Thu.Sep 21, 2023

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TikTok Videos With Misinformation About Cancer Might be Hurting Women’s Health

Drug Topics

A new study from Ohio State University found that the majority of TikTok content with information about gynecologic cancer was false or inaccurate.

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FTC sues PE-backed anesthesia provider for monopolistic roll-ups, price setting

Fierce Healthcare

Federal regulators have accused a major Texas-based anesthesia provider and its parent private equity firm of a decade-long, three-pronged scheme to suppress competition and drive-up prices. | U.S. Anesthesia Partners and Welsh, Carson, Anderson & Stowe, its private equity backer, have "cost Texans tens of millions of dollars more each year" by suppressing competition over the course of a decade, the regulator alleges.

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Trending Sources

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Baltimore Pharmacy Owners Driven by Helping Patients with Health Barriers

Drug Topics

Pharmacy owner Thuy Cao helped a patient who was struggling after her mother's death.

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FTC sues private equity firm Welsh Carson, U.S. Anesthesia Partners for allegedly creating a monopoly

STAT

The Federal Trade Commission has sued U.S. Anesthesia Partners and its private equity owner, Welsh, Carson, Anderson & Stowe, alleging in federal court the two partners formed a monopoly in order to drive up prices and boost their profits. Normally, the FTC sues the company that it believes has violated antitrust law. But this lawsuit is novel by also going after a private equity sponsor that it believes hatched the entire alleged scheme — and could serve as a warning to other private

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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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Dormant HIV Infections Elicit Small Immune Response, Though Not Significant

Pharmacy Times

Two separate study findings reported that a subset of dormant CD4+ cells could spontaneously produce HIV RNA and proteins, impacting a patient’s HIV-specific immune responses.

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Opinion: Brain drain, skills loss, and other unintended consequences of overturning Roe v. Wade

STAT

Every day at the Kansas clinic where I perform abortions, I take care of pregnant people who have driven 10 hours or more across state lines for their procedures. They’re exhausted after moving mountains to get there: taking time off work, arranging child care, gathering funds. They’re excessively grateful, and their gratitude makes me sad.

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STAT+: They carry a gene for ALS but aren’t sick. What does medical research owe them?

STAT

Nine months after her mom died of ALS, Jean Swidler walked into a doctor’s office at Columbia University and asked to learn her own fate. A genetic counselor swabbed her cheek or took a blood sample — Swidler can’t remember which — and called the next month. Gently, the counselor told her she had the same mutation as her mom.

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An inside look at Walgreens’ primary care and pharmacy model

Fierce Healthcare

Despite a recent leadership shakeup and sub-par third quarter financial results, Walgreens’ executives maintain that its transformation from a retail store to a full-blown healthcare company is the | Walgreens execs gave reporters a peek behind the curtain at its Chicago primary care office and micro-fulfillment center. Here's what we learned.

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STAT+: FDA panel votes against GLP-1 therapy from former diabetes unicorn Intarcia

STAT

An advisory panel to the Food and Drug Administration unanimously voted against a diabetes implant from Intarcia Therapeutics — a former biotech unicorn that faltered after the FDA rejected said implant not once, but twice. Intarcia called for the panel meeting because of those two rejections, seeking outside input on the FDA’s decision.

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Novo Nordisk Foundation pumps $136M into new clinical cell therapy manufacturing 'hub' in Denmark

Fierce Pharma

Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technica | Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technical University of Denmark (DTU) in Lyngby.

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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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AI claims top spot by far in annual survey of what excites hospital executives

Fierce Healthcare

Artificial intelligence soared to the top spot in an annual survey that measures what emerging technology excites hospital executives as having the potential to transform the industry. | Hospital executives in a new survey called AI the most exciting emerging technology, while patient care replaced patient access as to what respondents most want technology to tackle.

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Continuous Glucose Monitors Continue to Improve Diabetes Care

Pharmacy Times

Continuous glucose monitors can significantly improve the lives of patients with diabetes, offering less finger pokes, improved compliance, and easier use methods.

