Mon.Jul 10, 2023

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New report shows high-impact R&D happens after cancer medicines are first approved

PhRMA

A new report showcasing nine critical oncology treatments, highlights the vital role of post-approval research and development (R&D) in advancing cancer treatment options and delivering unprecedented progress in the fight against cancer over the past 10 years.

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How Pharmacies Can Help Move Health Equity Forward

Drug Topics

As costs increase and the number of people in need further outpaces resources, it becomes increasingly urgent to find ways to further extend services to the people who need them.

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Novo Nordisk's GLP-1 drugs under review in Europe after reports flag possible suicide risks

Fierce Pharma

Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbust | Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbuster products.

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How Comprehensive Medication Management Improves Patient Outcomes, Health Equity

Pharmacy Times

When a patient is engaged in the home by a team that includes a pharmacist resource, social determinants of health issues become more clear and the care team can help close the gaps.

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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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The 2023 Smarter Purchasing Report

Drug Topics

Our groundbreaking analysis of customer data uncovered valuable insights to empower pharmacies. Our annual reports shed light on enhanced data transparency and savings opportunities, helping pharmacies make informed decisions and drive efficiency.

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Monoclonal Antibodies as Pre-exposure Prophylaxis May Be Cost-Effective Approach to Reduce Severe Outcomes in COVID-19

Pharmacy Times

Pre-exposure prophylaxis of neutralizing SARS-CoV-2 monoclonal antibodies may be preventative against SARS-CoV-2 transmission, decreasing frequency of new infections and number of hospitalized patients who need antiviral therapies, thus lowering costs.

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The AI Revolution Has Arrived: Shaping the Next Generation of Pharma Marketing

PharmExec

Join five industry leaders as they unpack the transformative potential of artificial intelligence in the pharmaceutical industry, offering insights into real-world applications and the future of life sciences marketing in an era shaped by rapid technological evolution.

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Impact of Pharmacists on Polypharmacy in the Elderly Population

Pharmacy Times

Aside from the clinically significant risks associated with polypharmacy, an increased pill burden can be unaffordable and difficult to manage.

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Novartis pledges to appeal after Delaware court nixes patent on big-selling Entresto

Fierce Pharma

After a Delaware federal court ruled a Novartis combination patent on big-selling cardiovascular drug Entresto is invalid, the company pledged to continue its efforts to block generics with an appe | After a Delaware district court ruled a 2025 Entresto combination patent is invalid, Novartis will head to the U.S. Court of Appeals for the Federal Circuit in an effort to reverse the decision.

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Clinicians Should Monitor Diarrhea As Symptom of C. difficile Infection, Antibiotic Resistance in Infants

Pharmacy Times

Clostridioides difficile infection can be difficult to treat, but increasing disease awareness can improve screening and treatment outcomes.

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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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Advanced Health Care Technology Solutions Can Help Both Providers and Payers

Drug Topics

Integrating evidence-based treatment protocols through a streamlined approach enables the delivery of higher quality, comprehensive care.

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WuXi Bio telegraphs spinoff of its bioconjugate subsidiary XDC

Fierce Pharma

Angling for greater independence, it appears the time has come for WuXi’s bioconjugation offspring to leave the nest. | WuXi Biologics has unveiled a proposed spinoff and separate listing of WuXi XDC Cayman—a joint venture between WuXi Bio and WuXi STA bred to tackle contract research, development and manufacturing of bioconjugates, including antibody-drug conjugates, antibodies and other biologic intermediates.

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STAT+: The new weight loss drugs are revolutionizing our understanding of desire. Food cravings could be just the beginning

STAT

One month it was pizza. Starting in the late afternoon, while he was teaching a chem lab or grading student work, a part of Anthony Fernandez’s brain would stray to visions of steaming pies. The thought of sinking his teeth into one would tug at him as he packed up his things and walked to his car. By the time he pulled out of the Merrimack College campus, the urge would become a tractor beam, reeling him into the small shop just shy of Route 125 for a slice or three.

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Harnessing AI for Pharma Sales

PharmExec

Artificial intelligence is steadily becoming a game changer for the pharma industry, particularly in commercialization activities, such as sales and marketing—and efforts to help highly sought treatments reach the right patients.

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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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Why nearly half of Americans with Parkinson’s don’t see a neurologist

STAT

It took Richard Huckabee nine years to get a Parkinson’s diagnosis. A district manager for a convenience store chain, he first noticed symptoms in 2004 when his voice would suddenly falter while speaking to large groups of employees. “It’s probably just stress,” Huckabee remembered his doctor saying. A year later came the brain fuzziness, with Huckabee forgetting his colleagues’ names, having his thoughts freeze mid-conversation, and fully losing his ability to

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Crossing the Brain Barrier

PharmExec

COMPASS Pathways’ CEO, Kabir Nath, has a clear vision for psychedelics—and is leading the way with the company’s focus on psilocybin and efforts to separate the science from the hype.

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A rare disease has run through five generations of his family, so he’s built community for others

STAT

For Jack Johnson, getting diagnosed with Fabry disease at age 7 was more of a formality. He’d been experiencing symptoms for several years already, and had watched multiple family members struggle with the rare condition. But around 7 was when Johnson’s pain started — triggered by exercise or being outdoors when it was too hot. Fabry disease is characterized by a buildup of the fatty lipid Gb3, which can cause gastrointestinal issues, kidney failure, stroke, chronic pain, an

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EMA revises guidance on nitrosamine impurities

European Pharmaceutical Review

As of 7 July 2023, the European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities. The regulatory body has amended Q&A 10 to include the Carcinogenic Potency Categorization Approach (CPCA) and the enhanced Ames test (EAT) for establishing acceptable intakes (AIs) for N -nitrosamines. The assessment report of the Committee for Medicinal Products for Human Use (CHMP)’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal produ

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Opinion: How ARPA-H can master the subtle art of risk-taking

STAT

Despite remarkable progress in health and medicine, biology’s final frontiers remain beyond our reach. Humanity has not yet cured Alzheimer’s or ended cancer, and was unable to prevent Covid-19 from growing into a pandemic. As physicians and scientists, we understand the frustration of patients who still feel left behind despite the marvels of modern medicine.

