Thu.Apr 04, 2024

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FDA Approves Antibiotic Ceftobiprole Medocaril for Injection for 3 Indications

Drug Topics

The antibiotic was approved to treat Staphylococcus aureas bacteremia, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia.

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Baylor wins 2024 STAT Madness with ‘smoke alarm’ for viral disease outbreaks

STAT

It began with injecting monkeys with sewage to see if they developed polio. Building off that early polio work from the 1940s, researchers from the Baylor College of Medicine analyzed public wastewater and showed they could detect over 450 disease-causing viruses. Their study demonstrating the power of sewage as an early-warning system for outbreaks won the 2024 STAT Madness popular vote.

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Federal Retail Pharmacy Program Partners Critical in Ensuring Vaccine Access

Drug Topics

Understanding the role of pharmacies in vaccination rates can help prepare officials for the next public health emergency.

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What ‘de-extinction’ of woolly mammoths can teach us: a Q&A with evolutionary biologist Beth Shapiro

STAT

Humans have long tinkered with the evolutionary trajectories of other species. Thousands of years ago we tamed wolves into dogs and transformed a wild grass into the agricultural wonder wheat. Within the past few centuries, we exterminated the Tasmanian tiger and doomed the dodo bird to oblivion. Now, we stand on the brink of an ambitious new era in how humans may transfigure life around us: by pursuing the science of de-extinction, or the resurrection of species once lost to this world.

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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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Vistagen Enrolls First Phase 3 Trail Participant for Social Anxiety Disorder Drug Fasedienol

Drug Topics

Vistagen has enrolled the first participant in the PALISADE-3 phase 3 trial of fasedienol for the treatment of social anxiety disorder.

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STAT+: Amylyx to pull ALS drug from market, cut 70% of staff

STAT

Amylyx Pharmaceuticals will take its ALS drug Relyvrio off the market in the U.S. and Canada, ending a multi-year saga for patients with the rare neurodegenerative disease. Relyvrio was approved by the Food and Drug Administration in 2022 , based on data that showed a modest slowing of disease progression. The approval was contentious — regulators initially advised Amylyx not to file for approval until it had conducted another test, but ultimately cleared the drug.

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STAT+: Matt & Adam’s Take: Amylyx did the right thing by withdrawing its ALS drug. That’s rare and worthy of praise

STAT

On Thursday morning, Amylyx Pharmaceuticals announced that it would withdraw its ALS drug , Relyvrio, after a large clinical trial showed that the medicine, approved by the Food and Drug Administration in 2022, was not effective. Amylyx’s co-CEOs, Joshua Cohen and Justin Klee, had previously publicly promised that they would withdraw the drug if further testing failed to show a benefit.

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Marshfield Clinic Health System laying off hundreds of furloughed employees

Fierce Healthcare

Months after furloughing hundreds of its employees, Marshfield Clinic Health System has informed many of those workers that they will be terminated “in early May,” a spokesperson of the 11-hospital | Though more than five dozen of the employees furloughed in January have found new positions in the organization, hundreds of others will be eliminated "in early May.

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Opinion: Hospital care costs are out of control. Price caps can help

STAT

Here’s just the tip of the iceberg: $722.50 for a nurse to push a drug into an IV. $21,500 for ten stitches. The prices charged by hospitals are exorbitant and rising. Private health insurance premiums paid by working age adults are rising rapidly. Many Americans skip necessary medical care, while those who do get treated can end up bankrupt.

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Amylyx to pull failed ALS drug Relyvrio from market, cut 70% of staffers

Fierce Pharma

Amylyx Pharmaceuticals is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. | Amylyx is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. And 70% of the company's staff will soon lose their jobs.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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STAT+: Nuclear Regulatory Commission advisers beset by conflicts of interest, report finds

STAT

The oversight division of a U.S. government agency tasked with ensuring the safe use of radioactive materials issued a recent report that the agency’s advisers had key undisclosed conflicts of interest, raising fresh concerns about controversial decisions around the reporting of radioactive injection accidents. The report, released on March 26 and conducted by the Nuclear Regulatory Commission’s (NRC) Office of the Inspector General, identified conflicts of interest involving two m

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A Call to Pharmacists in the Delivery of Oncology Care

Pharmacy Times

The expanded role of oncology pharmacists includes the opportunity to work in ambulatory settings, infusion centers, delivery of specialized in pharmacy services, evaluation of investigational new drugs, and manager roles in drug chain supply and in coordination of care.

