STAT

JUNE 20, 2024

In 2012, the Elsevier journal Personality and Individual Differences published a special issue that included articles with titles like “Life history theory and race differences: An appreciation of Richard Lynn’s contribution to science” and “National IQs and economic outcomes.” At a celebratory dinner at the Oxford and Cambridge Club in London, contributors to the issue awarded Lynn a ceremonial sword and a pair of horns.

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Pharmacy Times

JUNE 20, 2024

Ambient-UVB radiation could improve 25(OH)D prediction in the future, improving widespread vitamin D deficiencies among non-White individuals.

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STAT

JUNE 20, 2024

Gilead said Thursday that twice-a-year injections of a new antiviral drug, called lenacapavir, completely protected cisgender women from contracting HIV in a large Phase 3 trial. In the study, none of the 2,134 women who received lenacapavir contracted HIV. By comparison, 16 of the 1,068 women who received the long-running daily pill Truvada contracted HIV.

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Fierce Pharma

JUNE 20, 2024

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Patient Care

STAT

JUNE 20, 2024

Change Healthcare is beginning the process of notifying a “substantial proportion” of Americans that their private information, such as Social Security numbers and medical diagnoses, was compromised in the cyberattack that brought portions of the U.S. health care system to a halt earlier this year. On Thursday, Change will begin to notify health care providers, insurance companies, and other customers that their patients’ data was stolen in the company’s February cybe

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Insurance 144

Fierce Healthcare

JUNE 20, 2024

UnitedHealthcare is offering a look at the impacts its Level2 diabetes program is having on members. | UnitedHealthcare unveiled the program in 2020. Level2 provides members with multiple connected devices they can use to manage Type 2 diabetes, including a continuous glucose monitor and activity tracker.

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Fierce Pharma

JUNE 20, 2024

There’s no slowing the momentum of Sarepta’s groundbreaking Duchenne muscular dystrophy (DMD) gene therapy Elevidys—not even the failure of a confirmatory trial. | The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. It’s a major boost for the first gene therapy to treat the inherited disorder, which received an accelerated approval a year ago—nearly to the date—but only for ambulatory boys ages 4 to 5.

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Labelling FDA 126

STAT

JUNE 20, 2024

The Food and Drug Administration on Thursday approved Elevidys, Sarepta’s gene therapy for Duchenne muscular dystrophy, for nearly all patients with the fatal muscle-wasting disease, dramatically expanding the initial, narrow authorization handed down last year. The decision will likely be greeted by many families and doctors as a turning point in the fight against the muscle-wasting disease, even if it’s not nearly the seismic shift some had hoped for just a couple of years ago.

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FDA 142

Fierce Pharma

JUNE 20, 2024

Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. | Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs. The Indianapolis-based drugmaker is suing six wellness centers, medical spas and others that it claims are using "deceptive" advertising.

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Compounding 122

STAT

JUNE 20, 2024

For a third time, Sarepta Therapeutics has convinced a top Food and Drug Administration official to overrule the prevailing view of their staff and approve a drug for Duchenne muscular dystrophy. On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year.

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FDA Documentation 141

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.

Fierce Pharma

JUNE 20, 2024

In May, Johnson & Johnson touted the success of its intraven | After touting the success of its intravenous (IV) formulation of Tremfya in two head-to-head trials against its own Stelara in Crohn’s disease, Johnson & Johnson has shown the success of a subcutaneous (SC) version of Tremfya in another Crohn's disease study.

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STAT

JUNE 20, 2024

A coalition of researchers, historians, and journalists is urging that major scientific publishers, including Elsevier and Springer, retract the racist articles of an academic known — and sometimes lauded for — a long career espousing ideas of racial superiority and eugenics. The call for retraction, made Thursday in a First Opinion published in STAT, focuses on hundreds of papers published by the late Richard Lynn of the University of Ulster, who has described “the decay of

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pharmaphorum

JUNE 20, 2024

International Society for Infectious Diseases (ISID) publishes six priorities focusing on challenges faced by low- and middle-income countries (LMICs).

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STAT

JUNE 20, 2024

When they work, immunotherapy drugs called checkpoint inhibitors can shrink cancers and, in some cases, eradicate tumors altogether. These drugs, which include Keytruda and Opdivo, are prescribed to hundreds of thousands of patients a year for dozens of different kinds of cancer — but they only work for a minority of them. Most patients ultimately end up progressing or relapsing.

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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

pharmaphorum

JUNE 20, 2024

Discover how AI-powered analytics are revolutionising life sciences marketing. Learn how to leverage these cutting-edge technologies to drive insights and success in the industry.

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STAT

JUNE 20, 2024

Gestational diabetes affects one in seven expecting women globally and rates of this troubling condition are rising. Blood glucose levels that become elevated for the first time during pregnancy can lead to severe complications, such as preeclampsia, and increase the risk of stillbirth. And while the condition typically resolves after birth, it is linked to a tenfold increase in the risk of developing type 2 diabetes, along with risks for the child including obesity, cardiovascular disease, and

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Fierce Pharma

JUNE 20, 2024

On a revised dealmaking spree this year, Korea’s Samsung Biologics is re-tooling its long-running drug manufacturing pact with Baxter Healthcare. | The revised deal, first established back in July of 2017, will now see Baxter pay Samsung upwards of $223 million for its manufacturing services through end of 2034. Previously, Baxter was on the hook to pay just $15 million for Samsung’s production assistance.

