Thu.Feb 15, 2024

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Fragmented Policy, Insurance Landscape Challenges Newly Approved Vaccines

Drug Topics

Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. But they face a difficult landscape where federal policies dictate coverage.

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Study Shows 40% of Participants Sustain Cognitive Improvement After Surgery-Induced Weight Loss

Pharmacy Times

Sustained cognitive improvement is likely a result of lower inflammation, remission of comorbidities, higher physical activity, and better mood.

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Opinion: Independent doctors like me are becoming an endangered species

STAT

More than 100,000 doctors have  left private practice  and become employees of hospitals and other corporate entities since 2019. Today, nearly  three in four physicians  are employees of larger health care entities or other corporations — a record high. As an independent physician, I know exactly why so many are making that choice.

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Biosimilars: Are They Delivering the Cost Savings Promised?

Pharmacy Times

Since the first FDA biosimilar approval of filgrastim-sndz (Zarxio) in 2015, a total of 44 biosimilars for 15 originator products have been approved and more than 20 are marketed.

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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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Juul’s internal playbook opens a rare window into influence in Washington

STAT

WASHINGTON — A new trove of internal emails and other documents from the e-cigarette maker Juul reveals the company’s extensive behind-the-scenes efforts to promote its interests in Washington — a rare insight into the otherwise opaque methods corporations use to influence the government. It’s well documented that Juul spent significant sums on registered lobbyists and political donations back in 2018 and 2019, when the head of the Food and Drug Administration declare

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Pharmacy Focus: Policy Editions - February 2024 Rx Roundup

Pharmacy Times

The meeting provided a brief overview of California's new Stop Dangerous Pharmacies Act, the benefits of e-prescribing for improving patient safety and outcomes, and New Jersey's pilot program for anonymous dispensing of opioid antidotes from pharmacies.

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More Trending

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'A giant unknown': What the alleged $2B Medicare catheter fraud scheme means for ACOs

Fierce Healthcare

Seven durable medical equipment companies cost the Medicare system $2 billion in payments, the National Association of ACOs (NAACOS) told the federal government in recent months. | ACOs could face lasting financial difficulties because of a recent, alleged $2 billion Medicare catheter fraud scheme. Experts worry this could be just the beginning.

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HHS fills key vaccine advisory panel slots

STAT

The Department of Health and Human Services announced Thursday that it is filling eight vacancies, including the chairmanship, on an important advisory panel on vaccine policy that was down to less than half of its normal roster for months. It’s still not clear why so many positions were left unfilled on the Advisory Committee on Immunization Practices.

Vaccines 141
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Alnylam changes analysis plan for key Amvuttra heart trial, jolting investors

Fierce Pharma

Changing a clinical trial’s statistical analysis plan on the cusp of a readout? | Changing a clinical trial’s statistical analysis plan on the cusp of a readout? That’s exactly what Alnylam just did for a closely watched study of its next-generation RNA interference therapy Amvuttra in a rare heart disease.

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STAT+: FDA cracks down on websites that claim to sell chemicals in obesity drugs Wegovy, Zepbound

STAT

The Food and Drug Administration is cracking down on websites that claim to sell the underlying chemicals of popular diabetes and obesity drugs like Ozempic, Wegovy, and Zepbound, saying that the websites are selling unapproved and misbranded drug products. The regulator this week posted warning letters that it sent to two websites, Synthetix Inc. DBA Helix Chemical Supply and US Chem Labs.

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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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Advise Patients About the Risks of a Sedentary Lifestyle

Pharmacy Times

Finding simple solutions to improve movement during the day can make important differences to their overall health

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STAT+: Hospital claims it was ‘drastically’ overcharged by pharma in a federal drug discount program

STAT

For several years , some of the world’s largest pharmaceutical companies that participate in a U.S. drug discount program overcharged the federal government and numerous hospitals by hundreds of millions of dollars, according to claims made in a recently unsealed lawsuit. The allegations, which were made by Adventist Health System, turn on the complicated, behind-the-scenes calculations used to provide medicines to what is known as the 340B program.

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Pharmacists May See Patients With NSCLC More Often Than Other Care Team Members

Pharmacy Times

This frequency can allow for faster observation of toxicities and adherence issues.

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American Medical Association’s digital advisors table RPM coding reform proposal, again

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. Remote patient monitoring coding reforms tabled again Earlier this month, an  American Medical Association -anointed panel was set to consider proposed changes that would have simplified and broadened applicability of billing codes governing wearables and other devices d

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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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Catalent restructuring leaves 300 without jobs as CDMO awaits $16.5B Novo buyout

Fierce Pharma

Even as Catalent moves toward a $16.5 billion sale to Novo Holdings, hundreds of the CDMO's former staffers won't be in the mix going forward. | A recent buyout announcement didn't spare Catalent staffers from layoffs after the company this week revealed it's trimmed hundreds of jobs over the last few months. The move forms part of an ongoing restructuring scheme at Catalent.

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Nema Health, a virtual clinic for PTSD, announces Horizon BCBSNJ as partner

Fierce Healthcare

Nema Health, a virtual clinic focused on post-traumatic stress disorder (PTSD) treatment, has announced a partnership with a Blues plan in New Jersey. | Nema is now in-network for commercial members with Horizon Blue Cross Blue Shield of New Jersey. Through this and another contract with a major national payer, Nema will reach about 3.6 million lives in the state.

