Fierce Healthcare

SEPTEMBER 23, 2024

What began as a dispute between two health tech companies over healthcare data exchange practices has now led to a federal lawsuit alleging antitrust violations. | Venture-backed health tech company Particle Health filed an antitrust lawsuit against Epic in the Southern District of New York alleging that the electronic health records giant is trying to muscle out competition in the payer platform market.

145

145

STAT

SEPTEMBER 23, 2024

The health data company Particle Health has filed an antitrust lawsuit against Epic Systems, alleging that the electronic health record vendor has used its control of patient data to thwart competition and undermine its business. The suit filed Monday in federal court in the Southern District of New York is a full-throated assault on Epic’s dominance in the market for electronic health records, charging that the privately held company has become a “behemoth” and a “mo

144

144

Pharmacy Times

SEPTEMBER 23, 2024

Further trials are required to examine the long-term feasibility of intravenous immunoglobulin (IVIG) for multisystem inflammatory syndrome.

138

138

STAT

SEPTEMBER 23, 2024

WASHINGTON — The wheels on a big red bus emblazoned with anti-pharmaceutical industry messaging are going ’round and ’round all through the nation’s electoral battlegrounds, from Montana to Arizona to Pennsylvania. But nobody will say who’s paying to fill up the gas tank. A new dark-money group called Americans for Pharma Reform has launched a multi-state bus tour to bring awareness to what they characterize as bad behavior by the pharmaceutical industry.

141

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.

Drug Topics

SEPTEMBER 23, 2024

Drug Topics discussed independent pharmacy advocacy and PBM reform on the state level with Miguel Rodriguez, Executive Vice President and general counsel for American Pharmacies.

Community Pharmacies 98

Community Pharmacies Independent Pharmacies 98

STAT

SEPTEMBER 23, 2024

WASHINGTON — Of the roughly 15 million Americans who tried to quit smoking in 2022, 5 in 6 failed. It’s a jarring statistic — and an indictment of the treatment options for an addiction that kills 480,000 people in the U.S. each year. The smoking-cessation drugs on the market don’t work well for the majority of people, and they come with side effects and reputations that keep some smokers from ever trying them.

FDA 136

FDA Vaccines 136

STAT

SEPTEMBER 23, 2024

As the Hatch-Waxman Act approaches its 40th anniversary, it’s time to critically examine its legacy and what it actually gave us: the  highest drug prices in the world. One of the main objectives of the Hatch-Waxman Act was to bring more generic drugs into the market. If viewed through that lens only, the act has been an overwhelming success.

125

125

Drug Topics

SEPTEMBER 23, 2024

The monoclonal antibody was also approved for active non-radiographic axial spondyloarthritis and active ankylosing spondylitis.

FDA 112

FDA 112

STAT

SEPTEMBER 23, 2024

The federal watchdog at the Department of Health and Human Services issued a report on Tuesday calling for more oversight of remote patient monitoring in Medicare. The Office of Inspector General’s report called out the potential for fraud and misuse of tools like at-home blood pressure cuffs, connected scales, and continuous glucose monitors that can feed data directly to a patient’s doctor.

125

125

Drug Topics

SEPTEMBER 23, 2024

Albert Dahan, MD, PhD, discusses how cebranopadol could fit into the broader landscape of pain management therapies.

112

112

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

STAT

SEPTEMBER 23, 2024

Biogen and UCB said Tuesday that an experimental drug reduced disease activity and symptoms of systemic lupus, achieving the primary goal of a placebo-controlled Phase 3 study.  Detailed study results were not included in the press release issued by the companies, so how much participants benefited from the drug, called dapirolizumab pegol, won’t be known until data are presented at a medical meeting.

124

124

Drug Topics

SEPTEMBER 23, 2024

Initiatives such as media campaigns and legislative rulings by the agencies have likely contributed to the decline.

FDA 112

FDA 112

STAT

SEPTEMBER 23, 2024

The GLP-1 drug Wegovy tops the list of medications expected to be included in the next round of Medicare price negotiations, according to a paper in the Journal of Managed Care & Specialty Pharmacy.  Last month, Medicare officials unveiled prices for the first 10 drugs chosen for negotiation. Now, all eyes are on which Part D drugs will be chosen for the next round of 15 drugs.

Specialty Pharmacies 115

Specialty Pharmacies 115

Drug Topics

SEPTEMBER 23, 2024

“Pharmacies are processing prescriptions, our supply chain is fully operational, and most importantly, the first patients are now receiving neffy,” said Eric Karas, CCO of ARS Pharmaceuticals.

112

112

Advertisement

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.

Pharmacy Management Software

STAT

SEPTEMBER 23, 2024

On Tuesday, the Department of Health and Human Services published new policies  on research misconduct , which apply to research institutions receiving funding through the U.S. Public Health Service. The policies set standards that institutions must follow when investigating and potentially sanctioning researchers alleged to have engaged in research misconduct.

