Thu.Jun 06, 2024

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Cost Remains Significant Barrier to Respiratory Care for Patients

Pharmacy Times

By improving health insurance coverage and cost of inhalers, such as out-of-pocket caps, access to care can be increased. Some companies are aiming to improve access by implementing price caps.

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‘Concern is real’ about long Covid’s impact on Americans and disability claims, report says

STAT

The Covid pandemic has been called a “mass-disabling event” since early on — the kind of once-in-a-generation public health crisis that could shape millions of people’s lives forever. But while more people self-identified as disabled since the pandemic began, applications for disability benefits have stayed level, according to data from the Social Security Administration.

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Understanding the Connection Between Genetic Risk and Brain Cell Activity in Autism Spectrum Disorder

Pharmacy Times

Over the course of 15 years, epigenetic and transcriptional analysis of postmortem brain samples have revealed underlying molecular differences.

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Federal officials and physician groups express outrage over revelations of recent coercive sterilizations

STAT

Federal officials, medical organizations, and reproductive health advocacy groups have expressed outrage in response to STAT’s recent investigation revealing that women with sickle cell disease have felt pressured into sterilizations as recently as 2017 and 2022. Some said they knew of other contemporary instances of tubal ligations with questionable consent — in people with severe disabilities, for instance, or situations in which patients didn’t understand that the procedu

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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.

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Burdensome step therapy requirements could delay care for cancer patients: analysis

Fierce Healthcare

Restrictive health plan policies are increasingly relying on step therapy for cancer drugs, recent analysis from consulting firm Avalere shows. | Step therapy is embedded within prior auth requirements by health plans, potentially delaying critical access to care for cancer patients. In rare circumstances, patients must go through triple or quadruple step therapy.

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Opinion: A new initiative will help governors and local leaders fight the next pandemic

STAT

No one knows when the next pandemic will sweep across the United States. It could be bird flu , or an as-yet unknown infection. But after living through the Covid-19 pandemic, which claimed more than 1 million American lives, left more than 300,000 children orphaned, and shut down workplaces and schools, U.S. citizens should demand that the nation does better next time.

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Opinion: Close a regulatory loophole in the ACA to provide vaccine access for all Americans

STAT

The Patient Protection and Affordable Care Act , (generally known as the ACA), was signed into law in 2010. It expanded access to affordable, quality health care, and today is helping 45 million people — the highest total on record — be covered by health insurance. The law included long-overdue policy changes to ensure that Americans have access to recommended preventive care, which is critical to avoiding preventable illnesses and the health care spending associated with them.

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Can prednisone make you tired?

The Checkup by Singlecare

Prednisone is a corticosteroid medication that helps reduce inflammation. This versatile prescription drug is FDA-approved to treat autoimmune and inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, multiple sclerosis, and endocrine disorders. It can also treat severe allergic reactions. Like any medication, prednisone may cause side effects for some people.

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STAT+: Psychedelics companies see FDA panel’s vote as a growth opportunity, not a roadblock

STAT

A day after a panel of advisers to the Food and Drug Administration expressed deep concerns about the use of MDMA to help treat post-traumatic stress disorder, companies working to develop other psychedelics said their optimism had not been dimmed — and that the concerns provided a clearer blueprint for what it might take to get such a drug approved.

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Buoyed by new obesity data, Structure files $476m offering

pharmaphorum

Riding high from positive clinical trial results for its oral weight-loss therapy, Structure Therapeutics has filed a public offering that it hopes will raise $476 million

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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.

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STAT+: At BIO, signs Congress’ tough stance on China is chilling biotech relationships

STAT

SAN DIEGO — U.S. legislation that seeks to restrict American biotechs from working with certain Chinese firms and suppliers is for now just that — a proposal, not a law. But the looming bill’s impact was clearly visible at this year’s meeting of the industry’s largest trade group. A number of biotech companies in attendance at the meeting of the Biotechnology Innovation Organization told STAT they’re actively looking to strike deals with U.S.

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FDA Accepts Biologics License Application for Denosumab Biosimilar Candidate

Pharmacy Times

FKS518 (Fresenius Kabi) would be indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis and bone loss due to prostate or breast cancer.

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STAT+: FDA reviewers ask if approval of Lilly’s Alzheimer’s drug should be restricted to a smaller group

STAT

Scientists at the Food and Drug Administration have two big questions about Eli Lilly’s experimental Alzheimer’s drug donanemab ahead of a panel of outside experts that it is convening on Monday: Should the patients who receive the medicine be limited based on PET scans of a protein called tau that Eli Lilly used as a key criteria for trying to determine whether they should receive the drug?

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June 6 Marks National Naloxone Awareness Day

Drug Topics

Overdose deaths have decreased for the first time since 2018, but naloxone remains an important tool in fighting the opioid epidemic.

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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.

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Novovax will be able to supply Covid-19 vaccines this fall

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. Today, we discuss how psychedelics companies are responding to the negative ad comm vote on Lykos’ therapy, results of Zepbound in MASH, and the fate of Novovax this fall.

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FDA cracks down on China's Hengrui in scathing manufacturing write-up

Fierce Pharma

When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. | In an eight-observation Form 483, the FDA chided Hengrui for a laundry list of manufacturing missteps, including poor contamination controls, subpar cleaning protocols, failure to promptly hand over documentation to inspectors and quality control shortfalls.

