Wed.Oct 23, 2024

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Novo Nordisk asks FDA to prevent compounders from making copycat versions of GLP-1 star semaglutide

Fierce Pharma

The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and Wegovy, claiming the drugs are too complex to safely replicate.

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Vaccination Key to Preventing COVID-19 Hospitalizations Among Children

Drug Topics

A study found that children aged 6 months or younger who are not eligible for vaccination were at the highest risk for hospitalization due to SARS-CoV-2.

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Amgen pledges to launch Eylea biosim after legal win—but Regeneron stresses the fight's not over yet

Fierce Pharma

While Regeneron may have lost its latest bid to block the launch of Amgen’s Eylea biosimilar Pavblu, the New York-based pharma isn’t throwing in the towel just yet. | Amgen is preparing to launch its Eylea biosimilar, Pavblu, after another victory over Regeneron in court. That said, Regeneron is appealing the decision and stressed that it continues to believe Amgen's copycat infringes multiple Eylea patents.

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Exploring Alternative Pain Management Strategies for Headaches and Migraines | AMCP Nexus 2024

Drug Topics

New research presented at AMCP Nexus 2024 highlighted the effectiveness and cost-effectiveness of various migraine treatments, including onabotulinumtoxinA and fremanezumab, as well as the importance of migraine education programs for improving patient outcomes.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Roche CEO says Novo's Catalent buyout 'could be a problem' for smaller drugmakers

Fierce Pharma

While Novo Holdings and Catalent continue to voice confidence that their planned $16.5 billion merger will go through before the year is out, the deal has received near-constant criticism over the | While Novo Holdings and Catalent continue to voice confidence that their planned $16.5 billion merger will go through before the year is out, the deal has received near-constant criticism over the past several weeks.

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Healthy Sleep Patterns Reduced Risk of Digestive Disease

Drug Topics

Researchers addressed the association between sleep patterns and digestive diseases, as well as patients’ genetic likeliness of developing future digestive complications.

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The Association Between Cardiac Surgery and Gastrointestinal Complications

Drug Topics

In a comprehensive literature review, researchers addressed the impact cardiac surgery has on gastrointestinal outcomes.

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Clinicians, Pharmacists Should Work to Ensure Safety Compounded GLP-1 Medications

Pharmacy Times

Pharmacists can educate patients about how to recognize unsafe online sources of medications and ensure patients are properly educate on how to administer their medications.

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NCPA 2024: Exciting Sessions, Key Themes at This Year's Conference

Drug Topics

Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS, discusses what sessions he is looking forward to and key themes he expects to be the topic of conversation at NCPA 2024.

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What to Know About E Coli Outbreak Linked to McDonald’s Quarter Pounders

Pharmacy Times

Pharmacists will likely be the first contact for many affected patients, and they should be able to provide evidence-based advice on how to manage their infection.

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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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Rise of almost untreatable superbug linked to a common antibiotic

The Guardian - Pharmaceutical Industry

‘Surprising’ finding by Australian-led study is first recorded instance of one antibiotic causing resistance to another in a different class Follow our Australia news live blog for latest updates Get our breaking news email , free app or daily news podcast The rise of an almost untreatable superbug has been linked to a common antibiotic, an Australian-led study has found.

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Study challenges finding that Black babies are more likely to survive under the care of Black physicians

STAT

New research calls into question the high-profile conclusion of the first major study to show that the race of physicians influences health outcomes.  In August of 2020, a study published in the Proceedings of the National Academies of Science made headlines with its finding that Black infants were half as likely to survive to their first birthday when they were cared for by white doctors instead of Black ones.

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In boon for Pfizer and Merck, CDC panel backs expanded use of pneumococcal vaccines

Fierce Pharma

With an expanded recommendation from the Center for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP), pneumococcal conjugate vaccines (PCV) from Pfizer and | The CDC's immunization committee voted to expand the recommendation for pneumococcal conjugate vaccines, including both Pfizer’s Prevnar 20 and Merck’s newer Capvaxive.

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Scientists used infrared light to create artificial vision in patients with vision loss

STAT

Science Corporation published preliminary data from a late stage, multi-center clinical trial of a retinal implant that showed promising results Tuesday. Using this prosthetic, scientists partially restored vision to people whose central visual field has holes or blurry spots. Trial participants could read text and recognize playing cards when using the implant, even though they were legally blind.

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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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Transforming Oncology Care: Insights into NCODA’s PQI Initiatives

Pharmacy Times

Ginger Blackmon, PharmD, will discuss enhancing patient cancer care through implementation of medically integrated oncology team and NCODA’s PQI resources.

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More state Medicaid programs consider covering GLP-1 drugs

STAT

Most state Medicaid programs don’t cover the new class of weight loss drugs for obesity, but that could soon change. Half of those that don’t are considering adding coverage, per a new KFF report.  While all state Medicaid programs cover GLP-1 agonists for type 2 diabetes, it’s much less common for them to cover the drugs for obesity.

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Blue Cross plan accused of fraud in 'ghost network' class-action lawsuit

Fierce Healthcare

Anthem Blue Cross Blue Shield of New York’s directory of doctors is thoroughly inaccurate and forces patients to seek costly out-of-network care and delay care, a class-action lawsuit alleges. | Anthem Blue Cross Blue Shield of New York is making it hard for members to receive care from mental health professionals due to poorly run provider directories, or ghost networks, a lawsuit claims.

