Wed.Oct 05, 2022

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PDUFA and BsUFA reauthorizations are wins for patients

PhRMA

America relies on the U.S. Food & Drug Administration (FDA) to keep pace with the scientific advancements happening every day in labs across the country. That’s why the recently enacted Prescription Drug User Fee Act (PDUFA VII) and Biosimilar User Fee Act (BsUFA III) are both great news for biopharmaceutical innovation and for patients. With these programs reauthorized for another five years, the FDA can continue doing its vital work reviewing medicines.

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Vaccination Rates Among Children May Be Impacted by Safety Concerns

Pharmacy Times

Vaccines reduce the risk of COVID-19 infection and hospitalization, but a recent study suggests that misinformation could make adults hesitant to vaccinate children 5 to 11 years of age.

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Busting 3 Myths About Copay Coupons

PhRMA

Insurer-imposed barriers like high deductibles and coinsurance shift the cost of life-saving care onto patients. Manufacturers and others have stepped forward to assist patients who face high out-of-pocket costs, using programs like copay coupons to help eligible, commercially insured patients afford their out-of-pocket costs. In fact, the share of patients staying on treatment for one year increased by up to 47% when patients used copay coupons.

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High risk, high reward – the future of CAR-T therapy in CLL

Pharmaceutical Technology

In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial. In March this year, it was reported that these two patients were still in remission, making this the longest known CLL remission after CAR-T therapy and demonstrating to the industry that long-term remission is indeed possible.

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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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Watch: Why aren’t ectopic pregnancies viable?

STAT

Following the fall of Roe v. Wade, many clinicians have become fearful and uncertain about how they are allowed to treat pregnant people with potentially life-threatening complications. These include ectopic pregnancies, which can only be treated by termination. Ectopic pregnancies are not viable, but as STAT’s Olivia Goldhill reports , some providers are cautious about immediately providing treatment in states that have passed laws that criminalized abortion, as they can risk losing thei

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Assessing Up-and-Coming Hemophilia Treatments

Drug Topics

Long-acting recombinant replacement factor gets favorable rating from multidisciplinary group. Gene therapy was viewed with some wariness.

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Gestational Diabetes Associated with Increased Risks of Cardiovascular, Cerebrovascular Diseases

Pharmacy Times

Women with a history of gestational diabetes had a 45% increased risk of overall cardiovascular and cerebrovascular diseases.

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‘What a gift to give’: For a woman struggling with infertility, a sister’s unexpected offer of surrogacy brings new hope

STAT

Lydia Gatton’s first in vitro fertilization appointment was just a week away when the fifth-grade teacher fell to the floor in the cafeteria of Hopewell Elementary in Bettendorf, Iowa, suffering a grand mal seizure. She was rushed to the hospital, where doctors diagnosed the then 29-year-old with a brain tumor. Gatton and her husband had struggled to conceive naturally for years and completed six unsuccessful intrauterine inseminations.

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Sanofi wagers $400m on miRecule muscular dystrophy therapy

pharmaphorum

Sanofi has added to its rare disease pipeline by licensing an antibody-RNA conjugate (ARC) for facioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorder, from US biotech miRecule. FSHD is the second most common form of muscular dystrophy after the Duchenne type, and affects around 1 million people worldwide, with no approved treatments.

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Opinion: Listen: Wheelchair users and Medicare disagree on what’s ‘primarily medical in nature’

STAT

Modern wheelchairs have amazing capabilities. At the push of a button, they can position a user in a “standing” position, or elevate someone to eye level with a non-disabled person. It’s game-changing for wheelchair users who are looking to take care of themselves independently whenever they can. Standing technology promotes healthy circulation to avoid blood clots and bed sores, and reduces the risk of osteoporosis, urinary tract infections, and more.

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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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Aflibercept Leads to Sustained Improvements in Vision for Patients with Diabetic Macular Edema, Wet Age-Related Macular Degeneration

Pharmacy Times

Aflibercept 8 mg demonstrated non-inferiority in vision gains in both the 12- and 16-week dosing regimens.

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STAT+: The Q4 health tech tracker: 17 key industry events and milestones to watch

STAT

Health tech companies and their backers are increasingly cautious as they brace for uncertain market conditions leading into the new year. But industry gatherings are in full swing, and we’re expecting lively debate about which digital health offerings will win out as investments and contracts sink below their pandemic peak. And as two waves of federal health data rules take effect in early October and late December, providers and developers told STAT they’re getting to work ensuri

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NCPA Annual Convention Exhibitor Recap 2022

DiversifyRx

Here are the 10 most exciting companies I saw at the 2022 NCPA annual convention. NCPA held its 2022 annual convention in Kansas City. I know Ian kept some people home, as did some sickness. Fear not if you missed attending! I will recap the most exciting and profit-creating companies I saw on the exhibitor floor. Picking out the diamonds in the rough can be tricky even if you were there. .

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Opinion: Interoperability can’t wait: Don’t delay information blocking rules

STAT

Interoperability is a word you seldom hear uttered outside the health care sector (though there it seems to be on the tip of everyone’s tongues), yet it’s something that affects everyone. Interoperability is the ability — or inability, as is often the case — to easily and securely access and exchange medical data in a format that is usable and useful to the recipient.

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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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Walmart acquires robotics automation company

Drug Store News

The retailer will acquire Alert Innovation, a robotics automation company that develops material-handling technology for automating order fulfillment in retail supply chains.

