Tue.Nov 15, 2022

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What you should know about RSV

PhRMA

You are probably reading a lot about a surge of cases of respiratory viruses like respiratory syncytial virus (RSV), influenza (the flu) and SARS-CoV-2, which causes COVID-19. The triple threat of these highly contagious respiratory viruses circulating simultaneously is causing a ripple of effects on patients, health care providers and our health care system as a whole.

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Wellness is the Future of Pharmacy But is the Profession Prepared?

Pharmacy Times

Currently, no national pharmacy organization has defined wellness in the pharmacy profession, which is needed so that others have a sense of guidance around wellness within the profession.

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‘A very worrying scenario’: Internal documents on India Covid-19 vaccine raise troubling questions about approval process

STAT

As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. The shot engineered by Bharat Biotech was, in part, an important effort to create a home-grown product that could   bolster the fortunes of the Indian pharmaceutical industry.

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Mindfulness-Based Stress Reduction Found Effective Treating Anxiety Disorders

Pharmacy Times

Anxiety disorders include generalized anxiety, social anxiety, panic disorder, and fear of certain places or situations, including crowds and public transportation.

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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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Data privacy concerns don’t hinder digital health app usage

pharmaphorum

A new survey conducted by juli, an AI-powered chronic condition platform, has revealed that the value placed on digital privacy differs widely among US users. With the HLTH 2022 event now well underway, digital health industry leaders all gathered together to attend in Las Vegas this week, the juli survey results reveal consumer responses to be more varied than one would have expected when it comes to data privacy.

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Three Strategies for Pharmacists to Maximize Their Potential as Caregivers Beyond the Bench

Pharmacy Times

In recent years, pharmacist roles have evolved as critically important caregivers who increasingly provide essential health care services far beyond medication dispensing.

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FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-gynx for Platinum-Resistant Ovarian Cancer Treatment

Pharmacy Times

Mirvetuximab soravtansine-gynx (Elahere; ImmunoGen Inc) approved FR?-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

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COVID-19 Reinfection Could Carry More Risks Than Initial Infection

Drug Topics

Although initial infection of the virus has resulted in risk of hospitalization and mortality, researchers looked into the affects of reinfection as data has been unclear.

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HLTH 2022 – Day 2

pharmaphorum

Early on Day 2, Matthew Holt (who we recently featured in our Health Innovators video series ) will interview Walmart EVP Dr. Cheryl Pegus & SCAN Health Plan’s Dr. Sachin Jain. Then we’ll hear from Aptar Digital Health’s Sai Shankar and Pierre Laurent in a session all about patients as partners in healthcare. The day will continue with other hot topics for pharma, including health equity, cell and gene therapy, oncology, and pharmacy model disruption.

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Dapagliflozin Found Clinically, Cost Effective Treating Chronic Kidney Disease

Pharmacy Times

Dapagliflozin and standard of care found to slow the decline in kidney function and lower the incidence of kidney failure.

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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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STAT+: ‘If this works, it changes everything’: Altos Labs founders lay out plan to reverse disease

STAT

BOSTON — The executives behind Altos Labs would really, really like people to stop saying they’re trying to reverse aging. They have a couple things going against them on this count. For one, the first article about the biotech and its $3 billion stash talked about Silicon Valley billionaires “ living forever.” And then there’s their most prominent scientist’s tendency to talk openly about people living to 130.

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Intervention Groups May Help Lower HIV Risk Among Gay, Bisexual Youth

Pharmacy Times

Approximately 80% of all HIV infections among teens are from the gay and bisexual population.

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HLTH22: Google, Epic ink deal to migrate hospital EHRs to the cloud to ramp up use of AI, analytics

Fierce Healthcare

HLTH22: Google, Epic ink deal to migrate hospital EHRs to the cloud to ramp up use of AI, analytics. hlandi. Wed, 11/16/2022 - 02:42.

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FDA Approves First IUD For 8 Years of Pregnancy Prevention

Drug Topics

The approval extends the use of Liletta for an additional 2 years.

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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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Roche deepens ties with Jnana with a second licensing deal

pharmaphorum

Swiss pharma group Roche has doubled down on a partnership with Jnana Therapeutics, paying $50 million upfront to tap into the Boston-based biotech drug discovery platform for a wide-ranging push across cancer, immune-mediated, and neurological diseases. The new agreement – announced on the same day that Jnana finalised a $107 million series C financing – has a potential deal value of around $2 billion and comes two years after Roche paid $40 million upfront with $1 billion at the back-end for a

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Opinion: Replace the failure of Medicare Advantage with ‘Medicare Part F’

STAT

Medicare Advantage began life as a brilliant idea: a public-private partnership to keep older people healthier and reduce costs. At the time in 1992, both President George H.W. Bush and his challenger, Bill Clinton, supported it. An editorial in The New York Times declared, “The debate over health care reform is over. Managed competition has won.

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Propelling clinical research into the 21st century

pharmaphorum

Two and a half years ago, Covid-19 began to infect hundreds, then thousands, then millions of people, and was eventually declared a global pandemic. Lockdowns and 25-second handwashing, face masks, home-schooling, and working from home became the new normal. The term “social distancing” entered into common parlance and we transitioned to a life largely spent at home.

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A ‘bold vision’ to prevent diabetes

PharmaVoice

Despite hearing that there’s “no money in prevention,” the CEO of Sigrid Therapeutics is forging ahead with the company’s goal of stopping Type 2 diabetes before it starts.

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What’s the best heartburn medicine for you?

