Wed.Nov 01, 2023

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American Cancer Society expands lung cancer screening guidelines for cigarette smokers

STAT

Most lung cancer screening guidelines hinge on how much people smoked tobacco and when they last smoked, but the American Cancer Society now says it doesn’t matter how long ago they quit. On Wednesday, the ACS released guidance recommending that anyone with a significant smoking history get an annual low-dose CT scan for lung cancer. The new guidelines also expand the age range for lung cancer screening to 50 through 80, instead of 55 through 74, and lower the smoking history requirement

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Tools like ChatGPT can personalize clinical trials tech — if companies avoid the pitfalls

PharmaVoice

From hallucinations to data privacy, pharma looks to iron out the kinks of generative AI.

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Infant mortality in the U.S. rose last year for the first time in two decades, says CDC

STAT

The U.S. infant mortality rate rose 3% last year — the largest increase in two decades, according to the Centers for Disease Control and Prevention. White and Native American infants, infant boys and babies born at 37 weeks or earlier had significant death rate increases. The CDC’s report, published Wednesday, also noted larger increases for two of the leading causes of infant deaths — maternal complications and bacterial meningitis.

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ACMT Toxicology Visual Pearl: Who Doesn’t Like a Nice Rosé?

ALiEM - Pharm Pearls

What clinical presentation and medication is associated with this urinary discoloration? Critical illness requiring intubation and propofol sedation Cyanide toxicity requiring sodium thiosulfate Iron toxicity treated with deferoxamine Refractory vasoplegic shock treated with methylene blue Septic shock treated with vancomycin and cefepime Reveal the Answer 3.

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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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New antibiotic targets gonorrhea as well as last existing treatment, study shows

STAT

An important Phase 3 trial has shown that a new drug that targets gonorrhea works as well as the last existing antibiotic to treat the sexually transmitted infection, results that could lead to licensure of the first new treatment for gonorrhea in decades. The co-developers of the drug, the nonprofit Global Antibiotic Research & Development Partnership, or GARDP, and Innoviva Specialty Therapeutics, a subsidiary of Innoviva Inc., released topline results of the clinical trial on Wednesday.

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AstraZeneca and Cellectis to collaborate for cell therapy and genomic medicine development

Pharmafile

AstraZeneca has announced a collaboration and investment agreement with Cellectis for the development of next generation cell and gene therapeutics (CGTs) in areas such as oncology, immunology and rare diseases. Under terms of this agreement, AstraZeneca will utilise Cellectis’ proprietary gene editing technologies and manufacturing capabilities with the intention of designing novel CGT products. 25 […] The post AstraZeneca and Cellectis to collaborate for cell therapy and genomic medicine

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Pandemic vaccination regulations extended to 2026

The Pharmacist

Vaccination regulations adopted due to the Covid pandemic will be extended until 2026 following a Government consultation. Ministers will extend the regulations until 1 April 2026 to support the supply, distribution and administration of Covid and flu vaccines as the country transitions out of the pandemic. Among other things, the regulations make it easier to […] The post Pandemic vaccination regulations extended to 2026 appeared first on The Pharmacist.

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STAT+: Venture capitalists want to own hospitals. Can they do better than private equity?

STAT

General Catalyst’s plan to take over a hospital in the coming months could be the first of many such deals, driven by financially strained hospitals looking for saviors, and venture capitalists convinced that they have the technology solutions for fixing the health care sector’s vexing problems. The venture firm announced plans in October to acquire a health system and then use it as a proving ground for technology that its portfolio companies sell, including generative artificial

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Building resilience to regulatory risks

Express Pharma

In September this year, Alkem Laboratories sharpened focus on its API business, branding it as Alkem Activa. Promoter-MD Sandeep Singh’s ambition “to propel Alkem Activa into the forefront of the API market” no doubt echoes the sentiments of many API contract manufacturers in India. The logic is simple. API makers across the world are rebounding from COVID-related disruptions in 2020.

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STAT+: After Sarepta trial failure, families and doctors brace for another debate on Duchenne therapy

STAT

To hear Sarepta CEO Doug Ingram tell it, the results Monday afternoon from a large trial of its gene therapy for Duchenne muscular dystrophy marked a clear medical breakthrough. “A massive win,” he told investors, that could lead to its approval for all patients with the fatal muscle-wasting disease regardless of age. And yet the rest of the Duchenne community was more cautious in its enthusiasm.