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7 companies are rolling out Humira biosimilars

Drug Store News

Boehringer Ingelheim, Organon and Samsung Bioepis together, Sandoz, Fresenius Kabi, Celltrion USA, Coherus and Biocon Biologics have released biosimilars of AbbVie's Humira.

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STAT+: Pharmalittle: European regulator probes suicidal risks of weight loss drugs; Pfizer reports shortages of penicillin for fighting syphilis

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-so-predictable routine of meetings and online calls has returned. But what can you do? The world, such as it is, continue to spin no matter how hard we try to slow it down. So time to give it a nudge in a better direction.

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Telehealth largely drives fewer in-person follow-up visits, study shows

Fierce Healthcare

Telehealth came into its own during the COVID-19 pandemic< | Researchers found that for most specialties patients were more likely to have an in-person follow-up visit 90 days after an in-person visit rather than a telehealth visit.

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STAT+: Blue Cross Blue Shield insurers keep winning from Affordable Care Act’s risk program

STAT

A program that undergirds the Affordable Care Act’s health insurance marketplaces continues to bolster the balance sheets of large Blue Cross Blue Shield companies, according to a STAT analysis of new federal data. Conversely, that same program — called “risk adjustment” — has created substantial financial burdens for startup insurers including Bright Health Group, which has now exited all health insurance markets, and Friday Health Plans, which has shut down.

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Pediatric Medication Studies: A New Challenge for Institutional Review Boards, Ethics Committees

Pharmacy Times

Institutional review boards and ethics committees have seen it as their main task in the past few decades to protect children from questionable studies; however, they are faced with a new challenge with pediatric drug development.

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On the clock: a collaborative approach to advancing adoption of RMM

European Pharmaceutical Review

Traditional methods for assessing microbial contamination in pharmaceutical products can take weeks: sterility testing for final product requires 14 days of incubation (per USP <71> and Ph. Eur. 2.6.1), while mycoplasma determination in cell cultures can take up to 28 days (USP <63>, Ph. Eur. 2.6.7). Given their short shelf-life, there is a need for methods that generate more rapid results for emerging advanced therapy medicinal products (ATMPs) such as cell and gene therapies.

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HCA Healthcare reports data breach potentially impacting 11M patients

Fierce Healthcare

HCA Healthcare reported Monday that hackers stole personal information including patient names and dates of birth and posted it online. | The Nashville, Tennessee-based health system said the information was taken from an external storage location exclusively used to automate the formatting of email messages.

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The power of rapid methods for fungal ID

European Pharmaceutical Review

Fungal contamination in pharmaceutical products represents a potential hazard for two reasons. First, it may cause product spoilage; the metabolic versatility of fungi is such that any formulation ingredient may undergo chemical modification in the presence of a contaminating organism. Spoilage not only affects the therapeutic properties of a product but may also discourage the patient from taking the medication.

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Health Connect America to pay $4.6M to resolve Medicaid fraud allegations

Fierce Healthcare

Behavioral health provider Health Connect America will pay $4.6 million to resolve allegations that it improperly billed Virginia's Medicaid program, the Department of Justice (DOJ) said Friday.

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Titanium dioxide (E171) and its role in formulation

European Pharmaceutical Review

The ability to uniquely identify oral solid dosage (OSD) forms has been recognised by regulatory authorities worldwide as one of the mechanisms to reduce medication errors and to detect falsified medicines. Changes in the appearance of medicines has been identified as a factor in patient compliance and, therefore, clinical outcomes. In the development of a new drug product, it is necessary that each dosage form or strength incorporates mechanisms that enable its unique identification.

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Sally Hansen’s Xtreme Wear Concrete Jungle collection pays homage to NYC

Drug Store News

Sally Hansen’s Xtreme Wear Concrete Jungle collection features 10 trendy shades formulated with vegan ingredients, the company said.

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RPhAlly Soirée Preview & Full Schedule

Drug Topics

Join RPhAlly for three nights of education with industry leaders from July 18-20.

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General Mills gathers around the campfire with s’mores-inspired snacks

Drug Store News

General Mills is bringing the flavors of campfire s’mores to its portfolio of products with launches inspired by the dessert.

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Capsule formulation: future trends

European Pharmaceutical Review

What recent advancements have been made in pharmaceutical capsules? Gelatine also poses potential long-term performance challenges” Several major trends have emerged in recent years in the capsule space. First, we are seeing growing demand for new materials to replace the traditional gelatine capsule shell. One of the reasons for this is the growing importance of offering an alternative vegan capsule for patients who, for dietary reasons, do not want to consume animal products.

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Express Scripts joins Optum in adding more Humira biosimilars to its formulary

Fierce Healthcare

On the heels of a similar announcement from Optum Rx, pharmacy benefit management giant Ex | On the heels of a similar announcement from Optum Rx, pharmacy benefit management giant Express Scripts said Monday that it will add three biosimilars to its formulary to compete with Humira.

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