PhRMA

JUNE 27, 2023

On May 11th of this year, the COVID-19 national public health emergency (PHE) officially ended, marking an incredible milestone in the fight against COVID-19. While the end of the PHE signals a new chapter in the fight against COVID-19, the biopharmaceutical industry’s work continues to ensure our health care system is well-prepared for any curve balls this virus might throw as well as staying ahead of the next pandemic.

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Vaccines 225

STAT

JUNE 27, 2023

WASHINGTON — Grail is aggressively lobbying to get Medicare to pay for its cancer-screening test Galleri — but experts tell STAT that the company has a far more complicated path to that end than the makers of most medicines or medical devices. Grail’s controversial blood test Galleri screens for multiple cancers. The Food and Drug Administration has not yet approved it, so Medicare hasn’t had to make a decision on whether to cover it or not.

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FDA 145

Fierce Pharma

JUNE 27, 2023

AbbVie recently filed a patent infring | AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert.

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Pharmacy Times

JUNE 27, 2023

Race, ethnicity, years after diagnosis and mental and physical stress are among factors associated with unmet supportive care needs and a higher risk of hospitalization among patients with cancer.

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Hospitals 123

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.

STAT

JUNE 27, 2023

WASHINGTON — Hundreds of activists rallied today outside of the headquarters of the country’s largest health insurance lobbying group to protest against restrictions to coverage in private Medicare plans. The protesters were crammed into an already busy part of the city. A 10-minute walk from the Capitol building and a block off the National Mall, the headquarters for America’s Health Insurance Plans is located in a part of Washington that is crowded with tourists during the

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Insurance 120

Pharmacy Times

JUNE 27, 2023

The findings suggest that the research conducted will be useful in enhancing the development of the HIV vaccine and can also be used to improve other viral pathogens.

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Vaccines 123

Drug Topics

JUNE 27, 2023

Barriers that continue to exist include the challenges of recruiting exceptional pharmacists and the changing landscape of therapies for dermatologic conditions.

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Fierce Healthcare

JUNE 27, 2023

Medicare Advantage (MA) beneficiaries given home-delivered meals in the four weeks after being discharged from a hospital were not only less likely to be readmitted within 30 days, they were also l | Kaiser Permanente Southern California found that a meal delivery program for Medicare Ad-vantage beneficiaries cut mortality rates, and improved outcomes overall, according to a study in JAMA Health Forum.

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Hospitals 110

Fierce Pharma

JUNE 27, 2023

This has been a second straight year of regulatory struggles in the United States for UCB with one of the those issues revolving around the FDA needing additional time to

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FDA 110

Drug Topics

JUNE 27, 2023

The most frequently prescribed weight loss medication was semaglutide (Ozempic), followed by liraglutide (Saxenda), and dulaglutide (Trulicity).

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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.

FDA

Fierce Pharma

JUNE 27, 2023

Despite Regeneron’s impressive high-dose Eylea data, its high-stakes launch is delayed thanks to an unexpected FDA rejection. | In a surprise decision, the FDA issued powerhouse Eylea's high-dose version a complete response letter. But the company said it has nothing to do with the drug's efficacy or safety.

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FDA 105

Fierce Healthcare

JUNE 27, 2023

Drugstore chain Walgreens reported third-quarter sales were up nearly 9% to reach $35.4 million, but the company slashed its profit outlook for the year as it faces lower consumer spending and a dr | Drugstore chain Walgreens reported third-quarter sales were up nearly 9% to reach $35.4 million, but the company slashed its profit outlook for the year as it faces lower consumer spending and a drop in COVID-19 tests and vaccines.

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Vaccines 104

Fierce Pharma

JUNE 27, 2023

Eli Lilly is no stranger to age discrimination claims. | Eli Lilly will pay out $2.4 million as part of a settlement agreement with the U.S. Equal Employment Opportunity Commission, which sued the company in September over claims it had changed its hiring preferences in 2017 to prioritize recruitment of more millennials to its workforce.

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Drug Topics

JUNE 27, 2023

Immune-checkpoint inhibitors were comparably safe and effective in patients with chronic hepatitis B or occult hepatitis B infection.

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Immunization 98

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European Pharmaceutical Review

JUNE 27, 2023

Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. Recent developments in microbiome therapeutics In May this year, first-in-human study interim results revealed that a CRISPR-based microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”.

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Chemotherapy Immunization FDA Vaccines 103

STAT

JUNE 27, 2023

A year after two major drugmakers sued a wholesaler for its alleged role in distributing counterfeit HIV pills, the U.S. Food and Drug Administration warned the wholesaler for failing to ensure that “suspect” medicines did not enter the marketplace. In a June 8 letter, the agency rebuked Safe Chain Solutions for violating a federal law designed to bolster the integrity of the pharmaceutical supply chain.

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FDA 102

Pharmacy Times

JUNE 27, 2023

Drug shortages are a common issue in the health care industry. Florida Cancer Specialists & Research Institute (FCS) is highly skilled at proactively managing the drug supplies it needs to care for patients.

