Fri.Nov 18, 2022

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Expanding and Diversifying the Supply Chain

Drug Topics

Jay Dombi and Lamont Robinson share how the AmerisourceBergen Marketplace can help pharmacies and why having diverse suppliers is important.

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Holmes gets more than 11 years in prison for Theranos scam

STAT

A federal judge on Friday sentenced disgraced Theranos CEO Elizabeth Holmes to more than 11 years in prison for duping investors in the failed startup that promised to revolutionize blood testing but instead made her a symbol of Silicon Valley’s culture of audacious self-promotion. The sentence imposed by U.S. District Judge Edward Davila was shorter than the 15-year penalty requested by federal prosecutors but far tougher than the leniency her legal team sought for the mother of a year-o

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Pharmacist-Prescribed Paxlovid for COVID-19 Now Available at CVS

Drug Topics

CVS is the first pharmacy to offer this service nationwide.

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From finding the right candidates to keeping them, how hospitals are using AI to address workforce needs

Fierce Healthcare

From finding the right candidates to keeping them, how hospitals are using AI to address workforce needs. aburky. Fri, 11/18/2022 - 15:25.

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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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MHRA approves first gene therapy for infusion into the brain

European Pharmaceutical Review

Upstaza (eladocagene exuparvovec) is the first and only approved treatment for aromatic L-amino acid decarboxylase (AADC) deficiency and is the first marketed gene therapy for direct infusion into the brain. The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. It has been granted marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain.

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Pfizer CEO says Covid vaccine will remain ‘free for all Americans,’ overlooking indirect costs

STAT

BOSTON — As Pfizer prepares to hike the price of its Covid-19 vaccines, the company’s CEO, Albert Bourla, maintained at a conference this week that the jabs will continue to be “free for all Americans” because insurers are required to pay the extra cost. “Americans will see no difference,” said Bourla, speaking Wednesday at the STAT Summit.

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Moderna BA.4/BA.5 Targeting Bivalent Booster Met Primary Endpoint When Compared to Booster Dose

Pharmacy Times

Both of Moderna's bivalent boosters showed neutralizing activity against BQ.1.1, an increasingly dominant emerging variant, confirming that updated vaccines have the potential to offer protection as the virus continues to evolve.

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STAT+: Biosplice, once the most valuable biotech startup, sees a pair of osteoarthritis trials fail

STAT

Biosplice’s bid to transform the treatment of everything from arthritis to cancer ran into a snag this week, with the San Diego biotech announcing that its experimental osteoarthritis drug failed to benefit patients in a pair of Phase 3 clinical trials. The results, presented at the American College of Rheumatology conference in Philadelphia, show that the small-molecule drug lorecivivint failed to significantly soothe the pain of osteoarthritis patients.

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Dapagliflozin Improves Symptom Burden, Health-Related Quality of Life in Patients with Heart Failure

Pharmacy Times

Dapagliflozin is the first SGLT2 inhibitor approved by the FDA for treatment of patients with heart failure (NYHA class II-IV) with reduced ejection fraction.

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Myths and Concerns Surrounding Vaccines

Drug Topics

With closing remarks, Mitchel Rothholz, RPh, MBA, and Jeff Goad, PharmD, MPH, discuss common myths circulating around COVID-19 vaccines and vaccination.

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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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FDA Approves Teplizumab-mzwv, the First Drug to Delay Onset of Type 1 Diabetes

Pharmacy Times

Teplizumab-mzwv is administered through injection and can delay the onset of type 1 diabetes in adults and pediatric patients.

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STAT+: Nectar bats are ‘wonderful, majestic’ and sugar-obsessed. This researcher wants to know how they stay healthy

STAT

Nectar bats may have nature’s biggest sweet tooth. Each night, the creatures scour the jungle for blossoming flowers in order to consume as much as 150% of their body weight in liquid sugar. Such a feat would leave other mammals in shock or in a coma. But nectar bats push biology to the limit — making them “wonderful, majestic flying superheroes,” in the words of Jasmin Camacho, a postdoctoral researcher at the Stowers Institute for Medical Research who was recently n

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Treatment With Olpasiran Significantly Lowers Lipoprotein(A) Levels

Pharmacy Times

Patients administered 75 mg or higher of olpasiran every 12 weeks had a 95% or greater reduction in Lp(a) compared to placebo at week 36.

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Regeneron, CytomX announce bispecific therapeutics for cancer collab

pharmaphorum

Regeneron Pharmaceuticals, Inc. and CytomX Therapeutics, Inc. have announced a strategic research collaboration within the field of conditionally activated bispecific therapeutics for the treatment of cancer. Using CytomX’s Probody and Regeneron’s Veloci-Bi platforms, the collaboration and licensing agreement aims to enable the development of investigational next-generation bispecific immunotherapies.

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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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Expert: What Pharmacies Should Be Prioritizing to Stay Compliant With Updated USP Chapters , ,

Pharmacy Times

Annie Lambert, PharmD, BCSCP, discusses how to approach the implementation of the revised USP chapter guidelines for , , and before the enforcement date in fall 2023.

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mRNA drugs with a built-in ‘copy machine’ could lead to safer, more effective therapies

STAT

This story has been adapted from the STAT Report “The future of messenger RNA: Covid-19 vaccines are just the beginning.” R emember that messenger-RNA-based Covid-19 vaccine you got? Just a few days later, the teeny molecular messengers contained in the shot were already gone.

