Fri.Jun 17, 2022

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Six months after authorization, what do we know about Paxlovid?

pharmaphorum

It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19.” . At the time of authorisation, the United States federal government had already purchased 10 million doses of the drug.

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Creating Influence and Authority in Value-Based Healthcare

PharmExec

We may be only at the beginning of outcome-measured, value-based healthcare, but this is a chance for pharma organizations to show their mettle as roles are redefined and definitions of ‘value’ are agreed, says Gérard Klop of Vintura.

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Rumour mill says AstraZeneca may be eyeing a takeover of Mereo

pharmaphorum

AstraZeneca is rumoured to be considering a bid to take control of its longstanding partner Mereo BioPharma, according to a report in The Times, which doesn’t provide the source of the speculation. The UK-based but US-listed biotech licensed rights to AZ’s orally-active neutrophil elastase inhibitor alvelestat for the rare disease alpha-1 antitrypsin deficiency (AATD) five years ago, and has since advanced the project into a phase 2 trial which is due to read out in the second half o

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FDA User Fee Legislation Advances in Senate

PharmExec

Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access.

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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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Decentralised trials gaining ground in oncology, says report

pharmaphorum

A survey of clinical research executives working in the cancer arena has found that nearly three quarters of them will include decentralised designs in trials due to start in the next 12 months. The report from Science 37 found that 73% of respondents were planning either a hybrid study – including both remote and traditional investigation site elements – or a fully decentralised study, up from 49% a year earlier.

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Five Historic Pride Locations to Visit While Traveling

Aureus Medical Group

One of the exciting perks of travel nursing is the ability to visit amazing cities, parks, and monuments across the country. To help you celebrate Pride this year, we’ve assembled a handful of historic Pride landmarks and memorials across the U.S. that you can visit all year-long. So plan a road trip, a weekend getaway, or hop across town to discover, reflect, and celebrate the history that’s shaped the LGBTQIA+ community.

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Celebrating Juneteenth!

Aureus Medical Group

June 19th has been a day of remembrance and reflection for over 155 years, and in 2021 was officially declared a federal holiday. Juneteenth celebrates the day enslaved Americans first learned that slavery ended, two years after the Emancipation Proclamation was declared in 1863. Communities, schools, and businesses across the country come together to listen, learn, and spread awareness of the past and present issues facing the Black community.

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Pharmacy chain Walgreens plans to disrupt clinical trial sector

pharmaphorum

Walgreens is the latest US retail pharmacy giant to have a go at disrupting the clinical trials industry, with the launch of a new business unit that will tap into its reserve of patient data, as well as the ability to recruit patients across its retail network. The company says it plans to use a “flexible” model, drawing on both decentralised trial (DCT) and conventional site-based models via its Health Corner and Village Medical outlets at various Walgreens locations across the US.

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Q&A With Paul Ford, co-founder and president, DS9 Capital

PharmExec

Ford discusses how rising drug costs in impact patients, and how they can either avoid them or find less-expensive options.

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How digitalization can provide a competitive advantage

Pharma Manufacturing

The digitalization journey for pharmaceutical manufacturing can reap many benefits and there are many choices to be made in terms of these technologies and how to deploy them. In this episode, Andrea Corona talks about how digitalization is delivering a competitive advantage and assembly and inspection with Veronica Ghidotti and.

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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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The Benefits of Enhancing Adverse Event Intake With Case Collection Systems

PharmExec

Automated risk management and improved regulatory compliance among opportunities offered by case collection.

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Biogen waves bye to $217m ALS partnership with Karyopharm

pharmaphorum

Biogen has ducked out of a four-year-old collaboration with Karyopharm on a drug candidate for the neurodegenerative disease amyotrophic lateral sclerosis that could have been worth up to $217 million to the US biotech. The 2018 deal giving Biogen rights to the oral selective inhibitor of nuclear export (SINE) compound KPT-350 included a $10 million upfront payment, but Karyopharm said in a filing with the Securities & Exchange Commission (SEC) that it will no long be eligible for any of the

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NICE recommends Eli Lilly’s breast cancer therapy

Pharma Times

Verzenios in combination with endocrine treats people with early breast cancer who are at high-risk of recurrence

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The long drive to adoption

Pharma Manufacturing

Continuous manufacturing may finally come into its own, according to an industry panel

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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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Novartis receives vital licence for Scemblix

Pharma Times

Therapy represents the first STAMP inhibitor for patients with chronic myeloid leukaemia

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MD Logistics to Open Sixth Warehouse

Pharmaceutical Commerce

New Garner, NC location will be its first outside the Midwest.

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The War In Ukraine is a Global Crisis, Not a Ukraine-Only Crisis

Viseven

By this moment, four months of full-scale conquest war of Russia against Ukraine feel like a single day, and this day feels like years have gone by. Thousands of people have died, millions have been displaced, and tens of millions had to seek refugee elsewhere. Among these millions are Viseven staff. Our colleagues are also on the battlefields defending their motherland.

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BioCina Unveils pDNA Manufacturing Suite

Pharmaceutical Commerce

New service offering is GMP compliant, with single-use fermentation capacity of up to 300 L.

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