Mon.Oct 30, 2023

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HPV Vaccines Have Reshaped the Epidemiological Landscape

Drug Topics

Prophylactic HPV vaccines have demonstrated remarkable efficacy, exceeding 98%, and they are already proving to be effective in the prevention of anogenital warts, precancerous lesions, and cancer alike.

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American Pharmacists Month: Focusing on Patient Care

Pharmacy Times

Ramesh Cheruvu, PharmD, pharmacist and pharmacy manager at Health Mart Family Pharmacy at McKesson, discussed his journey in the pharmaceutical industry and how it has changed since he became a pharmacist.

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Extreme heat could lead to 233% increase in U.S. excess cardiovascular deaths, study says

STAT

When the human body is exposed to extreme heat, it tries to fight back. To keep us from cooking, our hearts pump faster and harder to distribute the hot blood out to our fingers and toes, away from precious internal organs. We produce more sweat, and when it evaporates, the blood beneath the skin’s surface cools down, helping to lower our body temperature.

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UPDATED: Pfizer plans to shutter New Jersey site, discloses layoffs amid $3.5B cost-cutting drive

Fierce Pharma

Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.

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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+: Cassava pulled back the curtain on its Alzheimer’s study — and revealed insurmountable problems

STAT

Cassava Sciences has long claimed its experimental drug, called simufilam, slows the cognitive decline of people with Alzheimer’s. On Friday, we learned how: The company recruited a large number of people into its clinical trial who don’t have Alzheimer’s. People who almost certainly had Alzheimer’s were also included in the study, but in this group, a placebo outperformed Cassava’s drug.

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Physical Health, Mental Health Associated With Insomnia in Veterans

Pharmacy Times

Study finds that probable insomnia disorder was associated with physical health problems and difficulty with anger in veterans.

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Redefining Person-Centered Care: Lessons from an Independent Pharmacy

Pharmacy Times

Person-centered care focuses on tailoring treatment plans, providing medication support, and ensuring access to resources that meet their unique needs.

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STAT+: Sarepta’s Duchenne gene therapy fails to meet primary endpoint in pivotal trial

STAT

Sarepta Therapeutics said Monday afternoon that its gene therapy for Duchenne muscular dystrophy failed to improve muscle function compared to a placebo in a large clinical trial — likely a major disappointment for patients and doctors who have been desperately awaiting the treatment for years. The company said all patients in the study improved and that secondary measurements indicated the drug was having an effect.

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Celebrating Pharmacists: The Growing Recognition for Transitions of Care Pharmacists

Pharmacy Times

Crystal Toribio, PharmD, Transitions of Care Clinical Pharmacist at St. Francis Hospital discusses the impact of direct patient care within her role to highlight this American Pharmacists Month.

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On the eve of Halloween, the FDA weighs whether medicine should ever taste like candy

STAT

WASHINGTON — M&Ms, Reese’s, gummy bears, and even cotton candy made an appearance at the Food and Drug Administration on the day before Halloween. Commissioner Robert Califf was not throwing a costume party.

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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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RFID Technology’s Pivotal Role in Modern Pharmacy Management

Pharmacy Times

RFID technology encompass a wide range of applications, including inventory management, medication authentication, patient adherence, and workflow efficiency.

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STAT+: Virtual care options flood the market as retailers take telehealth mainstream

STAT

When patients go shopping today, they might find themselves checking out with more than the vitamins or bulk toilet paper on their list. Several retailers have recently launched telehealth programs that let patients pick their medical concern off a menu of options, from hair loss and erectile dysfunction to acne and ear infections. Then they pay cash — no insurance accepted — to have a text or video visit with a provider.

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HHS proposes info blocking 'disincentives' for hospitals, clinician groups, ACOs

Fierce Healthcare

The Department of Health and Human Services (HHS) has released its plan to keep healthcare providers in line with data blocking requirements. | Providers determined to have committed information blocking would face changes to their status in certain Medicare programs, and subsequently a hit to program payments. Enforcement would begin once the proposed rule is finalized.

