Fri.Nov 10, 2023

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First Vaccine to Prevent Chikungunya Virus Approved by FDA

Drug Topics

Ixchiq contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.

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How pharmacy deserts are putting the health of Black and Latino Americans at risk

STAT

Pharmacies were once abundant in the South Side of Chicago. Now, residents living in the majority Black neighborhood often find themselves with few options when it’s time to get a prescription refilled or stock up on cold medicine. Ladell Johnson, a longtime resident of the South Side, drives half an hour from her house to the downtown area every time she needs to pick up her prescription.

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Trending Sources

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Simultaneous Inhibition of Proteins May Slow Growth of Aggressive, Drug-Resistant Breast Cancer

Pharmacy Times

Researchers determined that simultaneously targeting the BRD4 and LOXL2 proteins disrupts their interaction and inhibits the growth of triple-negative breast cancer cells.

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U.K. recommendation could lead to world’s first use of meningitis vaccine to curb gonorrhea

STAT

An expert panel that advises the United Kingdom on vaccine policy has recommended using a meningitis B vaccine to try to bring down spiking rates of gonorrhea. If adopted, the U.K. would be the first country to use the meningitis B vaccine for this purpose. The Joint Committee on Vaccination and Immunization released a report Friday saying that targeted use of a meningitis B vaccine — GSK’s Bexsero — in people at high risk of contracting gonorrhea should reduce the inci

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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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Law and Advocacy Update: The Issues Impacting Your Business

Drug Topics

Steve Postal, KD, director of policy and regulatory affairs at the National Community Pharmacists Association, shared an overview of federal- and state-level legislative, advocacy, and regulatory updates.

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Opinion: The end of affirmative action means it’s time to revise pre-med requirements

STAT

Luz (not her real name) could be a great doctor. A Latina student from Arizona, she graduated at the top of her high school class and has always aspired to give back to her community. But ultimately, she decided against medical school for one reason: chemistry. It’s not that she isn’t smart enough for chemistry — far from it. She just hates it, finding it dull and unrewarding.

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STAT+: What Amazon Prime’s new One Medical offering reveals about the future of health care

STAT

Amazon Prime members have a new offer in addition to the usual delivery and streaming services: Access to One Medical, the Amazon-owned primary care company. Members have the option, announced Wednesday, to pay an additional $9 per month, or $99 per year, for One Medical’s telehealth services and in-office appointments at a discount of about half its typical $199 yearly cost.

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Misoprostol Alone Can be Effective Abortion Method

Drug Topics

The World Health Organization recommends either mifepristone in combination with misoprostol or misoprostol alone for abortion, but clinical evidence has indicated misoprostol alone has an effectiveness of 80% compared to 95% for mifepristone alongside misoprostol.

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Report: High wait times, poor reimbursement drive autism diagnosis delays

Fierce Healthcare

Nearly two-thirds of specialty centers that conduct autism evaluations have wait times longer than four months, according to a new report. | Nearly two-thirds of specialty centers that conduct autism evaluations have wait times longer than four months, according to a new report.

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STAT+: Medicare’s new pay boost for primary care is angering specialists

STAT

WASHINGTON — Doctors are staring down a cut to their Medicare pay next year, and while the news has united them in outrage, it’s also turned one specialty against another. Medicare officials last week announced its major annual update to the way the program pays physicians. Along with other changes, it includes a policy that will boost payments to specialties that rely on evaluating and managing patients, as opposed to those that focus on procedures.

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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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Roundtable: Let’s Take Back Pharmacy

Drug Topics

Panelists in this round table conversation discuss the opportunities that are available for independent pharmacists to maximize revenue opportunities in their stores.

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Opinion: State and local governments across the country are sidelining science

STAT

In late August 2017, Hurricane Harvey brought Texas rain that just wouldn’t stop. After four torrential days, 75 people had died, and Houston — America’s fourth largest city — was deep under water. But given that the area is home to Superfund sites , fossil fuel-fired power plants, and other petrochemical hubs, this wasn’t ordinary rainwater.

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Evolving Pharmacy Practice: Embracing a New Paradigm

Drug Topics

Maimuna Bruce, PharmD, MBS, MS, manager of pharmacy advocacy and regulatory affairs at Outcomes, discussed the ways that technology can improve pharmacy workflow.

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Valneva wins race, gaining FDA approval for chikungunya vaccine Ixchiq

Fierce Pharma

Valneva has won the race in the U.S. | The FDA has approved the world’s first chikungunya vaccine, giving a thumbs-up to Valneva’s Ixchiq. The French company receives a priority review voucher from the FDA, which it said it will sell. It is an accelerated approval and subject to a confirmatory, real-world study.

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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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STAT+: EU regulator recommends expanding diabetes drug Mounjaro’s approval to include obesity

STAT

LONDON — Two days after similar decisions in the U.S. and U.K. , regulators in Europe on Friday recommended that the approval of Eli Lilly’s diabetes drug Mounjaro be widened to include obesity.   The ruling from a committee of the European Medicines Agency now goes to the European Commission, which makes the final decision but almost always follows the EMA’s guidance.

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Is Your Pharmacy—And Its Technology—Operating at Its Full Potential?

