Wed.Jun 12, 2024

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Michigan stands out for its aggressive bird flu response. Will other states follow its lead?

STAT

For weeks now, as the H5N1 bird flu has been spreading into dairy cattle herds in more and more places, one state continues to lead the pack. With reports of infections in 25 herds, Michigan currently accounts for about one-third of the country’s confirmed cases in livestock. And of the three people known to have contracted the H5N1 virus from sick cows since the outbreak began, two of them are farmworkers in Michigan, including one who experienced respiratory symptoms.

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Behind the powerful computations, AI’s role in pharma is still beset by challenges

PharmaVoice

Small biotechs are saving time and money leveraging AI to develop new drugs, but incomplete data and disease complexity remain hurdles for the space.

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World Trade Center responders exposed to more dust saw higher risk of early dementia

STAT

Nearly a quarter of a century after the 9/11 attacks in New York City, first responders continue to face steep health consequences for their exposure to particulate matter in the aftermath of the World Trade Center’s collapse. More than 10,000 people who were in the area have been diagnosed with cancer , with an incidence 30% higher than in the general population, and more first responders have died from long-term health issues associated with the collapse than during the attack.

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Despite adcomm rejection, Lykos CEO sees future for MDMA drug

PharmaVoice

Although the rebuff makes approval “a bit more challenging,” Lykos is moving forward with the psychedelic-based treatment for PTSD.

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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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Opinion: The J&J lawsuit should be a wakeup call to the PBM industry — and to companies everywhere

STAT

The ongoing legal dispute involving Johnson & Johnson has again thrust the topic of pharmacy benefit managers (PBMs) into the spotlight. Ann Lewandowski, a J&J employee, sued the company for overpaying for its employees’ prescription drugs through its PBM, Express Scripts, claiming that these overpayments resulted in higher health insurance premiums and out-of-pocket drug costs for employees.

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Pharmacy closures nearly five times higher in more deprived areas

The Pharmacist

EXCLUSIVE The most deprived areas in England have lost nearly five times as many community pharmacy premises as the least deprived areas in the last five years, new analysis from The Pharmacist has found. The 10% most deprived areas saw a net loss of around 250 local pharmacies between March 2019 and April 2024, while […] The post Pharmacy closures nearly five times higher in more deprived areas appeared first on The Pharmacist.

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Avidity drug for muscular dystrophy shows promise; Syntis takes new approach to weight loss

BioPharma Dive

Study results indicated Avidity’s medicine muted target genes. Elsewhere, Syntis revealed obesity drug plans and Nodthera chalked up more positive data for its NLRP3 inhibitor.

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STAT+: Pfizer’s gene therapy for Duchenne muscular dystrophy fails in phase 3 trial

STAT

Pfizer said Wednesday afternoon that a closely watched gene therapy for Duchenne muscular dystrophy failed to slow the disease’s progression in a phase 3 trial. This is now the second large, randomized, placebo-controlled trial of a Duchenne gene therapy to fail to reach its primary endpoint, a composite scale of muscle function designed specifically for the rare disease.

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OTC Hearing Aids: “Nothing to See Here” Says GAO Report

FDA Law Blog: Biosimilars

By Sara W. Koblitz & Jeffrey N. Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA once estimated that OTC hearing aids would save patients over $3000.) A recent GAO Report hasn’t found that OTC hearing aids have had much impact.

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Opinion: Getting farmworkers to use PPE is hard, but it’s the best way to stop an H5N1 bird flu epidemic

STAT

Although a third U.S. dairy worker has been confirmed to be infected with the H5N1 bird flu, many dairy farms are still unwilling to use even freely offered personal protective equipment (PPE). This is cause for alarm. Working with a pathogen assigned a biosafety level of 3 — meaning it “can cause serious or potentially lethal disease through respiratory transmission” — with at best BSL 2 level protections is playing with fire.

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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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DoH expands research partnership with Penn Medicine

Pharmaceutical Business Review

This partnership will focus on developing a translational medicine ecosystem and launching innovative research initiatives in Abu Dhabi. The second MoU outlines plans to design and develop a translational medicine ecosystem inspired by Penn’s Institute for Translational Medicine and Therapeutics (ITMAT). The aim is to utilise Abu Dhabi’s advanced infrastructure alongside Penn Medicine’s expertise to foster new treatments and discoveries within the region.

