Mon.Apr 29, 2024

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There’s never a good time to drink raw milk. But now’s a really bad time as bird flu infects cows

STAT

Scientists who know about the types of pathogens — E. coli and Salmonella among them — that can be transmitted in raw milk generally think drinking unpasteurized milk is a bad idea. But right now, they believe, the danger associated with raw milk may have gone to a whole new level. “If I were in charge, for the moment I would forbid the selling of raw milk,” said Thijs Kuiken, a pathologist in the department of viroscience at Erasmus Medical Center in Rotterdam,

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As BMS announces major cuts, its Karuna deal looks poised to drive growth

PharmaVoice

The company's schizophrenia drug picked up in its $14 billion acquisition of Karuna Therapeutics recently generated positive long-term data from its phase 3 program.

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Opinion: Medical students lose in the research arms race for residency slots

STAT

“Going to medical Spanish class really isn’t worth my time. I’d rather use the time to do research,” one of my classmates told me during the first week of my first year of medical school. Such a comment was my introduction to the publish-or-perish environment that is increasingly pervasive amongst medical students. Before then, I had known publish-or-perish as something for those seeking tenure at universities.

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How a biotech exec is leveraging Big Pharma lessons to advance tRNA

PharmaVoice

Michelle Werner shares how the lessons from her resumé — and personal experience — are driving her work with novel therapeutics.

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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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Expanded methadone access: giving patients greater choice

STAT

WASHINGTON — Nicholas Voyles, executive director of the Indiana Recovery Alliance, ended up missing his daily dose of methadone on Monday. He’d requested “guest dosing” before traveling to Washington, but discovered that day that the paperwork hadn’t been processed yet. Although he has requested guest doses in clinics across America, Voyles told an audience at the STAT policy in health care meeting, the process has only worked a single time.

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12 Questions with Dr Jay Shah

pharmaphorum

Get to know Dr Jay Shah, a prominent figure in the field of cardiovascular medicine, as he answers 12 intriguing questions about his role as Chief Medical Officer at Aktiia and his insights into the field.

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More Trending

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Merck, Huma alliance bears fruit with UK bladder cancer app

pharmaphorum

A partnership between Huma Therapeutics and Merck KGaA to develop digital support tools for cancer patients has borne fruit with the launch of a bladder cancer app in the UK

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STAT+: Doctors Without Borders challenges pharma by releasing costs for a key clinical trial

STAT

In a challenge to the pharmaceutical industry, Doctors Without Borders has revealed the detailed costs of a study it ran for a tuberculosis treatment regimen and maintained this is the first time that expenses incurred for an individual clinical trial had been publicized. Moreover, the charity argued that its decision should help undercut a long-standing contention by drug companies that high prices for their medicines can be justified by research costs, even though these expenses are never disc

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X4 Pharma gets first FDA okay for WHIM syndrome drug

pharmaphorum

Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light by the FDA. Oral CXCR4 antagonist Xolremdi (mavorixafor) can be used in patients aged 12 and over with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a congenital immunodeficiency characterised by low neutrophil counts that affects fewer than 1,000 people in the US.

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STAT+: Biden cybersecurity plan for hospitals entails carrots first, then sticks, health official says

STAT

WASHINGTON — The Biden administration’s plan to improve cybersecurity at hospitals starts off with incentives, but eventually hospitals will face penalties for not adopting measures to protect patient data, HHS Deputy Secretary Andrea Palm said Monday. In February, a cyberattack against Change Healthcare, a UnitedHealth Group subsidiary that operates the largest medical claims clearinghouse in the country, left many doctors unable to get paid by Medicare.

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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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The Relationship Between Cold Chain Logistics and Cell & Gene Therapies

Pharmaceutical Commerce

A one-on-one with Thermo Fisher’s Wilfredo Marin, who dives into the value of ultra-low temperature storage, the need for flexibility in the cold chain logistics space, and more.

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Opinion: Unseen battles: The harsh realities of veterans’ access to health care

STAT

I remember the day I left the military after six years of active-duty service. The crisp salute, the finality of it all. I was stepping into a world vastly different from the regimented life I had known. As a third-generation veteran, the military was more than a career; it was a legacy. But what I didn’t realize then was that leaving the military would mean entering a labyrinth of health care bureaucracy that seemed designed to confound and discourage.

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Sustainability in pharmaceutical manufacturing: a CDMO’s contribution

BioPharma Dive

Consideration of sustainability early in process development, throughout the entire development cycle, and across the entire supply chain must also become common practice.

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STAT+: FDA finalizes plan to regulate some lab-developed tests

STAT

The Food and Drug Administration will start actively regulating tests developed in laboratories, with some exemptions, the agency announced on Monday. The agency’s action, which is expected to face legal challenges in courts, comes after Congress failed to pass a law to regulate such tests. The tests have not faced FDA scrutiny historically, as the agency considered them low-risk.

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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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Pfizer’s Beqvez approved by FDA for haemophilia B treatment

Pharmafile

Pfizer has announced that the US Food and Drug Administration (FDA) has approved Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe haemophilia B. The post Pfizer’s Beqvez approved by FDA for haemophilia B treatment appeared first on Pharmafile.

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STAT+: Pharma’s reputation with patient groups is sliding again thanks to prices and shortages

STAT

The pharmaceutical industry saw its reputation slip last year among patient advocacy groups thanks to growing concern about the rising prices for medicines and a lack of confidence prompted by increasing shortages, according to a new survey. Of more than 2,500 groups queried, 57% reported that the industry maintained an “excellent” or “good” reputation as it goes about the business of developing and providing medicines.

