Fri.Jun 28, 2024

article thumbnail

FDA Authorizes Marketing of First-Ever Point-of Care Hepatitis C RNA Test

Drug Topics

Through a test-and-treat approach, patients who test positive for HCV RNA with the Xpert HCV test and GeneXpert Xpress System can be connected to care as soon as the same health care visit.

FDA 200
article thumbnail

Supreme Court undercuts regulators’ authority across government

STAT

Federal agencies’ longtime authority to regulate industries was significantly weakened by a Supreme Court decision on Friday. The 6-3 decision, though it stems from cases on fishing regulations , will ripple across government agencies that have broadly interpreted the powers handed to them by Congress since a 1984 decision known as Chevron. The so-called Chevron doctrine laid out that courts should generally defer to federal agencies’ reasonable interpretations of their authority w

142
142
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

GLP-1s May Benefit T1D, Uptake Increased Significantly in Patients with Obesity

Drug Topics

Two posters presented at the American Diabetes Association 84th Scientific Sessions looked into the impact of glucagon-like peptide-1 receptor agonists in type 1 diabetes management.

152
152
article thumbnail

Attitude, Education Among Non-Economic Barriers Hinder Adoption of Biosimilars

Pharmacy Times

Health professionals have expressed concerns regarding consistent naming standards, the regulatory process surrounding the approval of biosimilar drugs, and the lack of education they have about biosimilars.

131
131
article thumbnail

Position Your Pharmacy for Expansion

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.

article thumbnail

CDC, ACIP Announce Vaccine Recommendations and Updates

Drug Topics

The updates follow the Advisory Committee for Immunization Practice meeting held June 26 to 28, 2024.

Vaccines 178
article thumbnail

Supreme Court overrules Chevron deference, dealing blow to federal healthcare agencies

Fierce Healthcare

The U.S. Supreme Court, by a vote of 6-3, has overturned the Chevron deference, stripping power from federal agencies to interpret and enforce regulations. | The U.S. Supreme Court is overruling long-standing precedent. Here's how it could affect healthcare policy.

130
130

More Trending

article thumbnail

Blind employee takes VA to court saying new EHR from Oracle is inaccessible

STAT

A blind employee of the Department of Veterans Affairs is suing the federal agency on grounds that their new electronic health records system makes it impossible for her to do her job. A clinical social worker, Laurette Santos has worked for the VA for a decade, but when the agency switched to Oracle Health’s Cerner EHR in 2022, her productivity plummeted.

article thumbnail

Crucial Questions for Pharmacists to Ask Before Integrating AI

Drug Topics

At McKesson ideaShare 2024, Andrea Sikora discussed artificial intelligence and how it has gradually been integrated into health care systems.

112
112
article thumbnail

Can stress cause gout?

The Checkup by Singlecare

Gout is a form of inflammatory arthritis that affects the joints. It results from inflammation triggered by uric acid crystals deposited in the joints in individuals with elevated uric acid levels in the blood ( hyperuricemia). Not everyone who has hyperuricemia develops gout. Gout flares often come on suddenly at night, causing throbbing pain, redness, swelling, and tenderness that lasts a few days to a few weeks.

104
104
article thumbnail

How U.S. responses to public health emergencies could be hamstrung by the Supreme Court

STAT

WASHINGTON — The U.S. response to the Covid-19 pandemic got politically messy. A Friday Supreme Court ruling could frustrate government responses to public health emergencies even further. The Supreme Court struck down a long-standing legal doctrine that directed judges to defer to reasonable federal agency interpretations of ambiguous or technically challenging aspects of the law.

104
104
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

article thumbnail

Merck's Capvaxive gears up to challenge Pfizer's dominant Prevnar with CDC panel backing

Fierce Pharma

After scoring approval as the world’s first pneumococcal disease vaccine made specifically for adults earlier this month, Merck’s Capvaxive passed the next test in its bid to take on Pfizer an | The recommendation sets up Merck's new pneumococcal disease vaccine to potentially capture some of Pfizer's market share.

