Thu.Jul 11, 2024

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FTC Intends to Sue Biggest Pharmacy Benefit Managers for Unfair Negotiating Tactics

Pharmacy Times

In a follow-up to the interim FTC report documenting the business practices of PBMs and the power they hold in the pharmaceutical industry, the Commission now seeks to sue the 3 largest PBMs in the country for driving up the price of insulin and other essential drugs.

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Alcohol is driving a half-dozen types of cancer in the U.S., study finds

STAT

Alcohol has long been classified as a cancer-causing substance, but a study out Thursday gives a clearer sense of just how many cancer cases and deaths may be driven by drinking.  Researchers from the American Cancer Society and International Agency for Research on Cancer estimate 40% of all cancer cases in the United States in people 30 and up were due to “potentially modifiable risk factors,” including cigarette smoking, physical inactivity, consumption of processed meat, vi

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Senate unanimously endorses legislation targeting pharma 'patent thickets'

Fierce Pharma

Even as pharma companies have yet to feel the full effects of the Inflation Reduction Act, Senate lawmakers have turned their attention to another facet of drug pricing with a bill meant to cr | The bill looks to limit the number of patents that companies can assert in litigation on individual products. It's intended to crack down on "patent thickets," which can delay and thwart generic competition.

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Opinion: Doctors ‘overprescribing’ opioids isn’t the cause of the overdose epidemic — and it never was

STAT

A key part of the federal government’s narrative about the epidemic of addiction and overdose deaths in the U.S. has been that it is driven by doctors and other clinicians overprescribing opioid painkillers. That story line is false — and was never true. The Centers for Disease Control and Prevention has traditionally relied on death certificate data compiled by the National Center for Health Statistics for its data on overdose deaths, organized as Underlying Cause of Death data us

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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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Updated Guidelines for Statin Therapy in Patients With HIV

Pharmacy Times

Previous studies have shown that individuals living with HIV are at higher risk for heart disease than individuals without HIV

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Opinion: Preparing schools for the H5N1 bird flu they’re likely to face

STAT

As Covid-19 swept across the United States, schools were among the most highly affected public spaces. To prepare for a potential H5N1 avian influenza jump to humans, schools need to be preparing for the scenario now before a sustained transmission event occurs. The response to Covid-19, which first appeared in the U.S. in early 2020, has been scrutinized by numerous case studies, after-action reports , and Congressional fact-finding hearings.

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Medicaid is paying millions for salty, fat-laden ‘medically tailored’ cheeseburgers and sandwiches

STAT

WASHINGTON – They’re marketed as healthy, “dietitian-approved” meals and delivered directly to the homes of people seriously ill from cancer, diabetes, or heart disease: a Jimmy Dean frozen sausage breakfast sandwich, biscuits and gravy, a cheeseburger. These are among the offerings sold by an Idaho-based company, Homestyle Direct, which is paid millions of dollars each year by taxpayer-funded state Medicaid programs to deliver what the company calls medically tailore

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High-Dose Intravenous Immunoglobulin Responsive to Platelet-Activating Anti-PF4 Disorder

Pharmacy Times

Intravenous immunoglobulin was effective as an adjunctive treatment to anticoagulation in a patient with post-viral platelet-activating anti-PF4 disorder, indicating the need for accurate diagnosis and treatment selection.

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Elmo and his friends are helping little kids (and grown-ups) with their ‘big feelings’ amid a mental health crisis

STAT

WASHINGTON — When Elmo asked “How is everybody doing?” back in January, he was not expecting the onslaught of stress, despair, and anxiety that hit his replies. “I’m just looking for somebody to talk to and show me some love if you know what I mean,” famous singer T-Pain wrote back to the red Muppet.

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CMS proposes new payments for digital health under CY2025 PFS draft rule

Fierce Healthcare

The Centers for Medicare & Medicaid Services' (CMS') proposed calendar year 2025 physician fee schedule rule, out Wednesday, proposed an assortment of new payments and coverage for digital heal | CMS' proposed changes to digital health payment for physicians includes new codes for mental health-related digital therapeutics, an assortment of telehealth extensions and more flexibilities for opioid treatment programs to use audio and video telehealth services.

