Tue.Jun 18, 2024

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Opinion: Long Covid feels like a gun to my head

STAT

I have spent my career studying infectious diseases that fall under the heading of neglected tropical diseases. Now I have a neglected disease — long Covid — an incurable (for now and for me) disease. As a medical anthropologist working in global health, I thought I understood the despair of poor health. I didn’t. I join 7% of the U.S. adult population — or about 18 million Americans — who have experienced long Covid.

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Avoiding the pharma ‘junk pile’ with launch readiness, pipeline rigor and ‘quick kills’

PharmaVoice

Drug launches have underperformed expectations at a high rate, and pharmas need to get better at thinning the pipeline to make room for the real wins, says a life sciences consultant.

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Trending Sources

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Opinion: With the threat of H5N1 bird flu, hospitals must stay prepared

STAT

A third case of mammal-to-human transmission of the highly pathogenic H5N1 bird flu virus has been reported in the United States. This latest case, involving a dairy worker in Michigan , raises concerns due to the individual exhibiting respiratory symptoms, highlighting the pandemic potential of this virus. U.S. hospitals need to prepare for the worst and hope for the best.

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12 Questions with Caroline Phillips

pharmaphorum

Dive into an exclusive Medscape interview with HCP Caroline Phillips as she shares her insights, experiences, and advice. Discover the key takeaways that can benefit your medical practice.

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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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Another heat wave is hitting the U.S. Here’s what you need to know

STAT

Extreme heat is coming this week in many parts of the United States. The Midwest and Northeast in particular will see weather that puts them in the National Weather Service’s highest heat risk category — when lack of cooling or hydration can put almost anyone in harm’s way. It’s a new labeling system for the NWS, which launched the experimental rating at the end of April with the Centers for Disease Control and Prevention in response to the growing danger of extreme h

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Neuroplastogens: A novel approach to treat neurological diseases

pharmaphorum

Learn about the innovative approach of using neuroplastogens, including psychedelics, to treat neurological diseases. Explore the potential benefits and risks of this novel treatment method.

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More Trending

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FDA says yes to MSD’s 21-valent adult pneumococcal jab

pharmaphorum

The rivalry between Pfizer and MSD in pneumococcal vaccines has dialled up a notch with the FDA approval of MSD’s new shot Capvaxive, the first to be aimed specifically at adults.The 21-valent product – formerly known as V116 – covers a wider range of Streptococcus pneumoniae serotypes than any of MSD’s earlier vaccines and eight that are not covered by any other approved pneumococcal vaccine.

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To treat obesity in children, task force favors behavioral therapy over drugs like Wegovy

STAT

A national advisory organization has come down on the side of behavioral interventions, not obesity medications, to help children 6 and older with high BMI improve their health, wading into the debate over prescribing the blockbusters for kids before their long-term consequences are better understood. On Tuesday, the United States Preventive Services Task Force issued recommendations encouraging clinicians to provide or refer children and adolescents 6 years or older with a high body mass index

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NIH awards Cellibre $2M to advance sustainable cannabinoid ingredient production

Outsourcing Pharma

Cellibre, a pioneer in sustainable biochemical manufacturing, has received a $2 million grant from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH).

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STAT+: To feed an AI that designs new enzymes, Basecamp hunts rare proteins at the world’s end

STAT

Not many AI companies have expeditions to the rainforest on the calendar, or need scientists who’ve lived in Antarctica on the payroll. “One of them was the diving instructor for Jason Momoa,” said Philipp Lorenz, chief technology officer at Basecamp Research. “She’s one of our field scientists.” Basecamp, headquartered in London, positions itself as the “bridge between biodiversity and biotech.

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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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Novel immunotherapy combination approved for endometrial cancer

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the first anti-PD-1 therapy in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Merck (MSD outside of the US and Canada)’s KEYTRUDA (pembrolizumab) is authorised alongside treatment with carboplatin and paclitaxel, followed by KEYTRUDA monotherapy, for these patients.

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On the road to eliminate rabies, Gavi announces plan to improve human vaccination

STAT

Rabies has been in global health’s crosshairs for years. Around the world, the viral infection kills about 70,000 people a year — and since as early as 2015, groups including Gavi, the Vaccine Alliance, have had plans to shore up vaccine efforts to reduce the number. At one point, Gavi planned to include human rabies vaccines in its 2021 investment strategy — but then the Covid-19 pandemic got in the way.

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FDA clears Roche digital pathology platform for diagnosis

pharmaphorum

Roche’s move into the digital pathology category has been boosted by FDA approval of a lab instrument and toolkit for use as an aid to clinical diagnosis.The clearance covers Roche’s Ventana DP 200 slide scanner, digital pathology workflow software, and a display that can be used to review and interpret digital images of scanned pathology slides.

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STAT+: Freespira bets on slow and steady, amid spectacular digital health collapses

STAT

Many digital health companies have crashed and burned after promising investors speedy adoption and huge revenues. Freespira, maker of a software- and device-based treatment for panic and post-traumatic stress disorders, has taken a different strategy: Slowly build to profitability a few thousand patients at a time. Freespira CEO Joe Perekupka told STAT the company believes it will break even by the end of 2025 and will become cash flow positive in 2026.