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STAT+: Boehringer Ingelheim layoffs are a sign of dysfunctional Humira biosimilar market

STAT

WASHINGTON —  Boehringer Ingelheim is laying off or relocating its sales staff for its Humira biosimilar Cyltezo in a sign of how difficult it’s been to get drug middlemen to adopt less-expensive versions of the blockbuster, the company confirmed. Some employees may find positions elsewhere in the company, but they are mostly being pulled from the field.

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AI-powered real-world evidence generation for biotechs

pharmaphorum

Discover how AI-powered real-world evidence generation is revolutionising the biotech industry, providing valuable insights for biopharma companies to make informed decisions. Learn more about the impact of RWD on biotechs.

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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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Opinion: For national security, the U.S. must maintain its biotech dominance

STAT

For more than a century, the United States has been the undisputed leader in medical and biotechnology innovation. It saved millions of lives by mass-producing the first polio vaccines. U.S. researchers discovered new antibiotics that turned once-fatal infections into minor ailments, and developed antiretroviral cocktails that transformed HIV from a death sentence into a manageable, chronic disease.

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Does exercise help with period cramps?

The Checkup by Singlecare

Menstrual cramps are commonly described as a dull, throbbing, or spasming sensation in the lower abdomen or pelvic area. Also known as period cramps, they are caused by contractions of the uterus during menstruation and triggered by the release of prostaglandins, hormone-like substances that cause pain and inflammation. Low-intensity exercise, like walking, swimming, or yoga, can help alleviate painful periods by releasing endorphins, increasing blood flow, and reducing tension in the body.

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Health tech investor Glen Tullman launches 62 Ventures, a new $100 million fund

STAT

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. First the news: Glen Tullman, currently the CEO Transcarent , has a  new, roughly $100 million venture fund,  called  62 Ventures.

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FDA Approves Iloperidone for Acute Treatment of Manic, Mixed Episodes in Bipolar I

Drug Topics

The drug was previously approved in 2009 to treat schizophrenia.

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Trial finds benefit for GLP-1 agonist in Parkinson’s

pharmaphorum

A small study of Sanofi’s lixisenatide has suggested that the GLP-1 agonist could slow down the progression of Parkinson’s disease, pointing to another potential use for the fast-growing drug class.

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Opinion: How climate change is driving a global epidemic of immune health problems, and how to stop it

STAT

Many of the effects of climate change play out at a very large scale: Heatwaves that grip entire continents. Flooding that submerges vast swaths of island nations and continental coastal areas. Other effects are far less visible because they’re taking place inside people’s bodies. That doesn’t make them any less dangerous.

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FDA approves Basilea’s antibiotic Zevtera for three indications

Pharmafile

Basilea Pharmaceutica has announced that the US Food and Drug Administration (FDA) has approved Zevtera (ceftobiprole medocaril sodium for injection), as a new antibiotic for three indications. The drug is approved for the treatment of adult patients with Staphylococcus aureus bloodstream infections (SAB), including patients who have right-sided infective endocarditis, adult patients with acute bacterial […] The post FDA approves Basilea’s antibiotic Zevtera for three indications appeared

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Praia emerges with $20m for digital health platform

pharmaphorum

Healthcare system Providence has spun out a new company, Praia Health, focused on a platform to build and sustain connections between patients and health providers. The new company starts life with $20 million in Series A funding and a mission to develop the Praia Health Identity and Engagement Platform, which was launched within Providence’s digital innovation group (DIG) incubator in 2022 and already handles around 3.5 million user accounts.

