October, 2023

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STAT+: Pharmacists can make shortage drugs, but at what cost?

STAT

Pharmacists increasingly are being asked to make drugs in bulk for hospitals that are in short supply, and they’re even beginning to make chemotherapies. But some in the industry worry about the unintended consequences of overreliance. Hospitals’ reliance on pharmacist-made drugs, a practice called compounding, has risen in step with worsening drug shortages.

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Exclusive: Six in 10 pharmacists confident to deliver Pharmacy First this winter, suggests survey

The Pharmacist

More than six in 10 community pharmacists surveyed by The Pharmacist believe they have the capacity to deliver a common conditions service in England this winter. Those surveyed highlighted public and GP awareness, proper funding for the service and training for pharmacists as key enabling factors for the service. ‘More resources, clarity on payment reconciliation, […] The post Exclusive: Six in 10 pharmacists confident to deliver Pharmacy First this winter, suggests survey appeared first

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Pfizer to cut costs, lay off staff on waning demand for COVID products

BioPharma Dive

Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.

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Actor and epilepsy advocate Greg Grunberg wants the world to ‘talk about it’

PharmaVoice

The actor of “Heroes” and “Star Wars: The Force Awakens” fame is starring in another role as a patient advocate for people with epilepsy.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Cipla Foundation, NIMHANS partner to set up neuro-palliative care unit

Express Pharma

Cipla Foundation in partnership with National Institute of Mental Health and Neuro-Sciences (NIMHANS) has set up a neuro-palliative care unit in Bengaluru. The company informed that this unit has provided support to over 2,000 individuals with neurological conditions such as Alzheimer’s, Dementia, and Parkinson’s, through in-patient, out-patient, home care, and has offered teleconsultation services to patients as well as their families and caregivers. it also informed that at this ne

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PulmCrit blogitorial: Why I don’t believe the AMIKINHAL trial

EMCrit Project

Some folks on twitter asked my thoughts on AMIKINHAL trial, so I thought I'd jot them here. AMIKINHAL is a multi-center RCT that evaluated the ability of inhaled amikacin to prevent VAP (ventilator-associated pneumonia) among patients who had been intubated for three days. It's available here at NEJM. It was a positive trial, which is […] EMCrit Project by Josh Farkas.

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Sodium valproate reclassification ushers in full pack dispensing

The Pharmacist

All licensed medicines containing sodium valproate, valproic acid and semisodium valproate have been reclassified as special containers, meaning they are subject to full pack dispensing. The change, effective since 1 October, means that where the prescription quantity is not available in an original pack size or multiple of pack sizes, the nearest number of full […] The post Sodium valproate reclassification ushers in full pack dispensing appeared first on The Pharmacist.

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A decade later, biotech’s CRISPR revolution is still going strong

BioPharma Dive

Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

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Patient groups have become a powerhouse in R&D. Here’s a look at their impact.

PharmaVoice

“They have the money,” and they’re using it to influence drug development, according to the executive director of the IQVIA Institute for Human Data Science.

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LogiPharma USA 2023: Tracy Nasarenko Provides a Synopsis of “DSCSA—Final Checks to Have Before Deadlines.”

Pharmaceutical Commerce

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.

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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.

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Life Sciences Innovation Day – Accelerating Digital Transformation Ambition

European Pharmaceutical Review

Schneider Electric, a leader in digital transformation, energy management and automation, has announced the speaker lineup for its exclusive event, Life Sciences Innovation Day – Accelerating Digital Transformation Ambition. Set at the world-renowned Silverstone F1 Racetrack on 18 October 2023, it promises to be a day of immersive insights and top rate networking.

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STAT+: In major test for prime editing, scientists successfully correct mutations in monkeys

STAT

Prime Medicine said Friday it successfully used a new, ultra-versatile form of genetic surgery called prime editing to edit liver cells in monkeys. The results, presented at the European Society of Gene & Cell Therapy meeting in Brussels, are a major step for a technology that could transform treatment of numerous diseases. “I think the big celebration here is we’re showing, in primates, for the company, that we have a delivery system that is working and is safe,” said J

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CAR-TCR 2023 – Matt Lakelin

pharmaphorum

At CAR-TCR in Boston last month, pharmaphorum’s Jonah Comstock caught up with Matt Lakelin, co-founder of TrakCel, a software company that helps makers of advanced therapies manage their supply chain.

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Verve gets FDA green light to run base editing study in US

BioPharma Dive

The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.

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5 Reasons to Upgrade Your Pharmacy Management Software

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.

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The FDA might yank cold medicines from shelves — and that could be just the beginning

PharmaVoice

Phenylephrine’s future is up in the air with an FDA committee saying it’s not effective and a class action lawsuit alleging false advertising. What comes next could have big repercussions.

