Wed.Jun 26, 2024

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Three months into bird flu outbreak in U.S. dairy cows, experts see deep-rooted problems in response

STAT

Three months since an outbreak of avian influenza in U.S. dairy cattle was declared, the country is failing to take the necessary steps to get in front of the virus and possibly contain its spread among cows, according to interviews with more than a dozen experts and current and former government officials. The country still does not have a sufficient testing infrastructure in place, nor a full understanding of how the virus is moving within herds and to new herds, experts say.

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After 33 years, Geron’s first approval marks a turn in Nobel-winning science

PharmaVoice

The decades-long story of how a first-in-class blood cancer treatment went from bench to bedside.

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Trending Sources

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House panel proposes new strategy for Medicare to cover weight loss drugs Wegovy, Zepbound

STAT

WASHINGTON — As weight loss medications have exploded in popularity, a bill to allow Medicare to cover the drugs has languished virtually unchanged in Congress for a decade. Until now.

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Will the real Ozempic please stand up? Lilly, Novo face uphill counterfeit battle

PharmaVoice

Weight loss market leaders are warning patients and healthcare providers about the risks associated with knockoff versions of their popular obesity meds — and taking legal action.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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National Academies proposes reimagining health care to fix ‘fundamental flaws’ that underlie inequity

STAT

The nation’s longstanding racial and ethnic health inequities will not improve unless Congress steps in to provide affordable health insurance for all and federal agencies start enforcing existing laws against discrimination and improve collection of racial and ethnic data, said the authors of a new report released Wednesday. Called “ Ending Unequal Treatment ,” it was issued by the National Academies of Science, Engineering, and Medicine some two decades after the groundbre

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Analysis: Pharmacy closures risk exacerbating digital divides

The Pharmacist

EXCLUSIVE Pharmacy closures in deprived areas are not only impacting physical access to a local pharmacy. They may also be exacerbating health inequalities for those who are less likely to access online services. The Pharmacist’s exclusive mapping of pharmacy closures suggested that the most deprived areas in England have lost nearly five times as many […] The post Analysis: Pharmacy closures risk exacerbating digital divides appeared first on The Pharmacist.

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Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?

BioPharma Dive

Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.

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STAT+: Biotech accelerator Curie.Bio extends its reach with new $380 million fund

STAT

Industry veterans Alexis Borisy and Zach Weinberg had plenty of reasons to celebrate their new venture’s first success story. In November 2023, a small biotech called Forward Therapeutics became the first company to graduate from their startup accelerator, Curie.Bio. The accelerator had opened its doors less than a year prior, and this first launch was sign their program worked: Forward had come out the other side with enough promising data — and three drug candidates — to r

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First-of-its-kind Intellia data suggest CRISPR drug could be given more than once

BioPharma Dive

The findings provide early proof that multiple doses of a gene editing medicine can be safely administered with additive effects, overcoming a key constraint of the complex therapies.

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Supreme Court rejects challenge to Biden’s use of bully pulpit to fight Covid misinformation

STAT

The Supreme Court on Wednesday rebuffed states and anti-lockdown advocates who said the government violated their First Amendment rights by asking social media giants to remove or limit coronavirus misinformation. The 6-3 decision frees federal officials to talk with social media companies about combating misinformation.The majority found that the states and advocates didn’t have standing to bring the case, because they didn’t show that the government’s actions harmed them o

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Hack Your Hormones With Zenith Supplement | A Comprehensive Weight Loss Solution

Welltopia Pharmacy

Zenith supplement is a new and effective weight loss solution for people suffering from overweight problems. Weight loss is a significant health challenge that affects millions of people worldwide. The prevalence of obesity and overweight conditions has surged, leading to various health complications such as diabetes, cardiovascular diseases, and joint problems.

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STAT+: Journal retracts study tied to Micronoma’s effort to create cancer blood test

STAT

Nature retracted a high-profile paper that served as part of the scientific groundwork for Micronoma, a San Diego-based startup, on Wednesday. “Some of the findings of the article are affected and the corresponding conclusions are no longer supported,” Nature said in the retraction. The retraction comes after a team of researchers published work on the preprint site bioRxiv critiquing the Nature paper last August, describing what they called “fatal errors” in the pape

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Zealand Pharma rakes in $1bn in funding for obesity drugs

pharmaphorum

Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.

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FDA issues long-awaited draft guidance for enrolling more people of color in clinical trials

STAT

The Food and Drug Administration has drafted guidance aimed at getting drug companies and medical device makers to enroll more people of color and women in the clinical trials that test whether products work. The guidance is long-awaited. It’s the first step in carrying out a law that Congress passed in 2022, and it’s six months late. Congress sought to fix the chronic lack of diversity in clinical research by requiring that companies give the FDA their plans for enrolling patients

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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CDC advisory panel opts for a go-slow approach on expanding usage of RSV vaccines

STAT

Makers of RSV vaccines for older adults saw their plans to try to expand usage hit a significant hurdle on Wednesday, when an expert committee that advises the Centers for Disease Control and Prevention on vaccines recommended changes that will likely see fewer older adults qualify for insurance coverage for these products. In a related move, the Advisory Committee on Immunization Practices opted not to make a recommendation yet on use of GSK’s Arexvy vaccine in adults 50 to 59, saying th

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Benzodiazepine Tapering Guidelines 2024 New Draft Guidelines!