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Ono swoops on Deciphera in $2.4 billion takeover

pharmaphorum

Japan’s Ono Pharma has bolstered its cancer pipeline with a $2.4 billion agreement to buy Deciphera Pharma of the US and its fast-growing gastrointestinal stromal tumour (GIST) therapy Qinlock. Ono is offering $26.50 per share in cash for the Waltham, Massachusetts-based company, saying the deal will enable it to “build a robust presence in oncology,” one of the group’s key priority areas.

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STAT+: Ono Pharmaceutical to acquire Deciphera Pharma, maker of cancer drugs, for $2.4 billion

STAT

Ono Pharmaceutical of Japan said Monday it will acquire Deciphera Pharmaceuticals, a Boston-based maker of cancer drugs, for $2.4 billion.  The all-cash deal values Diciphera at $25.60 per share, or a 75% premium to its Friday closing stock price. Deciphera markets a drug called Qinlock for patients with advanced gastrointestinal stromal tumors, or GIST, a type of cancer that begins in the digestive system.

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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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ETH Zurich researchers use AI to develop drug molecules based on protein structures

Pharma Times

The new process makes generating active pharmaceutical ingredients quicker and easier

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Philips will pay $1.1 billion to resolve U.S. lawsuits over breathing machines that expel debris

STAT

WASHINGTON — Medical device maker Philips said Monday it will pay $1.1 billion to settle hundreds of personal injury lawsuits in the U.S. over its defective sleep apnea machines, which have been subject to a massive global recall. The Dutch manufacturer did not admit any fault and said it reached the agreement to resolve any uncertainty over the cases.

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AstraZeneca, Daiichi look to broaden Enhertu use again with new study data

BioPharma Dive

The drug benefited people whose tumors have “ultralow” levels of HER2 protein, a result that could extend its reach in HER2-positive breast cancer.

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STAT+: Activist investor Alex Denner, Bioverativ shareholder reach tentative settlement in insider trading case

STAT

A tentative settlement has been reached in a long-running shareholder lawsuit that accused health care activist investor Alex Denner of making nearly $50 million from insider trading in connection with the 2018 acquisition of Bioverativ. Denner, managing partner of Sarissa Capital Management, a health care hedge fund, had denied the accusations in the lawsuit filed in 2020 with Delaware’s Court of Chancery.

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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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Vitamins For Hormones | 4 Essential Vitamins For Hormonal Health

Welltopia Pharmacy

Vitamins For hormones play a vital role in regulating various physiological processes within the body, including metabolism, growth and development, mood,

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STAT+: Pharmalittle: We’re reading about MorphoSys drug risks, an AstraZeneca admission, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and inspiring, because that oh-too predictable routine of online meetings, phone calls, and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So to give it a nudge in a better direction, we are firing up the coffee kettle to brew some cups of stimulation.

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Milan & Lake Como Travel Recap + Tips

The Luxe Pharmacist

Conner & I are living our best DINK (dual income no kids) life and took a long weekend to go to Italy last week. We mainly went to see a rivalry soccer game between AC Milan and Inter Milan, which has been on Conner’s bucket list for years and I’ll never turn down a trip to Italy so we made it happen. I’m recapping our trip with general tips and must sees below!

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STAT+: House bill aimed at Chinese biotechs is advancing 

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning! Today, we learn there are some serious safety concerns around an experimental blood cancer drug from MorphoSys that has been the centerpiece of Novartis’ plan to acquire the company for $3 billion. Also, Doctors Without Borders is challenging the pharmaceutical industry to be more transparent about its dollars and cents, and we see more movement

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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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European Pharmaceutical Review Issue 2 2024

European Pharmaceutical Review

Articles included in Issue 2 of European Pharmaceutical Review – our cell and gene therapy focus – include: CELL & GENE THERAPY Proper planning prevents CMC disasters for cell and gene therapies Drew Hope, Ryan Guest and Clare Blue eXmoor Pharma SUPPLY CHAIN Fresh or frozen? Navigating the cryopreservation dilemma for CGT Priya Baraniak OrganaBio GUIDE TO TESTING LoD requirements of qualitative microbiological methods for short shelf-life products Edwin van den Heuvel Eindhoven U

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J&J gets CHMP nod for Rybrevant in first-line lung cancer

pharmaphorum

CHMP backs EU approval of J&J's Rybrevant as a first-line therapy for NSCLC with EGFR exon 30 insertion mutations, filling a void left after Takeda's Exkivity was pulled from sale

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CGT Catapult appoints new Non-Executive Directors

European Pharmaceutical Review

The Cell and Gene Therapy Catapult (CGT Catapult) has appointed three new Non-Executive Directors to its board. This supports the organisation ’s mission to advance the industry in the UK and facilitate wider adoption of advanced therapies. Dr Jim Faulkner is an “experienced, innovative biopharmaceutical development leader with specialist skills in cell and gene therapy”, according to CGT Catapult.

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Glenmark gets ANDA approval for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg

Express Pharma

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), determined by the FDA to be bioequivalent to Advil Dual Action with Acetaminophen Tablets, 250 mg/125 mg (OTC), of Haleon US Holdings. Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the US by Glenmark Therapeutics, US.

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Novel haemophilia B gene therapy approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. The treatment is indicated for adults with moderate to severe haemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening haemorrhage, Pfizer stated.

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