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HHS guidance on using online tracking technologies: How to make your analytics HIPAA-compliant

pharmaphorum

The HHS provides guidance on using online tracking technologies in a HIPAA-compliant manner. Learn how to ensure your analytics practices align with healthcare regulations and protect patient privacy.

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Psychedelic treatments for mental health: Is there substance behind the hype?

Pharmaceutical Technology

The success of recent trials treating mental health problems with psychedelic therapies has driven a rapid rise in investment in the area.

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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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Exercise ‘may be better than drugs for depression’

pharmaphorum

Exercise matched psychotherapy and was more effective than medication as a treatment for #depression in a meta-analysis of randomised clinical trials

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STAT+: Gaming Amylyx stock reactions to the next ALS drug test, and a chat with CRISPR’s CEO about a new investor

STAT

This week, a preview of the TUDCA study in ALS and thoughts on how it might impact Amylyx Pharmaceuticals. Also, I chatted with CRISPR Therapeutics CEO Sam Kulkarni about its new investor. Read to the end for some burning questions, random thoughts. The next ALS data readout — overdue but important A European academic consortium is expected to announce results soon from a clinical trial investigating the use of a widely available nutritional supplement called tauroursodeoxycholic acid, or

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Innsena backs CancerX’s digital drive to improve access

pharmaphorum

Healthtech specialist Innsena has committed funding and expertise to CancerX, launched last year to encourage the use of digital health technologies to overcome challenges in cancer care.

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Pharma’s contractors might finally be on the rebound

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with a look at a complicatedly important ALS study, biotech’s latest volatility, and some green shoots for a downtrodden part of the industry.

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FTC targets middlemen in generic drug shortages probe

pharmaphorum

The FTC is investigating wholesalers and other middlemen in the pharma supply chain to assess their possible role in worsening shortages of generic medicines

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Opioid Exposure During Pregnancy Linked With Increased Risk of Preterm Birth

Drug Topics

A new study found that opioid morphine milligram equivalents dose prescribed in the 60 days prior to delivery date was significantly associated with a higher likelihood of spontaneous preterm birth.

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Pfizer quells 12 years of Lipitor antitrust litigation with $93M settlement

Fierce Pharma

With a $93 million settlement, Pfizer can wash its hands of more than a decade's worth of antitrust litigation over the once-lucrative cholesterol med Lipitor. | Purchasers have long accused Pfizer—and Sun Pharma's Ranbaxy—of conspiring to keep Lipitor generics off the market with a "reverse payment" agreement. After the Pfizer settlement, the class action lawsuit against Ranbaxy will continue.

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Patients Experiencing Depression Preferred In-Person Visits During the COVID-19 Pandemic

Drug Topics

Even during times of peak transmission, individuals preferred in-person screening over video or telephone screening for depression.

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With good news on Lybalvi, Alkermes sees 10% share price increase

Fierce Pharma

As stripped down and divested Alkermes enters 2024 as a “pure-play neuroscience company”—as described by CEO Richard Pops on a conference call on Thursday—much will depend on the success of new sch | As Alkermes enters 2024 as a “pure-play neuroscience company”—as described by CEO Richard Pops on a conference call on Thursday—much will depend on the success of new schizophrenia and bipolar disorder drug Lybalvi.

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Aurlumyn Gets First FDA Approval for a Severe Frostbite Medication

Pharmaceutical Commerce

Patients with severe frostbite who were administered Aurlumyn monotherapy experienced a significantly reduced risk of the need for amputation.

FDA 109
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Biotechs ride obesity drug wave with novel approaches that go beyond GLP-1RAs

Pharmaceutical Technology

As the market is progressively becoming saturated by GLP-1 receptor agonists, companies are investigating alternative mechanisms of action.

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15 natural treatments for psoriasis

The Checkup by Singlecare

Psoriasis is an inflammatory condition affecting millions of Americans. The symptoms of psoriasis can overlap with other skin disorders such as eczema , and skin types, like dry skin. However, psoriasis isn’t just a skin condition—it’s an autoimmune disease. The most common type of psoriasis is plaque psoriasis, which is characterized by a buildup of skin cells that form plaques, or thick, scaly areas on the skin.

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New chemotherapy treatment could benefit multiple cancer types

European Pharmaceutical Review

A clinical trial in malignant pleural mesothelioma (MPM) has demonstrated the first successful combination of chemotherapy with a drug targeting cancer’s metabolism developed for the asbestos-induced disease in two decades. The anti-cancer treatment combines the new drug ADI-PEG20 and traditional chemotherapy. The Phase III ATOMIC-meso trial was led by Queen Mary University of London in the UK and studied 249 patients with the disease.

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Prime Medicine joins the biotech IPO queue, seeking $140m

pharmaphorum

Gene-editing biotech Prime Medicine has priced an initial public offering, hoping to raise $140 million to advance its pipeline of one-shot therapies for severe genetic disorders. The Cambridge, Massachusetts-based company is offering 19.2 million shares at $6.25 each and expects to start trading on the Nasdaq on 20th February under the PRME symbol.

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Listen: Pharma goes to Washington, Alnylam’s future, & Gilead’s dealmaking

STAT

Has PhRMA lost its fangs? Are 11th-hour changes ominous for clinical trials? And what’s next in pain medicine? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. The pharmaceutical industry, in court and in Congress, is working to water down legislation that will let Medicare negotiate certain drug prices.

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