The Checkup by Singlecare

If you’re one of the 60 million Americans that experience heartburn and indigestion every month, you may find yourself searching for relief and wondering what the best heartburn medicine is. With so many options on the market, it can be hard to know where to start. Whether you’re looking for an over-the-counter heartburn medicine or something a little stronger, it’s important that you find something that works for you because heartburn can be a sign of gastroesophageal reflux.

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The FDA has banned certain vapes and medicines. We still bought these 13 products in its backyard

STAT

WHITE OAK, Md. — The Food and Drug Administration, as the name suggests, is supposed to police the United States’ food and drug supply. But there are still illegal products available for easy purchase at gas stations and convenience stores all over the country — including in the FDA’s own backyard. We know, we bought them.

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Northwell Health's research arm studied 35,000 COVID patients for years. Using basic data, it built an AI tool to predict outcomes

Fierce Healthcare

Northwell Health's research arm studied 35,000 COVID patients for years. Using basic data, it built an AI tool to predict outcomes. agliadkovskaya. Tue, 11/15/2022 - 16:23.

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Pfizer musters J&J, PhRMA's support in closely watched Vyndaqel copay assistance case at Supreme Court

Fierce Pharma

Pfizer musters J&J, PhRMA's support in closely watched Vyndaqel copay assistance case at Supreme Court. fkansteiner. Tue, 11/15/2022 - 08:48.

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STAT+: Amazon jumps into direct-to-consumer telehealth, launching a rival to Ro and Hims

STAT

True to its e-commerce expertise, Amazon is jumping into the world of direct-to-consumer telehealth. On Tuesday, the tech goliath launched a virtual health storefront that individuals can access through the main Amazon website and its mobile app, offering the ability to message teleproviders and obtain prescriptions for about 20 health conditions. Amazon has been making significant shifts in its health care strategy in the last few months: In July, it announced plans to acquire primary care comp

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Create Your Holiday Marketing Plan in 5 Easy Steps

Digital Pharmacist

The holidays are right around the corner, and we’re here to help ensure you have the best marketing plan in place for your business. We know it’s difficult preparing your pharmacy for the holidays while also properly promoting your services, so we are here to help. . Below we are sharing five tips for creating a successful holiday marketing plan this season. 1.

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Perfection is too high a bar for CRISPR treatments, says STAT Biomedical Innovation Award winner David Liu

STAT

BOSTON — In science journalism, there’s a well-worn technique reporters reach for when they’re interviewing a researcher and the technical material starts whizzing over their heads. “OK, explain it again, and this time, as if you were talking to your mother.” The conjured image of a parent tends to do just the trick; prompting an illuminating alchemy of clarity infused with excitement.

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Ardelyx FDA docs portend another showdown at this week's expert hearing on kidney disease prospect

Fierce Pharma

Ardelyx FDA docs portend another showdown at this week's expert hearing on kidney disease prospect. fkansteiner. Tue, 11/15/2022 - 10:30.

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COVID-19 Vaccine Efficacy in Adolescents Shown Through Real-World Data

Drug Topics

A real-world study determined the efficacy of mRNA vaccines for protection against COVID-19 in adolescents.

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2022 WHO Biosimilar Guideline improves access, IGBA says

European Pharmaceutical Review

The International Generic and Biosimilar Medicines Association (IGBA)’s new whitepaper Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline suggests how the guideline provides great opportunity to revaluate how regulatory requirements can better advance biosimilar access. According to IGBA, the World Health Organization ( WHO) Biosimilars Guideline has been a useful tool for health authorities to boost international regulatory convergence and consistency of term

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Target's Q3 earnings miss the mark

Drug Store News

Target reported Q3 GAAP earnings per share of $1.54, down 49.3% from $3.04 in 2021 and adjusted EPS of $1.54, a decrease of 49.1% compared with $3.03 in 2021.

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Midwest nonprofits Sanford Health, Fairview Health Services target a 58-hospital merger for 2023

Fierce Healthcare

Midwest nonprofits Sanford Health, Fairview Health Services target a 58-hospital merger for 2023. dmuoio. Tue, 11/15/2022 - 13:05.

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BLA Submitted for Lebrikizumab Atopic Dermatitis Treatment

Drug Topics

BLA submission is based on phase 3 trial results evaluating the safety and efficacy of lebrikizumab.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

Since 1991, GAMP ® – a community of practice within the International Society for Pharmaceutical Engineering (ISPE) – has set the tone for the validation practices necessary for regulated pharmaceutical companies to meet the computerized system expectations of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the World Health Organization (WHO), the Medicines and Healthcare Regulatory Agency (MHRA) in the UK, the Chinese National Medicinal Products Ad

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LSX Inv€$tival Showcase round-up

pharmaphorum

On 14th November, investors and life science & healthcare executives descended on London’s famed Old Billingsgate building to attend LSX’s Inv€$tival Showcase, part of Europe’s biggest dedicated healthcare investment week. Now in its seventh year, the Showcase gives life science and healthcare corporates the opportunity to pitch, profile, and connect with investors and partners, alongside masterclasses and dedicated 1:1 partnering.

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STAT+: More drugmakers are expanding access in poorer countries, but progress continues to lag overall

STAT

For the first time, many of the world’s largest pharmaceutical companies are taking concrete steps to widen access to their medicines in low and middle-income countries, but the poorest countries continue to be disproportionately overlooked, according to a new analysis. All 20 of the drugmakers reviewed now have an access-to-medicine strategy, up from 17 previously, and all but one company has integrated access-to-medicine strategies into their overall corporate strategies.