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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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Science Magazine names Dr Reddy’s among Top 20 employers in pharma globally

Express Pharma

Dr Reddy’s Laboratories announced that the Science Magazine has ranked the company among its Top 20 Employers list in pharma, biotechnology and biopharma for 2023 for the second year in a row. Based in the United States, Science is the peer-reviewed academic journal of the American Association for the Advancement of Science (AAAS) and one of the world’s top academic journals.

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The scientist studying how fugitive fetal cells may affect maternal health

STAT

Chimeras — fantastical creatures composed of different animal parts —  have appeared across cultures representing the wondrous, the grotesque, and the inherent complexity of identity. In ancient Greece, the chimera was part lion, part goat, part serpent. In classical Japanese history, it was made up of a monkey, tiger, and dog. Now, modern biology holds that humans can also be chimeras , housing cells from different genetic origins.

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AI tools to speed up lung cancer diagnosis in NHS hospitals

Pharma Times

The AI tools to be deployed will help NHS staff to analyse X-rays and CT scans - News - PharmaTimes

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STAT+: New insights into how tumor cells hijack brain plasticity to drive cancer

STAT

The idea that cancer can hijack brain plasticity — subverting supple connections in the healthy brain that ordinarily lead to learning and memory formation — is gaining traction. First reported in Cell in 2015, research led by Stanford neuro-oncologist Michelle Monje showed that active nerve cells could promote the growth of high-grade gliomas, a form of brain cancer with a poor prognosis.

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Accelerating AMR vaccine development

European Pharmaceutical Review

In July 2022, the World Health Organization (WHO) released its inaugural report on the pipeline of vaccines currently in development to prevent infections caused by antimicrobial resistance (AMR) bacterial pathogens. 1 WHO’s analysis was stark. It asserted the need to accelerate trials for AMR-related vaccines in late‑stage development and maximise the use of those already on the market.

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Opinion: How the government can help lower the price — not just the cost — of cutting-edge gene therapies

STAT

At the bustling Chicago O’Hare airport, my luggage and I collided with an elderly couple. My heart sank when I realized my vision had failed me again. Because of a connective tissue disorder, my peripheral vision and balance were impaired, making such unintentional mishaps part of my journey. Moments like these are stark reminders of the day-to-day issues that patients with rare diseases often face.

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UK government to open 160 community diagnostic centres a year early

Pharma Times

All CDCs will be open by March 2024 to speed up lifesaving checks and tests - News - PharmaTimes

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STAT+: Nostrum Laboratories and its CEO — who once defended Shkreli price hikes — to pay up to $50 million over Medicaid rebates

STAT

A pharmaceutical company and its chief executive — who once defended Martin Shkreli for raising drug prices to controversial heights — agreed to pay up to $50 million to settle allegations of purposely underpaying Medicaid rebates. Nostrum Laboratories and its founder, Nirmal Mulye, violated the False Claims Act by underpaying rebates that were due for an antibiotic used to treat bladder infections, according a document released by the U.S.

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European approval for third adapted COVID-19 vaccine

European Pharmaceutical Review

The European Commission has authorised the Nuvaxovid XBB.1.5-adapted COVID-19 vaccine, developed by Novavax for this autumn and winter season. The vaccine, known as Nuvaxovid XBB.1.5, is to be used for preventing COVID-19 in adults and children from 12 years of age. It was developed to target Omicron XBB in line with recommendations from the European Medicines Agency’s Emergency task force (ETF) as well as other international regulators and the World Health Organization.

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Gene editing has had a big week in the spotlight. Here’s what’s going on

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with good news for biotech startups, a milestone in CRISPR, and an idea for making gene therapy cheaper — both to make and to take.

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Producing Excipients as a Platform Technology with Galvita at CPHI Barcelona

PharmaTech

Pharmaceutical Technology Europe® speaks with Dr. Rainer Schmidt from Galvita AG, an excipient manufacturer based in Switzerland, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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STAT+: Pharmalittle: Panel tells FDA that CRISPR sickle cell therapy is safe enough for patients; U.K. is urged to scrap IP demands in trade talks with India

STAT

Rise and shine, everyone. The middle of the week is upon us. Have heart, though. You made it this far, so why not hang on for another couple of days, yes? And what better way to make the time fly than to keep busy. So grab that cup of stimulation — our flavor today is pistachio creme — and get started. To help you along, we have assembled another laundry list of items of interest for you to peruse.

