Drug Topics

JUNE 29, 2023

The approval was based on safety and efficacy data from 30 participants in 2 open-label, single-arm studies that received 1 to 3 infusions of donislecel.

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Labelling FDA 187

Pharmacy Times

JUNE 29, 2023

Yet, physicians and advanced practice practitioners may have a limited understanding of the scope of an ambulatory pharmacy clinic and the value a clinical pharmacist can provide.

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Drug Topics

JUNE 29, 2023

The increase is expected to be somewhat offset by the impact of biosimilars coming to market and more care being provided in outpatient settings.

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Fierce Pharma

JUNE 29, 2023

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder. | After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.

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FDA 139

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.

Pharmacy Times

JUNE 29, 2023

The impact of pharmacist on reducing medication expenses cannot be overstated as they leverage their medication management expertise within hospital settings through collaboration with the 340B program.

Hospitals 123

Hospitals 123

STAT

JUNE 29, 2023

Medical leaders on Thursday reacted swiftly to the Supreme Court’s decision to severely restrict the use of race in college admissions, saying the ruling could reverse decades of progress toward diversifying the nation’s physician workforce — something seen as key to helping end the country’s widespread and deeply entrenched health disparities.

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Medical Schools 125

Fierce Pharma

JUNE 29, 2023

A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. | After a December FDA inspection revealed a principal trial investigator skirted several study protocols, BioXCel found forged emails making it out that the site had properly adhered to reporting requirements for adverse events.

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FDA 124

Pharmacy Times

JUNE 29, 2023

Investigators found that the first biosimilar of trastuzumab, trastuzumab-anns (Kanjinti; Amgen), did maintain a strong and persistent advantage over the other 4 biosimilar entrants.

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STAT

JUNE 29, 2023

Overturning decades of precedent, the U.S. Supreme Court on Thursday struck down the use of affirmative action, ruling that it is unconstitutional for colleges, universities — and professional schools for law, medicine, and nursing — to consider race as one factor in deciding who they will admit. The decision comes as a blow to many in the field of medicine, which has been unable to appreciably increase the numbers of Black, Hispanic, and Indigenous doctors in recent decades.

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Medical Schools 120

Pharmacy Times

JUNE 29, 2023

Investigators call for further public awareness of other breast cancer risk factors, besides dense breasts, which could help identify more women who are at high risk.

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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 29, 2023

After growing the Institute for Clinical and Economic Review (ICER) into an influential drug pricing watchdog, Steve Pearson, M.D., is stepping down. | After growing the Institute for Clinical and Economic Review into an influential drug pricing watchdog, Steve Pearson is stepping down.

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Fierce Healthcare

JUNE 29, 2023

Value-based care evolved from a pipe dream to a reimbursement code. The “food is medicine” movement is materializing from a pie in the sky into a pie on the table. | As the industry pursues value-based care and payment models, health systems, hospitals, providers and startups are exploring interventions and programs that a generation ago would have not been considered "healthcare.

Hospitals 118

Hospitals 118

Fierce Pharma

JUNE 29, 2023

Much attention has been paid to Vertex’s efforts to develop a stem cell therapy for Type 1 diabetes. | Much attention has been paid to Vertex’s efforts to develop a stem-cell therapy for Type 1 diabetes. But flying under the radar with an allogenic (donor) gene therapy for the disorder has been Chicago startup CellTrans. Thursday, the FDA signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for type 1 diabetes.

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FDA 115

Fierce Healthcare

JUNE 29, 2023

Iodine Software is charging ahead to integrate generative AI technology into its software to make a "quantum leap" in automation and predictive analytics capabilities. | Iodine Software is charging ahead to integrate generative AI technology into its software to make a "quantum leap" in automation and predictive analytics capabilities.

Hospitals 117

Hospitals 117

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STAT

JUNE 29, 2023

The ventilator alarm woke me at 3 a.m. It was the fourth alarm in the past two hours. My 5-year-old daughter Molly had been there eight days, intubated and heavily sedated so she wouldn’t feel her skin blistering off her body, the terrible effect of a severe drug reaction. I looked over and saw her nurse, Kelli, holding Molly’s hand with her right hand and trying to chart with her left.

Hospitals 113

Hospitals 113

Fierce Healthcare

JUNE 29, 2023

Following the COVID-19 pandemic, the rising tide of mental health concerns—particularly among children and adolescents—has been a major focus in the industry. | Following the COVID-19 pandemic, the rising tide of mental health concerns—particularly among children and adolescents—has been a major focus in the industry.

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Drug Topics

JUNE 29, 2023

Although biosimilars have been introduced with the aim of competing with expensive biologic therapies, their adoption has been more gradual than expected.

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Fierce Healthcare

JUNE 29, 2023

Medicare Advantage (MA) beneficiaries have less choice when it comes to finding a psychiatrist than Medicaid enrollees or those who buy coverage on the Affordable Care Act (ACA) marketplace do, acc | Medicare Advantage continues to grow, and so does the need for beneficiaries to have access to psychiatrists, says a study in Health Affairs.

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Fierce Pharma

JUNE 29, 2023

While Dupixent often steals the show, Sanofi isn’t sleeping on its vaccine franchise. | By 2030, Sanofi figures its immunizations could generate more than €10 billion in annual sales, the company said during a vaccines R&D event Thursday. Much of that momentum hinges on Sanofi’s pipeline, where the company is targeting an “accelerated pace of innovation” in a bid to launch at least five phase 3 vaccine programs by 2025.