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STAT+: An exit interview with Bristol Myers Squibb CEO Giovanni Caforio

STAT

It’s changing of the guard time at pharmaceutical giant Bristol Myers Squibb. On Wednesday, CEO Giovanni Caforio will step down. He’ll be replaced by Christopher Boerner, who is currently chief operating officer. When Caforio took over in May 2015, Bristol was known as a big pharmaceutical firm with the high-flying stock of a biotechnology company, largely due to its role as the company that brought cancer immunotherapy to market.

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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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FDA Approves Reformulation of Vonoprazan Tablets For Regimen Treatment of Helicobacter Pylori

Pharmacy Times

In a clinical trial, 2 vonoprazan-based regimens demonstrated higher rates of eradication as well as low rates of adverse effects compared to lansoprazole triple therapy.

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STAT+: For hospitals after No Surprises Act, physician subsidies are ‘the new contract labor’

STAT

Physician staffing firms, flailing in the wake of a federal law banning surprise bills, are demanding extra payment from hospitals to stay afloat. Hospitals, desperate for doctors to staff their facilities, have little choice but to comply. It’s a big topic of conversation on for-profit hospital earnings calls. Just last week, major hospital chains said those expenses, known as physician subsidies, were up 20% to 40% from last year.

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Biden to sign sweeping executive order pursuing 'safe, secure and trustworthy' AI development

Fierce Healthcare

President Joe Biden is set to sign a sweeping executive order establishing new safety, security and equity standards for artificial intelligence, including its use within the healthcare industry.

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STAT+: What to know about Sarepta’s upcoming data on its Duchenne gene therapy

STAT

In the next few weeks, Sarepta Therapeutics will release new data that could change the future of the company and the lives of thousands of patients with Duchenne muscular dystrophy. The Phase 3 trial is testing whether Sarepta’s gene therapy, Elevidys, can slow progression of the fatal, muscle-wasting disease significantly more than placebo.

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Eli Lilly, Redwire head to space to explore next frontier of drug development

Fierce Pharma

After Bristol Myers Squibb’s space odyssey earlier this year, another pharmaceutical major is pushing drug development to the fringes of Earth’s gravitational pull. | Eli Lilly is entering the orbit of Redwire Corporation to test the latter company's in-space drug manufacturing platform. The technology will be sent to the International Space Station aboard a SpaceX mission set to launch sometime after Nov. 5.

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In new order on AI, Biden is scrambling to catch up to emerging risks in health care

STAT

President Joe Biden ordered the nation’s leading health agencies on Monday to develop a plan for regulating artificial intelligence tools already widely in use within hospitals, insurance companies, and other health-related businesses. The order directs the US Department of Health and Human Services to establish a safety program to receive reports of AI-related harms and unsafe practices — and take actions to remedy them.

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AI Benefits, Challenges in Infectious Disease Treatment

Drug Topics

Isaac "Zak" Kohane, MD, PhD, the inaugural chair of Harvard Medical School's Department of Biomedical Informatics, discussed artificial intelligence during a plenary session at IDWeek 2023.

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Coherus rejects 'heavily discounted' pricing on Loqtorzi, the first China-made PD-1 drug to win FDA nod

Fierce Pharma

Market watchers have been waiting keenly to see whether a cheap China-made cancer drug could disrupt the multibillion-dollar U.S. PD-1 cancer immunotherapy market. | Market watchers have been waiting keenly to see whether a cheap China-made cancer drug could disrupt the multibillion-dollar U.S. PD-1 cancer immunotherapy market. But the first player with a chance to follow that path has opted not to.

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CGM Associated With Improved Glycemic Control in Cystic Fibrosis-Related Diabetes

Drug Topics

The use of continuous glucose monitoring may improve outcomes in patients with cystic fibrosis-related diabetes.

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Sarepta's Elevidys fails on primary endpoint, but executives see path to wider DMD approval anyway

Fierce Pharma

After Sarepta overcame several regulatory hurdles to finally win | After Sarepta overcame several regulatory hurdles to finally win FDA approval for its DMD gene therapy Elevidys, the company now faces the prospect of more FDA scrutiny because a pivotal study on the drug has failed on the primary endpoint.

