Thu.Apr 04, 2024

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STAT+: Amylyx to pull ALS drug from market, cut 70% of staff

STAT

Amylyx Pharmaceuticals will take its ALS drug Relyvrio off the market in the U.S. and Canada, ending a multi-year saga for patients with the rare neurodegenerative disease. Relyvrio was approved by the Food and Drug Administration in 2022 , based on data that showed a modest slowing of disease progression. The approval was contentious — regulators initially advised Amylyx not to file for approval until it had conducted another test, but ultimately cleared the drug.

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With an ovarian KRAS combo ready for review, Verastem’s CEO is poised for the transition

PharmaVoice

As its FDA filing approaches, Verastem Oncology CEO Daniel Paterson wants to go from “The Little Engine That Could” to a major oncology player.

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Trending Sources

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STAT+: Boehringer Ingelheim layoffs are a sign of dysfunctional Humira biosimilar market

STAT

WASHINGTON —  Boehringer Ingelheim is laying off or relocating its sales staff for its Humira biosimilar Cyltezo in a sign of how difficult it’s been to get drug middlemen to adopt less-expensive versions of the blockbuster, the company confirmed. Some employees may find positions elsewhere in the company, but they are mostly being pulled from the field.

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Study reveals new aptamer targeting tool can detect early signs of motor neurone disease

Pharma Times

The fatal, progressive neurological condition currently affects around 5,000 people in the UK

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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STAT+: Matt & Adam’s Take: Amylyx did the right thing by withdrawing its ALS drug. That’s rare and worthy of praise

STAT

On Thursday morning, Amylyx Pharmaceuticals announced that it would withdraw its ALS drug , Relyvrio, after a large clinical trial showed that the medicine, approved by the Food and Drug Administration in 2022, was not effective. Amylyx’s co-CEOs, Joshua Cohen and Justin Klee, had previously publicly promised that they would withdraw the drug if further testing failed to show a benefit.

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Baylor wins 2024 STAT Madness with ‘smoke alarm’ for viral disease outbreaks

STAT

It began with injecting monkeys with sewage to see if they developed polio. Building off that early polio work from the 1940s, researchers from the Baylor College of Medicine analyzed public wastewater and showed they could detect over 450 disease-causing viruses. Their study demonstrating the power of sewage as an early-warning system for outbreaks won the 2024 STAT Madness popular vote.

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AI-powered real-world evidence generation for biotechs

pharmaphorum

Discover how AI-powered real-world evidence generation is revolutionising the biotech industry, providing valuable insights for biopharma companies to make informed decisions. Learn more about the impact of RWD on biotechs.

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Opinion: Hospital care costs are out of control. Price caps can help

STAT

Here’s just the tip of the iceberg: $722.50 for a nurse to push a drug into an IV. $21,500 for ten stitches. The prices charged by hospitals are exorbitant and rising. Private health insurance premiums paid by working age adults are rising rapidly. Many Americans skip necessary medical care, while those who do get treated can end up bankrupt.

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Biden slams asthma inhaler prices in White House address

pharmaphorum

President Joe Biden has reiterated his pledge to take action against high drug prices and “beat big pharma,” singling out the cost of asthma inhalers in a speech delivered at a White House event with US Senator Bernie Sanders, a long-time critic of the industry’s pricing policies in the US.

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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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What ‘de-extinction’ of woolly mammoths can teach us: a Q&A with evolutionary biologist Beth Shapiro

STAT

Humans have long tinkered with the evolutionary trajectories of other species. Thousands of years ago we tamed wolves into dogs and transformed a wild grass into the agricultural wonder wheat. Within the past few centuries, we exterminated the Tasmanian tiger and doomed the dodo bird to oblivion. Now, we stand on the brink of an ambitious new era in how humans may transfigure life around us: by pursuing the science of de-extinction, or the resurrection of species once lost to this world.

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Trial finds benefit for GLP-1 agonist in Parkinson’s

pharmaphorum

A small study of Sanofi’s lixisenatide has suggested that the GLP-1 agonist could slow down the progression of Parkinson’s disease, pointing to another potential use for the fast-growing drug class.

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STAT+: Nuclear Regulatory Commission advisers beset by conflicts of interest, report finds

STAT

The oversight division of a U.S. government agency tasked with ensuring the safe use of radioactive materials issued a recent report that the agency’s advisers had key undisclosed conflicts of interest, raising fresh concerns about controversial decisions around the reporting of radioactive injection accidents. The report, released on March 26 and conducted by the Nuclear Regulatory Commission’s (NRC) Office of the Inspector General, identified conflicts of interest involving two m

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Conference report: Reuters Pharma USA

pharmaphorum

Last week, pharmaphorum editor-in-chief Jonah Comstock travelled to Philadelphia for Reuters Pharma USA. On today’s podcast, he chats with guest host and Deep Dive editor Eloise McLellan about his biggest takeaways from the two-day event.

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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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Opinion: For national security, the U.S. must maintain its biotech dominance

STAT

For more than a century, the United States has been the undisputed leader in medical and biotechnology innovation. It saved millions of lives by mass-producing the first polio vaccines. U.S. researchers discovered new antibiotics that turned once-fatal infections into minor ailments, and developed antiretroviral cocktails that transformed HIV from a death sentence into a manageable, chronic disease.

