Sat.Sep 09, 2023 - Fri.Sep 15, 2023

article thumbnail

FDA Grants Tentative Approval to Generic Triumpeq PD for Children With HIV

Drug Topics

Abacavir/dolutegravir/lamivudine is a fixed-dose combination containing two nucleoside reverse transcriptase inhibitors (NRTIs) and integrase strand transfer inhibitor (INSTI).

FDA 211
article thumbnail

Expert: Artificial Intelligence Changing the Field of Medical Writing

Pharmacy Times

The CEO of Yseop discusses how AI can have a positive impact in the development of high quality medical writing due to its efficiency and ability to reduce long, tedious tasks for writers.

152
152
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Polio transmission was supposed to end by 2023. A new report explains why it won’t.

STAT

The latest goal for the end of polio transmission will almost certainly not be met, according to a frank and concerning report about the future of the decades-long polio eradication effort that was released this week. After having missed multiple deadlines for ending polio transmission, the Global Polio Eradication Initiative had set 2023 as the year when both wild polio viruses would finally be snuffed out and so-called vaccine-derived viruses would also be stopped, putting an end to a family o

Vaccines 145
article thumbnail

Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Fierce Pharma

Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

Vaccines 145
article thumbnail

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.

article thumbnail

Breaking: FDA Approves, Authorizes Updated Monovalent COVID-19 Vaccines

Drug Topics

Bivalent COVID-19 vaccines by both Moderna and Pfizer-BioNTech are no longer authorized for use in the United States.

Vaccines 209
article thumbnail

Clinical Overview: Fecal Microbiota Transplantation vs Live Biotherapeutic Products for Management of Recurrent C Difficile Infection

Pharmacy Times

Although antibiotics are the standard-of-care treatment for Clostridioides difficile infection, they can cause further microbiota changes that predispose patients to recurrence.

149
149

More Trending

article thumbnail

Geisinger doubles down on collaboration with Best Buy Health, Geek Squad to support tech-driven care in the home

Fierce Healthcare

As at-home healthcare becomes more tech-driven—think wireless biosensors and connected blood pressure cuffs—it creates more logistical challenges for providers. | Geisinger's pilot program with Best Buy's Geek Squad resulted in quicker access to care, better adherence to care plans and more positive outcomes for chronic care patients, the organizations said.

138
138
article thumbnail

CDC starts ‘Wild to Mild’ campaign to reverse falling flu vaccine use in key groups

Fierce Pharma

The CDC wants to reset expectations for flu vaccines to correct falling uptake. | The CDC wants to reset expectations for flu vaccines to correct falling uptake. After tracking declines in vaccine use in pregnant people and children, the health body has initiated its “Wild to Mild” campaign to raise awareness of the benefits of vaccination and encourage more people to get their shots.

Vaccines 129
article thumbnail

Study Shows Not All IVIG Products Are Created Equal in Alzheimer Disease

Pharmacy Times

One IVIG product showed overall improvement in neuroprotection, including alleviating cognitive decline and ameliorating AB deposition in Alzheimer disease.

160
160
article thumbnail

The ‘Hispanic Paradox’ intrigues a new generation of researchers determined to unravel it

STAT

For 40 years, researchers have unsuccessfully tried to explain — or debunk — the “Hispanic Paradox,” the finding that Hispanic Americans live several years longer than white Americans on average, despite having far less income and health care and higher rates of diabetes and obesity. Now, armed with more comprehensive data, powerful genomic tools, and a rich cultural awareness of the communities they study, a new generation of scientists is finally making headway.

145
145
article thumbnail

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.

article thumbnail

Walgreens taps startup Pearl Health to expand into value-based primary care

Fierce Healthcare

On the heels of big-ticket acquisitions, Walgreens is ramping up its push into healthcare and is partnering with startup Pearl Health to get a foothold in the ongoing movement to value-based care.< | Walgreens' partnership with Pearl Health builds on the assets that the retail pharmacy giant has recently made investments in as it "moves more aggressively into healthcare," Steve Wogen, chief growth officer, told Fierce Healthcare.

135
135
article thumbnail

AstraZeneca, working to grow Fasenra’s reach, touts positive trial against GSK's Nucala in new use

Fierce Pharma

Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala. | AstraZeneca's Fasenra has achieved its primary endpoint in a phase 3 trial, demonstrating noninferior rates of remission in a head-to-head battle against GSK's Nucala in patients with eosinophilic granulomatosis with polyangiitis.