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Why very few people who are eligible for a cochlear implant actually get one

STAT

Cochlear implants have successfully improved hearing loss for decades, but few people who qualify for an implant actually get it. Even in countries with universal healthcare, the adoption rates are dismal. Researchers are finding further disparities for marginalized communities, especially for Black and Asian patients, according to a recent study of British hospitals published Thursday in PLOS Medicine.

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Valerian: Root of All Zzz’s or Just Another Bedtime Story?

Pharmacy Times

Several studies on valerian have been conducted in the past 50 years for indications varying from insomnia, anxiety, restless leg syndrome, headaches, and more.

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How resurrecting extinct species might impact medicine

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, it’s Meghana. Today, we see how the GLP-1s might be harnessed for Parkinson’s, we learn about species de-extinction efforts, and BIO’s CEO tells us why the U.S. needs to stay on top in biotech.

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Think Outside the Box for Front-End Profit Opportunities in the Pharmacy

Pharmacy Times

Taking steps to improve front-end sales takes some time and out-of-the-box thinking, but it can prove profitable and improve word-of-mouth recommendations.

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Championing UK ATMP clinical trials

European Pharmaceutical Review

A new £17.9 million initiative announced on 21 March is set to accelerate advanced therapy development in the UK. The scheme aims to support UK advanced therapy medicinal product (ATMP) clinical trials. UK Health Minister Andrew Stephenson commented on the news, stating that the investment “reaffirms the UK’s position as a global leader in clinical research”.

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STAT+: Weed for weight loss, and more from Biotech Land

STAT

This is the online edition of Adam’s Biotech Scorecard, a new subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered every Thursday to their inbox. Bankruptcies, restructurings, clinical trial setbacks, and falling stock prices: It’s been a disconcerting week in Biotech Land. Luckily, this newsletter has arrived like a warm hug.

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New partnership to aid supply of Ga-68-based radiopharmaceuticals

European Pharmaceutical Review

US radiopharmacy network RLS Radiopharmacies is expanding its radiopharmaceutical contract development and manufacturing (rCDMO) capabilities by establishing a partnership with global isotope technology company Eckert & Ziegler. As part of the agreement, all 31 of RLS’ radiopharmacies will be produce Gallium-68-based (Ga-68) radiopharmaceuticals by the end of June, the company confirmed.

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FDA Accepts sBLA for Bimekizumab-bkzx in Hidradenitis Suppurativa Treatment

Pharmacy Times

Bimekizumab-bkzx (Bimzelx; Union Chimique Belge) is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin (IL)-17A and IL-17F.

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First-in-class anaemia therapy granted expanded approval

European Pharmaceutical Review

The European Commission (EC) has expanded the approval of Reblozyl ® (luspatercept) to include the first-line treatment of adults with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS ). This indication expansion of Reblozyl covers all EU member states, excluding Great Britain. Bristol Myers Squibb stated that this makes it the fourth authorised indication in Europe for Reblozyl.

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Embracing a Precision Medicine Approach to KRAS G12C–Mutated Advanced NSCLC With Adagrasib

Pharmacy Times

Precision medicine revolutionized NSCLC treatment, targeting specific mutations like KRAS G12C with therapies such as adagrasib to improve patient outcomes.

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Conference report: Reuters Pharma USA

pharmaphorum

Last week, pharmaphorum editor-in-chief Jonah Comstock travelled to Philadelphia for Reuters Pharma USA. On today’s podcast, he chats with guest host and Deep Dive editor Eloise McLellan about his biggest takeaways from the two-day event.

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STAT+: Pharmalittle: We’re reading about Amylyx pulling its ALS drug, GLP-1 drugs for Parkinson’s, and more

STAT

Top of the morning to you, and a fine one it is. After two days of downpours and strong winds, the Pharmalot campus is now enveloped by sunny skies and pleasant breezes, which is very much a welcome change. To celebrate, we are quaffing cups of stimulation. Our choice today is toasted coconut. As always, you are invited to join us. Meanwhile, we are proud to present our latest list of interesting items for you to peruse.

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