Fri.Sep 27, 2024

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Four more health care workers reported illnesses after caring for bird flu case in Missouri

STAT

An investigation into the still unexplained human H5N1 bird flu infection in Missouri has turned up four additional health care workers who developed mild respiratory illness symptoms after caring for the patient in hospital in August, the Centers for Disease Control and Prevention reported on Friday. It is not clear if any of these people were actually infected with H5N1; they were not tested at the time when they were ill.

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Michael Reilly: Congress Should Maintain Current FDA Biosimilars Standards

Safe Biologics

Prioritize Patient Treatment Stability, Physician Confidence Michael Reilly September 25, 2024 Biologic medicines have revolutionized the treatment of serious chronic diseases including, arthritis, psoriasis, Crohn’s disease, and cancer. Nearly 10 years ago, the FDA approved the first “biosimilar” – a copycat medicine highly similar, but not identical to a previously-approved biologic.

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Opinion: Sequencing wastewater material may be the key to getting a grip on the H5N1 bird flu outbreak

STAT

Despite no known infections of H5N1 bird flu among its dairy cows, Missouri recently detected a case in a person with no apparent exposure to possibly infected animals or related products (i.e., raw milk). A close contact and two health workers who cared for the person all developed respiratory symptoms , but were never tested. There has not yet been a wider uptick of other potential cases in the same community to indicate efficient human-to-human transmission — the evolution of which is

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FDA, after delay, clears Regeneron and Sanofi drug for COPD

BioPharma Dive

Dupixent is the first biologic medicine approved in the U.S. for the lung condition, though competitors from GSK, AstraZeneca and Roche could follow.

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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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Sickle cell community scrambles to find safe plan after a drug is pulled from the market

STAT

She knew what it was to have pain she couldn’t put into words, but this was worse. As a child, Nana-Bilkisu Habib had felt it in her arms or legs or back, but this was everywhere, as if her whole body were shutting down. She couldn’t move. Her dad had to carry her into the car and lay her in the backseat. She spent the drive to the hospital reciting verses of the Quran, praying that she would make it through.

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‘Rivers you think are pristine are not’: how drug pollution flooded England’s national parks – and put human health at risk

The Guardian - Pharmaceutical Industry

High levels of antibiotics and other drugs have been found in water in the country’s most treasured and protected landscapes, raising concerns over antimicrobial resistance Photographs by Christopher Thomond Nestled within the Peak District national park, the stream known as Brook Head Beck meanders between undulating green hills. It is mossy and dank by the river, surrounded by the gentle trickling sound of water, the smell of leaves starting to rot underfoot, and a weave of branches overhead w

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More Trending

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More than 39 million people could die from antibiotic resistance by 2050

The Pharmacist

More than 39 million people around the world could die from antibiotic-resistant infections over the next 25 years, researchers have warned. Analysis of trends by the Global Research on Antimicrobial Resistance (GRAM) Project showed that one million people died a year from resistant infections between 1990 and 2021. Writing in The Lancet, they estimated that […] The post More than 39 million people could die from antibiotic resistance by 2050 appeared first on The Pharmacist.

Vaccines 101
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STAT+: Regeneron, Sanofi blockbuster Dupixent wins FDA approval for COPD

STAT

Dupixent is already a blockbuster therapy for a range of immune-mediated diseases, but the Food and Drug Administration’s approval of the drug for chronic obstructive pulmonary disease greatly expands its reach — and could give it an edge over rival treatments in development. The FDA decision, announced Friday, was based on a pair of late-stage trials that found Dupixent helped patients with the chronic lung condition, reducing the rate of flare-ups and improving their breathing.