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Amoxicillin interactions to avoid

The Checkup by Singlecare

Amoxicillin is a prescription-only, broad-spectrum antibiotic originally derived from penicillin that is approved by the U.S. Food and Drug Administration (FDA) to treat a wide range of respiratory bacterial infections, such as pneumonia and bronchitis , as well as infections of the ear , nose, throat , urinary tract infections , and skin. It can also be used together with other medicines, such as the proton pump inhibitor lansoprazole , to treat stomach ulcers ( H. pylori stomach infections ).

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Amgen, Regeneron and AbbVie join Lilly and Novo Nordisk in posting largest Q3 market-cap gains: report

Fierce Pharma

As sales of their GLP-1 diabetes and obesity drugs have surged, Eli Lilly and Novo Nordisk have become the most valuable biopharma companies in the United States and Europe, respectively. That didn | It was no surprise that GLP-1 drugmakers Eli Lilly and Novo Nordisk saw market-cap gains of 16.1% and 13.9% in the third quarter. But much less expected were the market-cap rallies of Amgen (22.1%), Regeneron (14.9%) and AbbVie (13.1%), according to figures compiled by GlobalData.

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Giant funds central Pennsylvania Food Bank’s hunger mapping initiative

Drug Store News

The funding is part of the retailer’s 100th anniversary celebrations and was announced at a “Hunger Mapping Summit” held at the food bank’s Healthy Food Hub in Harrisburg, Pa.

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Bluebird inks deal to sell its next FDA priority review voucher to Novartis for $103M

Fierce Pharma

As an FDA decision draws closer on bluebird bio’s sickle cell disease gene therapy, the company has lined up a potential sale of a priority review voucher (PRV). | The company entered an advance agreement for a priority review voucher ahead of the FDA's decision on the sickle cell disease gene therapy prospect. Bluebird expects the FDA to decide on its drug by December 20.

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Metformin helps manage weight gain side effect of SGAs

European Pharmaceutical Review

A large-scale study led by researchers at the University of Cincinnati and New York’s largest health care provider, Northwell Health, suggests that metformin can help prevent or reduce weight gain in youth taking second-generation antipsychotics (SGAs) to treat bipolar disorder. SGAs used to treat bipolar disorder are often effective at helping young patients’ mental health improve but can have significant side effects including elevated blood pressure and glucose, increased appetite, as w

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HDA Launches New Communications Initiative

Pharmaceutical Commerce

Effort displays the diverse perspectives, skills, and people involved with the healthcare supply chain, as industry aims to continue to push DE&I forward.

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Are we globally prepared for the next pandemic?

European Pharmaceutical Review

Echoes of the global health challenges we faced during the COVID-19 pandemic still linger as new variants emerge and COVID continues to make headlines. A question that continues to sit in the back of many people’s minds is what happens if there is another outbreak or global pandemic? Are we preparing and how ready are we for the next one? Vaccitech’s Chief Business Officer, Graham Griffiths, discusses key learnings in drug and vaccine development , the challenges of preparing for the unknown, an

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Azithromycin interactions to avoid

The Checkup by Singlecare

Azithromycin, also known under the brand name Zithromax or Z-Pak, is an antibiotic prescribed to treat various bacterial infections. It belongs to the macrolide class of antibiotics that work by blocking the growth of bacteria. Azithromycin is often used to treat tonsillitis, community-acquired pneumonia, and exacerbations of chronic obstructive pulmonary disease (COPD).

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EMA launches medicines supply support measures as part of wider EC initiative

Hospital Pharmacy Europe

A new solidarity mechanism that allows EU Member States to support each other in obtaining medicine stocks during a critical medicine shortage has been developed by the European Medicines Agency (EMA) Medicines Shortages Steering Group (MSSG). The voluntary solidarity mechanism , which is based on an informal setup during Covid-19, will enable any Member State that is facing a critical shortage and has already notified the EMA to request assistance from other Member States, which will then be ab

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FDA approves Zituvio for Type 2 diabetes

The Checkup by Singlecare

People with Type 2 diabetes now have another option to help manage blood sugar. The U.S. Food and Drug Administration (FDA) approved Zituvio (sitagliptin) for adults with Type 2 diabetes. Manufactured by Zydus Pharmaceuticals, this medication joins other diabetes medications with the same active ingredient that are already on the market, namely Januvia (sitagliptin) and Janumet , a metformin-sitagliptin combination medication.

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