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Opinion: Needed: stricter screening of gene synthesis orders, customers

STAT

Scientists rely on gene synthesis technologies as a research tool for everything from basic research to vaccine development and drug target identification. Oligonucleotides, which are pieces of DNA about 15 to 30 base pairs long, are used in gene synthesis laboratories all over the world, along with DNA strands that may be thousands of bases long. Ever since the inception of gene synthesis, there have been concerns about possible misuse of synthetic genes.

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Frontiers Health Steering Committee spotlight: Roberto Ascione

pharmaphorum

As we close in on Frontiers Health 2022, pharmaphorum is chatting with members of the Steering Committee to give you a sneak peek of what to expect in Milan. Interested in signing up? pharmaphorum readers get a discount through this link. As digital therapeutics come into their own, they’ve become a necessary force to be reckoned with for pharma, payers, and providers – as well as for the patients that will use them and the tech companies that make them.

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Documentation Pays Off in More Than Way Than One

Drug Topics

Quality documentation ensures that pharmacies get paid for clinical services and offers a way to engage with patients.

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RBX2660 for Treatment of Recurrent C. difficile Infection (rCDI)

Pharmacy Times

Drs Feuerstadt, Abraham, and Chopra discuss clinical trial data for RBX2660, a live biotherapeutic product, in treatment of recurrent C difficile infection (rCDI), as well as data with RBX2660 that were presented at DDW 2022.

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New drug could be ‘gamechanger’ for chronic cough sufferers

The Guardian - Pharmaceutical Industry

Lung doctor says Gefapixant could be first new treatment for condition to be approved in UK for more than 50 years A new drug to treat chronic coughs could be a “gamechanger” treatment for the thousands of Britons who cough uncontrollably, many times a day. Prof Surinder Birring, a leading lung doctor, has led a global trial that found Gefapixant reduces a person’s coughing by up to 60% and brings some relief to 70% of those who take it.

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Digital health financing drops again, but don’t worry yet

pharmaphorum

After a bumper 2021, the fall-off in digital health financing deals that started to appear early this year has continued, with the three month to send September the lowest funded quarter since the tail end of 2019. All told, digital health companies raised $2.2 billion from 125 deals in the third quarter, taking the tally for 2022 to $12.6 billion and 458 deals, respectively, according to new figures from Rock Health which point to a big pullback in late-stage deal financing.

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What Pharmacists Should Know About Medicare Open Enrollment 2023

Digital Pharmacist

The Medicare Open Enrollment period for 2023 is quickly approaching – this is a critical time for both your patients and your pharmacy. Every year, the enrollment period runs from October 15 to December 7. This leaves very little time before patients need to re-evaluate their insurance. . Below are a few tips on how your pharmacy can prepare for the upcoming enrollment period.

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Tip of the Week: Effective Changes in Practice Can be Spurred by Small Adjustments

Pharmacy Times

Dispensing naloxone provides an example of how small changes can make a significant difference.

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Loblaw, DoorDash launch on-demand grocery delivery for Canadians

Drug Store News

Delivery via DoorDash is now available across the Loblaws, Shoppers Drug Mart, Real Canadian Superstore, Atlantic Superstore, Provigo and Maxi & Cie banners.

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Researchers Suggest That Engineering Specific B Cell Response Could Make the First HIV Vaccine Possible

Pharmacy Times

A large collective of researchers may be one step closer to developing a vaccine against HIV after engineering a protein that triggers a widespread antibody response.

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Collaborations between pharma and academia increase

European Pharmaceutical Review

The Association of the British Pharmaceutical Industry (ABPI)’s survey identified that the sector is helping industry entrants by embracing hands-on training methods such as apprenticeships, degree placements, PhDs and post-doctoral researcher awards, with data showing that apprentices being trained by pharmaceutical companies is the highest on record.

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NACDS reflects on achievements at White House conference on Hunger, Nutrition, and Health

Drug Store News

NACDS also extended the physical and virtual reach of the White House conference by hosting an in-person satellite event.

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Diabetes Improves After Health Worker, Pharmacist Intervention

Drug Topics

Building relationships with patients showed long-term benefits.

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Scale Down Before Scaling Up: Digital Innovation in a Highly Regulated Industry

PharmExec

The highly-regulated pharmaceutical industry poses serious challenges that can derail digital health programs. But, there are solutions.

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Amazon seeks to hire 150K employees for holidays

Drug Store News

Seasonal, full-time and part-time roles are available across Amazon’s operations, with sign-on bonuses up to $3,000 in select locations.

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Expert Discusses Changes to Drug Supply Chain Security Act

Pharmacy Times

Lisa Schwartz, PharmD, RPh, senior director of Professional Affairs at NCPA, discusses the Drug Supply Chain Security Act and why it was updated for the distribution of naloxone.

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Walgreens to sell Lexie Lumen hearing aids OTC

Drug Store News

Starting Oct. 17, Lexie Lumen hearing aids can be purchased at Walgreens stores nationwide, including Puerto Rico, for $799.

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SER-109, CP101, VE303 for Treatment of Recurrent C. difficile Infection (rCDI)

Pharmacy Times

Drs Abraham and Feuerstadt share recent data with emerging live biotherapeutic products, SER-109, CP101, and VE303, for treatment of recurrent C difficile infection (rCDI).

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Walgreens to sell Lexie Lumen hearing aids OTC

Drug Store News

Starting Oct. 17, Lexie Lumen hearing aids can be purchased at Walgreens stores nationwide, including Puerto Rico, for $799.

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