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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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Bayer receives Breakthrough Therapy designation in China for BAY 2927088

World Pharma News

Bayer announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy designation for BAY 2927088, a potential new targeted therapy for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC), whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.

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STAT+: Boston Scientific to buy vascular device maker for $1.16 billion

STAT

Boston Scientific said on Tuesday it will buy Silk Road Medical, a medical device company treating stroke, for $1.16 billion.  Silk Road Medical sells technology meant to prevent stroke in patients with carotid artery disease, a condition creating blockages in the major blood vessels connected to the brain. The company’s core products enable a procedure that temporarily sends blood flow away from the brain to prevent plaque from blocking the vessel.

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Johnson & Johnson submits BLA to FDA for lung cancer drug

Pharmaceutical Technology

Johnson & Johnson has filed a BLA with the US FDA seeking approval for SC amivantamab for the treatment of non-small cell lung cancer.

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A biotech’s binary bet ends badly

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! Elaine Chen is away, so I’m here in her stead. Take it slow out there, Northeast-ers, the outside temps are about to hit “wicked hot.

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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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KalVista files first oral on-demand HAE drug with FDA

pharmaphorum

KalVista files sebetralstat with the FDA, aiming to make it the first oral, on-demand treatment for rare disease hereditary angioedema (HAE)

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UMC Utrecht and VectorY collaborate to identify biomarkers of ALS in new study

Pharma Times

The progressive neurological disorder currently affects more than 200,000 people worldwide

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The new frontier of microbiome-directed human health

pharmaphorum

The microbiome is ever more frequently spoken about of late, and so the pharmaphorum podcast invited Leo Grady, founder and CEO of Jona, to speak about at-home personal microbiome profiling, uncovering the relationship between human health and the gut.

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'Appropriately regulate' online pharmacies, urges PDA manifesto

The Pharmacist

The Pharmacists' Defence Association (PDA) has called for the next government to ‘prioritise patient safety around medicines’ and 'appropriately regulate' rapid advances in AI and online healthcare provision. And it said that pharmacy funding should be ringfenced for staffing to help address workplace pressures and burnout. In a manifesto launched this week, the PDA said […] The post 'Appropriately regulate' online pharmacies, urges PDA manifesto appeared first on The Pharmacist.

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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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Roche and Ascidian Therapeutics Collaborate on Treatments for Neurological Diseases

PharmaTech

The research collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.

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Alembic Pharma announces U.S. FDA approval for Dabigatran Etexilate Capsules, 75 mg and 150 mg and tentative approval for Dabigatran Etexilate Capsules, 110 mg

Express Pharma

Alembic Pharmaceuticals (Alembic) has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg and 150 mg and Tentative approval for Dabigatran Etexilate Capsules, 110 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, (Boehringer).

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Can supermarket pharmacies plug urgent healthcare gaps?

Pharmaceutical Technology

As Asda sets up a nationwide retail pharmacy in the UK and US grocer pharmacies expand, scaling up this model will be the next frontier.

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AZ has another setback with Truqap after failed TNBC trial

pharmaphorum

AstraZeneca’s AKT inhibitor Truqap was unable to improve overall survival in a phase 3 triple-negative breast cancer (TNBC) trial

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Wanbury’s Patalganga manufacturing facility clears U.S. FDA inspection with zero observations

Express Pharma

Wanbury, a pharmaceutical company having a presence in API global market and domestic branded formulation has announced the successful completion of the United States Food & Drug Administration (USFDA) inspection at Patalganga site, Maharashtra. The inspection that started from Monday, June 10, 2024 and completed on Friday, June 14, 2024 was concluded with zero-483 observations.

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PulmCrit: PPIs are safe and effective for GI prophylaxis… the end.

EMCrit Project

REVISE is the latest multicenter RCT on the use of PPIs for GI prophylaxis in critical illness. I would view this as the triquel following SUP-ICU and PEPTIC. In order to understand REVISE in context, let's briefly review SUP-ICU and PEPTIC trials, before discussing REVISE. Part I: SUP-ICU (2018) This was a large multicenter RCT […] EMCrit Project by Josh Farkas.

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Novo Nordisk CEO agrees to testify on semaglutide pricing

pharmaphorum

Novo Nordisk CEO agrees to appear at a Senate hearing to defend the pricing of Ozempic and Wegovy in the US.

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SPH-4336 by Shanghai Pharmaceutical Group for Well Differentiated Liposarcoma: Likelihood of Approval

Pharmaceutical Technology

SPH-4336 is under clinical development by Shanghai Pharmaceutical Group and currently in Phase II for Well Differentiated Liposarcoma.

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FOPE and PharmaState Academy sign MOU to enhance pharma workforce skillsets and capabilities

Express Pharma

Federation Of Pharma Entrepreneurs (FOPE) and PharmaState Academy (PSA) announced the signing of a Memorandum of Understanding (MOU) on June 15, 2024 at FOPE’s annual general meeting held at Panchkula near Chandigarh, India. The strategic collaboration aims to advance the dissemination of knowledge management activities and resources around the pharmaceutical workforce capacity and other aspects of capacity building and training.

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The lasting impacts of the pandemic on cybersecurity in healthcare

Pharmaceutical Technology

The high speed of the transition meant many information technology security teams had insufficient time to install adequate cybersecurity.

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