Mon.Oct 02, 2023

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2023 Nobel Prize in Medicine: Karikó, Weissman awarded prize for mRNA research

STAT

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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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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STAT+: Nobel Prize, in a rarity, celebrates a fruitful and durable partnership

STAT

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.

Vaccines 361
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5 FDA decisions to watch in the fourth quarter

PharmaVoice

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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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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Can the world still invent an HIV vaccine? Progress in one area creates new problem

STAT

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.

Vaccines 339
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SAEM Clinical Images Series: Unusual Scalp Lesions

ALiEM - Pharm Pearls

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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The PharmaVoice 100: Cancer care visionaries

PharmaVoice

Leaders shaping the future of oncology and cancer care through grit and determination in the face of one of healthcare’s greatest challenges.

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The stability of $0 premiums in Medicare Advantage

STAT

You’re reading the web edition of Health Care Inc., STAT’s weekly newsletter following the flow of money through the health care system.  Sign up here  to get it in your inbox. Arbitration, the land where nobody is happy After Congress officially outlawed most types of surprise medical bills last year, there’s been endless, litigious debate as to how health insurance companies and providers should settle their differences while patients are held harmless.

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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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STAT+: Former FDA official lays out how to keep patients safe from risky medical devices

STAT

Madris Kinard’s unlikely journey to becoming a champion for patient safety started in a fire station. As a fresh-faced college intern for a company insuring volunteer firefighters, she asked one of the firefighters if she could do something on every child’s bucket list: slide down the fire pole. “They were like, you work for our insurance company,” Kinard said.

Hospitals 300
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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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Negotiations on £645m funding hoped to conclude by November

The Pharmacist

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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WHO recommends second malaria vaccine, hoping to address supply issues

STAT

Just two years after the World Health Organization’s historic recommendation of the first malaria vaccine, the global health agency on Monday recommended a second , seeking to broaden access to a tool it hopes can save lives. The vaccine, called R21/Matrix-M, was developed by the University of Oxford and will be produced by the Serum Institute of India, the world’s largest vaccine manufacturer.

Vaccines 295
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NERA Economic Consulting raises concerns over DHSC’s Statutory Scheme

Pharma Times

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

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STAT+: Verily lands $38 million deal with CDC for wastewater surveillance

STAT

Alphabet’s life sciences company Verily has scored its first Centers for Disease Control and Prevention contract, a high profile job leaders hope will boost its brand in public health as well as its nascent wastewater surveillance business, executives told STAT. Under the up-to-five year, $38 million contract, Verily will collect samples from hundreds of wastewater treatment centers across the country, analyze them for Covid-19 and the mpox virus at its South San Francisco lab, and return

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Covid antiviral stock advice issued

The Pharmacist

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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Opinion: The new fertility technology IVG is supposed to change everything. Don’t count on it yet

STAT

There are times when a new medical technology is thrust into the public spotlight because it seems like it might solve what we thought was unsolvable. Not for the first time, this is being played out in the field of reproductive technology with in vitro gametogenesis, or IVG. It’s been hailed as revolutionary technology that will be life-altering for those with infertility.

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Factors that May Predict the Likelihood of Generic Drug Marketing Applications

Drug Patent Watch

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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STAT+: New lawsuit highlights another wrinkle for settling disputes over surprise medical bills

STAT

After Congress officially outlawed surprise medical bills last year, there’s been endless, litigious debate as to how health insurance companies and providers should settle their differences over how much to pay for out-of-network medical bills. Now, an air ambulance provider that already went through the arbitration process is suing Blue Cross Blue Shield of Arizona, which the company says won’t pay the agreed-upon amounts.

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5 FDA decisions to watch in the fourth quarter

BioPharma Dive

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+: Syndax’s leukemia drug succeeds in pivotal study

STAT

Syndax Pharmaceuticals’ treatment for a genetically defined form of advanced leukemia met its goal in a pivotal study, leading to complete remission for about a quarter of patients in the trial. The results, disclosed Monday , will set in motion an application for Food and Drug Administration approval, which the company expects to complete by the end of the year.

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Fewer MS patients are prescribed DMTs in UK compared to Europe

Pharma Times

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

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STAT+: Congress extends some pandemic preparedness programs, but not all

STAT

WASHINGTON — Congress temporarily extended a few pandemic-preparedness programs when it forestalled a government shutdown at the last minute Saturday evening. But a program that encourages the development of countermeasures for big public health problems like pandemics expired without reauthorization. With hours left before a funding lapse, Congress passed a measure to keep the government running for another 45 days.