Med Ed 101

I’ve encountered a significant proportion of patients who are on chronic benzodiazepines. Drug interactions, adverse effects, and other risks to my geriatric patient population are significant when using this class of medication. Benzodiazepine withdrawal is another real issue and one of the reasons why we try to limit their use to short-term only.

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STAT+: Pharmalittle: We’re reading about rejection of an AbbVie Parkinson’s drug, PBM markups on mail order, 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 upon us. After all, we have made it this far, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy.

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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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New US fill finish facility receives $4.1 billion investment

European Pharmaceutical Review

Novo Nordisk has announced one of its largest manufacturing investments; $4.1 billion will support the construction of a second fill and finish facility for aseptic manufacturing in Clayton, North Carolina, US. The increased capacity will add 1.4 million ft 2 of production space, double the combined square footage of all three of the company’s existing facilities in North Carolina.

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Opinion: FDA: Don’t rush publishing your diversity guidance plan. Take your time and do it right

STAT

When Congress passed the Food and Drug Omnibus Reform Act (FDORA) in December 2022, it was hailed as a landmark step toward codifying diversity and inclusion in clinical trials. Under FDORA, sponsors of Phase 3 and other pivotal trials are required to submit a diversity action plan to the Food and Drug Administration along with their study protocol.

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We want your feedback!

pharmaphorum

Take part in the pharmaphorum reader survey 2024 and share your views on the latest trends and developments in the pharmaceutical industry. Your input helps us tailor our publication to meet your needs.

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STAT+: Q&A: How Flagship’s Cellarity is using AI to understand cell disease biology before treating it

STAT

Flagship Pioneering launched Cellarity in December 2019. The startup says it’s using artificial intelligence and other computational technologies “to move away from reductionist drug discovery, and unravel the complexities of disease biology to produce ‘game-changing’ medicines out of reach previously.” Why does the company view traditional drug discovery as “reductionist”?

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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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FDA awards record number of review designations to mRNA vaccines in 2023: GlobalData

Express Pharma

The success of the COVID-19 mRNA vaccines highlighted the major advantages of utilising mRNA technology in vaccine development. Consequently, the FDA has awarded a rising number of review designations to mRNA vaccines in recent years. In 2023, a record nine designations were awarded to mRNA vaccines for eight conditions, displaying the FDA’s commitment to encouraging the development of these products across a broader range of indications, says GlobalData.

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Intellia says its CRISPR-based therapy can be redosed

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. It’s Wednesday, which means it’a also “The Bear” season 3 premiere day. For my Boston readers, know that Ayo Edebiri has been thinking deeply  about the tragedy of  the Great Molasses Flood of 1919.

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Abcuro completes enrolment for phase 2/3 IBM treatment trial

Pharmafile

Abcuro has announced that it has completed the enrolment for its registrational phase 2/3 MUSCLE clinical trial, which aims to assess ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM). The post Abcuro completes enrolment for phase 2/3 IBM treatment trial appeared first on Pharmafile.

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Augustine Therapeutics raises €17m to advance lead candidate into trials

Pharmaceutical Business Review

The funding round was spearheaded by Asabys Partners and saw contributions from Eli Lilly and Charcot-Marie-Tooth Research Foundation in the US. Existing investors, including AdBio Partners, PMV, V-Bio Ventures, VIB and Gemma Frisius Fund also participated. AGT100216 is a small molecule HDAC6i with a distinct mechanism-of-action, showing promise for Charcot-Marie-Tooth disease (CMT) and chemotherapy-induced peripheral neuropathy (CIPN).

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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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PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA Law Blog: Biosimilars

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.

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Magazine: UK’s new Netflix-style funding model for antibiotics goes live

Pharmaceutical Technology

In this issue: UK’s new Netflix-style funding model for antibiotics, the Swiss biotech ecosystem recuperates from financial instability of 2023, how patient advocacy can lead to more successful clinical trials, and more.

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EvolutionaryScale emerges with $142m for AI drug discovery

pharmaphorum

AI in drug discovery start-up EvolutionaryScale raises $142m in seed financing for its LLM-powered platform for designing protein structures.

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Novo nixes trial of blood pressure drug it bought in deal worth $1.3B

BioPharma Dive

The failure of a Phase 3 trial led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.

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Wales and NI follow England in backing Vertex CF therapies

pharmaphorum

Three of the four UK nations have agreed a long-term deal with Vertex Pharma for reimbursement of its cystic fibrosis therapies, ensuring permanent access to the drugs for eligible patients.The new agreement with England, Wales, and Northern Ireland marks the end of a long-standing and sometimes bitter dispute over the high cost of Vertex's CFTR modulator drugs.

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