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STAT+: Cigna wins case to block former executive from jumping to CVS

STAT

CVS Health viewed Amy Bricker as a potential CEO. But she won’t be going to the health care conglomerate anytime soon. A federal appeals court has ruled Bricker, a former high-ranking executive at Cigna, cannot jump to CVS because it would violate her noncompete agreement that she signed while at Cigna. The appeals court’s decision backs up what a district court had previously ruled.

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Mexican man dies in first human case of H5N2 bird flu

pharmaphorum

A man in Mexico has died in what the WHO has said is the first lab-confirmed human infection with the H5N2 strain of bird flu

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Do digital physical therapy solutions work? New report has some insights

STAT

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it  delivered in your inbox every Tuesday and Thursday. A new  report  from the  Peterson Health Technology Institute  suggests virtual physical therapy services could decrease health care spending for payers that invest in them.

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Italy opens antitrust case against Novartis, Roche and others, claiming collusion to delay biosim launch

Fierce Pharma

A new antitrust investigation in Italy has ensnared Novartis, Genentech, Biogen and Samsung Bioepis for allegedly colluding to suppress competition of a Lucentis biosimilar in the country. | Italy's antitrust agency is going after Novartis, Genentech, Biogen and Samsung Bioepis for allegedly working together to delay the launch of a Lucentis biosimilar in Italy.

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Telix prices $200m IPO in big week for radiopharma financing

pharmaphorum

Trio of radiopharma financings this week, as Telix files $200m US IPO, ITM raises $202m in a private round, and AstraZeneca invests in CDMO Nucleus.

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FDA and CluePoints extend collaboration to enhance clinical trial integrity and safety

Outsourcing Pharma

Yesterday (June 5) CluePoints, providers of established statistical and AI-driven software solutions, and the Food and Drug Administration (FDA) announced an extension to their long-standing collaboration.

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Amgen preps Uplizna filing for a second indication

pharmaphorum

Amgen's Uplizna could become the first FDA-approved treatment for rare disease IgG4-RD, after showing efficacy in the phase 3 MITIGATE trial

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CGM Optimization Program in Resource-Limited Setting Can Help Patients with Diabetes Improve Glycemic Control

Drug Topics

HbA1c levels decreased significantly after an average of 154 days in patients who used a continuous glucose monitor.

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Data needed to forge the link between AI and mRNA

Pharmaceutical Technology

While the potential for using AI to develop mRNA therapeutics is now a real possibility, accurate and diverse data is needed to make it a reality.

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Roquette's US innovation center marks first year of pharmaceutical advancements

Outsourcing Pharma

As Roquette's US Innovation Center marks its first anniversary, Roquette took the opportunity to reflect on its interesting journey and achievements over the past year.

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Mirikizumab Shows Improvements Across Clinical, Endoscopic Outcomes for Crohn Disease

Pharmacy Times

Mirikizumab met both co-primary end points and all secondary end points at week 52, according to results presented at Digestive Disease Week in Washington DC.

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Does Stardog AI hold the key to faster pharma success?

Outsourcing Pharma

In today's fast-paced pharmaceutical industry, major players like are seeking innovative solutions to accelerate the drug development process.

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Listen: Psychedelics at the FDA, ASCO recap, & MorphoSys update

STAT

How did advisers react to the first psychedelic therapy to go before the Food and Drug Administration? And did the American Society of Clinical Oncology meeting surpass expectations? We discuss that and more in this week’s episode of “The Readout LOUD.” STAT colleague Meghana Keshavan joins us to dissect Lykos Therapeutics’ meeting with an FDA advisory committee.

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CDC recommends first post-exposure antibiotic for STIs

pharmaphorum

CDC recommends doxyPEP as first post-exposure antibiotic for STIs including syphilis, gonorrhoea and chlamydia

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STAT+: Pharmalittle: We’re reading about the aftermath of FDA vote on MDMA, rising pharma layoffs, and more

STAT

Top of the morning to you, and a fine one it is, despite the gray skies hovering over the Pharmalot campus again. We are doing our best to maintain sunny spirits, though, because we recall a bit of insight from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us.

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Slideshow: Assessing Long COVID Complications, Increased Fracture Risk in Diabetes

Drug Topics

Four poster presented at ENDO 2024 examined the current landscape of diabetes.

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White House enlists doctors and hospitals to combat gun violence

Fierce Healthcare

The White House is calling on hospital executives, doctors and other healthcare leaders to take bolder steps to prevent gun violence by gathering more data about gunshot injuries and routinely coun | In 1996, Congress cut federal funding for gun control research by the CDC, essentially shifting the responsibility for funding and conducting the research to the private sector and academia—and with a fraction of the previous budget.

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France's Orano Med debuts radiotherapy manufacturing plant near Indianapolis

Fierce Pharma

Amid a nuclear medicine boom, France’s Orano Med has chosen the U.S. to establish a manufacturing plant as it progresses on its radiopharma journey. | Orano Med—which is working on targeted alpha therapies for cancer—on Thursday inaugurated its first Alpha Therapy Laboratory (ATLab) in Brownsburg near Indianapolis, Indiana. The site marks the world’s first industrial-scale facility dedicated to production of lead-212-based radioligand therapies, the company said.

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