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mRNA researchers awarded 2023 Nobel Prize

European Pharmaceutical Review

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.

Vaccines 107
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Bracing for rough respiratory virus season, European officials urge vaccination

STAT

LONDON — Health officials in the U.K. and Europe are ramping up their campaigns urging eligible people to get another vaccine round against Covid and flu, promoting the immunizations as people’s best way to protect themselves and reduce pressure on health systems during what is expected to be another tough winter. In the 2022-2023 season, parts of Europe endured early and severe waves of respiratory viruses and consequently suffered drug shortages, with a particular crunch on medic

Vaccines 254
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Will novel antibiotic become front-line for C. difficile?

European Pharmaceutical Review

Due to observed clinical success, Acurx Pharmaceuticals, Inc. has discontinued the Phase IIb clinical trial of its lead antibiotic candidate, ibezapolstat, for Clostridioides difficile infection (CDI). In the trial, ibezapolstat and the control antibiotic vancomycin, a standard treatment for C. difficile infection, delivered high rates of clinical cure without any emerging safety concerns.

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STAT+: More hospital and outpatient visits expected to persist through fall and winter

STAT

Health care providers and health insurance companies are closing the books on their third quarters, and one major question continues to hang over them: How much care is everyone actually getting, now that Covid-19 isn’t scaring so many away from doctors and hospitals? The short answer, according to financial analysts and the companies themselves: It appears people continue to fill prescriptions, see their doctors, and get recommended surgeries.

Hospitals 252
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Navigating Health Insurance Coverage for Innovative and Specialty Drugs: Q&A With Maria Kirsch, President of Patients Services at EVERSANA

PharmExec

Kirsch discusses the complexity of the drugs and the verification process, along with EVERSANA’s new platform, ACTICS eAccess.

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STAT+: The biotech scorecard for the fourth quarter: 16 stock-moving events to watch

STAT

Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the fourth quarter: The Food and Drug Administration’s decision in June to grant conditional approval to a gene therapy for Duchenne muscular dystrophy was a watershed moment for the treatment of the neuromuscular disease, and a big win for its maker, Sarepta Therapeutics.

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Expert Speak | Panel Discussion: Responsible nutraceutical

Express Pharma

In this video: + Abhiroop Chatterjea, Director, Marketing at Cipla Health Ltd + Rahul Adakmol, CEO, International Operations & Global BD, Bharat Serums & Vaccines + Bharat Jhaver, President, Tablets India Limited + Ravi Vaidhyanathan, Vice President, Signutra + Viveka Roychowdhury, Editor, Express Pharma, The Indian Express Group (Moderator) The post Expert Speak | Panel Discussion: Responsible nutraceutical appeared first on Express Pharma.

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STAT+: Pharmalittle: Court allows Medicare drug price negotiation to proceed; J&J will not enforce patents on key TB drug

STAT

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 deadlines, calls, and online meetings has returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction by firing up the coffee kettle and quaffing a cup or three of stimulation.

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EMA validates MAA for novel telomerase inhibitor

European Pharmaceutical Review

The European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for imetelstat, a first-in-class telomerase inhibitor as a treatment for transfusion-dependent anaemia in lower risk myelodysplastic syndromes (MDS). Commenting on the validation of the MAA, Dr John Scarlett, Geron’s Chairman and Chief Executive Officer declared: “Based on the clinical profile of imetelstat to date, we are optimistic about its potential to become a standard of care and address longsta

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STAT+: Mirum’s Chenodal succeeds in late-stage trial for rare metabolic disorder

STAT

Mirum Pharmaceuticals reported on Monday that a drug it recently acquired to treat cerebrotendinous xanthomatosis, a rare and serious disease in which the body doesn’t metabolize cholesterol properly, succeeded in a late-stage trial. The results potentially pave the way for the treatment, already used by physicians, to reach a wider pool of patients.

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Nobel Prize awarded for research that paved the way for Covid-19 mRNA vaccines

Pharmaceutical Technology

The Physiology and Medicine Prize has gone to two researchers whose work laid the foundation for Pfizer and Moderna’s Covid-19 vaccines.

Vaccines 102
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Here’s what’s moving the needle in biotech stocks, in the final quarter of a dismal year

STAT

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good day. Today we have the Nobel in medicine! We’re also talking about Johnson & Johnson’s sudden patent generosity, and learn about another roadblock in the quest to develop an HIV vaccine.

Vaccines 221
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FDA lifts partial hold on Phase III plans for rare ataxia drug

Pharmaceutical Technology

An NDA submission for EryDex is currently intended for Q4 2025, assuming positive Phase III study results.

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