Fri.Sep 20, 2024

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FTC Files Lawsuit Against ‘Big 3’ PBMs for Drug Price Inflation

Drug Topics

In its first move since the July interim report detailing pharmacy benefit manager practices, the FTC is now suing CVS Caremark, Express Scripts, and Optum Rx.

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FTC formally sues PBMs over insulin prices and warns manufacturers

Fierce Healthcare

The Federal Trade Commission is suing the titans of the pharmacy benefit manager industry for anticompetitive practices and artificially raising the price of insulin drug prices, the agency announc | As expected for weeks, the Federal Trade Commission is taking legal action against the biggest three PBMs and its related group purchasing organizations.

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Trending Sources

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Second health care worker tied to Missouri bird flu case had respiratory symptoms

STAT

A second health worker who cared for a person hospitalized in Missouri with H5N1 bird flu developed mild respiratory symptoms but was not tested for influenza, the Centers for Disease Control and Prevention reported on Friday. The CDC said Missouri health officials didn’t learn that the health worker had symptoms until after the individual had recovered, too late to run a diagnostic test.

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Q&A: PCMA on the Role of PBMs and Drug Pricing Transparency

Drug Topics

Johnny Garcia, Senior Director of Policy at the Pharmaceutical Care Management Association, discussed the common misconceptions surrounding PBMs and their role within the supply chain.

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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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STAT+: FTC sues big 3 PBMs for ‘artificially inflated’ insulin prices caused by ‘perverse’ rebating

STAT

The U.S. Federal Trade Commission filed a lawsuit against the largest pharmacy benefit managers and their group purchasing organizations for allegedly anticompetitive practices that “artificially inflated” the price of insulin and, consequently, impeded patient access to the life-saving treatment. The administrative complaint accused CVS Caremark, Cigna’s Express Scripts, and UnitedHealth’s OptumRx of creating a “perverse” system of rebates that favored

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Opill Marks a New Era for Birth Control Access

Drug Topics

Stephanie Sober, MD, MSHP, shares insights into the research that led to Opill’s FDA approval and its implications for women’s access to contraception.

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More Trending

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Study: A Walk a Day Keeps Low Back Pain Away

Drug Topics

“By encouraging active self-management using health coaching principles, the WalkBack intervention might be able to reduce the prevalence of recurrent low back pain and associated burden on health care systems,” wrote investigators.

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Mild Cognitive Impairment is Extremely Undiagnosed, Expert Says

Pharmacy Times

The chief product and strategy officer at Linus Health is hopeful that pharmacists can be key players in the detection of mild cognitive impairment.

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Opinion: How I fought Big Pharma on insulin prices — and won

STAT

In 2013, I sat down at my computer and secured the URL t1international.com. I wanted a place where I could collect and share everything I was learning about the global insulin price crisis. I was only 25 years old, and I had already been living with type 1 diabetes for more than two decades. I had struggled with the ups and downs of high and low blood sugars, been hospitalized multiple times, and faced wildly high costs for my insulin and diabetes supplies in the United States.

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FDA Approves Isatuximab With Bortezomib, Lenalidomide, and Dexamethasone for NDMM

Pharmacy Times

The decision expands treatment options for patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).

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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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Opinion: I’m a pediatrician. My bosses want me to cut new-patient visit times in half

STAT

As a pediatrician working for NYC Health + Hospitals (H+H), one of the largest public health care systems in the country, I have witnessed firsthand the challenges of providing quality care to patients from all walks of life. Whether they’re American-born or newly arrived children, my colleagues and I are tasked with ensuring they get the medical attention they need.

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Bristol Myers Squibb axes 79 more in NJ as $1.5B cost-reduction program rolls on

Fierce Pharma

The hits just keep on coming for Bristol Myers Squibb staffers amid the company's cost-savings program. | Bristol Myers Squibb is laying off an additional 79 staffers in Lawrenceville, New Jersey. The cuts will be effective between Dec. 12 and May 30 of next year and are part of BMS's $1.5 billion cost reduction program.

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FDA Approves Amivantamab-vmjw for NSCLC With EGFR Exon 19 Deletions or L858R Mutations

Pharmacy Times

Amivatamab-vmjw is a fully-human bispecific antibody targeting EGFR and MET with immune cell-directed activity.

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Cigna trims Medicare Advantage plans in eight states

Fierce Healthcare

Cigna is reshaping its Medicare Advantage (MA) plan lineup across eight states, affecting members in 36 health plans. | Cigna is the latest company to rethink its Medicare Advantage offerings, choosing to cut plans in eight states including Florida.

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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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STAT+: Novo’s new obesity drug shows modest results, raises concerns of psychiatric side effects

STAT

A next-generation obesity drug candidate from Novo Nordisk produced modest weight loss, along with a higher rate of some psychiatric side effects like anxiety and sleep disturbances — results that pose a challenge to the pharma giant’s efforts to find novel obesity drugs that could extend its success from its blockbuster Wegovy. A Phase 2a trial tested monlunabant, a pill that inhibits CB1 receptors that Novo got through its acquisition of Inversago Pharma last year.

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Arimoclomol Becomes First FDA Approved Treatment for Neimann-Pick Disease Type C

Pharmacy Times

The rare disease can result in progressive neurological symptoms and organ complications.

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FDA Approves First Treatment for Niemann-Pick Disease Type C

Drug Topics

Zevra Therapeutics said it expects the therapy to be commercially available in the United States in 8 to 12 weeks.

