Tue.Nov 19, 2024

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Does Adderall affect sleep?

The Checkup by Singlecare

Adderall is a controlled prescription medication commonly used to treat attention deficit hyperactivity disorder ( ADHD ). It is also approved by the Food and Drug Administration (FDA) to promote wakefulness in people with narcolepsy , a sleep disorder. The standard, immediate-release Adderall is usually taken two or three times per day, while extended-release Adderall XR is taken once daily.

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Opinion: The FDA’s risky action on compounding weight loss drugs

STAT

When Makena, a drug designed to prevent preterm births, hit the market in 2011 at $1,500 per dose, it drew rife backlash. The drug was based on an active ingredient that had been available for many years at a much lower cost. Confronted with the public outcry, the FDA took an unusual step: It allowed pharmacies to continue making their own copies of the drug through the practice of pharmacy compounding, selling it at a fraction of Makena’s price.

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Great Place To Work® and Fortune Name Chiesi Group No. 23in 2024 World’s Best Workplaces™ List

Pharmafile

18 November 2024 – Manchester, UK – Chiesi Group, an international biopharmaceutical company focused on research, has been named one of the 25 World’s Best Workplaces™ in 2024 by Great Place To Work® (GPTW) and Fortune magazine, ranking 23rd on this year’s list.The news marks the first time any European pharmaceutical company has achieved the […] The post Great Place To Work® and Fortune Name Chiesi Group No. 23in 2024 World’s Best Workplaces™ List appeared first on Pharmafile.

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STAT+: Pharma still ‘falling short’ in providing access to low- and middle-income countries, analysis finds

STAT

Although more pharmaceutical companies are tailoring their business models to focus on low-income countries, a new analysis finds that overall industry efforts remain limited and patient access continues to suffer as a result. Notably, momentum has stalled in reaching licensing deals that are designed to make lower-cost generic drugs available in parts of the world where brand-name medicines are unaffordable, and few companies have pursued technology transfer agreements.

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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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Novartis and Ratio to progress next-gen radiotherapeutic

European Pharmaceutical Review

Novartis Pharma AG has agreed to a radiotherapeutic radioligand therapy-focused license and collaboration with Ratio Therapeutics. Through this deal, Ratio is eligible to receive milestone payments up to $745 million. The collaboration will utilise Ratio’s expertise in radioligand therapy and its technology platforms for development of a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer.

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STAT+: Merck says study of under-the-skin version of Keytruda, a bid to extend the drug’s sales, succeeded

STAT

Merck said a new formulation of the best-selling drug, Keytruda, appears to deliver similar blood levels of the medicine when it is given as a shot as when it is given intravenously. For Merck, the new under-the-skin, or subcutaneous, formulation of Keytruda could represent a major way of holding on to a larger share of Keytruda’s $25 billion in annual sales than would otherwise occur when the medicine’s U.S. patent expires in 2028.

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STAT+: Pharmalittle: We’re reading about a key Merck drug trial, cheap Wegovy in China, and more

STAT

Top of the morning to you, and a fine one it is. Clear blue skies and cool breezes are wafting over the Pharmalot campus, where the official mascots are snoozing after foraging for their breakfast. This means we are free to focus on the matters at hand — rummaging through our to-do list and making cups of stimulation. Our choice today is Mexican cinnamon.

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Endo expands clonazepam recall to cover more than a dozen additional batches

Fierce Pharma

After a labeling mix-up prompted a recall of a popular panic disorder drug this summer, Endo’s U.S. subsidiary is widening the scope of its product pull. | Endo USA is expanding its previous recall of orally disintegrating clonazepam tablets to include more than a dozen additional product lots. The recall is being issued thanks to an “error by a third-party packager” that led to certain cartons displaying the wrong strength and National Drug Code for the product they contain, Endo said.

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STAT+: Why the crowded market for ambient AI medical scribes might be ripe for consolidation

STAT

Ambient AI medical scribes are about the easiest — and hottest — way into health care for AI-based startups. Just take a look at this graphic that lists 35 companies who are (or at one point were) trying to use ambient voice for translating the audio of doctors’ visits into written notes.  The area is both well within the capabilities of AI tools and also — theoretically — doesn’t directly affect patient care.

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Taking its best shot at Roche, Merck scores in phase 3 trial of subcutaneous Keytruda

Fierce Pharma

Two months after Roche scored FDA approval for its subcutaneous ve | Two months after Roche scored FDA approval for its subcutaneous version of PD-LI inhibitor Tecentriq, Merck has achieved a key milestone in lining up its checkpoint inhibitor Keytruda to follow suit. On Tuesday, the company revealed that its subcutaneous formulation of Keytruda has aced a phase 3 trial, demonstrating non-inferiority to the immunotherapy’s intravenous version.

FDA
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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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STAT+: In first meeting of FDA’s digital health advisory committee, generative AI is up for debate

STAT

Robert Califf has made no secret of the Food and Drug Administration’s struggles to regulate generative AI. Large language models and their application to health care “provide a massive example of a technology with novel needs,” FDA commissioner Califf said in an address earlier this year to the Coalition for Health AI.  This week, the agency will turn toward that challenge, focusing the first-ever meeting of its Digital Health Advisory Committee on the question of whet

FDA
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Medication Optimization Needed for Patients with Long COVID

Drug Topics

Investigators said there is an imperative to optimize medication utilization and explore the consequences of medication burden on treatment outcomes in patients with long COVID.

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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine

PharmaVoice

AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.