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Watch: How pharmacy benefit managers influence drug pricing

STAT

This is Part 2 of “Behind the Counter,” an in-depth video series demystifying the complex world of patents and drug pricing. The point of prescription drugs is to help people improve their quality of life. When a doctor writes a prescription and sends it along to the pharmacy, oftentimes they’re more focused on the drug’s effectiveness than its cost.

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How long does a patent last for drugs?

Drug Patent Watch

Sure, here’s a more detailed explanation with examples: Drug Patent Duration Drug patents are granted by the United States Patent and Trademark Office (USPTO) for a period of 20 years… Source

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Watch: The role of PBMs, patents, and public health in drug pricing

STAT

This is Part 1 of “Behind the Counter,” an in-depth video series demystifying the complex world of patents and drug pricing. Prescription drug costs are remarkably higher in the United States than in other countries, so it’s no surprise that more than half of U.S. adults say they are worried about being able to afford their medications.

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Pfizer gene therapy for Duchenne fails to meet goals of key trial

BioPharma Dive

The negative results from the Phase 3 study, called Ciffreo, come a little more than a month after Pfizer said a patient died in another trial of the gene therapy.

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Senators slam the FDA’s new vape enforcement plan: ‘What in the hell have you been waiting for?’

STAT

WASHINGTON — The Food and Drug Administration and the Department of Justice claim they’re getting serious about clearing store shelves of illegal vapes. Lawmakers made clear Wednesday they aren’t buying it.

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NICE declines to look again at depression drug Spravato

pharmaphorum

Johnson & Johnson has slammed a decision by NICE not to carry out a new appraisal of its antidepressant Spravato, claiming it has “grave concern” about access to new mental health treatments through NHS England.

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Opinion: FDA: Do your job and stop letting companies sell illicit vapes to kids

STAT

If it were common knowledge that a company was targeting kids to consume highly addictive and dangerous products, you’d expect the government to do something about it. Yet millions of illegal vapes are being smuggled into the U.S. and sold widely — mainly to kids — and the Food and Drug Administration is doing little about it. The FDA needs to step up and end this scourge before the country finds itself in another vaping epidemic , this one caused by government inaction.

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New study reveals how brain cell communication is linked to Alzheimer’s disease

Pharma Times

Two support cells, microglia and astrocytes, were found to communicate with each other

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STAT+: New AI for biopsies can analyze microscopic images, talk to pathologists about your tumor

STAT

To non-pathologists, the histology slide looked, as all histology slides do, like a sea of mottled lilac and burgundy. Oblong pink spots, like sprinkles on a cookie at a Barbie-themed birthday party, spotted the left side of the image. To LLaVA 1.5, an open-source artificial intelligence mode, the cells looked like they were from the cheek. LLaVA-Med, a version of LLaVA trained on medical information, told researchers the cells were from breast tissue.

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ACG partners with EY-Parthenon

Express Pharma

ACG, announced a partnership with EY-Parthenon, aiming to enhance ACG’s sustainability initiatives through a comprehensive net zero strategy and implementation roadmap aligned with the Science Based Targets initiative (SBTi), a globally recognised framework for companies to set science-based emissions reduction targets in line with the latest climate science.

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STAT+: Avidity Biosciences says its experimental drug showed potential against form of muscular dystrophy

STAT

Avidity Biosciences said Wednesday morning that an experimental medicine successfully knocked down the gene behind a form of muscular dystrophy being pursued by a fleet of drug companies. The early-stage study examined patients with facioscapulohumeral muscular dystrophy, or FSHD, who generally experience slowly progressive muscle loss in the face, shoulder blades, arms, or lower legs.

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IPA to host 9th Global Pharmaceutical Quality Summit

Express Pharma

The Indian Pharmaceutical Alliance (IPA) is set to host the ninth edition of the Global Pharmaceutical Quality Summit, on June 27 and 28, 2024 in Mumbai. The theme for this year’s Summit is ‘Advances in Manufacturing and Quality – Patient Centricity’. The summit will showcase sessions that explore how the industry can leverage technology to build the next decade for pharmaceutical operations and manufacturing.

