STAT

JUNE 9, 2023

Expert advisers to the Food and Drug Administration on Friday voted unanimously in favor of expanding the approval of Leqembi, an Alzheimer’s disease treatment from Eisai and Biogen, further clearing the way for what could be the first widely available medicine that delays the disease’s progress. The group voted 6-0 that an 1,800-patient study of Leqembi confirmed its benefits for patients in the early stages of Alzheimer’s, recommending the FDA widen the drug’s

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Hospitals Drug Development 348

PharmaVoice

JUNE 9, 2023

The CEO of Sunstone Therapies said the results of a recent trial testing psilocybin in cancer patients with depression were “remarkable.

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STAT

JUNE 9, 2023

Heart monitoring company iRhythm is in hot water with the Food and Drug Administration, which issued a stern warning letter to the device maker this week for marketing its product for “high risk” patients and changing its algorithm without seeking the FDA’s permission. The letter highlights FDA’s growing scrutiny of digital health and patient monitoring tools — as well as the grave impacts even small device glitches can have on patients.

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BioPharma Dive

JUNE 9, 2023

The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.

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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 9, 2023

The scientific paper inspired international headlines with its bold claim that the combination of brain scans and machine learning algorithms could identify people at risk for suicide with 91% accuracy. The promise of the work garnered lead author Marcel Adam Just of Carnegie Mellon University in Pittsburgh and co-author David Brent of the University of Pittsburgh a five-year, $3.8 million grant from the National Institute of Mental Health to conduct a larger follow-up study.

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BioPharma Dive

JUNE 9, 2023

In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

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Pharmaceutical Technology

JUNE 9, 2023

WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University.

Vaccines 107

Vaccines 107

STAT

JUNE 9, 2023

In 2017, the Massachusetts state Legislature passed a law to ensure ease of access to birth control. It says there should be no copay for hormonal birth control prescriptions. It also allows women to fill a 12-month prescription at once. Infertility care has similar protections. The state mandates that plans cover “ medically necessary expenses of diagnosis and treatment of infertility ” if the insurance provides other pregnancy-related benefits.

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Pharma Times

JUNE 9, 2023

Erdafitinib boosted survival in patients with certain conditions including metastatic urothelial carcinoma - News - PharmaTimes

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STAT

JUNE 9, 2023

FRANKFURT — Updated results released Friday highlighted the lasting benefits of a CRISPR-based medicine for blood disorders developed by Vertex Pharmaceuticals and CRISPR Therapeutics, as the treatment awaits regulatory decisions in the United States and Europe.   The treatment, a one-time infusion known as exa-cel, uses CRISPR to fix the genetic faults at the root of sickle cell disease and beta thalassemia.

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Pharmacy Management

BioPharma Dive

JUNE 9, 2023

CMS named 43 Part B drugs for which prices rose more than inflation, and which will have lower coinsurance rates next quarter as a result.

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STAT

JUNE 9, 2023

In May, a National Public Radio story asked , “Can a chatbot help people with eating disorders as well as another human?” It focused on a chatbot that we developed to prevent eating disorders and help people with body image concerns and who are otherwise not likely to have access to other resources. We’ve committed our careers to increasing detection of eating disorders and access to care, and we received research funding from the National Eating Disorders Association (NEDA)

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Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% to treat the signs and symptoms of dry eye disease. VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.

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STAT

JUNE 9, 2023

WASHINGTON — After getting burned by the high-profile implosion of a digital health company, a senior official at Oklahoma’s Medicaid program said the state would be hesitant to buy into similar products again. “I don’t want to say we’re not receptive,” Terry Cothran, the senior pharmacy director at Oklahoma Health Care Authority said at the Digital Therapeutics Alliance’s summit this week.

Hospitals 225

Hospitals 225

PharmExec

JUNE 9, 2023

The new era of generative AI is poised to impact pharma marketing and engagement in powerful and lasting ways. But amid all the technological praise, what are the key considerations brand teams must navigate?

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STAT

JUNE 9, 2023

The Food and Drug Administration is convening a meeting of outside experts on Friday to consider full approval for Leqembi, the Alzheimer’s treatment made by Eisai and Biogen. Leqembi was granted conditional approval in January based on preliminary evidence showing it could eliminate toxic brain plaques from people diagnosed with early-stage Alzheimer’s.

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PharmExec

JUNE 9, 2023

The core building blocks of trust must be operationalized for pharma companies to strengthen their social contract, deliver business value, and improve patients’ quality of life.

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STAT

JUNE 9, 2023

Editor’s Note: A livestream of the event will be embedded below on Monday, June 12 at 1 p.m. ET Running a successful clinical trial is as much about execution as science, as companies and researchers must nail operational details from picking the right trial sites to ensuring patients remain in the study. How can you tell which studies are best positioned to end on time with high-quality data?

