STAT

OCTOBER 4, 2024

Experimental vaccines and therapeutics to combat the deadly Marburg virus will begin arriving this weekend in Rwanda, where they will be used in clinical trials expected to begin soon, a U.S. government official confirmed on Friday. There are currently no licensed vaccines or drugs to prevent or treat Marburg, a cousin of the Ebola family of viruses that transmits and causes illness in the same way as Ebola.

Vaccines 311

Vaccines 311

PharmaVoice

OCTOBER 4, 2024

Cassava Sciences’ beleaguered investigational Alzheimer’s therapy is in two phase 3 studies.

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STAT

OCTOBER 4, 2024

You’ve probably heard of Damar Hamlin, who as starting safety for the Buffalo Bills has helped lead his team to a 3-1 record to start the National Football League season. Damar survived a cardiac arrest during a Monday Night Football game in January 2023, with more than 60,000 people watching in person and another  23 million  tuned in.

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Express Pharma

OCTOBER 4, 2024

Indoco Remedies has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets USP, 10 mg (OTC). The product is a generic equivalent of the Reference Listed Drug, Zyrtec Allergy Tablets, 10 mg, produced by Johnson & Johnson Consumer Inc.

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Advertisement

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STAT

OCTOBER 4, 2024

Exact Sciences won Food and Drug Administration approval on Friday for an improved version of a stool-based screening test for colon cancer that should result in fewer cancer-free patients receiving unnecessary follow-up colonoscopies. The FDA approved the test, Cologuard Plus, for adults 45 and up with an average risk of cancer based on results from a large clinical trial, dubbed Blue-C, which recruited more than 20,000 participants.

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pharmaphorum

OCTOBER 4, 2024

FDA declares an end to tirzepatide shortage, the active ingredient in Eli Lilly’s popular weight loss medication Zepbound and diabetes drug Mounjaro.

Diabetes 101

Diabetes 101

pharmaphorum

OCTOBER 4, 2024

Bristol Myers Squibb (BMS) has been granted approval by the US Food and Drug Administration (FDA) for Opdivo to treat adults with resectable non-small cell lung cancer (NSCLC).

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STAT

OCTOBER 4, 2024

Next year’s Medicare Advantage market will be two things at once: remarkably stable broadly, but rife with changes under the surface. Health insurance companies will still offer older adults a lot of plan choices with low, or completely free, premiums. That’s why the federal government expects enrollment in the $500 billion Medicare Advantage program to grow once again in 2025 — a stark contrast from insurers’ cries that modest payment reforms would damage them and se

Health Insurance Companies 225

Health Insurance Companies 225

The Pharmacist

OCTOBER 4, 2024

The government will 'continue to discuss' issues raised around its proposed hub-to-patient model of hub and spoke dispensing with the community pharmacy negotiator, Community Pharmacy England (CPE) has said. And it suggested briefing new ministers before changes could be implemented 'could take some time'. Hubs could 'disrupt' community pharmacy market without controls In a statement […] The post Government 'discussing' hub-to-patient model with CPE appeared first on The Pharmaci

Community Pharmacies 88

Community Pharmacies 88

STAT

OCTOBER 4, 2024

As primary care physicians, we see a scene play out almost daily. A patient is sitting in front of us, explaining her symptoms: She could have difficulty breathing, stress at home, fatigue. We know there is nothing more important than being fully present. However, our minds and eyes keep darting to the computer screen and the growing inbox of messages from other patients: “I forgot my Lipitor for a week, should I double up tomorrow?

Vaccines 212

Vaccines 212

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.

The Pharmacist

OCTOBER 4, 2024

Around one million people now vape despite never having been regular smokers, a study in The Lancet has suggested. This is a ‘substantial’ increase over the past three years, and one that ‘coincided with the introduction of new disposable e-cigarettes to the UK market’, the authors added. The research surveyed 153,073 participants across England and found the […] The post One million people vape despite never smoking regularly appeared first on The Pharmacist.

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STAT

OCTOBER 4, 2024

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Hello, hello. Today we talk about whether the AI overlords will commandeer cancer research (on top of everything else in this world), WuXi is looking to sell some of its operations, ostensibly because of the BIOSECURE Act, and more.

Drug Pricing 187

Drug Pricing Drug Development 187

The Honest Apothecary

OCTOBER 4, 2024

Founded in 1947 with a mission to provide compassionate care while pursuing cutting-edge research to combat cancer, Dana-Farber Cancer Institute, is a world leader in cancer treatment and research. One of its most notable fundraising events is the Jimmy Fund Walk, which began in 1989.

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STAT

OCTOBER 4, 2024

Georgina Peacock vividly remembers a night when she admitted 20 babies, all struggling to breathe, into the hospital where she was doing her pediatric medical training. The illness that was robbing them of breath? Respiratory syncytial virus, or RSV. Peacock and many others who are responsible for the care of the country’s youngest children have been moving heaven and earth for the past year and a bit, to make experiences like that a thing of the past.

Hospitals 181

Hospitals 181

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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.

Outsourcing Pharma

OCTOBER 4, 2024

Rebekah's father passed on his passion for science and problem solving to her and much her of childhood was spent doing fun hands-on activities from taking apart household mechanics to building rockets.