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STAT+: Four burning questions about the potential 85,000-worker Kaiser Permanente strike

STAT

This week, the Coalition of Kaiser Permanente Unions is negotiating a new national contract with the health care giant. More than 75,000 Kaiser Permanente health care workers across the country have voted to authorize a strike if Thursday and Friday’s bargaining sessions do not end in an acceptable deal. If announced, the strike will affect the more than 12 million people served by Kaiser’s 39 hospitals and 715 medical offices in California, Colorado, Oregon, Washington, Hawaii, Ge

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Race, Ethnicity Data in Screening Model Could Reduce Lung Cancer Screening Disparities

Drug Topics

The ‘life-years gained from screening–computed tomography’ lung cancer screening model is recommended by the American College of Chest Physicians for personalizing patients’ shared decision-making in screening for lung cancer.

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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+: Travere kidney drug narrowly fails confirmatory trial following FDA approval

STAT

Travere Therapeutics said Thursday that a study meant to confirm the benefit of its newly approved drug for a rare kidney disorder narrowly failed. In the trial, 404 patients with the disorder, IgA nephropathy, were randomized to receive either Travere’s daily pill, Filspari, or irbesartan, a decades-old blood pressure drug often used to help manage the disease.

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Travere's Filspari misses the mark in key trial, but market removal looks unlikely: analysts

Fierce Pharma

Six months after Travere Therapeutics’ Filspari won an accelerated nod to treat patients with a rare kidney disease, the first-of-its-kind drug narrowly failed its confirmatory trial. | Six months after Travere Therapeutics’ Filspari won an accelerated nod to treat patients with a rare kidney disease, the first-of-its-kind drug narrowly failed its confirmatory trial.

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AlphaFold developers and eye scan inventors among Lasker Award winners for 2023

STAT

The prestigious Lasker Awards for biomedical research are sometimes referred to as “America’s Nobel,” and with good reason — about a fourth of Lasker laureates have gone on to receive the Swedish award, too. The winners of the 2023 awards, announced on Thursday in New York, distinguished themselves in AI-enabled protein modeling, groundbreaking eye test technology, and in a wide-ranging career in medical science that combined innovative discoveries with attention to m

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New manufacturing facility could drive gold standard in cell therapy

European Pharmaceutical Review

A new Denmark-based manufacturing facility is set to establish the final development steps and upscaling of cell therapies. To establish it, the Novo Nordisk Foundation is committing up to £127 million. CEO of the Novo Nordisk Foundation Cellerator, Thomas HR Carlsen, told EPR that for cell therapy manufacturing, “The biggest challenge is producing high-quality, consistent cell therapies at the scale required for use in clinical trials… biological complexity [of living cells] means that the man

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A thorny ALS debate at the FDA, and the promise of artificial wombs

STAT

Can the FDA be too flexible? How do you test a mechanical womb? And who decides what’s good enough for patients in need? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Lizzy Lawrence joins us to explain the promise of artificial wombs and the debate over how to ethically develop them.

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CommonSpirit Health launches national value-based care platform

Fierce Healthcare

CommonSpirit Health announced this week the launch of a value-based care platform that will spread and support best practices learned during recent years across the Catholic giant’s 24-state footpr | Called Population Health Services Organization, the platform will leverage the nonprofit health system's scale and recent learnings to bolster networks across its 24-state footprint, execs say.

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Aurinia quells investor unrest, names founder and ex-CEO Foster to its board

Fierce Pharma

Long categorized as a takeover target, autoimmune disease specialist Aurinia Pharmaceuticals has remained independent, to the frustration of some investors who believe the Canadian company has not | Aurinia has responded to criticism from some investors who believe the company has not maximized its opportunity with lupus nephritis drug Lupkynis. The company named its founder and former CEO Robert Foster to its board of directors in an agreement with major stockholder MKT Capital.

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FDA Accepts Priority Review for Pembrolizumab in Progressive Cervical Cancer

Pharmacy Times

The approval of pembrolizumab with brachytherapy could aid individuals who were newly diagnosed with progressive cervical cancer.