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The Many Dental Triggers of Hashimoto’s

The Thyroid Pharmacist

According to functional medicine, the gut is at the center of autoimmune disease — and a growing body of scientific research backs this up. As we look at the gut as a key factor behind many autoimmune diseases, including Hashimoto’s, we need to consider all parts of the gut — including the stomach, the intestines, and the mouth. When we have an infection in the mouth, even a minor one, or something else that disrupts the oral microbiome (the community of microorganisms found naturally in the mou

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STAT+: Q&A: MedStar Health’s Raj Ratwani on health AI and the battle raging over regulation

STAT

In the raging debate about how to regulate artificial intelligence in health care, “there seem to be two camps that are emerging,” says Raj Ratwani, vice president for scientific affairs at MedStar Health. On one side is the heavyweight Coalition for Health AI , now home to over 4,000 health care organizations looking to be involved in the AI regulation conversation — even the Food and Drug Administration.

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Grow Big, Pay Smart: How To Unlock Efficiency In Payroll Management

Speaker: Joe Sharpe and James Carlson

Running a small business is no small feat. Payroll management, in particular, can be one of the most time-consuming and complex parts of that equation. Yet, businesses that crack the code on streamlining these processes often discover not just savings, but new avenues for growth. Our expert speakers will share actionable insights and real-world examples of how businesses have reduced overhead and improved payroll efficiency.

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First-in-class therapy approved for schizophrenia

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) for schizophrenia in adults. “Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” shared Dr Chris Boerner , PhD, Board Chair and Chief Executive Officer at Bristo

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Opinion: WHO director general: A breakthrough global agreement on combatting antimicrobial resistance

STAT

At the U.N. General Assembly in New York on Thursday, all countries approved a major new political declaration to radically scale up efforts to combat antimicrobial resistance (AMR) — a major threat to modern medicine. As director-general of the World Health Organization, I see this declaration as a strong signal from countries that they are committed to addressing this global threat.

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SEC charges Cassava over 'misleading' Alzheimer's claims

pharmaphorum

Cassava Sciences will pay $40m to settle SEC charges that it made misleading claims about a phase 2b study of Alzheimer's candidate simufilam.

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The FDA is ‘making sandwiches,’ ‘breakfast salad’ in DC, and what keeps us from choking on food

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. In a new study in JAMA Oncology , researchers found an association between oral bacteria and head and neck squamous cell cancer. The bacteria didn’t cause the cancer, but indicated up to a 50% higher risk.

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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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PCNs can claim more per ARRS role but no overall funding increase

The Pharmacist

Primary Care Networks (PCNs) in England will be able to claim £65,838 (annual equivalent) per clinical pharmacist from October, following updates to the PCN DES issued yesterday. Under the new framework, the government will reimburse PCNs 5.6% more per clinical pharmacist Additional Roles Reimbursement (ARRS) role from 1 October 2024 than they have done since […] The post PCNs can claim more per ARRS role but no overall funding increase appeared first on The Pharmacist.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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USV launches Quinidine Sulphate tablets to address rare heart arrhythmia

Express Pharma

USV has launched Q-rite tablets, containing 200 milligrams of Quinidine Sulphate, to treat patients with rare irregular heartbeat conditions. This marks the commercial availability of Quinidine Sulphate tablets in India, aimed at improving patient care for those with cardiac arrhythmias. India faces a significant burden of cardiovascular diseases, with approximately 40% of cardiac patients displaying signs of heart rhythm disorders.

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Pharmacy damaged by fire re-opens to patients

The Pharmacist

A Rowlands pharmacy in Rhos-on-sea, North Wales, has reopened weeks after being 'considerably damaged' by fire. Local mayor of Colwyn Bay Councillor Ricki Owen cut the blue ribbon to open the new-look premises yesterday, at a special event to celebrate the pharmacy's commitment to serving the local community. After a fire broke out at the […] The post Pharmacy damaged by fire re-opens to patients appeared first on The Pharmacist.