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How long does Nurtec take to work?

The Checkup by Singlecare

How does Nurtec work? | Nurtec dosing instructions | Do I need Nurtec? Before the first migraine-specific drugs hit the pharmaceutical market in 2018, the medications used to treat migraine were meant for other health conditions. Antidepressants, beta blockers, and epilepsy drugs reduced migraine symptoms in many people, but no one knew for sure how or why.

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Takeda’s Iclusig bests imatinib in first-line leukaemia trial

pharmaphorum

Takeda has a chance of breaking into new territory with its blood cancer therapy Iclusig, after the drug performed better than mainstay therapy imatinib in a phase 3 study of adults with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). The PhALLCON trial compared Iclusig (ponatinib) to imatinib – sold by Novartis as Glivec/Gleevec, but also available as a generic – on top of a reduced-intensity chemotherapy regimen in 230 patients with this type of leukae

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STAT+: Sales of antibiotics for food-producing animals dropped by nearly half in Europe over the past decade

STAT

Amid ongoing concerns over the use of medically important antibiotics given to food-producing livestock and farmed fish, sales of veterinary medicines across Europe dropped by nearly half between 2011 and 2021, which regulators reported is the biggest drop ever recorded and a sign that campaigns to reduce use are working. At issue is the extent to which antibiotics are given to food-producing livestock to prevent and treat disease — a practice that has contributed to an alarming rise in a

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FDA approves first drug to delay type 1 diabetes

European Pharmaceutical Review

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” remarked Dr John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.

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Opinion: STAT+: Removing barriers to biosimilar adoption in the United States

STAT

Biosimilars, a much-lauded approach to reducing drug costs in the United States, are still underused here, even as they are proving successful in Europe. Why? Two key reasons are misperceptions of inferiority and the intricacies of U.S. market access. As the head of U.S. market access for Samsung Bioepis, a South Korean developer and manufacturer of biosimilars, I routinely introduce our capabilities to key stakeholders in the U.S. health care market.

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After disappointing trial, Editas puts lead CRISPR drug up for sale

pharmaphorum

Gene-testing specialist Editas Medicine has halted development of its lead clinical programme for congenital eye disorders after it generated lacklustre results in a phase 1/2 trial. The BRILLIANCE study of EDIT-101 in Leber congenital amaurosis type 10 (LCA10) – an inherited form of blindness – was reported to be the first ‘in vivo’ CRISPR/Cas9 medicine to be administered to a patient when it started in 2020.

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STAT+: Pharmalittle: WHO pandemic accord may force pharma to disclose prices; FDA OKs first therapy to delay type 1 diabetes

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall our treasured signal to daydream about weekend plans. Our agenda is in the proof-of-concept phase, but we hope to promenade with the official mascot, hang with Mrs. Pharmalot, catch up on our reading, and nap extensively. And what about you? Those of you on this side of the pond may want to prepare for an upcoming celebration, although we hear turkeys are pricey, so perhaps pivoting to som

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Moving from data collection to action: Health system execs weigh in on addressing disparities systemwide

Fierce Healthcare

Moving from data collection to action: Health system execs weigh in on addressing disparities systemwide. agliadkovskaya. Fri, 11/18/2022 - 17:07.

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Student Pharmacists Can Play Important Role as Patient Advocates

Pharmacy Times

Education and support inspire trust between patients and pharmacists.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Considerations When Selecting COVID-19 Vaccines

Drug Topics

Expert panelists highlight special considerations when selecting COVID-19 vaccines.

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First COVID-19 impact report on global vaccine markets

European Pharmaceutical Review

The World Health Organization (WHO)’s Global Vaccine Market Report 2022 , the first report to examine the impact of COVID-19 on the global vaccine market, shows that inequitable distribution is not unique to COVID-19 vaccines, with poorer countries consistently fighting to access vaccines in demand by wealthier countries. The WHO stated limited vaccine supply and unequal distribution is driving global inequalities.

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Sanders, Cassidy in line to lead pivotal Senate HELP committee in next Congress

Fierce Healthcare

Sanders, Cassidy in line to lead pivotal Senate HELP committee in next Congress. rking. Fri, 11/18/2022 - 16:16.

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With Sanofi as its marketing partner, Provention Bio grabs long-awaited FDA nod for diabetes drug

Fierce Pharma

With Sanofi as its marketing partner, Provention Bio grabs long-awaited FDA nod for diabetes drug. kdunleavy. Fri, 11/18/2022 - 10:21.

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News Roundup: November 14 to November 18

Drug Topics

Your weekly roundup of the latest news from Drug Topics®.

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CDC: Home births soared to a 30-year high in 2021

Fierce Healthcare

CDC: Home births soared to a 30-year high in 2021. fdiamond. Fri, 11/18/2022 - 14:51.

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Handling Hazardous Drugs Presents Opportunities

Pharmacy Times

A compliance officer role represents an exciting new challenge to ensure safe handling in compliance with United States Pharmacopeia.

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Lilly wades deeper into copycat insulin market, scoring interchangeability tag for Lantus biosim

Fierce Pharma

Lilly wades deeper into copycat insulin market, scoring interchangeability tag for Lantus biosim. fkansteiner. Fri, 11/18/2022 - 11:01.

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