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Advocate Health wiping all judgment liens on patients' property, canceling associated debt

Fierce Healthcare

The country’s third-largest nonprofit health system announced Thursday it will strike all judgment liens on patients’ homes and real estate, as well as eliminate the associated outstanding debts fo | The major nonprofit health system said the plan builds on its post-merger charity care policy changes, and will help improve access and affordability of care.

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Study: Shingles Reactivation Could Occur in Rare Cases Following RZV

Pharmacy Times

Dermatomal reactions could occur following recombinant zoster vaccine to treat shingles.

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STAT+: FDA’s new head of device safety held senior role at company troubled by safety warnings

STAT

The Food and Drug Administration has tapped Ross Segan, a former device industry exec and Army veteran, to lead its division charged with ensuring medical device safety.  Segan was chief medical officer at Olympus from 2020 to 2023. Olympus is a leading distributor of endoscopes and the recipient of FDA warning letters claiming the company did not adequately address product defects — including instances where endoscope caps fell into patients’ bodies.

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Can you drink alcohol while taking omeprazole?

The Checkup by Singlecare

If you get heartburn after eating some of your favorite foods—like fried chicken or pasta— omeprazole can be a lifesaver, helping prevent painful symptoms. But what if you want to have a beer or a glass of wine along with your meal? Can you safely mix omeprazole and alcohol? The short answer is yes; there is no interaction between the two. However, most healthcare providers recommend against drinking while taking this medication—also known by its brand names Prilosec and Zegerid.

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Johnson & Johnson tacks on another NSCLC approval in pursuit of AstraZeneca's Tagrisso

Fierce Pharma

Approvals are coming fast and furious for Johnson & Johnson’s Rybrevant as it is lining up to challenge the dominance of AstraZeneca’s Tagrisso in non-small cell lung cancer (NSCLC). | Approvals are coming fast and furious for Johnson & Johnson’s Rybrevant as it is lining up to challenge the dominance of AstraZeneca’s Tagrisso in non-small cell lung cancer (NSCLC).

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STAT+: Amazon cuts ties with fertility benefits company Progyny

STAT

Amazon is terminating its contract with Progyny, a company that sells fertility benefits such as in vitro fertilization and egg freezing to employers, according to a source familiar with the matter. Starting Jan. 1, 2025, Amazon employees will no longer have access to Progyny’s services. Instead, Amazon will use Maven as its fertility benefits vendor, the person said.

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Europe's CHMP turns down Apellis' pegcetacoplan appeal, endorses new drugs from Pfizer, ImmunoGen and Henlius

Fierce Pharma

Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been left in the cold once again. | Europe’s Committee for Medicinal Products for Human Use has confirmed its negative stance on pegcetacoplan in geographic atrophy, an advanced form of age-related macular degeneration that can lead to blindness.

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STAT+: PhRMA scores a small win in legal challenge to Medicare’s drug price negotiation

STAT

WASHINGTON — A federal appeals court ruled that three organizations, including the brand drug lobby PhRMA, can challenge Medicare’s drug price negotiation program in a lower court based in Texas.

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FDA Roundup: First 1-Year CGM, Lebrikizumab-lbkz for Atopic Dermatitis

Drug Topics

Check out important updates from the FDA for the week of September 16.

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Ponsegromab Could Offer Further Treatment for Cancer Cachexia

Pharmacy Times

Ponsegromab displayed significant and robust increases in body weight at the completion of the study for all doses.

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Astellas brings its first digital health product to US

pharmaphorum

Astellas is ready to launch its first digital health product in the US, called Digitiva, which provides at-home monitoring of people with heart failure

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No Major Differences Identified Between R-CHOP21 Regimens for Treatment of Advanced-Stage Diffuse Large B-Cell Lymphoma

Pharmacy Times

Improvements in survival outcomes were seen among those at high risk for DLBCL who received 6x R-CHOP21 + 2R.

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J&J nets another key approval for blockbuster hope Rybrevant

pharmaphorum

J&J's target of $5bn in sales for Rybrevant has moved a step closer, after an FDA approval for second-line treatment of EGFR+ NSCLC

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After prior snub, Zevra clinches FDA approval for rare lysosomal storage disorder drug Miplyffa

Fierce Pharma

For Zevra Therapeutics and its rare neurodegenerative disease med arimoclomol, the second time’s the charm. | The FDA approved Zevra’s arimoclomol capsules to treat the rare lysosomal storage disorder Niemann-Pick disease type C in conjunction with Johnson & Johnson’s enzyme inhibitor miglustat. Arimoclomol, which will fly under the brand name Miplyffa, is now the first FDA-approved therapy for NPC.

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Are generalist investors good or bad for biotech?

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 see Ginkgo pivot into AI, becoming yet another contender in a crowded market. Also, we see more documents destroyed at an Indian drug manufacturing plant, and offer up a fabulous podcast.

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Breaking: FDA Approves FluMist as First-Ever Self-, Caregiver-Administered Flu Vaccine

Drug Topics

The vaccine will be made available via third-party online pharmacies.

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A big week for rats, genetics of picky eating, and research misconduct rules

STAT

If you’re a health care worker who vibes with this Tiktok , have I got a newsletter for you: STAT’s Health Care, Inc. by Bob Herman (#BobHive rise up), who makes the crushing monetization of our health at least kind of fun? (Important info: If you’re already a subscriber to HCI, get a friend to sign up at this link with the referral code provided in Monday’s newsletter and be entered to win a $100 bookshop.org gift certificate!

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