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Pain After Traumatic Injury Worse for Younger Adults Than Those 65 and Over

Drug Topics

Researchers aimed to determine the frequency of pain assessments and the extent of pain scores by age for patients undergoing traumatic surgery.

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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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The Dodgers’ World Series run brought attention to a rare disease. Annexon is stepping up to the plate.

PharmaVoice

The company is looking to score an FDA nod for its investigational therapy that targets a molecule linked to Guillain-Barré syndrome and other autoimmune diseases.

FDA
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Over Half of US Population Concerned About Prescription Drug Access, Prices

Drug Topics

Wolters Kluwer Health conducted a survey of just over 1000 respondents to get US adults’ feelings about notable trends in the pharmacy industry.

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FDA advisory committee to roll up sleeves on generative AI

Fierce Healthcare

The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. | The FDA seeks advice on regulatory challenges it has identified for generative AI used in medical devices, which include uncertainty about the foundation model, hallucinations and the ability to define intended use.

FDA
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Community Pharmacies Must Diversify Their Revenue Streams to Survive in Today’s Landscape

Drug Topics

Drug Topics talked with Kelly Malkamaki, pharmacist, former independent community pharmacy owner, and senior product pharmacy analyst at AssureCare, about how community pharmacies can continue to thrive with decreased medication reimbursement rates.

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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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Providers, payers focused on initial 'quick wins' for AI with plans to grow investment: survey

Fierce Healthcare

More than half of health system and health plan executives say AI is an immediate priority, and 73% are increasing their investments in the technology, a new C-suite survey finds. | More than half of health system and health plan executives say AI is an immediate priority, and 73% are increasing their investments in the technology, a new C-suite survey finds.

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Rite Aid Pharmacist’s Exploration of Immunization, Clinical Programming

Drug Topics

Adam J. James, PharmD, joined Drug Topics to discuss his career journey as a chain pharmacist.

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Researchers Assess Incidence of Shingles Vaccination Among Individuals with Asthma

Pharmacy Times

An increase of shingles vaccination was reported among individuals with asthma.

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Eating Problems, Diabetes Distress Associated with Worse Time-in-Range

Drug Topics

Patients with type 2 diabetes who had eating problems and higher levels of diabetes distress had worse time-in-range.

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FDA Grants Breakthrough Therapy Designation for Nipocalimab to Treat Sjögren Disease

Pharmacy Times

This marks the first and only therapy to receive this designation for Sjögren disease, which currently has no approved treatment.

FDA
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Former Oak Street CEO Mike Pykosz leaves CVS

Fierce Healthcare

Mike Pykosz, the former CEO of Oak Street Health, will leave CVS Health as part of the company's latest leadership shake-up. | Mike Pykosz, the former CEO of Oak Street Health, will leave CVS Health as part of the company's latest leadership shake-up.

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Advancing Pharmacogenomics Education: Standardization and Opportunities in Pharmacy

Pharmacy Times

Christine Formea, PharmD, MHI, BCPS, FCCP, FASHP, discusses the need for standardized pharmacogenomics education in pharmacy, highlighting opportunities for collaboration, professional growth, and integration of key competencies across curricula to advance the profession.

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An emerging cyberthreat: vishing

Fierce Healthcare

Cyberattacks against healthcare organizations are becoming increasingly sophisticated, with new threats constantly emerging. | This week on "Podnosis," we explore the rise of voice phishing, or vishing, where cybercriminals use AI to mimic voices and breach sensitive healthcare data.

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FDA Grants Fast Track Designation to VAD044 for Treatment of Adults With HHT

Pharmacy Times

Clinical trial analysis results studying VAD-44 in patients with hereditary hemorrhagic telangiectasia (HTT) will be presented at the 2024 American Society of Hematology Annual Meeting & Exposition.

FDA
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Payer Roundup—CVS insider trading scandal; DOJ closely examining PBMs

Fierce Healthcare

Below is a roundup of payer-centric news headlines you may have missed during the month of November 2024. | In this month's payer roundup, a man was charged with insider trading for purchasing Oak Street Health stock before CVS made public the acquisition, the DOJ is honing in on pharmacy benefit managers and OIG found Medicare improperly paid acute-care hospitals by $190 million.

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FDA Grants Fast Track Designation to Potential Gene Therapy for Osteoarthritis of the Knee

Pharmacy Times

GNSC-001 is a first-in-class gene therapy designed to offer long-term relief of musculoskeletal diseases such as osteoarthritis.

FDA
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Can you take Theraflu and ibuprofen together?

The Checkup by Singlecare

When you or someone you care for come down with the common cold or the flu , the only thing you want is relief—and the faster, the better. The dizzying array of over-the-counter (OTC) painkillers and cold medications can get confusing, especially if there’s no single drug that will solve all your symptoms. Theraflu and ibuprofen are two common OTC medications for symptom relief.

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Study: In-Room Air Purifiers Could Impact RSV Incidence Among Older Adults

Pharmacy Times

Use of in-room air purifiers with HEPA-14 filters did not result in a significant reduction of acute respiratory infections.

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GSK drug raises hopes for patients with PBC itch

pharmaphorum

GSK has reported promising phase 3 results with linerixibat in treating severe itching that plagues patients with primary biliary cholangitis

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With patent settlement, BeiGene defends blockbuster Brukinsa from MSN's generic threat until 2037

Fierce Pharma

As BeiGene works to grow the reach of its cancer offerings, the company inked a patent settlement with MSN over its star medicine Brukinsa.