Mon.Feb 26, 2024

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Digital Health Tools Could Increase PrEP Uptake Among Young Individuals At-Risk For HIV

Drug Topics

Participants of a recent study who received automated text messaging and monitoring, as well as peer support and coaching, increased PrEP uptake from 11% to over 20%.

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Hyperbaric Oxygen Therapy May Be the First, Only Clinically Effective Treatment for Long COVID

Pharmacy Times

ā€œIā€™m better than I was before I had long COVID, and in so many ways,ā€ said a patient in an interview with Pharmacy Times.

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Trending Sources

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Denied care: Trans men often struggle for inclusive gynecologic healthcare

Fierce Healthcare

When Joseph Schneier, a transgender man then in his early 40s, started experiencing unusual spotting and elevated progesterone levels in 2021, his partner urged him to get checked out. | When Joseph Schneier, a transgender man in his early 40s, started experiencing unusual spotting and elevated progesterone levels in 2021, his partner urged him to get checked out.

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STAT+: Liver disease MASH is next target for obesity drugs in development

STAT

As drugmakers race to join the obesity drug market ignited by the approval of Wegovy and Zepbound , they’re not just competing on their drugs’ weight loss effects. They’re also competing on their products’ ability to treat a severe form of liver disease. A new update of the STAT Obesity Drug Tracker shows that at least 23 — about one-fifth — of the 105 obesity treatments in development or on the market are also being investigated for metabolic dysfunctio

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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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Expert Predicts Psychedelics Will Be Integrated into Current Regimens for Treating Mental Health Diseases

Pharmacy Times

Investigators continue to conduct regulated and controlled clinical trials to build compelling, high-quality evidence on their therapeutic potential.

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STAT+: Obesity treatment from Boehringer Ingelheim, Zealand Pharma succeeds in study in liver condition MASH

STAT

LONDON — A drug in development as a weight loss treatment succeeded in a Phase 2 study in a serious liver condition, its developers said Monday, as the competition in the broader obesity medicine field pushes ahead. The drug, survodutide, is being developed by the privately held German firm Boehringer Ingelheim and the Danish biotech Zealand Pharma.

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More Trending

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STAT+: MD Anderson tried ā€” and failed ā€” to resolve research credit dispute between two scientists, new documents show

STAT

Early last year, MD Anderson Cancer Center leadership had a problem on their hands: a contentious dispute between one of its most powerful researchers and a junior scientist over authorship, credit, and charges of verbal abuse. High-ranking officials at the cancer center tried — and failed — to resolve the feud, and documents obtained by STAT shed new light on the deep divisions at the heart of this case.

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Amgen boots up Ohio 'smart facility' where it plans to employ 400ā€”and a trio of robots, too

Fierce Pharma

Amgen is now open for business in Central Ohio after cutting the ribbon at its ā€œmost advanced facility to date.ā€ | Amgen is now open for business in Central Ohio after cutting the ribbon at its ā€œmost advanced facility to date.ā€ Dubbed ā€œAmgen Ohio,ā€ the nearly 300,000-square-foot biomanufacturing plant in New Albany, Ohio, is set to employ 400 full-time employees and leverage the ā€œlatest innovation and technology.

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Opinion: A new Louisiana capital-punishment bill would fundamentally alter physician licensing

STAT

After the recent nitrogen gas execution in Alabama of Kenneth Smith, state Attorney General Steve Marshall said that nitrogen gas “was intended to be — and has now proved to be — an effective and humane method of execution.” It is hard to imagine a statement so obviously disconnected from facts. Eyewitness accounts described Smith’s death as a harrowing experience of dry heaving, thrashing, straining against leather straps, seizures, and terror.

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Bristol Myers blueprints $400M Ireland expansion with plans to add sterile drug firepower and hire 350

Fierce Pharma

Bristol Myers Squibbā€™s first drug substance facility outside the United States is now set to become the companyā€™s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million- | Bristol Myers Squibbā€™s first drug substance facility outside the United States is now set to become the companyā€™s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million-dollar expansion expected to add hundreds of new jobs in the coming years.

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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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FTC sues to block Krogerā€™s acquisition of Albertsons

Drug Store News

The FTC alleges that the largest supermarket merger in U.S. history will eliminate competition and raise grocery prices for millions of Americans, while harming tens of thousands of workers.

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With global expansion planned, Krystal lays out blockbuster ambitions for topical gene therapy

Fierce Pharma

Not even one year after becoming a commercial biotech, Krystal Biotech has blockbuster dreams for its flagship product. | In its first six months of commercial availability, Krystal's topical gene therapy Vyjuvek raked in more than $50 million. Now, the company is looking toward bringing the drug to Europe and Japan and testing a new eye-drop formulation.

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GSK antibiotic gepotidacin clears phase 3 gonorrhoea trial

pharmaphorum

GSK has reported topline results from a phase 3 trial of its novel antibiotic gepotidacin that could spell the end of a decades-long drought in new oral therapies for gonorrhoea.

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BeiGene grows global workforce by 1,000+ as Brukinsa surges, Tevimbra launches outside China

Fierce Pharma

The chilling wind of the biotech winter has apparently spared BeiGene. | The chilling wind of the biotech winter has apparently spared BeiGene. While layoffs have been commonplace in the industry, BeiGene employed 1,400 more people at the beginning of 2024 than it did a year ago.

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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 ā€“ all with our Pharmacy Cloud.

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Sanofi trumpets win for oral BTK drug in chronic hives

pharmaphorum

Sanofi gets a win for its oral BTK inhibitor rilzabrutinib in chronic hive disorder CSU, setting up a phase 3 programme as it chases after Novartisā€™ remibrutinib in this indication.