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PulmCrit Blogitorial – New IDSA/SCCM guidelines on fever evaluation in ICU

EMCrit Project

More guidelines! Today we'll walk through some interesting bits of the new IDSA/SCCM guideline on evaluation of new fever in the adult ICU patient (available free here). how should temperature be evaluated? This is frankly a mess. Bladder catheter or esophageal probe are best, but usually not used. Rectal temperature is 2nd best, but unwieldy […] EMCrit Project by Josh Farkas.

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MHRA finds fake Ozempic pens in UK supply chain

The Pharmacist

Pre-filled pens falsely labelled as Ozempic have been identified in the UK supply chain, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed. The pens were identified before reaching UK patients, and all affected pens have now been recalled and accounted for, the MHRA said. The products were imported from legitimate suppliers in Austria […] The post MHRA finds fake Ozempic pens in UK supply chain appeared first on The Pharmacist.

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‘We’re absolutely making it too hard’: The complexity of adult immunization delivery hinders vaccine uptake

STAT

Alison Buttenheim was floored by a sign she saw in her doctor’s office when she went to get the first jab of the two-dose shingles vaccine to protect her against painful flare-ups of varicella zoster. “Medicare patients cannot receive Tdap or zoster vaccines here. They need to obtain [them] at their pharmacy. If they receive it here, they need to pay out of pocket,” the notice read.

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Dr Reddy’s launches D2C e-commerce website ‘Celevida Wellness’ for diabetes

Express Pharma

Dr Reddy’s Laboratories announced the launch of its first direct-to-consumer (D2C) e-commerce website ‘Celevida Wellness’ for diabetes patients by its wholly-owned subsidiary, Svaas Wellness. A company statement informed, “The website will host the Celevida range of products as well as other third-party brands to offer a product portfolio that takes care of a diabetic patient’s daily nutritional requirement and at the same time fits into the complete occasion framework of the day i.e., breakfast

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Vertex, CRISPR therapy for sickle cell passes FDA panel test

BioPharma Dive

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

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The ALS therapy keeping the human pig heart transplant pumping

PharmaVoice

Eledon’s investigational ALS drug tegoprubart could also help prevent organ transplant rejections, the company says.

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First-in-class phosphate absorption inhibitor approved by FDA

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. Ardelyx’s first-in-class oral treatment is indicated to reduce serum phosphorus in adults with chronic kidney disease ( CKD ) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant to phosphate binder therapy.

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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog: Biosimilars

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

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Opinion: I lost my son to OxyContin. ‘The Fall of the House of Usher’ is my Sackler revenge fantasy

STAT

Editor’s note: This essay contains spoilers for the Netflix show “The Fall of the House of Usher.” “W atch “ The Fall of the House of Usher” on Netflix when you can. F**cking Great! Totally based on the Sacklers—Fictional obviously but so damn good!

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Local authorities in England are failing to meet dementia diagnosis targets

Pharma Times

The APPG has called for urgent improvements in rural and ethnically diverse-areas - News - PharmaTimes

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Tracking the FDA’s meeting on Vertex, CRISPR’s sickle cell therapy

BioPharma Dive

Expert advisers are reviewing the companies’ case for approval of what could be the first medicine based on the gene editing technology. Follow their discussion here.

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Has the science of anti-aging caught up with the dream of a longer life?

PharmaVoice

Billionaire investors and a new crop of longevity biotechs are betting big money on a lifespan-altering tipping point.

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An Evolving ‘Opinion’ Landscape: New Paths—and Synergies—for Pharma KOLs & DOLs

PharmExec

Industry experts discuss the relationship between digital and traditional (key) opinion leaders and how companies are adjusting their strategies to harness the unique brand engagement benefits each role can provide in driving better patient outcomes.

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Hyloris wins painkiller approval amidst amplified anti-opioid efforts

Pharmaceutical Technology

The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.

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Maternal Covid-19 vaccination offers infants immunity for up to 6 months

STAT

The risks of severe neonatal morbidity, neonatal death, and admission to the neonatal intensive care unit were all significantly lower during the first month of birth in infants whose mothers were vaccinated against Covid-19, and protection against the virus continued for up to six months after birth, according to a new study published Monday in JAMA Pediatrics.

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AstraZeneca granted licence for Nanoform’s AI technology

Pharma Times

STARMAP will accelerate the selection of AZ’s best molecule candidates - News - PharmaTimes

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Vertex gearing up for launch as sickle cell therapy review advances

BioPharma Dive

Executives at the biotech say they’re trying to get ahead of the payer and production challenges that will face their gene editing treatment exa-cel, which is now under FDA review.

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How the rise of medical device use in pharma R&D is driving wearable technology in healthcare and revolutionising the medical industry

pharmaphorum

How the rise of medical device use in pharma R&D is driving wearable technology in healthcare and revolutionising the medical industry Mike.

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Topical Ketamine: A Promising New Avenue for PTSD Treatment

Pharmacy Times

Ketamine topical cream may alleviate symptoms of PTSD without causing the adverse effects and abuse potential often associated with other forms of ketamine administration.

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