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After FDA rejection, Lilly's ulcerative colitis drug Omvoh picks up support from England's NICE

Fierce Pharma

Even after Eli Lilly missed its first swing at the lucrative U.S. market with ulcerative colitis drug mirikizumab, the company’s launch is gaining steam overseas. | Lilly's mirikizumab is one of several launches the company is counting on for growth in the near term. Even after an FDA rejection, the launch is gaining steam overseas.

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STAT+: Thermo Fisher just opened a $180 million plant. Executives already are talking about expanding.

STAT

Thermo Fisher Scientific’s  giant plant to manufacture gene therapies for drug companies  is barely a year old, but executives at the maker of scientific tools are already talking about expanding. Standing inside a cavernous unfinished section of the plant, Paul Fitzgerald, vice president and general manager of the site, told a group of biotech executives, journalists, and other visitors that he’s eager to transform it into laboratories.

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Takeda settles antitrust lawsuit over gout drug Colcrys after trial kicked off

Fierce Pharma

Takeda has managed to close one of the antitrust cases that have been hanging over the company. | Takeda has managed to close one of the antitrust cases that have been hanging over the company. The Japanese pharma giant has inked a settlement with drug wholesalers who accused the company of using anti-competitive deals to delay generic entry to its gout drug Colcrys.

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Report urges for new Pharma standards on antimicrobials

European Pharmaceutical Review

A new report published by the Center for Global Development (CGD) has highlighted the need for coordinated global action against antimicrobial resistance (AMR). Experts from organisations such as the Wellcome Trust and Africa Centres for Disease Control and Prevention contributed to the paper, urging governments, industry and international organisations to create a political agreement, or ‘Grand Bargain’, to improve innovation, access, and stewardship for antimicrobials, particularly in low- and

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FDA accepts Takeda’s NDA resubmission for eosinophilic esophagitis therapy

Pharmaceutical Technology

The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.

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Every Man Jack teams up with Matt James for 1st beard campaign

Drug Store News

The “Them Beardles,” campaign features the debut of an imaginary musical group that shows up to address common struggles faced by those who sport facial hair.

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Annex 1 in Force! Join the First Discussion after the 25 August Effective Date

ISPE

Annex 1 in Force! Join the First Discussion after the 25 August Effective Date Trudy Patterson Thu, 09/21/2023 - 08:38 iSpeak Blog iSpeak Annex 1 in Force! Join the First Discussion after the 25 August Effective Date Richard Denk Matthew P. Gorton 21 September 2023 PIC/s Annex 1, and the WHO Annex 2 for the manufacturing of sterile products took effect on 25 August 2023, and the time to attend the 2023 ISPE Pharma 4.0™ and Annex 1 Conference couldn’t be better.

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STAT+: What to know about the polarizing ALS drug headed for FDA scrutiny next week

STAT

Years of polarizing scientific discourse and bruising online debate will come to a head next week when advisers to the Food and Drug Administration weigh in on NurOwn , a potential treatment to slow the progression of ALS that has bitterly divided physicians and patient advocates. On Sept. 27, a panel of experts will consider the convoluted data supporting the potential approval of NurOwn, a stem-cell therapy the FDA previously refused to even consider.

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Hy-Vee sets date for next Local Brands Summit

Drug Store News

Held in partnership with ECRM and RangeMe, the summit will consist of 15- to 30-minute virtual presentations from selected suppliers.

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Ophelia partners with MSK provider Vori Health to address chronic pain, opioid use disorder

Fierce Healthcare

Ophelia, a provider of opioid use disorder (OUD) treatment, is joining forces with Vori Health, a musculoskeletal (MSK) and orthopedic care provider, to help patients manage pain in an opioid-free | Vori will refer patients to Ophelia for opioid use disorder treatment, while Ophelia will refer patients to Vori for opioid-free musculoskeletal pain management.

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The SPC waiver: How do we restore the intended balance between protection and innovation?

pharmaphorum

The SPC waiver: How do we restore the intended balance between protection and innovation? Mike.

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Expert Discusses Unique Employee-Owned Pharmacy Model

Pharmacy Times

Pharmacist discusses the success of a unique employee-owned pharmacy model.

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