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STAT

JUNE 20, 2024

The non-alcoholic beverage market is booming right now : zero-proof bottle shops and bars are popping up across the country ; a non-alcoholic beer brand is even taking over as the top selling beer at Whole Foods. And the Olympic Games have their first beer sponsor , courtesy of alcohol-free Corona Cero. While it’s great that more people are taking to heart public health messages that reducing alcohol consumption can improve well-being and extend life , an important lesson from vaping as a

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Pharmacy Management Software

pharmaphorum

JUNE 20, 2024

Sarepta gets best-case approval from the FDA for an expansion to the label for its Duchenne muscular dystrophy gene therapy Elevidys.

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Labelling FDA 111

STAT

JUNE 20, 2024

After months of haggling, Vertex Pharmaceuticals and the National Health Service in England reached agreement over access to several cystic fibrosis treatments, capping an end to a long-running saga that frequently enraged patients and families who sought the treatments. Specific details were not released, but the deal was announced after a U.K. cost-effectiveness watchdog decided to recommend the Vertex medicines for coverage by the NHS.

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pharmaphorum

JUNE 20, 2024

AbbVie’s Skyrizi is approved by the FDA for ulcerative colitis, making it the first IL-23 inhibitor indicated for both major types of inflammatory bowel disease.

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FDA 111

STAT

JUNE 20, 2024

Zealand Pharma on Thursday reported early positive results of an investigational obesity drug that activates a hormone that’s not targeted by popular treatments Wegovy and Zepbound. In one part of a Phase 1b study, petrelintide, which targets the amylin hormone, led to 8.6% weight loss at 16 weeks, more than the 1.7% weight loss among patients taking placebo, the Danish company said.

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Fierce Pharma

JUNE 20, 2024

After plugging nearly 50 million euros into its Italy operations in the first half of the decade, Johnson & Johnson Innovative Medicine is significantly upping its commitment to the country.

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STAT

JUNE 20, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. Here in Chicago, temperatures are high and tensions are even higher as two major hot dog restaurants are  reportedly beefing. Apparently PETA is involved and taunted one of the restaurants with a “pig mobile” even though that restaurant doesn’t even serve pork.

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FDA 125

Pharmacy Times

JUNE 20, 2024

Ryan Haumschild discusses the evolving treatment landscape for patients with multiple myeloma.

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STAT

JUNE 20, 2024

BEVERLY HILLS, Calif. – When Amanda Rees was in her twenties she moved in with her grandmother, who was in her 80s, and saw first-hand the issues older adults face with falls and balance. “It really radicalized how I thought about aging,” she said. Serving as her grandmother’s caretaker inspired her to shift into health care and start Bold , a health tech startup that provides at-home digital exercise programs targeted at adults 65 and older.

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Hospitals 123

Fierce Pharma

JUNE 20, 2024

Everybody sweats, but for the 10 million people in the U.S. living with primary axillary hyperhidrosis, sweating can take on a whole new meaning. | The med is the first new chemical entity to win FDA approval specifically to treat primary axillary hyperhidrosis, or excessive underarm sweating. It's also Botanix's first approved product.

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FDA 110

STAT

JUNE 20, 2024

Rise and shine, everyone, another hot day is on the way. The forecast – at least on this side of the pond – is warning us to find some shade. So to prepare, we are grabbing a parasol and, naturally, brewing a few cups of stimulation to see us through. Our choice today is orange creme. No matter the weather, though, there is work to be done.

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Compounding FDA 118

pharmaphorum

JUNE 20, 2024

After rejection of its multiple myeloma therapy Sarclisa by NICE, Sanofi claims the drug would not have been deemed cost-effective 'even at zero price'

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STAT

JUNE 20, 2024

BOSTON — Ginkgo Bioworks, the once-high-flying Boston life sciences firm, on Thursday said it has notified 158 employees that they will be laid off and expects to announce another batch of layoffs next week. On May 9, Ginkgo said it would slash labor costs by at least 25 percent. But the Boston-based cell programming and biosecurity company declined to specify the number of workers who would be let go.

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pharmaphorum

JUNE 20, 2024

Vanda Pharma is unimpressed with takeover offers from Cycle Pharma and Future Pak, saying they both substantially undervalue the company

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STAT

JUNE 20, 2024

This is the online edition of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here  to get it delivered every Thursday to their inbox. The outcome of the HELIOS-B study — expected at the end of June or early July — is an enormous stock-moving event for Alnylam Pharmaceuticals. Billions of dollars in potential revenue — sufficient to power Alnylam into profitability — are on the line.

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Pharmacy Times

JUNE 20, 2024

Additionally, the high cost of the cell therapy raises concerns for broader access.

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