms of Chronic PTSD in Male Veterans
Pharmacy Times
MAY 26, 2023
The steroid could be more effective for veterans with post-traumatic stress disorder who do not have a history of traumatic brain injury.
Omada tackles obesity drugs, Boston Scientific nixes deal, and Microsoft health exec on GPT
STAT
MAY 26, 2023
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday. Omada Health announced it will launch a new service to help employers respond to the soaring demand for e xpensive GLP-1 weight loss treatments like Wegovy.
Counsel Patients On the Range of Treatments for Depression
Pharmacy Times
MAY 26, 2023
Patients with depression require long-term treatment and supportive care, either with medications or non-pharmaceutical options.
STAT+: Neuralink can now study its brain implant in humans, but it’s still catching up to its peers
STAT
MAY 26, 2023
Neuralink can now study its brain implant in humans after securing a go-ahead from the Food and Drug Administration. It’s a critical turning point for the Elon Musk-led company — but the startup, however closely watched, is playing catch-up compared to its peers in the neurotechnology field. “In terms of first in human, Neuralink is almost two decades behind,” said JoJo Platt, a neurotech strategist.
Priority review granted by FDA for 'landscape changing' colorectal cancer drug
Outsourcing Pharma
MAY 26, 2023
A drug that has the ability to âtransform the landscapeâ for people living with metastatic colorectal cancer (CRC) has been granted priority review by the US Food and Drug Administration (FDA).
STAT+: Pharmalittle: EMA urges revoking authorization for Novartis sickle cell drug; U.K. tries to placate pharma execs
STAT
MAY 26, 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 still taking shape, but we hope to check in on the Pharmalot ancestors, hang with our shortest person, promenade with the official mascot, and squeeze in a listening party — the rotation will include this , this , this and this.
EU regulators recommend yanking authorization for Novartis' sickle cell med Adakveo after phase 3 miss
Fierce Pharma
MAY 26, 2023
EU regulators recommend yanking authorization for Novartis' sickle cell med Adakveo after phase 3 miss zbecker Fri, 05/26/2023 - 10:48
STAT+: Up and down the ladder: The latest comings and goings
STAT
MAY 26, 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.
CVS braces for $1B hit following Medicare Advantage star ratings drop
Fierce Healthcare
MAY 26, 2023
CVS braces for $1B hit following Medicare Advantage star ratings drop pminemyer Fri, 05/26/2023 - 12:45
New recognition routes to fast-track UK medicine access
European Pharmaceutical Review
MAY 26, 2023
The Medicines and Healthcare products Regulatory Agency ( MHRA ) has announced that new international regulatory recognition routes for medicines will be established using approvals from the EU, Switzerland, US, Canada, Australia, Singapore and Japan. According to the MHRA, the recognition routes mark the start of a new international recognition framework for medicines that will be in place by the first quarter of 2024.
Fierce Pharma Asia—Carvykti's EU filing; Thermo Fisher's Singapore expansion; Celltrion's Humira biosim nod
Fierce Pharma
MAY 26, 2023
Fierce Pharma Asia—Carvykti's EU filing; Thermo Fisher's Singapore expansion; Celltrion's Humira biosim nod aliu Fri, 05/26/2023 - 08:43
Report: Retailers are vying for 'a piece of the medical pie.' How should traditional providers respond?
Fierce Healthcare
MAY 26, 2023
Report: Retailers are vying for 'a piece of the medical pie.' How should traditional providers respond?
Gilead, Teva reach 11th-hour settlements with some groups in HIV antitrust case
Fierce Pharma
MAY 26, 2023
Gilead, Teva reach 11th-hour settlements with some groups in HIV antitrust case zbecker Fri, 05/26/2023 - 09:09
The ‘superpowers’ pharma leaders should cultivate
PharmaVoice
MAY 26, 2023
Executives honored by the Healthcare Businesswomen’s Association share the key traits that help them drive results.
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