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Chemotherapy Patient Care 94

STAT

JUNE 27, 2023

Sometimes, an apple a day really is just what the doctor ordered. And for the past several years, organizations like About Fresh , the Boston-based nonprofit where I work, have been developing tools to make such produce prescriptions possible for those who can’t afford the fresh fruits and vegetables they need. Since January 2021, we have enrolled more than 4,101 Medicaid members in our Fresh Connect produce prescription program, and to date they have spent nearly $2.8 million on the fres

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Fierce Pharma

JUNE 27, 2023

Diabetes patients in the United Kingdom may have to wait a bit longer to get their hands on Eli Lilly’s Mounjaro after the country’s drug value watchdog kiboshed its coverage recommendation. | England’s National Institute for Health and Care Excellence (NICE) on Tuesday said more evidence is needed on the clinical efficacy and cost-effectiveness of Mounjaro, also known as tirzepatide, before the health technology assessor can recommend Lilly's dual GIP/GLP-1 drug for use by the country’s Na

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STAT

JUNE 27, 2023

Finding a new medicine is never easy. But developing treatments for patients with rare diseases — conditions that afflict fewer than 200,000 people in the United States — is particularly challenging. When there are only a few thousand or even a few hundred people living with a particular condition, finding enough patients for clinical trials can take years.

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Drug Topics

JUNE 27, 2023

Nearly two-thirds of individuals with T2D eventually develop atherosclerotic cardiovascular disease in the United States.

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European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. This follows FDA clearance of the Investigational New Drug (IND) application, enabling expansion to the US of the ongoing Phase Ib/II ABATE study of ACI-24.060 in Alzheimer’s patients and individuals with Down’s syndrome.

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Vaccines Immunization FDA 98

STAT

JUNE 27, 2023

The makers of minimally invasive surgical devices seemed poised to capture a wide swath of the obesity treatment market. Patients needed an option that lay between the two treatment extremes: cutting open the abdomen to perform permanent bariatric surgery, or changing your diet or exercise routine. Then, a new class of weight loss medications that successfully mimic the feeling of fullness hit the market, and the landscape changed.

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Fierce Pharma

JUNE 27, 2023

Swiss skincare company Galderma is keeping its eyes on a highly anticipated initial public offering (IPO) after scooping up around $1 billion in private placement funding for newly issued shares.

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STAT

JUNE 27, 2023

Early this spring, dozens of volunteers fielding requests from people struggling with eating disorders — many of whom call amid mental health crises — received surprising and abrupt news: Their service at the National Eating Disorders Association would end within weeks. In their place, the nonprofit would offer an AI chatbot called Tessa.

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European Pharmaceutical Review

JUNE 27, 2023

Lonza and Vertex Pharmaceuticals Incorporated have agreed to collaborate to support the manufacture of Vertex’s Type 1 diabetes cell therapy portfolio. The companies will partner in the process development and manufacturing scale-up at a new, large-scale facility in Portsmouth, New Hampshire, US. Operated by Lonza, the 130,000 square foot facility is anticipated to create up to 300 new jobs at peak capacity.

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Immunization 97

STAT

JUNE 27, 2023

Dear Readers, Today is an important day in the history of STAT: We have refreshed the look of our homepage and adjusted the teal color that has been synonymous with STAT since we launched nearly eight years ago.

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Pharmacy Times

JUNE 27, 2023

The NCPA Convention will be held from October 14, 2023 through October 17, 2023, in Orlando, Florida.

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The Checkup by Singlecare

JUNE 27, 2023

If you’re trying to prevent pregnancy, you’re probably using some form of birth control, or contraception. Birth control is any medication, device, method, or surgical intervention that stops a pregnancy before it begins. There are many kinds—from condoms to oral contraceptives and vaginal rings. If you’re on a hormonal form of birth control like the patch, ring, or the pill, it’s important to know that some medications can make your contraceptive less effective.

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Pharmaceutical Commerce

JUNE 27, 2023

In an interview at the DIA Global Annual Meeting with Pharma Commerce Editor, Nicholas Saraceno, Cal Collins, CEO of OpenClinica discusses impacting the broader supply chain.

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Fierce Healthcare

JUNE 27, 2023

What should we take away from the controversy surrounding Bud Light’s marketing campaign featuring transgender influencer Dylan Mulvaney? | We assert that healthcare organizations have an obligation to put members of the LGBTQ+ community at the heart of their business strategies.

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Drug Store News

JUNE 27, 2023

The U.S. retail pharmacy segment had third quarter sales of $27.9 billion, an increase of 4.4% from the year-ago quarter, while comparable sales increased 7% from the year-ago quarter.

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STAT

JUNE 27, 2023

SAN DIEGO — It was Novo Nordisk’s Ozempic and Wegovy that set off a new era in obesity medicine, delivering unprecedented levels of weight loss and working its way into popular culture, inescapable ads, and hundreds of thousands of medicine cabinets. But Eli Lilly has been following close behind with new treatments, and after dropping result after result from successful trials at the American Diabetes Association conference here this past weekend, the Indianapolis-based drugmaker l

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European Pharmaceutical Review

JUNE 27, 2023

Included in this issue of European Pharmaceutical Review : FOREWORD Nitrosamines: the beginning of the end? David Elder, David P Elder Consultancy MANUFACTURING Meeting rising demands of a new radiotheranostic era Leila Jaafar-Thiel, Nuclidium AG Developing point‑of-care CAR T manufacturing Arnon Nagler, Sheba Medical Center and Tel Aviv University IN-DEPTH FOCUS: FORMULATION Titanium dioxide (E171) and its role in formulation Mike Tobyn, Bristol Myers Squibb, Jonathan Kaye, GSK David Harris

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