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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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Alkem Laboratories denies claims of substandard quality for Pan-D and Clavam 625

Express Pharma

Alkem Laboratories (BSE: 539523, NSE: ALKEM) has denied claims that batches of its products Pan-D and Clavam 625 are not-of-standard quality (NSQ). This follows reports from several media outlets based on a list issued by the Central Drugs Standard Control Organization (CDSCO). The media reports refer to an update from the CDSCO East Zone in Kolkata, which mentioned one batch of Pan-D capsules (Batch No. #23444296) and one batch of Clavam 625 tablets (Batch No. #23443940) among several other dru

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BMS ends decades-long drought in novel schizophrenia drugs

pharmaphorum

BMS' acquisition of Karuna looks set to pay off after it gets FDA approval for the schizophrenia drug at the heart of the $14bn takeover

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BREAKING: Community Pharmacy Scotland gets 6% global sum uplift

The Pharmacist

The negotiator for community pharmacies in Scotland has reached a deal on funding for the sector for 2024/25, it has announced. The deal was agreed with the Scottish Government yesterday following 'considerable effort on both sides of the negotiating table to reach a mutually acceptable solution', Community Pharmacy Scotland (CPS) said. It gives the sector […] The post BREAKING: Community Pharmacy Scotland gets 6% global sum uplift appeared first on The Pharmacist.

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From PDURS to D2C, Frontiers Health speaks to cutting edge healthcare news

pharmaphorum

Stay up to date on cutting edge healthcare news, from PDURS to D2C, with Frontiers Health. Explore the latest in digital health trends and innovations.

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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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J&J builds case for Talvey; FDA panel questions PD-1 drugs for certain cancers

BioPharma Dive

New data show Talvey’s potential in multiple myeloma drug combinations. Elsewhere, AbbVie got more positive Parkinson’s drug data and Biogen ended a Sage collaboration.

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Alembic Pharmaceuticals receives U.S. FDA approval for Paliperidone extended-release tablets

Express Pharma

Alembic Pharmaceuticals (Alembic) announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paliperidone Extended-Release Tablets in strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. The approved product is therapeutically equivalent to Invega Extended-Release Tablets, the reference listed drug from Janssen Pharmaceuticals, Inc.

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BMS wins approval for schizophrenia drug acquired from Karuna

Pharmaceutical Technology

The FDA has approved the first treatment for schizophrenia that targets cholinergic receptors rather than dopamine receptors.

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Pruritus in PBC: Understanding its impact and the need for raising awareness

pharmaphorum

Pruritus, or itching, is a common symptom of Primary Biliary Cholangitis (PBC). Learn more about its impact and the importance of raising awareness about this condition.

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Biocon signs licensing agreement with Tabuk Pharmaceuticals for GLP-1 products

Express Pharma

Biocon (BSE code: 532523, NSE: BIOCON), a global biopharmaceutical company, announced the signing of a licensing and supply agreement with Tabuk Pharmaceutical Manufacturing Company, a subsidiary of Astra Industrial Group. The agreement will focus on commercialising GLP-1 products for diabetes and chronic weight management in select countries of the Middle East.

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Roche's PNH drug PiaSky backed for NHS use by NICE

pharmaphorum

NICE backs Roche's PiaSky for NHS treatment of paroxysmal nocturnal haemoglobinuria, the first drug that can be self-administered by patients.

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Lupin partners with Celnova Pharma to distribute NaMuscla in Argentina and Colombia

Express Pharma

Global pharmaceutical company Lupin has announced that its subsidiary, Lupin Atlantis Holdings SA, has entered into a distribution agreement with Celnova Pharma for Lupin’s orphan drug, NaMuscla (mexiletine). Celnova will commercialise NaMuscla in Argentina and Colombia for the treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders.

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UNICEF secures one million mpox vaccines for Africa

Pharmaceutical Technology

Bavarian Nordic has already said it would prioritise mpox vaccine production to fulfil orders this year.

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World leaders seek 10% cut in antibiotic resistance deaths

pharmaphorum

World leaders seek 10% cut in antibiotic resistance deaths Phil.

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Sanofi/Regeneron’s Dupixent set to dominate COPD biologics market following FDA approval

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has announced the approval of Sanofi and Regeneron’s interleukin (IL)-4 and IL-13 monoclonal antibody, Dupixent, for the US market.

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