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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+: Pfizer says it will advance once-daily GLP-1 pill after all

STAT

Pfizer said Thursday that it plans to advance a new, once-a-day formulation of its experimental obesity drug danuglipron, meant to be a pill version in the same class as popular injections like Wegovy and Zepbound. The medicine had at one point been a key focus for many investors, with Pfizer talking up the potential of the obesity market and saying it had two potential experimental obesity medicines in development.

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The end of the beginning: Lilly execs eye top spot in burgeoning Alzheimer's market after Kisunla's FDA approval

Fierce Pharma

Following this month's FDA approval of Eli Lilly’s amyloid-busting antibody Kisunla (donanemab), the Alzheimer’s disease market is set to grow in earnest—and Lilly is already eyeing a spot at the t | On top of Eisai and Biogen's Leqembi, Kisunla’s approval likely marks the “end of the beginning in treating this disease,” Andrew Lechleiter, VP of U.S.

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STAT+: Medicare proposes to cover some digital therapies in a breakthrough for health tech firms

STAT

In what could prove to be a lifeline for a new crop of health tech startups, Medicare regulators proposed new codes that support payment for digital mental health treatments, like apps that deliver cognitive behavioral therapy. The new codes  in the Centers for Medicare and Medicaid Services’ 2025 Medicare Physician Fee Schedule Proposed Rule released this week would allow clinicians to bill for supplying apps and other digital treatments as part of behavioral health treatment, as we

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Court pauses CMS broker compensation rule for Medicare Advantage plans

Fierce Healthcare

A recent lawsuit has pushed back against an industry-opposed Centers for Medicare & Medicaid Services (CMS) final rule on broker compensation in Medicare Advantage (MA) plans. | A district court in Texas is halting a federal rule that changes broker compensation and overhauls marketing to seniors.

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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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Listen: Biotech layoffs, founder-focused VC, & a big pharma exit

STAT

Why are pharmaceutical companies cutting more staff than cash-strapped biotechs? And who will Pfizer scout out as its next science chief? STAT’s West Coast biotech reporter Jonathan Wosen joins “The Readout LOUD” to discuss what’s driving workforce cuts.

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FTC said to be planning legal action against PBMs

pharmaphorum

The FTC is said to be gearing up to file lawsuits against the top three pharmacy benefit managers in the wake of its damning report on the sector.

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Understand the Effects of Topical Nasal Decongestants on Blood Pressure

Pharmacy Times

Because decongestants act by constricting blood vessels, their use can be problematic in individuals who have hypertension.

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Bill that would cut down ‘patent thickets’ clears Senate

pharmaphorum

The US Senate has come together to pass a bill that aims to prevent pharma companies from filing multiple patents around biologic drugs as a way to delay biosimilar competitors.Lawmakers unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150), which is part of a lengthening list of measures being taken by Congress to curb the prices of medicines in the US.

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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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Citing manufacturing issue, FDA rejects Novo Nordisk's once-weekly insulin

Fierce Pharma

In surging to the top spot in the market cap rankings in Europe, Novo Nordisk has been on an extended winning streak. | The FDA has slowed the roll for Novo Nordisk, rejecting its once-a-week insulin icodec for patients with Type 1 and Type 2 diabetes. In a complete response letter, the U.S. regulator made "requests related to the manufacturing process and the type 1 diabetes indication," which the company said it does not expect to remedy by the end of this year.

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SK Life Science Leverages Smart, Efficient Solutions Across its Engaged Industry-Leading Sales Team

pharmaphorum

SK Life Science Leverages Smart, Efficient Solutions Across its Engaged Industry-Leading Sales Team Mike.