127
127
article thumbnail

Ensuring Health Equity in Vaccination Access: How Pharmacies Can Work With Community Organizations

Pharmacy Times

Community pharmacies and organizations can collaborate to tailor strategies and interventions and address the challenges and specific needs of the community.

article thumbnail

Novelist John Green launches attack on Cepheid over the price of its TB test

STAT

John Green, a novelist and high-profile YouTuber, is once again leveraging his star power in the global fight to end tuberculosis. His latest target? The diagnostics company Cepheid and the price of its tuberculosis test, GeneXpert. Cepheid sells individual test cartridges for $9.98 each, which lab technicians can analyze in a speedy machine that is also sold by the company.

145
145
article thumbnail

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.

article thumbnail

Kroger Health teams up with meal delivery company on medically tailored meals for chronic conditions

Fierce Healthcare

Kroger Health, part of the Kroger Co., is teaming up with Performance Kitchen to offer medically tailored meals to people with chronic conditions. | Performance Kitchen’s team of chefs, doctors and registered dietitians focuses on delivering nutritionally balanced meals. The meals will be both approved by Performance Kitchen’s team and Kroger Health registered dietitians.

133
133
article thumbnail

Developing an effective contamination control strategy

European Pharmaceutical Review

As part of The Future of Pharma/Biopharma Analysis 2023 , which took place on 28-29 June 2023, European Pharmaceutical Review ( EPR ) gathered an expert panel to discuss developing a modern contamination control strategy. The participants were: Dr Tim Sandle, Head of GxP Compliance at Bio Products Laboratory Limited (BPL) as moderator; Dr Edward Tidswell, Executive Director within the Microbiological Quality and Sterility Assurance organisation of Merck & Co; Frederic Ayers, Research Scienti

article thumbnail

Clinical Overview: Ongoing Review of GLP-1 Receptor Agonists for Suicidal Ideations

Pharmacy Times

Although GLP-1 receptor agonists have shown promise in promoting weight loss, they are prescription medications and should be used under the guidance of health care professionals.

139
139
article thumbnail

CDC recommends updated Covid vaccines for everyone 6 months and older

STAT

A panel of advisers to the Centers for Disease Control and Prevention voted 13-1 Tuesday to recommend updated Covid-19 booster shots for all Americans 6 months and older. CDC Director Mandy Cohen signed off on the recommendation hours later, and vaccines would be available within 48 hours. The recommendation applies to mRNA shots from Pfizer-BioNTech and Moderna, both of which were approved by the Food and Drug Administration Monday.

Vaccines 145
article thumbnail

Oracle CEO warns Cerner EHR business facing 'near-term' headwinds for revenue growth

Fierce Healthcare

Oracle shares fell 13% Tuesday as the software giant's near-term revenue forecast was weaker than Wall Street analysts expected. | Oracle chairman and CTO Larry Ellison told investors Monday that the company is working to modernize the Cerner EHR platform using an application code generator to enhance the software "one piece at a time." "On the business side of things, we think the Cerner business is going to get stronger and stronger," Ellison said.

Cerner 132
article thumbnail

It's unanimous: FDA panel says decongestant drug phenylephrine does not work

Fierce Pharma

For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.

FDA 126
article thumbnail

Propanolol Oral Solution (Hemangeol): A Breakthrough in Treating Infantile Hemangioma

Pharmacy Times

As research and clinical experience continue, Hemangeol's role in the management of infantile hemangioma is likely to expand, further improving the lives of affected children.

139
139
article thumbnail

The food industry has tried to stack a key nutrition policy panel with its preferred experts, documents show

STAT

WASHINGTON — There’s a panel of 20 nutrition experts that has outsized influence on the American diet — and the food industry has worked hard to get friendly researchers into the group, new documents obtained by STAT show. The National Potato Council, for example, nominated one of the researchers behind an industry-funded study showing eating french fries each day doesn’t result in more weight gain than eating a comparable amount of almonds.

article thumbnail

Walmart exploring buying majority stake in primary care company ChenMed: media report

Fierce Healthcare

Retail giant Walmart is reportedly exploring buying a majority stake in primary care clinic operator ChenMed to expand its healthcare business. | Retail giant Walmart is reportedly exploring buying a majority stake in primary care clinic operator ChenMed to expand its healthcare business.

