Mon.Feb 26, 2024

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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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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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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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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Antidepressant Dispensing Soared Among Adolescents, Young Adults After COVID-19 Pandemic

Drug Topics

The increasing use of antidepressants observed before and after the public health crisis suggests a concerning mental health trend, especially among females.

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Dollar General opens 20,000th store

Drug Store News

Dollar General celebrated the grand opening of its 20,000th store at its DG Market location in Alice, Texas.

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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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Geologieā€™s acne solution kits roll out to Target shelves

Drug Store News

Geologie, a gender-neutral skin care brand, is making its exclusive debut at more than 800 Target locations nationwide.

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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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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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Boehringerā€™s survodutide shows monster MASH potential

pharmaphorum

Boehringer Ingelheim and Zealand Pharma report stellar top-line results for GLP-1/glucagon agonist survodutide in liver disease MASH.

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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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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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Merckā€™s Keytruda regimen gains positive EMA CHMP opinion

Pharmaceutical Technology

Merck's KEYTRUDA has received a positive opinion from the EMA CHMP for use in combination with chemotherapy for non-small cell lung cancer.

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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: 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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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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SK bioscienceā€™s typhoid vaccine receives WHO prequalification

Pharmaceutical Technology

SK bioscience has achieved a significant milestone with its typhoid conjugate vaccine, SKYTyphoid, receiving WHO prequalification.

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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