Thu.Aug 24, 2023

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Mid-Year Updates on PBM Legislation

Drug Topics

The Modernizing and Ensuring PBM Accountability Act, recently passed by the Senate Finance Committee, aims to regulate PBMs in the Medicare Part D, Medicare Advance, and Medicaid spaces.

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Study: Pain After Heart Attack Linked With Long-Term Survival

Pharmacy Times

Notably, 65% of the participants experiencing pain at the 2-month follow up were also experiencing pain at their 12-month follow up, suggesting persistent and long-term pain.

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Rise of Third-Party Pharmacy Audits

Drug Topics

A greater number of pharmacy audits are originating not only from third party payors, but also from various government agencies, such as Medicare and Medicaid.

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Vaccine Candidate Shows Promise for Slowing Cognitive Decline in Mild Alzheimer Disease

Pharmacy Times

UB-311 has shown to be well-tolerated with a durable antibody response in a previous phase 1 trial, and new results from a phase 2a study support its continued development.

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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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ChatGPT Often Provides Inaccurate Cancer Treatment Recommendations

Drug Topics

A new study found that 34% of the chatbot’s answers included 1 or more recommendation that did not align with clinical guidelines.

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Researchers Advance Survodutide Use for Obesity into Phase III Study

Pharmacy Times

The phase 3 study will advance the safety findings of survodutide reported in the phase 2 study to aid overweight and obesity.

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More Trending

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FDA Approves Remdesivir to Treat COVID-19 in Patients with Hepatic Impairment

Pharmacy Times

The drug is the first approved antiviral COVID-19 treatment that could be used across all stages of liver disease.

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On a roll, Novo's star obesity drug Wegovy shows benefits in patients with heart failure

Fierce Pharma

Just a few short weeks after Wegovy posted a major cardio outcomes win, Novo Nordisk has chalked up another heart-related victory for its semaglutide star. | In a phase 3 study, semaglutide at the 2.4 mg dose bested placebo at reducing symptoms and physical limitations in patients with obesity and heart failure with preserved ejection fraction. The drug also led to greater improvements in exercise function and more weight loss versus a dummy drug, according to study results published in The New

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Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America

The FDA Law Blog

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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10 benefits of acidophilus probiotics

The Checkup by Singlecare

Maybe you’ve heard that acidophilus is excellent for your gut health. Or perhaps a friend has recommended it as an immunity booster for fighting the cold or flu. The truth is that acidophilus—a beneficial bacteria found in your body, certain foods, and most probiotic supplements —has many health benefits. L. acidophilus probiotics can help your body in several ways, including aiding in weight loss, reducing cholesterol levels, and helping to treat vaginal infections.

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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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Cabometyx study ends early after researchers see 'dramatic' benefits in neuroendocrine tumors, Exelixis says

Fierce Pharma

It's not always a good thing when a drug developer stops a cancer trial. But in a recent case for Exelixis, a Cabometyx trial ended early because of an undeniable efficacy showing. | Exelixis' drug proved its worth in treating advanced pancreatic and extra-pancreatic neuroendocrine tumors, so much so that an independent board unanimously recommended an early stop.

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Birch bark extract recommended by NICE for epidermolysis bullosa-induced wounds

Hospital Pharmacy Europe

A birch bark extract has been recommended by NICE for treating skin wounds associated with dystrophic and junctional epidermolysis bullosa. In the UK, draft guidance from NICE has recommended a birch bark extract within its marketing authorisation, as an option for treating partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa in people aged 6 months and over.

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Krystal Cascetta, Lindsay Clancy, and the impossibility of being a mom in American medicine

STAT

In Igbo-Nigerian culture, new moms receive exquisite care from their own mothers, mothers-in-law, or surrogate mothers for the first few months postpartum. After each of my daughters was born, I was blessed to participate in this tradition, called omugwo, which allowed me to be nurtured by the mothers who came before me. They cooked and cleaned. Massaged my belly and taught me how to breastfeed.

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Humana cuts 13-state kidney disease management deal with Interwell Health

Fierce Healthcare

A new value-based care agreement has been announced between Humana and Interwell Health, a kidney care management company, in 13 states. | Humana and Interwell Health, a kidney care management company, have partnered to begin a new value-based care agreement to certain Medicare Advantage members in 13 states.

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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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Ferring inks $500M deal with Royalty Pharma on new bladder cancer gene therapy

Fierce Pharma

Royalty Pharma has built a niche by finding innovative products pre- and post-approval from companies that need an infusion of cash in exchange for future royalties. | Royalty Pharma has signed a deal with Ferring Pharmaceuticals to collect royalties on bladder cancer drug Adstiladrin. Royalty will pay $300 million up front and $200 million in a potential milestone tied to Ferring meeting certain manufacturing goals.

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Pandemic ushered 'unprecedented' declines in hospital patient experience scores, study finds

Fierce Healthcare

Though hospitals’ patient experience scores broadly suffered during the COVID-19 pandemic, the “unprecedented” declines were greatest among facilities that were already facing staffing issues prior | Patient experience score declines were steepest among facilities already understaffed or poorly rated, though no hospital exited 2021 with their HCAHPS scores unscathed, according to a new CMS-backed analysis.