Vaccines 102
article thumbnail

Protein maps in cerebrospinal fluid offer insight into Alzheimer’s biology

STAT

Fighting Alzheimer’s disease is a race against time. By the time most patients are diagnosed and treated, their cognitive symptoms have already advanced significantly. New research, though, pinpoints protein changes in cerebrospinal fluid highly associated with the development of Alzheimer’s disease. A better biological understanding of the brain disorder could foster new treatments and earlier intervention — as early as 20 years before onset of symptoms according to models

103
103
article thumbnail

House committee backs some Medicare cover for obesity drugs

pharmaphorum

The House Ways and Means Committee in the US voted in favour of a new bill which would end a two-decade-long restriction on the coverage of drugs to treat obesity under Medicare.The Treat and Reduce Obesity Act of 2023 (TROA) was originally intended to overturn the restriction completely, but has been hugely scaled back in its scope.

102
102
article thumbnail

STAT+: Don’t write off MDMA yet: How the FDA got on board with psychedelics

STAT

Days after an advisory committee resoundingly voted for the Food and Drug Administration to reject MDMA as medical treatment, the founder of the company that applied for approval was ebullient. Rick Doblin, who has spent decades driving forward MDMA research, told a psychedelics conference in the Netherlands that his dream was not simply possible, but likely.

FDA 103
article thumbnail

5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

article thumbnail

FDA Approves New Drug Application for Tepylute to Treat Breast, Ovarian Cancer

Pharmacy Times

Tepylute is a ready-to-dilute, injectable formula that reduces preparation time and enable dosing accuracy.

FDA 120
article thumbnail

Upending Purdue Pharma’s settlement does little to help today’s opioid crisis, advocates say

STAT

The drug policy world has been left torn by the Supreme Court’s ruling on Thursday that Purdue Pharma’s bankruptcy deal could not move forward if it included legal protections for the company’s billionaire owners. In one camp are those who were eager to see the agreed-upon $6 billion settlement put to work preventing and treating opioid addiction.

100
100
article thumbnail

Children With Asthma on Medicaid Less Likely to Receive Specialist Care

Pharmacy Times

The findings show that the largest gaps are among pediatric patients with persistent asthma.

122
122
article thumbnail

STAT+: FDA rejects Rocket Pharmaceuticals’ gene therapy for ultra-rare condition, another setback for field

STAT

Rocket Pharmaceuticals said Friday that the Food and Drug Administration rejected its gene therapy for an ultra-rare, sometimes fatal immuno-deficiency syndrome, saying the company needed to submit more information to prove it can safely manufacture the product. The New York-based biotech said the FDA asked for only “limited” additional information.

FDA 96
article thumbnail

Teva Launches Generic Formulation of Liraglutide in US

Pharmacy Times

This marks the first launch of a generic glucagon-like peptide 1 receptor agonist.

116
116
article thumbnail

Opinion: To secure the U.S.’s biotech supply chain, pay attention to domestic companies

STAT

Scientific breakthroughs will enable a future of personalized drug discovery, where precision medicine makes it possible to receive the right dose of the right medicine at the right time. America’s ability to lead this global frontier of medicine is contingent upon our willingness to recognize China as a competitor and respond accordingly. But often overlooked in this essential conversation is the importance of investing more in U.S. biotech firms and innovation ecosystems — includ

89
article thumbnail

Amylyx ventures into metabolic diseases market with $35.1m deal

Pharmaceutical Technology

On 17 June, Amylyx acquired the rights to Eiger Biopharmaceutical’s experimental GLP-1 receptor antagonist, avexitide, for $35.1m.

98
article thumbnail

Will Medicare finally begin covering weight loss drugs like Zepbound and Wegovy?

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Morning! Today, we discuss how a House committee has overwhelmingly voted in support of four health-related bills. Also, there’s still reason to believe that MDMA-assisted therapy could win FDA approval, and more.

