PharmaVoice

OCTOBER 2, 2023

The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.

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STAT

OCTOBER 3, 2023

The Food and Drug Administration on Tuesday authorized Novavax’s updated Covid-19 vaccine, giving Americans seeking to update their protection against the SARS-CoV-2 virus another option. Though the FDA’s green light came three weeks after the approvals for the updated Moderna and Pfizer-BioNTech shots, it contained some welcome news for the Gaithersburg, Md.

Vaccines 364

Vaccines 364

ALiEM - Pharm Pearls

OCTOBER 2, 2023

A 6-year-old male presented to the pediatric emergency department (PED) for scalp lesions. He was seen by his pediatrician 2 weeks prior and prescribed antibiotics and a delousing shampoo for suspected cellulitis versus lice infestation. Symptoms did not improve despite completion of treatment. An outpatient ultrasound was performed showing “multiple scalp echogenic nodular lesions measuring from 0.5 cm to 1.2 cm in the long axis diameter.

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Medical Schools 186

The Pharmacist

OCTOBER 2, 2023

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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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.

PharmaVoice

OCTOBER 4, 2023

The FDA wouldn’t review a drug that was 90% effective. In rare diseases, this is too common, said the UltraGenyx CEO and a leading rare disease researcher.

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OCTOBER 3, 2023

WASHINGTON — It started with a tweet: A year-old, 43-second clip of Kevin Wang talking about how parents and teachers can help affirm and support a child’s gender identity, encouraging children to explore. The vitriolic tweets were swift, and they snowballed. Right-wing influencers accused Wang, an unassuming Seattle physician, of “mutilating” and “destroying” children, though he did not discuss surgery in the clip.

Hospitals 363

Hospitals 363

Express Pharma

OCTOBER 4, 2023

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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Communication 124

PharmaVoice

OCTOBER 2, 2023

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

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OCTOBER 2, 2023

LONDON — Two pioneers of mRNA research — the technology that helped the world tame the virus behind the Covid-19 pandemic — won the 2023 Nobel Prize in medicine or physiology on Monday. Overcoming a lack of broader interest in their work and scientific challenges, Katalin Karikó and Drew Weissman made key discoveries about messenger RNA that enabled scientific teams to start developing the tool into therapies, immunizations, and — as the pandemic spread in 2020 &

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Immunity Immunization Vaccines 363

BioPharma Dive

OCTOBER 6, 2023

The funding, which is part of ACT for ALS, will support expanded access studies of drugs developed by Prilenia Therapeutics, Clene Nanomedicine and Rapa Therapeutics.

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Drug Development 122

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Pharmacy Management

The Pharmacist

OCTOBER 2, 2023

The community pharmacy sector should know how the additional £654m Primary Care Recovery Plan funding will be spent by the end of November, as negotiations draw to a close. Community Pharmacy England (CPE) said in its September update that it hopes to conclude its negotiations with the government about how the funding will be allocated […] The post Negotiations on £645m funding hoped to conclude by November appeared first on The Pharmacist.

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Community Pharmacies 118

PharmaVoice

OCTOBER 4, 2023

Judges have found fault with drug manufacturers’ First and Fifth Amendment arguments against the IRA’s drug pricing measures.

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Drug Pricing 279

STAT

OCTOBER 1, 2023

Health insurer Cigna is paying more than $172 million to settle allegations that it committed fraud by knowingly submitting inaccurate diagnoses of its Medicare Advantage members, the company and Department of Justice announced Saturday. The settlement stems from a wide-ranging government investigation into the coding practices of Medicare Advantage insurers, as well as a specific whistleblower lawsuit against Cigna that the DOJ joined last year.

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Pharma Times

OCTOBER 2, 2023

The proposed changes could limit patients’s access to treatments and clinical trials - News - PharmaTimes

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Med Ed 101

OCTOBER 4, 2023

It’s hard to believe that I have been following pharmacist board certifications and helping pharmacists pass the BCPS exam for over 10 years since I first passed it in 2013! Each year in updating and creating our study materials, I review the content outline and any possible changes in the BCPS exam. There are definitely […] The post 2024 BCPS Exam – What’s Changing?

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PharmaVoice

OCTOBER 3, 2023

Not every unicorn company lives up to its $1 billion promise. Here are four worth watching.

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STAT

OCTOBER 2, 2023

The most noteworthy aspect of awarding the Nobel Prize in medicine or physiology to two pioneers of mRNA research was not who won Monday — Katalin Karikó and Drew Weissman were widely expected to get the accolade for discoveries that made it possible to deliver the finicky molecule to cells and enabled the record-breaking development of vaccines that tamed the Covid-19 pandemic.

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Vaccines Immunity Immunization 361

Pharma Times

OCTOBER 5, 2023

The research approach will help small- to mid-sized organisations to advance their clinical studies - News - PharmaTimes

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Drug Patent Watch

OCTOBER 2, 2023

The FDA conducted a study to identify factors that may predict the likelihood of generic drug marketing applications. The study focused on abbreviated new drug applications (ANDAs) submitted to the… The post Factors that May Predict the Likelihood of Generic Drug Marketing Applications appeared first on DrugPatentWatch - Make Better Decisions.

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BioPharma Dive

OCTOBER 2, 2023

The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.

