STAT

SEPTEMBER 27, 2024

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.

Hospitals 364

Hospitals 364

Safe Biologics

SEPTEMBER 27, 2024

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.

Biosimilars 100

Biosimilars 100

STAT

SEPTEMBER 27, 2024

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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BioPharma Dive

SEPTEMBER 27, 2024

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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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

Communication

STAT

SEPTEMBER 27, 2024

Finally, it seemed, Sarah Jenssen would have a chance to get a treatment that her family hoped could help her. A gene therapy for Sarah’s condition, Duchenne muscular dystrophy, won a wide approval from the Food and Drug Administration earlier this year. The authorization encompassed most patients with the degenerative neuromuscular disorder, regardless of their age or whether or not their disease had advanced to the point that they used wheelchairs.

Drug Pricing 350

Drug Pricing 350

The Guardian - Pharmaceutical Industry

SEPTEMBER 27, 2024

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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European Pharmaceutical Review

SEPTEMBER 27, 2024

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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STAT

SEPTEMBER 27, 2024

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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Immunization Immunity 319

pharmaphorum

SEPTEMBER 27, 2024

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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STAT

SEPTEMBER 27, 2024

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.

Hospitals 299

Hospitals 299

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Express Pharma

SEPTEMBER 27, 2024

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.

Labelling 105

Labelling 105

STAT

SEPTEMBER 27, 2024

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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pharmaphorum

SEPTEMBER 27, 2024

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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STAT

SEPTEMBER 27, 2024

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.

Drug Development 248

Drug Development 248

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.

Express Pharma

SEPTEMBER 27, 2024

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.

Hospitals 105

Hospitals 105

STAT

SEPTEMBER 27, 2024

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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pharmaphorum

SEPTEMBER 27, 2024

Discover how GenAI leverages cutting-edge technology to automate the generation of regulatory dossiers, saving time and resources for your organization. Explore how GenAI can streamline the process and enhance efficiency.

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Express Pharma

SEPTEMBER 27, 2024

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

Packaging 107

Packaging Labelling Pharmaceutical Companies Pharmaceutical Companies 107

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The Pharmacist

SEPTEMBER 27, 2024

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 96

Vaccines 96

Express Pharma

SEPTEMBER 27, 2024

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.

Diabetes 104

Diabetes Pharmaceutical Manufacturing 104

The Pharmacist

SEPTEMBER 27, 2024

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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pharmaphorum

SEPTEMBER 27, 2024

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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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.

The Pharmacist

SEPTEMBER 27, 2024

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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Pharmaceutical Technology

SEPTEMBER 27, 2024

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

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BioPharma Dive

SEPTEMBER 27, 2024

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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Pharmaceutical Technology

SEPTEMBER 27, 2024

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

Vaccines 105

Vaccines 105

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Pharmacy Management

The Pharmacist

SEPTEMBER 27, 2024

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.

Community Pharmacies 81

Community Pharmacies 81

Express Pharma

SEPTEMBER 27, 2024

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.

Pharmaceutical Companies 91

Pharmaceutical Companies Pharmaceutical Companies 91

pharmaphorum

SEPTEMBER 27, 2024

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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Pharmaceutical Technology

SEPTEMBER 27, 2024

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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pharmaphorum

SEPTEMBER 27, 2024

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

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