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STAT+: Frustrated with Change Healthcare breach, senators propose removing limits on HIPAA fines

STAT

Linda Barbour thought she was more interested in the Change Healthcare cyberattack than most. Having worked as a medical director for several large health insurance companies and having suffered through the Change fiasco herself as a rehab doctor with a private practice in Kansas City, she figured that if her data had been exposed in that February breach, she would have been notified by now.

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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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HLTH24: Atropos Health unveils chat-based AI co-pilot for real-world evidence

Fierce Healthcare

LAS VEGAS—Atropos Health's large language model for real-world evidence is now ready for prime time after a successful beta program. | Atropos Health's large language model for real-world evidence is now ready for prime time after a successful beta program.

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STAT+: U.K.’s cost-effectiveness agency says Alzheimer’s drug donanemab does not provide good value

STAT

LONDON — For the second time in a matter of months, the U.K.’s cost-effectiveness watchdog has said the limited benefits of a newly approved Alzheimer’s drug do not justify its costs, threatening the possibility of the medicine reaching patients. The National Institute for Health and Care Excellence said in draft guidance released Wednesday that the drug, Eli Lilly’s donanemab, “cannot currently be considered good value for the taxpayer,” given the

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HLTH24: Jill Biden announces $110M ARPA-H funding award, prods industry to invest in women's health

Fierce Healthcare

LAS VEGAS—First lady of the U.S. | LAS VEGAS—“The women of America are waiting on you,” Jill Biden said in her speech at HLTH 2024, calling on the healthcare industry to make women’s health research and development a bigger priority.

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Opinion: How to make sure opioid settlement money isn’t wasted

STAT

The opioid and overdose crisis is a national tragedy, claiming more than 1 million lives since 1999. In the past three years, more than $55 billion has flowed into state, county, and city coffers from opioid manufacturers, distributors, and chain pharmacies as a result of their collective role in instigating and perpetuating this public health crisis.

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HLTH24: Employers still in an 'experimental' mode around GLP-1s

Fierce Healthcare

LAS VEGAS — Demand for GLP-1s has not slowed, and employers still have not cracked the code on the perfect solution for medications that represent a growing portion of spend. | LAS VEGAS — Demand for GLP-1s has not slowed, and employers still have not cracked the code on the perfect solution for medications that represent a growing portion of spend.

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STAT+: What’s on the docket for Congress post-election: Chinese biotech, Medicare payments, ACA subsidies

STAT

WASHINGTON — When Congress returns on Nov. 12 after the elections, lawmakers will have just over a month to fund the government.  That deadline pressure creates an opportunity to potentially enact health care legislation. Regardless of what happens this year, next year will be huge for health care policy, in part because lawmakers need to address major expiring policies.

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Roche's Vabysmo will rise above Eylea biosim threat, exec says, as DMD gene therapy Elevidys delivers sales surprise

Fierce Pharma

By squeezing Regeneron’s Eylea, eye disease drug Vabysmo has become one of the biggest growth drivers for Roche. | Despite the potential imminent launch of a biosimilar to Regeneron's Eylea, Roche expects the market potential will remain stable for Vabysmo. Meanwhile, Sarepta-partnered Elevidys delivered a big surprise in the third quarter.

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STAT+: Morning Rounds: Study on racial health disparities called into question

STAT

Does anyone here listen to Who Weekly? They sort celebrities into “Whos” (the not-as-famous) and “Thems” (the universally-well-known). So, like: RFK is a Them, while Casey and Calley Means are Whos. The study below on sense of smell and breathing made me think: What’s the Who-to-Them ranking of the five senses? First I thought smell was the Whoiest, but my editor wisely suggested touch as the sense people most often forget.

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Sanford Health, Marshfield Clinic Health System officially ink merger agreement

Fierce Healthcare

Sanford Health and Marshfield Clinic Health System have signed a merger agreement, the health systems announced on Wednesday, after first revealing their intent to combine in July. | Sanford Health and Marshfield Clinic Health System have signed a merger agreement, the health systems announced on Wednesday, after first revealing their intent to combine in July.

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No one wants to talk about Medicare policy

STAT

Medicare policy has been conspicuously absent from the 2024 presidential race. Health policy scholar Paul Ginsburg thinks this is because both Democrats and Republicans understand that the reforms needed in the Medicare system are not going to be popular. “Our policy is broken,” Ginsburg said in his conversation with First Opinion editor Torie Bosch on this week’s podcast.

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Novo joins Lilly in asking FDA for ban on GLP-1 compounding

pharmaphorum

Novo Nordisk has asked the FDA to stop compounding pharmacies making cheaper versions of its semaglutide-based therapies for obesity and diabetes, saying the drug is too complex to be made safely by these manufacturers.

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Wojcicki projects confidence amid 23andMe stumbles

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning. It’s been a while since I shared some local news: Chicago has yet again proved itself not only to be the best, but also the rattiest city in the U.S.

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Red light, green light: England's NICE not sold on Lilly's Kisunla despite UK approval

Fierce Pharma

Eli Lilly’s Alzheimer’s disease offering Kinsunla is poised to face a tough road ahead in the U.K. | Lilly's Alzheimer treatment fell to the same fate as Biogen and Eisai's rival Leqembi in the U.K., with the region's cost watchdog declining to support reimbursement through its National Health Service.

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Lawmakers seek answers on Pfizer, Lilly telehealth moves

pharmaphorum

US lawmakers fear Pfizer and Lilly's recent forays into direct-to-consumer distribution of medicines via telehealth could violate anti-kickback laws.

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A slow start for self-amplifying mRNA vaccines

Pharmaceutical Technology

A year after the first samRNA vaccine approval, experts say others are likely to face scientific and regulatory hurdles.