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Three scientists win Kavli Prize for nanoscience in biomedicine

STAT

Three scientists — Robert Langer, Paul Alivisatos, and Chad Mirkin — were awarded the 2024 Kavli nanoscience prize for their seminal work in biomedicine, the Norwegian Academy of Sciences and Letters announced Wednesday. The $1 million Kavli Prize recognizes scientists for significant contributions and breakthroughs in astrophysics, nanoscience, and neuroscience once every two years.

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Revealed: Map of community pharmacy closures over last five years

The Pharmacist

EXCLUSIVE: The Pharmacist mapped community pharmacy closures across England over the last five years, and uncovered a net loss of more than 1,000 bricks and mortar pharmacies since 2019. Read the first article in our series on how pharmaceutical services are changing in England: Of the 11,893 community pharmacies registered with the General Pharmaceutical […] The post Revealed: Map of community pharmacy closures over last five years appeared first on The Pharmacist.

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What do Parkinson’s and obesity have in common?

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 morning. STAT is running a promo this week — you can get 40% off an annual subscription with the discount code STAT40. Learn more  here.

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Regenxbio CEO to step down after 15 years

BioPharma Dive

Kenneth Mills will become chair of the gene therapy developer's board while Curran Simpson, the current chief operating officer, will take his place as company head.

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STAT+: Pharmalittle: We’re reading about Sanders dogging Novo Nordisk, Teva patents, and more

STAT

Hello, everyone, and how are you today? We are doing just fine, thank you, especially since the middle of the week is already upon us. After all, we have made it this far, so we are determined to hang on — hang in? — for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing.

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ICL receives £10m donation to advance heart and lung research

Pharma Times

The donation will help scientists and clinicians collaborate and make new advances in research

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Opinion: Listen: Paying off people’s medical debt won’t fix our broken health care system

STAT

This week’s episode of the “First Opinion Podcast” explores the issue of medical debt, which burdens as many as 40% of U.S. adults. They collectively owe more than a whopping $200 billion. Private organizations, philanthropies, and even state and federal governments have established various debt relief programs to tackle the problem.

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Crius Life Sciences unveils oil-infused gummies

Express Pharma

Crius Life Sciences, a leading name in the nutraceutical industry, announced the launch of its oil-infused gummies. This product offers an alternative to traditional softgels. Subbarao Chinni, Founder and Managing Director of Crius Group, said, “We are proud to introduce our advanced oil-infused gummies technology, which integrates up to 500mg of oil into each gummy.

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Data sharing will be key in repairing the UK clinical ecosystem

Pharmaceutical Technology

Lord James O'Shaughnessy, the former health minister, outlines places where the UK is falling behind other countries with clinical research.

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NHSE chief: GP workforce can't be only solution for primary care

The Pharmacist

Primary care is the ‘bedrock of the NHS’, but a ‘modern vision’ is needed to meet new demands, delegates at the NHS Confederation Expo heard this week. The 2022 Fuller stocktake report, which gives a central role to community pharmacy, is one such vision that 'we can all get behind', NHS chief executive Amanda Pritchard […] The post NHSE chief: GP workforce can't be only solution for primary care appeared first on The Pharmacist.

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IIIT-Delhi’S AMRSense secure second prize at Trinity Challenge on AMR

Express Pharma

The Trinity Challenge has announced the winners of its second competition (the Trinity Challenge on Antimicrobial Resistance), aimed at tackling the escalating threat of antimicrobial resistance (AMR). The awarded projects focus on addressing critical data gaps in communities and lower-income countries, which are disproportionately impacted by antibiotic-resistant infections.

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ABPI embraces proposals for pharma’s growth ahead of UK elections

European Pharmaceutical Review

The Association of the British Pharmaceutical Industry (ABPI) has welcomed proposals from the Conservative and Unionist Party’s recently published Manifesto for the UK’s 2024 general election. We encourage other parties to come forward with equally specific proposals to boost the sector, so that the progress of recent years can be maintained” For example, this includes plans to accelerate NHS patient access to new medicines, which propose to “ remove bureaucratic obstacles to the use of