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STAT

OCTOBER 4, 2024

A pleasant Friday morning to you! Adam Feuerstein, here, reporting from the Pharmalittle campus, temporarily relocated to Cambridge, Mass., as your regular New Jersey host Ed takes the day off. Like the one-and-only Mr. Pharmalot, I enjoy my daily headlines with a hot cup of joe. Have a great weekend.  Italian pharma company Recordati said it will buy from Sanofi the global rights to an approved drug to treat cold agglutinin disease , a rare autoimmune disorder, for $825 million, Reuters re

Health Insurance Companies 159

Health Insurance Companies Diabetes 159

Express Pharma

OCTOBER 4, 2024

Lower- and middle-income countries stand to gain the most from policies that combat AMR but resources and implementation are difficult to put into place. What are the findings from the report which policy makers from such countries should take note of? The economic gains from tackling AMR are greatest in lower-middle-income countries like India, as resistance rates tend to be higher in these countries than in high-income countries.

Vaccines 70

Vaccines Pharmaceutical Manufacturing Packaging 70

STAT

OCTOBER 4, 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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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.

BioPharma Dive

OCTOBER 4, 2024

Having already been on a winding journey, Enjaymo, which Sanofi acquired through a 2018 buyout of Bioverativ, is now headed to Recordati as part of a deal announced Friday.

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STAT

OCTOBER 4, 2024

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Today’s item on bacterial outbreaks linked to hospital ice machines reminded me of The National’s song “Ice Machines,” so pardon me for slipping into music recommendation mode for a second.

Hospitals 142

Hospitals 142

BioPharma Dive

OCTOBER 4, 2024

An experimental Alzheimer’s therapy from Cassava Sciences is still being tested in two Phase 3 studies, even as the company has come under regulatory scrutiny.

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Pharmaceutical Technology

OCTOBER 4, 2024

Teva Pharmaceuticals International and mAbxience have entered into a worldwide licencing agreement to develop an anti programmed cell death protein 1 oncology biosimilar candidate.

Biosimilars 52

Biosimilars 52

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Pharmacy Management

BioPharma Dive

OCTOBER 4, 2024

Bristol Myers' immunotherapy can now be used before and after surgery in the U.S. Elsewhere, J&J, Bayer, Bristol Myers Squibb and Pfizer are trimming staff.

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Pharmaceutical Commerce

OCTOBER 4, 2024

In this video interview with Pharma Commerce Editor Nicholas Saraceno, John Stefankiewicz, VP of Analytics, Cencora, details why these pharmacy deserts have become so widespread.

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BioPharma Dive

OCTOBER 4, 2024

The gene editing company is selling to DRI Healthcare Trust future license fees that are owed to it under an agreement with Vertex last year.

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PharmaTech

OCTOBER 4, 2024

Pharmaceutical Technology Europe chats with Klaus Ullherr, senior product manager at Syntegon, about challenges facing companies when trying to comply with Annex 1 and how automated systems can help.

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Express Pharma

OCTOBER 4, 2024

The Indian pharma industry, long hailed as a global powerhouse, finds itself at a crossroads. Once a beacon of growth and profitability, the sector is now grappling with a complex web of challenges that are eroding margins and inflating overheads. Pressure on margins: A reality check for India Pharma In recent years, Indian pharmaceutical companies have seen a substantial decline in profitability, dropping by approximately 20-30 per cent over the past six to eight years, aside from a brief surg

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

Big Molecule Watch

OCTOBER 4, 2024

On September 19, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s aflibercept biosimilar AFQLIR. On September 20, 2024, Samsung and Biogen announced that the CHMP also adopted a positive opinion for their aflibercept biosimilar OPUVIZ. AFQLIR and OPUVIZ have been recommended for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retin

Biosimilars 52

Biosimilars Diabetes 52

Pharmaceutical Commerce

OCTOBER 4, 2024

Headlining our October issue of Pharmaceutical Commerce is a look inside an emerging key component of cold chain transport and management—ensuring the safety and control of novel injectable drugs through to their "last mile.

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Big Molecule Watch

OCTOBER 4, 2024

On September 27, 2024, Formycon AG (“Formycon”) and its commercialization partner Fresenius Kabi (“Fresenius”) jointly announced that the European Commission (EC) has issued a marketing authorization for FYB202/OTULFI (ustekinumab-aauz), a biosimilar to STELARA®. FYB202/OTULFI is an interleukin-12 and interleukin-23 antibody and was approved for moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis in Europe.

Biosimilars 52

Biosimilars 52

European Pharmaceutical Review

OCTOBER 4, 2024

A study has reported an approach for optimising metronidazole colonic delivery systems, to increase their potential efficacy when treating diverticulitis. Researchers developed intestinal colon-coated sustained-release matrix metronidazole tablets, using a Quality by Design (QbD) approach. Arévalo-Pérez et al. noted that metronidazole is a synthetic nitroimidazole and has activity against anaerobic bacteria.

Dosage 52

Dosage 52

PharmExec

OCTOBER 4, 2024

Approval for Opdivo was based on results from the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival and pathologic complete response in adults with resectable non-small cell lung cancer without EGFR or ALK rearrangements.

Chemotherapy 52

Chemotherapy 52