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Sanofi CEO Hudson takes another small dip in pay to ā‚¬10.57M

Fierce Pharma

For the third straight year, Sanofi CEO Paul Hudson has seen a slight dip in his compensation. | For the third straight year, Sanofi CEO Paul Hudson has seen a slight dip in his compensation. For 2023, Hudson will receive 10.57 million euros ($11.44 million) in total pay, according to the companyā€™s annual filing.

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STAT+: Pharmalittle: Weā€™re reading about state moves on drug pricing, an asthma med for kids and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because — you know what we are going to say — that oh-so familiar routine of online meetings, endless calls and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So let us be optimistic and convince ourselves we can nudge it in a better direction with a cup of stimulation.

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Ciltacabtagene-Autoleucel Recommended for Approval to Treat Relapsed/Refractory Multiple Myeloma

Pharmacy Times

The recommendation comes after positive phase 3 trial results in adult patients with relapsed and refractory multiple myeloma.

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HRGā€™s five notable products from January

Drug Store News

HRG reviewed 28 products in the health category, 136 items in the wellness sector and 114 items in the beauty aisle to see which ones stood out as Products to Watch.

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CHMP backs AZā€™s danicopan for anaemia in patients with PNH

pharmaphorum

AstraZeneca has moved a step closer to EU approval of oral Factor D inhibitor danicopan in the EU, after the EMAā€™s human medicines committee, the CHMP, backed the drug as a treatment for residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria (PNH).

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Short Sleep Duration May Reduce Lifespan, Study Shows

Pharmacy Times

Investigators found genetic evidence that certain sleep behaviors can be risk factors for lifespan.

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STAT+: The quest for psychedelics in the Amazon would push a Harvard botanist to his limits

STAT

The Aztecs called it teonanácatl, or “flesh of the Gods.” Some who ate the intoxicating mushroom “saw themselves dying in a vision and wept,” according to an account by a 16th-century Franciscan friar. “Others saw themselves being eaten by a wild beast; others imagined that they were capturing prisoners in battle, that they were rich.

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FDA Withdraws Approval of Melphalan Flufenamide for the Treatment of Multiple Myeloma

Pharmacy Times

The withdrawal comes after clinical trial results failed to demonstrate the safety and efficacy of melphalan flufenamide when combined with dexamethasone.

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Shionogi takes Akiliā€™s ADHD digital therapy to Japan

pharmaphorum

Digital health company Akili expands beyond the US as partner Shionogi files for approval for its ADHD digital therapeutic (DTx) in Japan

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STAT+: Private equity firm offers $5.8 billion buyout of hospital billing company R1 RCM

STAT

R1 RCM, a large publicly traded technology company that helps hospitals and physicians collect money from insurers and patients, may be going private. Private equity firm New Mountain Capital has offered to purchase R1 for $13.75 per share, or roughly $5.8 billion in cash, according to new financial disclosures filed Monday. New Mountain Capital is R1’s second-largest investor, owning nearly one-third of the company’s shares.

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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

Pharmaceutical Technology

Bayerā€™s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.

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The FDA isnā€™t afraid to yank a disappointing drug

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning, everyone. Damian here with a look at some renewed interest in a yesteryear biotech craze, news of an FDA flex, and a dive into the science of vaccinology.

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FDA: Simlandi Becomes Third Interchangeable Humira Biosimilar After Approval

Drug Topics

Simlandi is the only biosimilar to Humira on the market that is high-concentration, citrate-free, and interchangeable.

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Ketorolac interactions to avoid

The Checkup by Singlecare

Drug interactions | Food interactions | Other interactions | Avoiding interactions | When to see a doctor We have all experienced acute pain, be it from any number of causes, anything from spraining an ankle to passing a kidney stone. The agony can make us desperate for relief. When we end up at a doctorā€™s office, emergency room, or urgent care center looking for help, ketorolac may be offered as a pain medication.

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Boehringer reveals major data from liver disease trial

European Pharmaceutical Review

[The Phase II trial showed that] up to 83.0 percent of adults given survodutide (BI 456906) achieved a statistically significant improvement of the liver disease metabolic dysfunction-associated steatohepatitis (MASH)” Up to 83.0 percent of adults given survodutide (BI 456906) achieved a statistically significant improvement of the liver disease metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2 percent) in a Phase II trial.

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CarelonRx to launch weight management program with digital coaching

Fierce Healthcare

Elevance Health's CarelonRx will begin offering a weight management program, providing its members access to digital-first coaching and wellness tools. | Elevance Health's CarelonRx will begin offering a weight management program for members, including those that take GLP-1 medications.

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CHMP meeting highlights: February 2024

European Pharmaceutical Review

At its February 2024 meeting, the EMAā€™s human medicines committee (CHMP) recommended the extension of marketing authorisations for six treatments, and positive opinions for the approval of ten medicines. The committee adopted positive opinions for two vaccines intended for active immunisation against the H5N1 subtype of influenza A virus: Celldemic (zoonotic influenza vaccine (H5N1)(surface antigen, inactivated, adjuvanted, prepared in cell cultures)), is intended for immunisation during outbre

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RoC Skincare adds Serum Stick to Derm Correxion family

Drug Store News

The Firming Serum Stick features a retinol-based formula that glides on clear and is packaged in an easy-to-apply stick format, the brand said.

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Samsung Bioepis Initiates Phase 1 Trial for Proposed Keytruda Biosimilar

Pharmacy Times

As of January 2024, Keytruda has been approved for 6 indications in NSCLC across the metastatic and earlier stages of the disease.

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