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European Pharmaceutical Review

JUNE 9, 2023

Samsung Biologics, the South Korean contract development and manufacturing organisation (CDMO), has entered into a strategic partnership for the long-term commercial manufacturing of Pfizer’s multi-product biosimilars portfolio. Under the deal, Samsung Biologics said it will provide Pfizer with “additional capacity for large-scale manufacturing of a multi-product biosimilars portfolio covering oncology, inflammation, and immunology.

Biosimilars 94

Biosimilars 94

STAT

JUNE 9, 2023

FRANKFURT, Germany — Even as other cutting-edge genetic therapies for sickle cell disease move closer to approval, the CRISPR company Editas Medicine believes there is still a need and a commercial opportunity for its treatment, which remains further behind in development. On Friday, Editas offered a preliminary update on the handful of patients who’ve received its gene-editing-based therapy for sickle cell, which is also being tested for another blood disorder, beta thalassemia.

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Drug Development 200

The Pharmacist

JUNE 9, 2023

Updated service specifications outlining how pharmacy technicians can deliver NHS blood pressure check and smoking cessation services have been published this week. Pharmacy technicians have been legally permitted to perform pressure checks as part of the hypertension case-finding service and deliver the smoking cessation service since 28 March. But the updated service specifications had to […] The post Pharmacy technician service specifications published appeared first on The Pharmacist.

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Pharmacy Technician 91

STAT

JUNE 9, 2023

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we plan to promenade with the official mascots, attend a soiree, and hold the de rigueur listening party, which will likely include this , this , this and this in the rotation.

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Documentation Vaccines 183

The Pharmacist

JUNE 9, 2023

Taking a step back and enabling others to help in the workplace were key lessons learned by a pharmacy business manager who won a reality TV competition in which she raced across Canada. But while Cathie Rowe (Left) had hoped the experience had made her re-evaluate her work-life balance, she said the busy workload in […] The post Return to busy pharmacy for Race Across the World winner appeared first on The Pharmacist.

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STAT

JUNE 9, 2023

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.   That’s right. Send us your changes, and we’ll find a home for them.  Don’t be shy. Everyone wants to know who is coming and going. However, we are interrupting our usual programming to note that we will return with a featured person next week.

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Pharma Times

JUNE 9, 2023

International data questions the assumption that chronic myeloid leukaemia is now a ‘solved’ disease - News - PharmaTimes

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European Pharmaceutical Review

JUNE 9, 2023

Telix Pharmaceuticals has opened a new radiopharma production facility in the Wallonia region of Belgium, which will serve as the company’s primary manufacturing site for radioisotopes and commercial and clinical products. The 2,800 square metre plant – Telix Manufacturing Solutions – is one of Europe’s largest radiopharmaceutical production facilities, Telix said.

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PharmExec

JUNE 9, 2023

Amid the shifting focus from primary care to specialty care, using data-driven tactics can create tailored campaigns and meaningful relationships with nurse practitioners and physician assistants.

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Big Molecule Watch

JUNE 9, 2023

As we have previously reported , Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, in the Northern District of West Virginia. On April 20 th , both parties filed motions for summary judgment. Regeneron requested summary judgment of nonobviousness on U.S.

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Biosimilars 73

World Pharma News

JUNE 9, 2023

In a new study published in The Lancet Infectious Diseases, University of Minnesota researchers found that metformin, a drug commonly used to treat diabetes, prevents the development of long COVID. The study, called COVID-OUT, investigated if early outpatient COVID-19 treatment with metformin, ivermectin or fluvoxamine could prevent long COVID. Long COVID is a chronic illness that can affect up to 10% of people who have had COVID-19.

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Diabetes 78

PharmExec

JUNE 9, 2023

Jag Dosanjh, president of US neuroscience and eye care for AbbVie and HBA’s 2023 honorable mentor of the year, shares what leadership qualities are most important in today’s “people industry”—and the impact more voices can make in stakeholder communication and messaging.

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Communication 98

BioPharma Dive

JUNE 9, 2023

The positive panel vote for AstraZeneca and Sanofi’s treatment is the latest development a flurry of regulatory activity that’s brought forward new options for preventing RSV-related respiratory disease.

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pharmaphorum

JUNE 9, 2023

One size does not fit all: Why a shift is needed in how we treat depression Mike.

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Pharmacy Times

JUNE 9, 2023

The study will assess the use of the drug to treat impaired social motivation, or asociality, which is a difficult-to-treat symptom of schizophrenia that can cause significant functional impairment.

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Pharmaceutical Technology

JUNE 9, 2023

Clinical-stage biotech company Upstream Bio has raised $200m in a Series B financing round to advance its UPB-101 to treat allergic and inflammatory diseases. Co-led by Venrock Healthcare Capital Partners (Venrock) and Enavate Sciences, the financing round has seen participation from new investors Wellington Management and Bain Capital Life Sciences.

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pharmaphorum

JUNE 9, 2023

Developing bold medicines to preserve vision and transform the treatment landscape for DME Mike.

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