Mon.Apr 01, 2024

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H5N1 avian flu found in Texas individual who apparently was infected by dairy cows

STAT

Texas health officials reported Monday that an individual who had been in contact with cattle has contracted H5N1 avian flu, only the second case ever recorded in the U.S. The person had contact with dairy cattle that are believed to have been infected with the virus, the Texas Department of State Health Services said in a statement. It went on to say that the individual’s only symptom is eye inflammation — infection of the conjunctiva, the tissue surrounding the eye.

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With a rise in animal-human organ transplants, a drugmaker aims for a new standard of care

PharmaVoice

Eledon Therapeutics is developing a drug that could facilitate organ transplants from animals to humans as the procedure gains steam.

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Trending Sources

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New HHS guidance requires consent for pelvic, breast, and other sensitive examinations

STAT

Hospitals performing pelvic and other sensitive exams for training purposes without patients’ explicit consent, including on anesthetized patients, won’t be eligible for Medicare and Medicaid reimbursement, according to new guidance released on Monday by the Department of Health and Human Services’ Centers for Medicare and Medicaid Services.

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To advance women’s leadership, an effort ‘has to be purposeful,’ says EMD Serono exec

PharmaVoice

Gender diversity in leadership “doesn’t just happen,” — it requires institutional change, from investing in women’s startups to providing more generous family leave.

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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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Opinion: Banning teens from social media won’t help their mental health. Here’s what might

STAT

Since the U.S. surgeon general’s 2023 advisory on social media and teen mental health, public concern has skyrocketed around adolescents’ digital lives. Major news organizations and even state governments have pinned social media apps as addictive , dangerous, and the cause of the youth mental health crisis. In turn, calls to ban teens from social media apps have started to emerge, with mixed reception from policymakers nationwide.

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SAEM Clinical Images Series: Red Rash on My Legs

ALiEM - Pharm Pearls

A 23-year-old female with no known past medical history presented with a rash concentrated on her legs, with a few areas on her arms and chest. The rash began the day before presentation when she became overheated while wearing sweatpants in 104°F weather. The rash was mildly pruritic but not painful. She denied any prior reaction to her sweatpants that she has had for several months.

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More Trending

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5 FDA decisions to watch in the second quarter

BioPharma Dive

The FDA could soon expand use of two multiple myeloma cell therapies as well as a top-selling medicine from Sanofi and Regeneron, while Pfizer’s years of gene therapy work might finally pay dividends.

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STAT+: Otsuka’s digital treatment for depression cleared by FDA, as pharma tries to crack tricky market

STAT

The Food and Drug Administration has cleared Otsuka Pharmaceutical’s digital treatment for major depressive disorder, offering a new option for millions of people who struggle with the stubborn mental health condition. Called Rejoyn , the smartphone-based treatment for major depressive disorder symptoms, developed with digital health company Click Therapeutics, is intended for use by prescription alongside antidepressants.

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A step towards global harmonisation of GMP inspection protocols

Express Pharma

In a letter dated March 21, the US FDA India office country director Sarah McMullen said that four states (Gujarat, Telangana, Goa and Karnataka) had been ‘sensitised to FDA’s inspection process and, as such, are eligible for inclusion as observers for relevant inspection in their respective states.’ The letter goes on to mention, ‘We would appreciate relevant opportunities being made available to state inspectors to attend as observers as practical.’ US FDA’s ̵

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STAT+: Scientists uncover potential path to treating deadly childhood tumor

STAT

Most targeted cancer drugs work like tranquilizer darts, snaring an overzealous gene that has spurred the cell into murderously rapid growth. But many tumors don’t have a hyperactive gene. Like the mayhem in “Cat in the Hat,” they are enabled by parental absence. They grow because the genes that are meant to provide discipline, guiding the activity of other genes or self-destructing a cell whose DNA is too damaged, are broken or missing.

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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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FDA clears first DTx for depression from Otsuka, Click

pharmaphorum

Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder

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STAT+: Critics say U.K. decision on ALS drug could have ‘chilling effect’ on access to new genetic medicines

STAT

LONDON — Neurologists and patient advocates are up in arms over a policy decision by a U.K. health agency that they say will imperil access to an ALS treatment that’s available in the U.S. and on its way to approval in the European Union. The medicine in question, Biogen’s tofersen, is designed to treat a rare genetic form of the neurodegenerative disease, accounting for some 2% of all ALS cases.

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Bora Pharmaceuticals acquires Upsher-Smith

Express Pharma

The acquisition expands Taiwan-based Bora’s North American footprint with its first US manufacturing site Bora Pharmaceuticals (Bora) completed the acquisition of Upsher-Smith Laboratories (Upsher-Smith), a generics manufacturer and marketer based in Minnesota, US, from its sellers, Sawai Group Holdings and Sumitomo Corporation of Americas. Upsher-Smith, founded in 1919, has a diversified portfolio of 48 generic products with manufacturing facilities in Plymouth and Maple Grove, Minnesota.

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STAT+: Net prices for medicines fell considerably in 2023’s last quarter, mostly thanks to Humira biosimilars

STAT

The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — fell by 2.8% in last year’s fourth quarter, the largest decline ever measured by SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends. A key reason for the big drop — which dwarfed the 0.4% decline seen at the same time a year earlier — was pricing pressure on the Humira treatment for rheumatoid arthritis and psoriasis.

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Breaking barriers: Advances and challenges in therapeutic cancer vaccines

BioPharma Dive

The development of cancer vaccines has provided some hope in the battle against cancer worldwide; however, there are still many challenges to overcome when developing these life-saving treatments.