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Vaccines Immunization 104

Fierce Healthcare

JUNE 29, 2023

Healthcare costs will balloon 7% next year, as payers hammer out new contracts with providers, the labor shortage stretches on and drug prices continue to increase, according to a new

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STAT

JUNE 29, 2023

Patients fast before surgery to prevent food from getting into their lungs while they’re under — a serious concern that can lead to lung infection. But for those taking a class of treatments that include the widely popular Ozempic and Wegovy, fasting may not be enough to ensure an empty stomach. The American Society of Anesthesiologists issued guidance Thursday recommending that patients stop taking this class of treatments, called GLP-1 drugs, before undergoing surgery.

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Fierce Pharma

JUNE 29, 2023

Half a decade after Abcam quit its 270 million pound sterling pursuit of Horizon Discovery, the British antibody research expert has potentially found itself on the opposite end of the dealmaking t | Half a decade after Abcam quit its £270 million pursuit of Horizon Discovery, the British antibody research expert has potentially found itself on the opposite end of the dealmaking table.

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STAT

JUNE 29, 2023

The Food and Drug Administration on Thursday approved a gene therapy to treat people with hemophilia A, an inherited and rare bleeding disorder. The treatment, called Roctavian, is made by BioMarin Pharmaceutical. It was first approved in Europe in August 2022. Roctavian is a one-time therapy that, in clinical trials, dramatically reduced bleeding episodes and helped patients live without the blood transfusions used to treat the disease.

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FDA 98

European Pharmaceutical Review

JUNE 29, 2023

The US Food and Drug Administration (FDA) has approved Lantidra, the first cell therapy for certain adults with Type 1 diabetes. The allogeneic pancreatic islet therapy is made from deceased donor pancreatic cells and is indicated for Type 1 diabetes patients who are unable to approach target glycated haemoglobin due to current repeated severe hypoglycaemia episodes even with intensive diabetes management and education.

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Adverse Reactions FDA 97

STAT

JUNE 29, 2023

In 2005, Nick Voyles was diagnosed with hepatitis C after being released from five years of incarceration. A nurse told him he had only six months to live. He was prescribed a drug cocktail, a combination of interferon and ribavirin, that proved ineffective and gave him severe side effects. “It ripped me apart — the entire treatment was killing me,” Voyles, who lives in Bloomington, Ind., recalled.

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Fierce Pharma

JUNE 29, 2023

After years of back-and-forth with several generics makers, Sanofi came out on top in its latest Jevtana litigation, successfully blocking generic competition to the prostate cancer drug from Novar | Sanofi has vigorously defended its Jevtana patents for years and has now fought off the last outstanding competitor to the aging prostate cancer med.

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STAT

JUNE 29, 2023

The owner of a pharmaceutical wholesaler has been indicted for his alleged role in distributing misbranded HIV pills, a sign that U.S. authorities are now targeting an extensive scheme that pumped the medicines into the pharmaceutical supply chain. Steven Diamantstein, who runs Scripts Wholesale in Brooklyn, N.Y., was indicted for participating in a conspiracy in which at least $150 million worth of HIV medicines were purchased at “steeply discounted” prices from patients and then

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Labelling FDA 97

PharmaVoice

JUNE 29, 2023

Transgender and nonbinary patients suffer more adverse health outcomes than the general population, yet are often underrepresented in clinical research. Now, there’s momentum to change the status quo.

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STAT

JUNE 29, 2023

Alkermes shareholders voted Thursday to re-elect all of the drugmaker’s current directors, ending an acrimonious proxy fight with hedge fund Sarissa Capital Management, which had sought to seat three directors on the board. At the company’s annual meeting, shareholders voted in favor of Alkermes’ proposal to retain all seven of the director nominees to the 11-person board.

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European Pharmaceutical Review

JUNE 29, 2023

New drug mirikizumab doubled remission rates up to 50 percent in certain patient groups in two ulcerative colitis (UC) Phase III trials. Results from the studies were recently published in the New England Journal of Medicine. Researchers identified Interleukin-23 as an important protein in triggering and maintaining gut inflammation. This is relevant in Crohn’s disease, ulcerative colitis and chronic skin disease psoriasis.

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STAT

JUNE 29, 2023

Can Novavax finally get it right? What’s a “triple-G” drug? And is Novo Nordisk losing ground? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Elaine Chen joins us to explain how the era of Wegovy could be short-lived in light of powerful new weight-loss medicines from Eli Lilly.

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Vaccines 95

European Pharmaceutical Review

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. However, it is difficult to predict exactly how processes could behave and how materials could react under each process conditions.

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FDA Compounding 92

STAT

JUNE 29, 2023

Top of the morning to you. A delicious cool breeze and shiny sun are hovering over the Pharmalot campus, where birds are singing, mascots are barking, and another cup of stimulation is brewing (our choice today is roasted coconut). A fine start to the day, yes? Hopefully, things will continue on this trajectory, despite the smoky skies heading our way from Canada.

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FDA 94

Drug Store News

JUNE 29, 2023

Rite Aid’s retail pharmacy segment revenues increased 3.4% over the prior year quarter driven by an increase in acute and maintenance prescriptions.

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