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Akebia unveils IRA-driven price tag for kidney disease drug Vafseo, ends CSL collab

Fierce Pharma

After a rocky road to approval and two amendments to the original pact, Akebia Therapeutics and CSL Vifor have terminated their collaboration around the oral chronic kidney disease (CKD) anemia dru | As it ends a licensing agreement with CSL Vifor, Akebia has priced its chronic kidney disease anemia drug Vafseo by incorporating an uncertain future label expansion that it plans to discuss with the FDA later this year.

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How is the rise of GenAI changing the field of pharma medical writing?

pharmaphorum

The rise of GenAI is revolutionising the field of pharma medical writing in biopharma. Explore how this innovative technology is transforming the industry and its impact on medical writing practices.

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Q&A: How an Army Veteran Began His Journey to Overcoming PTSD

Drug Topics

“They may not understand. But I tell people, ‘I don't want you to understand me.’ I don't understand me. But if you can relate to me, then that furthers our conversation—the relatedness,” said Farron Dozier on his experience with PTSD.

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Clinical trial trends and the rise of site networks

pharmaphorum

Tune in to Caroline Redecker and Jason Casarella as they discuss clinical trial trends and the rise of site networks in this insightful podcast episode brought to you by Advanced Clinical.

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STAT+: Pharmalittle: We’re reading about a Pfizer daily weight loss pill, a Novo Nordisk setback, and more

STAT

Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day as well, despite expectations of still more heat. The skies are clear and sunny, the birds are chirping, and the official mascots are capturing creatures on the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of blueberry muffin for the occasion.

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After $185M asset buy, Merz Therapeutics plots US workforce expansion as CEO eyes more deals

Fierce Pharma

Freshly equipped with two approved meds from Acorda Therapeutics, Frankfurt, Germany’s Merz Therapeutics is kicking its specialty neurology ambitions into high gear. | Equipped with two approved meds from Acorda Therapeutics, Germany’s Merz Therapeutics is kicking its specialty neurology ambitions into high gear.

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FDA rejects Novo Nordisk’s weekly basal insulin

pharmaphorum

FDA rejects Novo Nordisk’s once-weekly basal insulin for people with diabetes, which would reduce the number of injections needed

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AbbVie asks Supreme Court to uphold attorney-client privilege in AndroGel lawsuit

Fierce Pharma

AbbVie is asking the U.S. | AbbVie is asking the U.S. Supreme Court to overrule a lower court's ruling that the company must turn over records of communications with its lawyers regarding a patent lawsuit it filed against a generic drug maker more than a decade ago.

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AbbVie lines up Thakkar to replace outgoing CSO Hudson

pharmaphorum

Change of R&D chiefs at AbbVie, as Thomas Hudson steps down as CSO and is replaced by Roopal Thakkar.

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STAT+: Roche’s TIGIT study was a bust. What’s the outlook for its next big bet?

STAT

This is the online edition of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up  here to get it delivered to their inbox. A few years back, TIGIT was hailed as the next blockbuster target for cancer immunotherapy. Based on early data, drugmakers were hopeful that blocking two checkpoint proteins on immune cells — TIGIT and PD-1/PD-L1 — would be more effective at killing tumors than just blocking one, potentially offering greater benef

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Meet Ketaki Patwardhan - from experiements with dad to excipients and manufacturing at Roquette

Outsourcing Pharma

Ketaki Patwardhan, a global technical developer at Roquette, has built a remarkable career in the pharmaceutical industry by leveraging her curiosity and passion for science.

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AbbVie appoints new Chief Scientific Officer

European Pharmaceutical Review

Dr Roopal Thakkar has been appointed as Executive Vice President, Research & Development and Chief Scientific Officer of AbbVie. He is the company ’s current Senior Vice President, Chief Medical Officer, Global Therapeutics. “As AbbVie’s Chief Scientific Officer, Dr Thakkar will continue to build momentum across discovery and all stages of development to fully realise the potential of our diverse pipeline.

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Pharma Pulse 7/11/24: Thermo Fisher Scientific Completes Acquisition of Olink, 7 Takeaways From the FTC Interim Report on PBMs & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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