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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.
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.
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.
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.
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
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.
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.
By John W.M. Claud & Mark I. Schwartz — Over the past few days, we’ve been blogging about changes that are sure to come to FDA under Trump 2.0. Calls to more generally gut Federal agencies are everywhere, including from Robert F. Kennedy, Jr., the current nominee to lead the department of Health and Human Services. But shedding regulators in sensitive areas like drug manufacturing—even in the era of influencer-driven medicine—can lead to compromises in safety and efficacy, especially when FD
By John W.M. Claud & Mark I. Schwartz — Over the past few days, we’ve been blogging about changes that are sure to come to FDA under Trump 2.0. Calls to more generally gut Federal agencies are everywhere, including from Robert F. Kennedy, Jr., the current nominee to lead the department of Health and Human Services. But shedding regulators in sensitive areas like drug manufacturing—even in the era of influencer-driven medicine—can lead to compromises in safety and efficacy, especially when FD
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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