131
131
article thumbnail

J&J, GSK and other companies knowingly marketed ineffective decongestants, lawsuits claim

Fierce Pharma

Questions first circulated about decongestant pills containing phenylephrine in 2007. | Several companies, including Johnson & Johnson, GSK, Procter & Gamble and Walgreens, face class-action lawsuits that claim the drugmakers knew that over-the-counter cold and flu pills containing phenylephrine did not work as advertised.

121
121
article thumbnail

Impact of the Inflation Reduction Act on Vaccinations: What Pharmacists Need to Know

Pharmacy Times

By educating their patients on the provisions of the Inflation Reduction Act, pharmacists can have an even greater impact by increasing vaccine uptake in historically underserved groups.

Vaccines 139
article thumbnail

STAT+: Here are the dozens of weight loss drugs in development to catch a booming market

STAT

The blazing success of weight loss drugs like Wegovy and Mounjaro has electrified the pursuit of new treatments for obesity. For now, Novo Nordisk and Eli Lilly are leading the market with injectable drugs that target receptors of the GLP-1 hormone to mimic the hormone’s effects of helping people feel full. But dozens of companies are also jumping into the race, seeing the potential to make millions of dollars if they can bring to market medications that are oral, longer-lasting, avoid si

145
145
article thumbnail

Ascension wraps the year with $2.7B loss thanks to higher expenses, one-time impairment loss

Fierce Healthcare

Ascension closed out its 2023 fiscal year with a $2.66 billion net loss, according to financial disclosures for the period ended June 30. | Discarding a $1.5 billion one-time write-down still left the Catholic giant with a $1.55 billion loss from recurring operations.

129
129
article thumbnail

FDA raises questions about Onpattro's efficacy in Alnylam's bid to challenge Pfizer in lucrative heart disease use

Fierce Pharma

Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin amyloidosis (ATTR).

FDA 121
article thumbnail

Researchers Assess Connection Between Socioeconomic Status, Cardiovascular Health

Pharmacy Times

Heart disease prevention efforts should acknowledge non-biological factors that can cause issues within cardiovascular health rather than relying on decreasing socioeconomic disparities.

139
139
article thumbnail

Popular nasal decongestant doesn’t actually relieve congestion, FDA experts say

STAT

WASHINGTON — The leading decongestant used by millions of Americans looking for relief from a stuffy nose is no better than a dummy pill, according to government experts who reviewed the latest research on the long-questioned drug ingredient. Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the key drug found in popular versions of Sudafed, Allegra, Dayquil and other medications stocked on store shelves.

FDA 145
article thumbnail

Priority Health launches program to back placement of service dogs in schools

Fierce Healthcare

Worsening mental health among young people is a growing national concern, and, in a bid to tackle the issue in its home state of Michigan, insurer Priority Health is going to the dogs—literally.

Insurance 129
article thumbnail

Moderna CEO expects endemic COVID vaccine market will take ‘a few years’ to fully develop

Fierce Pharma

Moderna has spent the last several years riding the ups and downs of the COVID-19 pandemic. | Moderna CEO Stéphane Bancel is optimistic that the company will beat the low end of its $6 billion to $8 billion COVID vaccine sales estimate for 2023. But his optimism comes as Moderna reportedly eyes manufacturing cuts as it shifts to an endemic market response.

Vaccines 120
article thumbnail

SARS-CoV-2, Seasonal Influenza Vaccine Coadministration is Safe, Effective in Protection Against Viruses

Pharmacy Times

Compared with COVID-19 vaccination alone, recent study findings show health care workers who received both a COVID-19 booster and influenza vaccinations did not have lower immune response or more frequent adverse events.

Vaccines 139
article thumbnail

FDA approves updated Covid vaccines

STAT

The Food and Drug Administration announced Monday that it had greenlit two   updated Covid-19 booster shots in people as young as 6 months old, triggering a process that could see the Moderna and Pfizer-BioNTech vaccines become available in doctors’ offices, clinics, and pharmacies later this week. The updated approvals relate only to the two messenger RNA vaccines on the U.S. market.

Vaccines 145