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FDA grants approval for Novartis’ hidradenitis suppurativa treatment

Pharmaceutical Technology

The US FDA has granted approval for Novartis’ Cosentyx to treat adult patients with moderate to severe hidradenitis suppurativa (HS).

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Opinion: Listen: Sniffing out the power, and limits, of the placebo effect

STAT

Have you ever taken phenylephrine for a stuffed-up nose and then felt better? If so, you might have been perplexed when Food and Drug Administration experts recently said that that the drug — which is in some versions of DayQuil, Sudafed, and other medicines — is no more effective than a placebo. But to Michael H. Bernstein, an assistant professor of diagnostic imaging at the Warren Alpert Medical School of Brown University, it all makes sense.

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AstraZeneca announces collaboration and investment agreement with Cellectis to accelerate cell therapy and genomic medicine ambitions

World Pharma News

AstraZeneca today announced a collaboration and investment agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases.

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Could centrifugal bioreactor accelerate cell-therapy manufacturing?

European Pharmaceutical Review

Washington State University researchers have developed a centrifugal bioreactor that is able to manufacture T cells, at 95 percent of the maximum growth rate — about 30 percent quicker than current technologies. The centrifugal bioreactor, which was developed using T cells from cattle, is expected to perform similarly on human cells, according to the research, which was published in the journal Biotechnology Progress.

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FDA Grants Fast Track Designation to Sellas Life Sciences’ SLS009 for Lymphoma

Pharmaceutical Commerce

SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas.

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Pfizer posts reported net loss of $2.38bn for Q3 2023

Pharmaceutical Technology

Pfizer has posted a net loss of $2.38bn in Q3 2023 compared to a net income of $8.61bn during the same period of 2022.

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Venus gets FICCI Healthcare Award 2023 for ‘Organ-on-a-Chip’ research model

Express Pharma

Venus has won the FICCI Healthcare Award 2023 in the “Excellence in Patient Safety and Care” category. The award recognises Venus’s ‘Organ-on-a-Chip’ research model, showcased at the Venus Medicine Research Centre (VMRC), the organisation’s R&D wing. A company statement informed that VMRC’s ‘Organ-on-a-Chip’ model replicates human organ functionality, granting researchers precision in their studies and stated, “It elevates the fidelity of

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Rare disease clinical trials: The need for more patient- and site-centricity

Outsourcing Pharma

OSP had a quickfire interview with Rebecca Starkie, senior global patient engagement director, at Advanced Clinical where she explains the challenges faced by rare disease patients - and suggests ways to improve.

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ImmunoACT to lead journey of indigenous CAR-T cell therapy in India but market access a hurdle: GlobalData

Express Pharma

Immunoadoptive Cell Therapy (ImmunoACT)’s NexCAR19 (actalycabtagene autoleucel) chimeric antigen receptor T-cell (CAR-T) therapy was approved in October by the Central Drug Standards Control Organisation (CDSCO) of India for the treatment of relapsed or refractory (r/r) B-cell lymphomas and leukemia. With the approval, ImmunoACT is set to lead the journey of indigenous CAR-T cell therapy in the country, but the drug is expected to face market access challenges in India, says GlobalData.

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Vaccination access ‘key’ to tackling health inequalities

The Pharmacist

Ensuring good access and information around vaccinations is ‘key’ to tackling health inequalities, director of market access and policy affairs at Moderna told delegates at a Westminster Health Forum this week. Stuart Carroll, from the pharmaceutical company behind one of the Covid-19 jabs approved in 2021, also highlighted the importance of keeping ‘a very close […] The post Vaccination access ‘key’ to tackling health inequalities appeared first on The Pharmacist.

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Bayer launches support tool for diabetic kidney disease

pharmaphorum

Bayer launches support tool for diabetic kidney disease Phil.

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Citius Oncology set to form following agreement between Citius Pharmaceuticals and TenX Keane

Outsourcing Pharma

A transaction between Citius Pharmaceuticals and TenX Keane which will result in the formation of Citius Oncology, Inc. is due to close in the first half of next year (2024).

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Q&A With Derron Stark, Managing Director of Strategy and Transactions at EY

PharmExec

Stark discusses pharma’s supply chain and the issues it is facing.

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