May, 2023

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2022 Prescription Trends

PharmExec

The market for prescription medicines in the United States was subject to major shifts in use across therapeutic areas in 2022, reflecting changes in patient health needs, the development, and availability of novel medicines, and complex market dynamics.

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Opinion: Cancer patients shouldn’t be responsible for out-of-pocket costs

STAT

In 2023, just under 2 million Americans will be diagnosed with cancer. Many will endure multiple CT and MRI studies and intensive medical care, including surgery, radiation, chemotherapy, or immunotherapy. Fortunately, advances in treatment and novel therapies have steadily improved survival following a cancer diagnosis. Cancer death rates have declined by 27% over the past 20 years.

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New PhRMA Ad Campaign Sheds Light on PBM Abuses

PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) today launched a new ad campaign that continues to shed light on the role of pharmacy benefit managers (PBMs) in driving up health care costs and denying coverage of lifesaving medicines.

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Novel Treatment Achieves Up to 14.9% Weight Loss After 46 Weeks

Pharmacy Times

BI 456906 activates the GLP-1 and glucagon receptors that help to control metabolic function, and could potentially offer clinically relevant benefits for those living with obesity or overweight without type 2 diabetes.

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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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BioNTech’s RNA vaccine sparks potential in pancreatic cancer

Pharmaceutical Technology

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez

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European biotechs choosing Switzerland as base, research shows

European Pharmaceutical Review

New research by IQVIA and recently published in the 2023 Swiss Biotech Report shows that 20 percent of European biotech companies are now headquartered in Switzerland. Sixty three out of a total of 265 companies settling in Switzerland were biotechs. This makes it the second most important sector after ICT, the research found. 2022 statistics by the Swiss federal government confirm that the trend to base here is continuing.

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STAT+: Addiction treatment center founder indicted in sprawling fraud scheme

STAT

Over the last few years, Daniel Cleggett Jr. appeared to be living a charmed life. The founder of a small Boston-area   addiction treatment empire knew he was under scrutiny; the Globe and STAT News  published investigations  in 2017 and 2019 into his questionable business dealings, and the Massachusetts attorney general’s office announced   shortly after that   it was examining alleged scams involving addiction treatment.

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Americans want state policymakers to lower out-of-pocket costs

PhRMA

Too many Americans are struggling to access and afford their health care. While policy debates about how to address these issues can seem never ending, American adults largely agree on what state policymakers should be doing to help deliver relief to patients at the pharmacy counter.

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Novavax’s COVID-19 Vaccine Demonstrates Efficacious, Safe Response in Adolescents

Pharmacy Times

Analysis shows that the ratio of neutralizing antibody geometric mean titers in adolescents compared with young adults was 1.5 after vaccination with NVX-CoV2373.

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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.

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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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Kaiser Permanente discloses timeline, financial commitments for its VBC megadeal with Geisinger Health

Fierce Healthcare

Kaiser Permanente discloses timeline, financial commitments for its VBC megadeal with Geisinger Health dmuoio Tue, 05/16/2023 - 12:40

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Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25

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‘Stunning’ change to United’s colonoscopy coverage roils physicians and patients

STAT

When gastroenterologists learned in March that UnitedHealthcare plans to barricade many colonoscopies behind a controversial and complicated process known as prior authorization, their emotions cycled rapidly between fear, shock, and outrage. The change, which the health insurer will implement on June 1, means that any United member seeking surveillance and diagnostic colonoscopies to detect cancer will first need approval from United — or else have to pay out of pocket.

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Can GLP-1 obesity therapy restore NK cell function?

European Pharmaceutical Review

NK cell functionality was restored in participants following gold-standard pharmacological obesity GLP-1 analogue treatment, according to a study published in Obesity. This may contribute to the benefits reported with these medications in people with obesity, the data showed. Reducing the risk of cancer in obese individuals Boosting function of NK cells Previous research has found that people with obesity are at higher risk for developing cancer.

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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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Lipid Nanoparticles Could Be Effective Carriers for mRNA Vaccines for Viral Lung Infections

Pharmacy Times

Nanoparticles could improve the solubility of drugs, aid in treatment escape from the immune system, and increase the half-life of drugs in the circulatory system against viral lung infections such as influenza, coronavirus, and respiratory syncytial virus.

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SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine

Pharmaceutical Technology

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.

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Missouri nonprofit health systems BJC HealthCare, Saint Luke's targeting $10B merger

Fierce Healthcare

BJC HealthCare of St. | The two organizations are hoping to close their cross-market deal by the end of the year, potentially creating a new 28-hospital, integrated, academic health system.