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STAT+: UnitedHealth’s surprising new target: Struggling Steward’s physician group

STAT

UnitedHealth Group has gobbled up physician practices at an astounding rate — roughly 20,000 last year alone. Most of them share a common trait: They’re independent groups, not affiliated with hospital chains. The Minnesota conglomerate’s plan to roll Stewardship Health, the physician arm of for-profit Steward Health Care, into its Optum subsidiary would mark a noteworthy departure from its usual fare.

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Alembic Pharma appoints Manish Kejriwal as Independent Director

Express Pharma

Alembic Pharmaceuticals has appointed Manish Kejriwal as an Independent Director of the company for the period of five consecutive years effective from March 31, 2024. Kejriwal brings over 30 years of experience in private equity investments and is currently the founder and Managing Partner of Kedaara Capital. Prior to founding Kedaara Capital, Kejriwal served as the head of the India office of Temasek Holdings, managing all investments and activities.

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Why a bill meant to stop surprise medical bills hasn’t worked

STAT

You’re reading the web version of Health Care Inc.,  STAT’s weekly newsletter  following the flow of money in medicine.  Sign up  to get it in your inbox every Monday.  Optum scooping up more docs during Change outage Just when you thought things couldn’t get weirder, UnitedHealth Group plans to buy Steward Health Care’s physician practice.

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Merck gets grant for patent granted for tricyclic heterocycle compounds for treating HIV

Pharmaceutical Technology

Discover the groundbreaking patent by Merck & Co Inc for Tricyclic Heterocycle Compounds to combat HIV infection. Learn about the innovative formula and treatment methods for a potent solution in antiretroviral therapy.

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Aardvark Therapeutics gearing up for $200 million IPO

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hey there. Today, we learn about how scientists had a happenstance discovery about tumor-suppressor genes and used them to target aggressive pediatric tumor cells. We see a U.K. health agency make a controversial call about an ALS drug made by Biogen, and more.

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Leqembi maintenance dose filed in US, but SC form delayed

pharmaphorum

Eisai has filed to extend the label for its Alzheimer’s drug Leqembi to include a once-monthly maintenance regimen

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STAT+: Pharmalittle: We’re reading about AstraZeneca’s CEO pay, an ALS drug spat in the U.K., and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of phone calls, online meetings, and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup of stimulation.

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FDA clears AZ’s new PNH therapy Voydeya

pharmaphorum

AstraZeneca’s Voydeya has been approved by the FDA as an add-on to treatment with Soliris or Ultomiris for rare disease PNH

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WHO INN approves ‘Usnoflast’ as recommended name for ZYIL1 from Zydus

Express Pharma

Zydus Lifesciences has received approval from WHO International Non-proprietary Names (INN) for “Usnoflast” as the recommended name for ZYIL1. The INN system aims to provide healthcare professionals with a unique and universal designated name for each pharma substance. Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor discovered at Zydus.

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Understanding CVS Health/McKesson and Why Pharmacies Lose Money on GLP-1s (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: Drug Channel Implications of the Inflation Reduction Act. Click here to see the original post from December 2023. Consider two apparently unrelated drug channel anomalies: In McKesson’s 2023 fiscal year, CVS bought $75 billion in pharmaceuticals from McKesson’s wholesale business—a jump of more than 35% compared with the previous year.

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US FDA grants fast track status to LISCure’s LB-P8 drug for PSC

Pharmaceutical Technology

FDA has granted fast track designation to LISCure Biosciences’ investigational drug LB-P8, for the treatment of PSC.

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Mayo Clinic scientists pioneer immunotherapy technique for autoimmune diseases

World Pharma News

Mayo Clinic scientists have developed an immunotherapy strategy that potentially lays the groundwork for treating a spectrum of autoimmune diseases. The new technique, detailed in a preclinical study published in Nature Biomedical Engineering, involves combining chimeric antigen receptors (CAR) with mesenchymal stromal cells (MSC), resulting in engineered stem cells known as CAR-MSCs.

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How Dobbs v Jackson Women’s Health Organization Decision Influenced Self-Management Medication Use

Pharmaceutical Commerce

Cross-sectional study explores the impact of this monumental Supreme Court ruling.

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Express Pharma April 2024

Express Pharma

Scaling New Heights Click to download: April 2024 Digital Magazine The post Express Pharma April 2024 appeared first on Express Pharma.

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Fail-First Policies Are Harming Patients

Pharmaceutical Commerce

Patients should not have to wait to access the medication they need.

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AstraZeneca gets FDA OK for rare disease drug acquired in Alexion buyout

BioPharma Dive

The clearance of Voydeya as an add-on therapy for an uncommon blood disease validates a bet Alexion made on original developer Achillion five years ago.

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Pharma Pulse 4/1/24: Uncertainties Associated with Accelerated Approval, Understanding DSCSA & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Vertex moves kidney disease drug into late-stage testing

BioPharma Dive

The drug, inaxaplin, is an important pipeline prospect for Vertex, which is working to expand beyond the cystic fibrosis medicines that made its name.

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Jubilant Pharmova gets grant for radiopharmaceutical composition for diagnostic imaging with stable attributes

Pharmaceutical Technology

Discover the innovative patent by Jubilant Pharmova Ltd for a stable radiopharmaceutical composition of tetrofosmin, ensuring high purity and effectiveness in diagnostic imaging.

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FDA Approves Alexion’s Voydeya as Add-on Treatment for Adults with Extravascular Hemolysis

PharmExec

Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis.

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