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 469

PharmaVoice

JUNE 29, 2023

From AI to diversity and decentralized trials, here’s how clinical trial operations are evolving.

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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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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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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

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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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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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 128

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 126

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.

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Hospitals 123

pharmaphorum

JUNE 29, 2023

FDA approves first cell therapy for type 1 diabetes Phil.

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FDA 122

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

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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pharmaphorum

JUNE 29, 2023

England turns to digital health checks to cut GP pressure Phil.

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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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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.

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Hospitals 119

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

Pharmacy Times

JUNE 29, 2023

Somatrogon-ghla (Ngenla; Pfizer Inc, OPKO Health Inc) is a subcutaneous injection that is administered once weekly via a device allowing for titration based on patients’ needs.

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FDA 122

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.

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Hospitals 118

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 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 109

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Pharmacy Management Software

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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pharmaphorum

JUNE 29, 2023

Why the key to success lies in leadership diversity Mike.

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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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Pharmaceutical Technology

JUNE 29, 2023

Genprex has announced that the FDA has granted fast-track designation for Reqorsa, its small cell lung cancer (SCLC) therapy.

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FDA 105

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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pharmaphorum

JUNE 29, 2023

BioMarin’s haemophilia A gene therapy gets US approval Phil.

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STAT

JUNE 29, 2023

Rochelle Walensky, the outgoing director of the Centers for Disease Control and Prevention, will miss aspects of leading the nation’s top public health agency when her term ends Friday. But testifying before Congress is not likely to be among them. Walensky squared off against congressional committees 17 times during her 2½ years as head of the CDC, most recently in mid-June, when she faced a grilling from Republicans on the House Committee on Oversight and Accountability.

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pharmaphorum

JUNE 29, 2023

Sanofi sets out plan to lead the RSV vaccine market Phil.

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Vaccines 104

STAT

JUNE 29, 2023

DENVER — He could have been a rock star, a religious icon, the way ecstatic applause from thousands of attendees greeted the man dressed in a crisp, all-white suit as he strode onto a backlit stage. He was neither. This was Rick Doblin, the founder and evangelist of a movement to legalize psychedelic MDMA and bring the drug into mainstream medicine.

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Pharmaceutical Technology

JUNE 29, 2023

The FDA has announced that Lantidra, a cellular therapy for type 1 diabetes, has become the first treatment of its kind to be approved.

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FDA 98

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

Pharmaceutical Technology

JUNE 29, 2023

Carrie Harney, the vice president of government and regulatory Affairs at US Pharmacopeia (USP) explains US drug shortages.

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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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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 98