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Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type

Fierce Pharma

Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type aliu Wed, 05/17/2023 - 09:41

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STAT+: Pear Therapeutics sold for parts at $6 million auction

STAT

Four different companies agreed to buy the assets of Pear Therapeutics at auction on Thursday morning after the digital health company filed for bankruptcy last month. Click Therapeutics, Welt Corp, Harvest Bio, and Nox Health Group each acquired bits of the company for $6.05 million, far short of the $32 million in debt Pear carried. A hearing to approve the sale will be held on May 22.

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A CEO’s quest to solve a 400-year-old medical mystery — and he’s also a patient

PharmaVoice

The CEO of Ventoux Biosciences has the disease that his company is aiming to treat, and it's driving him to find better medications.

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Variation in Psoriasis Treatment Regimens Come at a Cost

Pharmacy Times

Due to the disease’s chronicity, the variability in treatment response and drug safety profiles, and the availability of multiple therapies, switching or discontinuing treatments is common in psoriasis.

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XtalPi announces $250m AI drug discovery collaboration with Eli Lilly

Pharmaceutical Technology

XtalPi has made a partnership deal with US-based Eli Lilly to leverage artificial intelligence (AI) for drug discovery. XtalPi will receive $250m in upfront and milestone payments. The two companies will use XtalPi’s integrated AI capabilities and robotics platform for the de novo [without consideration of previous instances] design and delivery of drug candidates for an undisclosed target.

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Employers hope to weather inflation without shifting healthcare costs to workers: survey

Fierce Healthcare

Employers are bracing for 2024, fearing they’ll face inflation and soaring healthcare costs while still trying to recruit and retain workers in a tight labor market, a new survey shows. | Employers got something of a break last year from inflation when it comes to healthcare costs because most contracts with providers last three years. A survey by the consulting company Mercer says they won’t be so lucky in 2024.

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Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis

Fierce Pharma

Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis zbecker Mon, 05/22/2023 - 14:43

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What explains rare heart condition among young men after Covid vaccines? A new study offers clues

STAT

A new study sheds light on what may be causing very rare cases of heart inflammation in young men after receiving an mRNA Covid vaccine. Early hypotheses as to what was driving the heart inflammation, called myocarditis , included an allergic response to the vaccine, vaccine-induced antibodies, or an autoimmune response in which the immune system attacks the body’s own healthy tissue by mistake.

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Big Pharma inventory management trends revealed

European Pharmaceutical Review

The inventory position of 28 major pharmaceutical manufacturers in 2022 has been revealed in an annual report. Analysis explored the impact of macro-trends on inventory management from corporate reports of Big Pharma companies including Merck, AstraZeneca and Pfizer. It investigated how excessive inventories are affecting the industry and what factors could influence inventory growth in 2023.

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AI, Machine Learning Improve Patient Care, Can Empower Health Care Professionals

Pharmacy Times

There are still significant unresolved issues in artificial intelligence and machine learning, which must be addressed before they can be safely and effectively used more broadly in medicine.

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The emergence of tranq amidst the fentanyl crisis

Pharmaceutical Technology

In February, the FDA issued an alert restricting the import of the veterinary sedative xylazine or tranq and the ingredients used to make the drug. This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet. According to a June 2022 study, xylazine has been detected in the illicit drug supply in 36 US States, and the DEA has reported that approximately 30% of the f

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Cybersecurity attack against Amazon-owned online pharmacy PillPack exposed user health data

Fierce Healthcare

Cybersecurity attack against Amazon-owned online pharmacy PillPack exposed user health data aburky Fri, 05/19/2023 - 16:16

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ImmunoGen touts 'home run' as ovarian cancer drug Elahere extends lives in landmark trial win

Fierce Pharma

ImmunoGen touts 'home run' as ovarian cancer drug Elahere extends lives in landmark trial win aliu Wed, 05/03/2023 - 14:50

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STAT+: In its first tough test, CRISPR epigenome editing cuts cholesterol levels in monkeys

STAT

A defanged form of CRISPR, which doesn’t slice or nick DNA, but rather alters the epigenome — the layers of chemical coding that sit on top of DNA and control the activity of genes — has aced its first substantive test. When researchers used CRISPR “ epigenome editing ” to dial down a cholesterol-associated gene in monkeys, the animals’ blood levels of heart-disease-causing LDL, or “bad” cholesterol, plummeted by more than 50%, Jennifer Kwo

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Walgreens reaches $230M opioid settlement with San Francisco

Drug Store News

In a statement, Walgreens said it "disputes liability" and did not admit fault, but settling allows it to focus on patients, customers and communities.

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Novavax’s COVID-Influenza Combination Vaccine Demonstrates Reassuring Preliminary Safety Profile

Pharmacy Times

Investigators of the phase 2 study also found a comparable reactogenicity to the individual influenza and COVID-19 vaccines from Novavax or authorized vaccine comparators.

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Astellas Pharma agrees to buy Iveric bio for about $5.9bn

Pharmaceutical Technology

Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share. Both the companies’ Boards of Directors have unanimously approved the deal.

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