Drug Topics

Stephen Barnes, BA, MA, director of sales and marketing at BestRx Pharmacy Software, discussed the ways that software can optimize a pharmacy's revenue.

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FDA Approves First Vaccine to Prevent Infection from Chikungunya Virus

Pharmacy Times

The vaccine provides treatment prevention for individuals that are high risk of exposure to the chikungunya virus.

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Instacart, Door Dash now allowing users to buy health items using HSAs, FSAs

Fierce Healthcare

As cold and flu season truly sets in, major home delivery platforms are now allowing customers to purchase products using their health benefits. | As cold and flu season truly sets in, major home delivery platforms are now allowing customers to purchase products using their health benefits.

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Pharmacy Focus: Psychedelic Pharmacy- Investigating Psilocybin-Assisted Therapy

Pharmacy Times

Jordan Sloshower, MD, MSc, describes his experience working in several clinical trials investigating psilocybin-assisted therapy.

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Survey: It's beginning to look like an omnichannel holiday shopping season

Drug Store News

Grocery Doppio's latest survey reveals grocers' holiday prep strategies, including stress testing digital channels, increasing digital promotions and expanding delivery and pick-up options.

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The Path Forward: Navigating the DSCSA Stabilization Policy

Drug Topics

Learn more about the ins and outs of the new DSCSA stabilization policy, delaying some facets of DSCSA implementation to November 2024.

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New method could replace microbiology CFU assay

European Pharmaceutical Review

US researchers have developed the Geometric Viability Assay (GVA), which has been shown to be a fast, cheap and sustainable method for counting microorganisms. Since it is 36 times faster than conventional methods, uses 15 times less plastic, and is low cost, Geometric Viability Assay could “replace existing viability assays and enable viability measurements at previously impractical scales”, the paper noted.

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Happy Veterans Day!

OctariusRx

Happy Veterans Day to all who are serving or have served our country! “We remember those who were called upon to give all a person can give, and we remember those who were prepared to make that sacrifice if it were demanded of them in the line of duty, though it never was. Most of all, we remember the devotion and gallantry with which all of them ennobled their nation as they became champions of a noble cause.” — Ronald Reagan Join the OctariusRx team in giving thanks.

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Novo Nordisk plans multi-billion Denmark manufacturing expansion

European Pharmaceutical Review

Novo Nordisk has announced plans to invest over 42 billion Danish kroner (nearly £5 billion) starting in 2023, to expand its manufacturing facilities in Kalundborg, Denmark. According to the pharma company , the financing will add to global capacity: from manufacturing of active pharmaceutical ingredients (API) through to packaging. Most of the investment will be focused on API capacity.

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STAT+: Pharmalittle: Novo Nordisk to spend $6 billion to boost production; FDA okays world’s first vaccine for chikungunya

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, so far, is uncertain. We do expect, however, to catch up on our reading, manicure the grounds, and promenade with the official mascots. We may also hope to hold another listening party with Mrs.

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QA/QC & Microbiology In-Depth Focus 2023

European Pharmaceutical Review

Bioburden and sterility testing: how to conserve gene therapy product Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals, and Tom Bujold, Senior Director of Quality Control at REGENXBIO, discuss the challenges of bioburden and sterility testing for gene therapies and why industry must come together to drive increased harmonisation.

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FDA approves Takeda’s Adzynma for rare blood clotting disorder

Pharmaceutical Technology

The US FDA has granted approval for Takeda’s Adzynma for congenital thrombotic thrombocytopenic purpura, a rare blood clotting disorder.

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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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VaxServe's Kevin Carrozza talks about what's new in vaccines and how the company is helping grow retail immunizations

Drug Store News

At NACDS’ Total Store Expo, Kevin Carrozza discussed what the company is doing to help retail pharmacies expand immunizations.

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The first vaccine for the increasingly prevalent chikungunya virus is here

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Today we have two FDA approvals, preview late-breakers at this weekend’s American Heart Association scientific sessions, and offer up your very favorite podcast.

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AstraZeneca posts 16% drop in Q3 2023 profit after tax

Pharmaceutical Technology

AstraZeneca has posted a profit after tax of $1.37bn for Q3 2023 versus $1.64bn in the same quarter of the previous year, a decline of 16%.

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Formulation In-Depth Focus 2023

European Pharmaceutical Review

Exploring the complex pathway of paediatric drug development The formulation development of paediatric medications poses unique challenges compared to that of adult medications. Tom Hegarty, Head of Technical Operations for Almac Pharma Services, delves into some of the key considerations when looking to develop child-friendly formulations. Definitive screening design to accelerate process characterisation Mourad Mellal, Director of Statistics, Product Development at Catalent, elucidates the rol

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FDA Approves First Licensed Chikungunya Virus Vaccine

Drug Topics

Ixchiq was approved through the FDA Accelerated Approval pathway.

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6 Root Causes Behind Leaky Gut and Autoimmunity

The Thyroid Pharmacist

I often get messages from people with Hashimoto’s and other autoimmune diseases, that say: “Thanks for your efforts, but I’ve already tried everything. I have cut out gluten, dairy, and soy from my diet, and still have Hashimoto’s. How can your work help me?” While changing your diet is an incredibly important first step that will greatly help many of you, if you do not see a complete remission of your symptoms within three to six months, I encourage you to dig deeper.