Mon.Oct 02, 2023

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Nobel Prize Awarded to Scientists Whose mRNA Work Allowed Development of COVID-19 Vaccines

Drug Topics

Katalin Karikó, PhD, and Drew Weissman, MD, PhD, were cited "for their discoveries concerning nucleoside base modifications that enabled the development of effective mRNA vaccines against COVID-19.

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American Pharmacists Month: Recognizing the Vital Role and Professional Challenges

Pharmacy Times

The origins of American Pharmacists Month trace back to October 1925, when radio stations nationwide aired special programming for a week to spotlight the pharmacy profession.

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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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FDA Approves Nedosiran for Patients With Primary Hyperoxaluria Type 1

Pharmacy Times

Nedosiran (Rivfloza; Novo Nordisk Inc) injection is designed to inhibit the expression of liver enzyme lactate dehydrogenases leading to oxalate overproduction in patients 9 years of age and older with PH1.

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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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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.

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Cigna to pay $172M to settle claims it overcharged Medicare Advantage program

Fierce Healthcare

Cigna will pay $172 million to settle allegations brought by a whistleblower and the U.S. | Cigna will pay $172 million to settle allegations brought by the U.S. government that it submitted false and inaccurate Medicare Advantage diagnostic codes in a bid to boost its reimbursement.

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Digital health investments shift to disease treatment, workflow solutions and VBC in Q3: Rock Health

Fierce Healthcare

Digital health founders and investors continue to face a tighter funding cycle with fewer deals and lower check sizes. | In Q3 2023, U.S. digital health startups raised $2.5 billion across 119 deals, the second-lowest quarter by funding total since the fourth quarter of 2019, Rock Health reports.

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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.

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Pharmacy Focus: Policy Edition - Navigating Provider Status: Challenges, Implications, and Advocacy in Pharmacy

Pharmacy Times

Tune in to this enlightening episode of Pharmacy Focus: Policy Edition to gain a deep understanding of the challenges, implications, and advocacy strategies surrounding provider status for pharmacists.

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How Pharmacies Can Prepare for the 2024 DIR Fee Changes

Drug Topics

In a webinar hosted by the National Community Pharmacists Association, experts from accounting agency Sykes & Company, PA discussed how pharmacies can navigate the upcoming changes.

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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.

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Celebrating Pharmacists This October

Pharmacy Times

Craig Dolan, PharmD, MBA, BSPharm discusses the role of the pharmacist, how the pharmacy profession has changed, and what is to come in the field.

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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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Biogen nabs FDA nod for biosimilar version of Roche's blockbuster Actemra

Fierce Pharma

Even as Biogen weighs strategic options for its biosimilars unit, the group is celebrating an industry first. | The exact launch timing of the biosimilar remains unclear, but Roche said it expects competition to kick off in the second half of 2023.

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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.

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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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Novo Nordisk challenges CMS drug price negotiations, then signs on to the program

Fierce Pharma

Novo Nordisk has joined the long list of biopharma companies that are challenging drug price negotiation provisions in the Inflation Reduction Act (IRA). | Two days after filing a lawsuit questioning the constitutionality of drug-price negotiations in the Inflation Reduction Act, Novo Nordisk has grudgingly signed on to the program. In addition, an Ohio court rejected a U.S.

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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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NDA for Investigational Schizophrenia Treatment Submitted to FDA

Drug Topics

The NDA was submitted for investigational muscarinic antipsychotic, KarXT (xanomeline-trospium), which functions as a dual M1/M4 muscarinic acetylcholine receptor agonist within the central nervous system.

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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.

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Report: CMMI has raised federal spending, not lowered it

Fierce Healthcare

The Center for Medicare and Medicaid Innovation (CMMI), once expected to save money and deliver healthcare at a lower cost, is increasing federal spending after all. | CMMI was designed to reduce federal healthcare spending, but a new CBO reports shows its had the opposite effect. Some say this is the necessary outcome of embracing value-based care.

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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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Intravenous Immunoglobulin Reduces Risk of Severe Infection When Used with BCMA Bispecific Antibody for Multiple Myeloma

Pharmacy Times

Intravenous immunoglobulin could potentially be given throughout the duration of anti-BCMA bispecific antibody therapy for the treatment of multiple myeloma.

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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

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Expanding How to Assess Adherence in Older Adults With Home Medication Management

Pharmacy Times

“There is method to this madness” describes routines that affect adherence to medication regimens.

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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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Taking a page from consumer-facing tech, Providence launches startup to modernize patient engagement

Fierce Healthcare

Renton, Washington-based Providence launched a new startup to modernize patients' digital experience with the traditional healthcare system. | Health systems must take a page from the book of other consumer-facing industries, said Sara Vaezy, chief strategy and digital officer at Providence. The health system launched Praia Health to modernize patients' experience with the traditional healthcare system.

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Eli Lilly slapped with third FDA rejection in 2023, this time for eczema treatment lebrikizumab

Fierce Pharma

After laying out a goal to launch four new drugs in 2023, Eli Lilly has run into yet another regulatory snag. | The FDA has rejected Lilly’s investigational atopic dermatitis treatment lebrikizumab over findings uncovered during the inspection of a third-party contract manufacturing organization.

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Study: Structural Racism Increases Cancer Mortality within Racial Minoritized Groups

Pharmacy Times

Cancer mortality rates increased by 3.3 deaths per 100,000 individuals and was higher for historically minoritized populations.

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Implementing a Year-Long Vaccine Program Helps Community Pharmacies Increase Profits

Drug Topics

By offering vaccines year-round instead of only during the typical flu season, community pharmacies can maximize profits and help patients live healthier lives.

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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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Biologics Offer Great Results in Treating Psoriasis—At a Cost

Drug Topics

Highly effective medications for severe disease are expensive and administered invasively, whereas the development of treatments for milder disease has lagged.

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After Pompe approval, Amicus clinches $430M financing deal with Blackstone

Fierce Pharma

Hot off an FDA approval for its Pompe disease combo treatment, Amicus Therapeutics has reeled in a major investor. | Amicus unveiled a $430 million financing pact with Blackstone Life Sciences and Blackstone Credit. The deal will see the asset manager furnish Amicus with a $400 million loan that will be used for the refinancing of existing debt, Amicus said in a press release.

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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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Johnson & Johnson says it won't enforce secondary patents on tuberculosis med Sirturo

Fierce Pharma

After allowing generic competition and slashing the price of its multidrug-resistant tuberculosis (MDR-TB) med Sirturo (bedaquiline) in low- and middle-income countries, Johnson & Johnson has t | The move follows months of pressure from advocacy groups, who called on the company to increase access to its tuberculosis med.

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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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