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Praia emerges with $20m for digital health platform

pharmaphorum

Healthcare system Providence has spun out a new company, Praia Health, focused on a platform to build and sustain connections between patients and health providers. The new company starts life with $20 million in Series A funding and a mission to develop the Praia Health Identity and Engagement Platform, which was launched within Providence’s digital innovation group (DIG) incubator in 2022 and already handles around 3.5 million user accounts.

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How resurrecting extinct species might impact medicine

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hey, it’s Meghana. Today, we see how the GLP-1s might be harnessed for Parkinson’s, we learn about species de-extinction efforts, and BIO’s CEO tells us why the U.S. needs to stay on top in biotech.

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Merck puts KRAS cancer drug competitor to the test

BioPharma Dive

A Phase 3 study will compare Merck’s experimental KRAS inhibitor together with its immunotherapy Keytruda against Keytruda alone in lung cancer.

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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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Health tech investor Glen Tullman launches 62 Ventures, a new $100 million fund

STAT

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. First the news: Glen Tullman, currently the CEO Transcarent , has a  new, roughly $100 million venture fund,  called  62 Ventures.

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SAVA Healthcare to set up second plant in Indore

Express Pharma

First phase with a builtup area of 29,000 square meters to be completed within a year, second phase by 2026 Gujarat-based SAVA Healthcare conducted the ground-breaking ceremony of its second manufacturing plant, in the Smart Industrial Park (SIP) of Madhya Pradesh Industry Development Corporation (MPIDC) in March. This green field project will expand the manufacturing capabilities of SAVA Healthcare as well as create 1000+ job opportunities, offering advanced skill development for the local tale

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STAT+: Pharmalittle: We’re reading about Amylyx pulling its ALS drug, GLP-1 drugs for Parkinson’s, and more

STAT

Top of the morning to you, and a fine one it is. After two days of downpours and strong winds, the Pharmalot campus is now enveloped by sunny skies and pleasant breezes, which is very much a welcome change. To celebrate, we are quaffing cups of stimulation. Our choice today is toasted coconut. As always, you are invited to join us. Meanwhile, we are proud to present our latest list of interesting items for you to peruse.

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SOPHiA GENETICS partners with Strand Life Sciences

Express Pharma

The companies will join forces to advance the use of precision medicine on a global scale SOPHiA GENETICS, a cloud-native software company in the healthcare space has announced a strategic partnership with Strand Life Sciences to deliver innovative solutions that will fuel the use of precision medicine globally. The new collaboration will leverage the industry-leading strengths from both companies to provide access to advanced genomics technologies, cutting-edge bioinformatics services and inno

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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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STAT+: Weed for weight loss, and more from Biotech Land

STAT

This is the online edition of Adam’s Biotech Scorecard, a new subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered every Thursday to their inbox. Bankruptcies, restructurings, clinical trial setbacks, and falling stock prices: It’s been a disconcerting week in Biotech Land. Luckily, this newsletter has arrived like a warm hug.

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Zeno Health acquires Tablt Pharmacy

Express Pharma

Zena Health plans to strengthen its reach and democratise healthcare in Eastern India Zeno Health, omni channel platform for quality and affordable generic medicines has announced its acquisition of Kolkata-based startup Tablt Pharmacy. As part of its expansion plans, Zeno Health along with Tablt will be strengthening its reach in the states of West Bengal, Odisha, Bihar and Jharkhand.

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Opinion: How climate change is driving a global epidemic of immune health problems, and how to stop it

STAT

Many of the effects of climate change play out at a very large scale: Heatwaves that grip entire continents. Flooding that submerges vast swaths of island nations and continental coastal areas. Other effects are far less visible because they’re taking place inside people’s bodies. That doesn’t make them any less dangerous.

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Pharma Pulse 4/4/24: Baltimore Bridge Collapse Upends US Supply Chains, Can Employees Realistically Expect Any Good Jobs for 2024? & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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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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Why very few people who are eligible for a cochlear implant actually get one

STAT

Cochlear implants have successfully improved hearing loss for decades, but few people who qualify for an implant actually get it. Even in countries with universal healthcare, the adoption rates are dismal. Researchers are finding further disparities for marginalized communities, especially for Black and Asian patients, according to a recent study of British hospitals published Thursday in PLOS Medicine.

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FDA approves Basilea’s antibiotic Zevtera for three indications

Pharmafile

Basilea Pharmaceutica has announced that the US Food and Drug Administration (FDA) has approved Zevtera (ceftobiprole medocaril sodium for injection), as a new antibiotic for three indications. The drug is approved for the treatment of adult patients with Staphylococcus aureus bloodstream infections (SAB), including patients who have right-sided infective endocarditis, adult patients with acute bacterial […] The post FDA approves Basilea’s antibiotic Zevtera for three indications appeared

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Federal judge rules against Philadelphia supervised drug consumption effort

STAT

A federal judge this week dealt a major and likely decisive blow to Safehouse, a Philadelphia nonprofit seeking to open a facility for supervised drug consumption. In a ruling on Wednesday, U.S. District Court Judge Gerald McHugh dismissed the nonprofit’s lawsuit, concluding that Safehouse was not a religious entity and therefore could not claim exemptions to drug laws under the Religious Freedom Restoration Act.

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