FDA 86
article thumbnail

ICYMI: Total Pharmacy June 2024 Issue

Drug Topics

Don’t miss out on the latest pharmacy insights in the Total Pharmacy June issue.

98
article thumbnail

Opinion: Medicare’s Part D policy is blocking progress needed to achieve Black health equity

STAT

A new and effective class of anti-obesity medicines, along with lifestyle interventions and sometimes bariatric surgery, can help stem the rising tide of obesity in the United States. But outdated rules set by the Centers for Medicare and Medicaid Services make access to these new medicines nearly impossible for the 50 million Americans covered by Medicare and its prescription drug coverage program.

86
article thumbnail

Amazon bundles its telehealth services under one brand

pharmaphorum

Amazon’s strategy in telehealth has coalesced around a pay-per-visit and subscription-based model under a new brand – Amazon One Medical.

90
article thumbnail

STAT+: Cassava Sciences collaborator charged with defrauding NIH in grants supporting its Alzheimer’s drug

STAT

A Cassava Sciences collaborator and paid consultant has been indicted by a federal grand jury on charges of defrauding the National Institutes of Health in grant applications supporting the company’s controversial Alzheimer’s drug, the U.S. Department of Justice announced on Friday. Hoau-Yan Wang, 67, a neuroscientist at the City University of New York, published key papers supporting the effectiveness of simufilam, an experimental Alzheimer’s therapy Cassava is now testing

article thumbnail

Without Pfizer appeal, Daiichi Sankyo closes long-running ADC patent arbitration with $47M win

Fierce Pharma

An antibody-drug conjugate patent arbitration fight that Seagen waged against Daiichi Sankyo has officially ended in a win for the Japanese company. | An antibody-drug conjugate patent arbitration fight that Seagen waged against Daiichi Sankyo has officially ended in a win for the Japanese company.

72
article thumbnail

STAT+: Optum walks away from its agreement to buy Steward’s doctors network

STAT

Health care provider Optum has backed away from its plan to purchase Steward Health Care’s national physicians group, dealing a major setback to Steward’s efforts to bolster its finances after filing for bankruptcy. Optum, an arm of health insurance giant UnitedHealth, struck a preliminary deal in March to acquire Stewardship Health for an undisclosed sum.

article thumbnail

IgRT in Patients With CLL, NHL Associated With Lower Odds of Infections and Associated Antimicrobial Use

Pharmacy Times

An increased frequency of immunoglobulin G testing in patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) was also associated with a lower likelihood of severe infections.

65
article thumbnail

STAT+: Pharmalittle: We’re reading about the Purdue bankruptcy ruling, a Merck rejection, and more

STAT

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 fairly modest. We hope to catch up on our reading, spend time with our Pharmalot ancestor, and promenade with the official mascots. We also hope to hold another listening party, where the rotation will likely feature this , this , this , this , and this.

article thumbnail

EU's drug regulator again rejects Apellis' eye med and PTC's Translarna in busy week of up-and-down decisions

Fierce Pharma

For the second time in six months, Europe’s CHMP has given a thumbs down to Apellis’ Syfovre for the treatment of patients with geographic atrophy.

79
article thumbnail

STAT+: Vape makers see Supreme Court ruling as a weapon in fighting FDA

STAT

WASHINGTON — Vape manufacturers are taking a victory lap over a Supreme Court decision that could dramatically weaken the Food and Drug Administration’s power to regulate tobacco and nicotine products as regulators see fit. The court on Friday overturned a judicial rule, known as the Chevron doctrine, which instructed courts to defer to regulators on certain legal issues.

FDA 77
article thumbnail

Expanding Roles, New Approaches for Pharmacists in Managing Graft-Vs-Host Disease

Pharmacy Times

When treating patients with graft-vs-host disease, pharmacists are often responsible for selecting treatment regimens while navigating other spheres of care.

65
article thumbnail

STAT+: Up and down the ladder: The latest comings and goings

STAT

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. And here is our regular feature in which we highlight a different person each week.

64