111

111

Drug Topics

SEPTEMBER 23, 2024

LEO Pharma expects the regulatory review process to be completed in the second half of 2025.

FDA 112

FDA 112

STAT

SEPTEMBER 23, 2024

Good morning! Health care challenges like anti-microbial resistance have long created narrative tension for shows like Grey’s Anatomy. But what about an entire musical about it? Ask and ye shall receive. The wheels on the anti-pharma bus … echo GOP talking points A new, dark money group called Americans for Pharma Reform is aiming to bring awareness to what they call bad behavior by the pharmaceutical industry.

103

103

Fierce Pharma

SEPTEMBER 23, 2024

Despite being thrown off its rhythm twice already, Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the compan | Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the company’s talc products caused users to develop cancer.

97

97

STAT

SEPTEMBER 23, 2024

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because — you guessed it — that oh-so familiar routine of online meetings, annoying commutes, and deadlines has predictably returned. But what can you do? The world, such as it is, somehow continues to spin no matter how hard we try to slow it down.

97

97

pharmaphorum

SEPTEMBER 23, 2024

RHYTHM AI has FDA approval for a new version of its algorithm for mapping areas of the heart that are affected by atrial fibrillation

FDA 105

FDA 105

STAT

SEPTEMBER 23, 2024

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 a bus with anti-pharma messaging that’s traversing the country, we see the FTC file a suit against the three biggest pharmaceutical benefit managers, and more.

92

92

pharmaphorum

SEPTEMBER 23, 2024

Zevra Therapeutics' Miplyffa is first drug approved by the FDA for ultra-rare disease Niemann-Pick type C.

FDA 115

FDA 115

STAT

SEPTEMBER 23, 2024

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine.  Sign up  to get it in your inbox every Monday. FTC v. the Big 3 Kevin Dietsch/Getty Images The animosity between the Federal Trade Commission and pharmacy benefit managers has reached a boiling point. The FTC sued the nation’s three biggest PBMs last week, accusing them and their secretive group purchasing organizations of creating a “perver

Insurance 89

Insurance 89

Pharmacy Times

SEPTEMBER 23, 2024

A 95% increase in private health center participation, monitoring, assessment, and vaccine coverage can be significant in improving outcomes.

Vaccines 132

Vaccines 132

Fierce Pharma

SEPTEMBER 23, 2024

For trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), the fight against pricing provisions in the Inflation Reduction Act isn’t over yet. | Late last week, the U.S. Court of Appeals for the Fifth Circuit reversed a previous dismissal of PhRMA’s Inflation Reduction Act (IRA) lawsuit from February, punting the complaint back to a lower Texas court.

86

86

Pharmacy Times

SEPTEMBER 23, 2024

The authors note this is the first study to assess cerebrovascular endothelial extracellular vesicles within a cognitive condition.

132

132

pharmaphorum

SEPTEMBER 23, 2024

Johnson & Johnson's long-running effort to put litigation claiming its talc products caused cancer has continued with a third attempt to place a subsidiary company into bankruptcy. Red River Talc LLC was set up specifically to resolve the thousands of claims related to ovarian cancer arising from cosmetic talc litigation, separated from the group's core business and armed with billions of dollars in settlement money to provide compensation to alleged victims.

89

89

Pharmacy Times

SEPTEMBER 23, 2024

If approved, delgocitinib cream would be the first US treatment indicated for moderate to severe chronic hand eczema.

FDA 138

FDA 138

Pharmaceutical Technology

SEPTEMBER 23, 2024

Download our free, extensive list of the leading Active Pharmaceutical Ingredients and Intermediates companies and suppliers today.

98

98

Pharmacy Times

SEPTEMBER 23, 2024

Erin McConnell, PharmD, discuss the clinical decision-making process for choosing between statins, PSCK9 inhibitors, or newer agents like inclisiran.

81

81

Pharmaceutical Technology

SEPTEMBER 23, 2024

The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.

Vaccines 96

Vaccines FDA 96

Fierce Pharma

SEPTEMBER 23, 2024

Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease trea | Along with psoriasis, the biologic is now FDA approved to treat psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

FDA 78

FDA 78

Pharmaceutical Technology

SEPTEMBER 23, 2024

View the top artificial intelligence (AI) companies in the pharmaceutical industry and download your free guide to AI in pharma here.

94

94

Fierce Pharma

SEPTEMBER 23, 2024

Ahead of a Senate hearing centered on high prices for Novo Nordisk’s in-demand semaglutide medications, lawmakers are pressing the government to use its “march-in” rights and allow generic versions | In a letter to HHS secretary Xavier Becerra, several lawmakers urged the government to allow generic licenses for Novo's GLP-1 medicines Ozempic and Wegovy.

73

73