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The drug, called Lumisight, is an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for a more complete resection. An NDA has been submitted to the FDA.
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The PhRMA blog welcomes guest contributors, including patients, stakeholders, innovators and others, to share their perspectives and point of view.
According to a study, patients are frequently prescribed broad-spectrum antibiotics instead of narrowly tailored antibiotics, which would be more optimized to treat them.
As experts wrestle with COVID-19’s lab leak versus animal market debate, here’s what experts say are the suspected origins for some of the worst viral outbreaks in the last century.
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
In a recent video , pharmaceutical microbiology expert Tim Sandle highlighted areas of concern and attention relating to mycological contamination control in manufacturing. Pharmaceutical product recalls due to fungal contamination have been increasing. These, together with environmental monitoring trend data, highlight several fungal contamination issues associated with pharmaceutical cleanrooms , cold rooms and other controlled areas.
Dupilumab met both its primary and key secondary endpoints in a phase 3 trial, demonstrating efficacy as a potential treatment for atopic hand and foot dermatitis.
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Dupilumab met both its primary and key secondary endpoints in a phase 3 trial, demonstrating efficacy as a potential treatment for atopic hand and foot dermatitis.
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.
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.
It’s no secret that prescription drugs cost more on average in the U.S. than they do anywhere else in the developed world. In fact, a 2018 study found that, on average, Americans pay more than two-and-a-half times as much for prescription drugs as citizens of 32 other countries involved in the study. Naturally, this has people looking beyond the border for more affordable alternatives, and Canada seems like an obvious choice.
The company's accelerator program, Walmart Start, will choose at least five unique brands to receive access to key resources specific to launch successfully at Walmart.
The 20 th anniversary edition of the CPHI Pharma Awards is open for entries. Three new categories have been created to reflect the surge of innovation sweeping the industry, from new methodologies to sustainability and philanthropic initiatives. The CPHI Pharma Awards 2023 will celebrate global leaders from across 12 categories, including returning categories spanning development and manufacturing of devices and drugs, alongside packaging , supply chain, sustainability, regulatory compliance, an
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.
The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. As computing has developed in the past decade, so has the potential to store and use information in the cloud.
Hovione, a contract development and manufacturing organisation (CDMO) and Laxxon Medical, a pharma-tech company will collaborate to advance 3D screen printing technologies for the pharmaceutical industry. Under the agreement, Hovione will establish Laxxon’s 3D screen printing technology at Hovione’s current good manufacturing practice (cGMP) production sites first in Portugal and later in the US.
Five years ago, I donated my “spare” kidney at the Mayo Clinic to a woman I read about in the newspaper. Though living with only one kidney has risks, I was not particularly concerned about my own health. The clinic’s medical evaluation was extremely thorough, and I knew their highly conscientious selection committee would not approve me to be a living donor if they were even the slightest bit concerned the procedure would cause me long-term health problems.
As a five-time biotech CEO, I’ve guided my companies through recessions, supply chain disruptions, Wall Street volatility, even a global pandemic. Yet nothing quite prepared me for the news on Thursday, March 9, that my cell therapy company’s ability to make payroll could be jeopardized by the mother of all bank runs unfolding at Silicon Valley Bank.
An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients. By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen.
Message From The Chair: Why Attend The 2023 ISPE Biotechnology Conference Trudy Patterson Wed, 03/22/2023 - 12:08 iSpeak Blog iSpeak Message From The Chair: Why Attend The 2023 ISPE Biotechnology Conference Liz M. Dooley, MSc. 22 March 2023 The Biopharmaceutical industry continues to grow and deliver life-changing medicines to patients as evidenced by the number of drug approvals by the FDA year after year.
CHICAGO — Abdullah Hassan Pratt is giving a tour of a sheep heart that sits, heavy and sodden, in his hand. Dressed all in black, with his Jordans and easy manner, Pratt doesn’t look all that different from his audience: dozens of teenagers from this city’s roughest and poorest neighborhoods. One student raises a tentative hand, utterly confused by how blood travels through the heart.
What is the most important Audit in Pharmacy? Our ManageRx team thinks the single most important audit is the Controlled Substance Invoice Audit. In fact, we think that if you are not conducting an audit like this, we would argue that you are neglecting your responsibilities. Why? Why is the Controlled Substance Invoice Audit so important? It is critical to stop drug diversion in your pharmacy, surgery center, or any location using controlled drugs.
Biotech company 89bio said Wednesday that its experimental treatment improved liver scarring at more than three times the rate of placebo without worsening other symptoms of patients with the fatty liver disease known as NASH. The results met the main goal of a mid-stage clinical trial, with the potential for less frequent injections than a similar experimental treatment being developed by a competing drugmaker.
Health policy circles have erupted in debate over a wonky administrative tool: the quality-adjusted life year ( QALY ) and similar metrics to value and price drugs and other health interventions. Rep. Cathy McMorris Rodgers (R-Wash.) has warned of the potential for these approaches to discriminate, arguing that “All lives are worth living. It’s unconscionable that a health care bureaucracy would so callously determine that someone’s life is worth less,” suggesting tha
A potential class-action lawsuit against troubled digital prescribing startup Cerebral raises crucial questions about whether online marketing methods violate legal and ethical standards — an issue with important implications for dozens of other telehealth companies doing largely the same thing , experts tell STAT. For years, Cerebral and other telehealth companies have used free tracking technologies known as “pixels” — provided by big technology companies like
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