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SEPTEMBER 30, 2023

Next week, 50 medical experts from the Karolinska Institutet in Stockholm will meet to award the 2023 Nobel Prize for Physiology or Medicine. The vote takes place on Oct. 2, but betting-minded scientists are already beginning to make their picks for who might take home the gold. Seasoned Nobel prognosticators will point out that the medicine prize often cycles between super-basic molecular biology and inventions that actually cure people.

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Diabetes 356

Pharma Times

OCTOBER 5, 2023

It will be the company’s first platform to be installed in an external scientific setting - News - PharmaTimes

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The Pharmacist

OCTOBER 2, 2023

NHS England (NHSE) has recommended that community pharmacies maintain stocks for one or two courses of Covid oral antivirals Paxlovid and Lagevrio, depending on usual demand, to dispense against prescriptions immediately. According to a notice issued in the NHS Primary Care Bulletin last week, Allied Healthcare is also increasing its holdings. NHSE said the measures […] The post Covid antiviral stock advice issued appeared first on The Pharmacist.

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Community Pharmacies 108

BioPharma Dive

OCTOBER 5, 2023

Kyowa will pay nearly $400 million to acquire Orchard, which sells the gene therapy Libmeldy in Europe but has struggled to find paths to market for other experimental treatments.

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STAT

OCTOBER 5, 2023

The Food and Drug Administration’s expert vaccine advisory panel on Thursday unanimously endorsed the idea of taking a strain of influenza viruses that no longer appears to circulate out of flu shots as quickly as possible, pressing the FDA and manufacturers to try to get the work done on an expedited timeline. While a representative of vaccine manufacturers warned it may not be possible to remove the influenza B/Yamagata component from the flu vaccines that will be made for the Northern

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Vaccines 346

Pharma Times

OCTOBER 4, 2023

The companies aim to bring gene therapies to patients sooner than traditional approaches - News - PharmaTimes

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European Pharmaceutical Review

OCTOBER 2, 2023

The Nobel Assembly has awarded Hungarian biochemist Katalin Karikó and US immunologist Drew Weissman the Nobel Prize in Physiology or Medicine 2023 for their breakthrough findings in RNA vaccine development. The discoveries by the two Nobel Laureates have revolutionised science’s understanding of how messenger RNA (mRNA) interacts with the immune system.

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Vaccines Immunity Immunization 107

Digital Pharmacist

OCTOBER 6, 2023

ConclusionI n July 2023, Florida passed the Prescription Drug Reform Act (Chapter 2023-29). Now, what is this act? The Prescription Drug Reform Act aims to regulate pharmacy benefit managers (PBMs) and pharmaceutical manufacturers in the state. The primary focus of this act is to bring transparency, accountability, and fairness to the outpatient pharmaceutical system in Florida, especially in relation to PBMs.

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Pharmaceutical Manufacturing Pharmacy Management 105

STAT

OCTOBER 2, 2023

Louis Picker is nervous. Last month, the first volunteer was injected with an HIV vaccine he spent over 20 years designing. It’s prototype No. 2. The last shot they tested, in 2021, didn’t do much of anything, and the 66-year-old worries that if this fails, he might not get another chance to redesign it.  Truthfully, though, Picker isn’t sure his HIV vaccine stands much of a chance.

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Vaccines Immunity Immunization 339

Pharma Times

OCTOBER 2, 2023

The study analysed and compared information from 65,000 MS patients - News - PharmaTimes

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PharmExec

OCTOBER 4, 2023

In this Q&A with Pharmaceutical Executive®, Andrew Hopkins, founder and CEO of Exscientia, reveals how artificial intelligence (AI) is currently being utilized in the pharma industry, predictions for where AI can be implemented in the future, and what pharma fears most about AI.

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Pharmafile

OCTOBER 6, 2023

Sanofi has shared new data for the long-term efficacy of Nexviazyme (avalglucosidease alfa) for the treatment of Pompe disease at the 28th Annual Congress of the World Muscle Society (WMS) in Charleston, South Carolina, US. Nexviazyme is approved in the US and elsewhere as a monotherqapy for the treatment of late-onset Pompe disease, and is […] The post Sanofi shares new data for long-term efficacy of Nexviazyme for Pompe disease treatment appeared first on Pharmafile.

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STAT

OCTOBER 6, 2023

If the Covid-19 pandemic has shown us one thing, it is how little we really know about how the human immune system works. Despite the remarkable success in development of vaccines to prevent severe disease from SARS-CoV-2, it remains unclear how SARS-CoV-2, a newly emerging virus, causes such a broad spectrum of disease , ranging from asymptomatic and mild cases to severe disease and death.

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Immunity Immunization Vaccines 335

The Pharmacist

OCTOBER 4, 2023

The first cohort of seven pharmacists have completed the advanced pharmacist e-portfolio pathway jointly delivered by the Royal Pharmaceutical Society (RPS), NHS England (NHSE) Workforce, Training and Education Centre for Advancing Practice and the Centre for Pharmacy Post Graduate Education (CPPE). They are now eligible for the NHSE Centre of Advancing Practice’s ‘Advanced’ digital badge, […] The post First pharmacists complete e-portfolio advanced pathway appeared first on The Pharmacist

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Express Pharma

OCTOBER 5, 2023

The Indian Pharmaceutical Alliance (IPA) recently organised 8th Advanced Good Manufacturing Practices Workshop with 20+ subject matter experts, industry leaders and global regulators from USFDA, MHRA, CDSCO. The workshop aimed to facilitate sharing of knowledge and the development of capabilities among Indian pharma companies, enabling them to embrace globally acknowledged manufacturing practices.

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