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Fierce Pharma Asia—Moderna's cancer combo plan; GSK's trial win; Glenmark's DOJ deal

Fierce Pharma

Moderna is considering pairing one of its mRNA cancer vaccine candidates with a CAR-T therapy from China's CARsgen. GSK's Shingrix showed 100% efficacy in a postmarketing trial in China. | Moderna is considering pairing an mRNA cancer vaccine candidate with a CAR-T therapy from China's CARsgen. GSK's Shingrix showed 100% efficacy in a Chinese post-marketing trial.

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GSK shingles vaccine achieves 100 percent efficacy in China trial

European Pharmaceutical Review

GSK’s Shingrix (Recombinant Zoster Vaccine or RZV) vaccine has been shown to offer 100 percent efficacy against shingles in adults 50 years old and over in China. The Phase IV trial (ZOSTER-076) is the first-ever efficacy trial of the shingles vaccine Shingrix in China. Almost 6,000 participants were enrolled in the trial, which was conducted between 2021 and 2023.

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After high-profile snub, Akebia plots vadadustat resubmission at FDA

Fierce Pharma

After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for | After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for a second bid at approval.

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STAT+: What past blockbusters can tell us about future of Wegovy and other weight loss medicines

STAT

The news that the weight loss drug Wegovy reduced the risk of heart attacks and strokes in overweight volunteers opens up the door to vastly expanded use of the drug and medicines like it, known as GLP-1 inhibitors. That could have a big, positive impact on public health, and it will very likely swell the coffers of the pharmaceutical companies that make these medicines, including Wegovy’s maker, Novo Nordisk, and Eli Lilly, now the most valuable drug company in history thanks largely to

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CVS Pharmacy, Walgreens to acquire prescription files from SEG's pharmacies

Drug Store News

The moves follows Aldi's definitive agreement to acquire Winn-Dixie and Harveys Supermarket as part of a larger divestiture of Southeastern Grocers to various entities.

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STAT+: Mid-year drug price hikes are back despite Inflation Reduction Act

STAT

It’s almost a tradition. At the start and halfway points of each year, many pharmaceutical companies raise drug prices to bolster revenue and reportedly fund new research. “It’s not just all selling new drugs,” said Juliette Cubanski, deputy director of the Program on Medicare Policy at Kaiser Family Foundation. “It’s increasing prices on their existing portfolio.

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CVS Health enters biosimilar fray with launch of new subsidiary

Pharmaceutical Technology

The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.

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Talquetamab approved by European Commission for relapsed/refractory multiple myeloma

Hospital Pharmacy Europe

Talquetamab has been granted a conditional marketing authorisation by the European Commission as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma. Talquetamab (brand name Talvey) is approved as a weekly or biweekly subcutaneous injection after an initial step-up phase. It can be used as monotherapy for the treatment of patients relapsed and refractory multiple myeloma who have had an inadequate response to at least three prior therapies, including an

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Opinion: How to save the U.S. News & World Report Best Hospitals rankings

STAT

U.S. News & World Report   recently issued its 2023-24 Best Hospitals ratings. The ratings come at a time of increased scrutiny and skepticism of ranking systems. In very public ways, many colleges, law schools, and medical schools have declined to participate in the U.S. News process, while some hospitals have expressed their desire to abandon the rankings as well.

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New Parkinson’s drug formulation “nearly doubles” exposure

European Pharmaceutical Review

A new drug formulation of a protein kinase inhibitor therapeutic designed to modify the course of Parkinson’s diseas e has been developed. The Abelson Tyrosine Kinase (c-Abl) inhibitor risvodetinib (IkT-148009), “nearly doubles” drug exposure, according to Inhibikase Therapeutics’ CEO. Dr Milton Werner, President & CEO of Inhibikase explained that the company “recently completed characterisation of a novel tablet formulation that mimics the oral drug formulation we used to evaluate eff

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'Far too speculative': Amgen fights FTC's request for injunction against $28B Horizon merger

Fierce Pharma

As the Federal Trade Commission tries to block Amgen’s $28 billion acquisition of Horizon Therapeutics with an injunction, Amgen has a lot to say in court filings. | The Federal Trade Commission is trying to block Amgen’s proposed $28 billion acquisition of Horizon Therapeutics. Amgen has a lot to say as the case plays out in court.

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Royalty Pharma Places $500 Million Bet on Ferring Gene Therapy

BioPharm

Royalty Pharma agreed to spend up to $500 million for a 5.1 to 8% royalty on net sales of Ferring’s gene therapy adstiladrin (nadofaragene firadenovec-vcng).

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Delayed-release budesonide effective in primary IgA nephropathy, study shows

Hospital Pharmacy Europe

An oral, delayed-release budesonide formulation provides a clinically relevant reduction in estimated glomerular filtration rate (eGFR) decline and a durable reduction in proteinuria versus placebo in patients with primary IgA nephropathy (IgAN), a new study has shown. The the first and only treatment indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, budesonide was approved by the FDA in 2021 under the accelerated approval scheme.

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Dizal receives approval in China for NSCLC therapy

Pharmaceutical Technology

Dizal has received approval from China’s NMPA for sunvozertinib to treat adult patients with locally advanced or metastatic NSCLC

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CVS Health launches Cordavis

Drug Store News

As its first product, Cordavis has contracted with Sandoz to commercialize and bring to market Hyrimoz, a biosimilar for Humira.

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Japan grants patent for BioArctic’s Parkinson’s disease antibody

Pharmaceutical Technology

Japan has granted a new drug substance patent for BioArctic’s monoclonal antibody (mAb), BAN0805, to treat Parkinson’s disease.

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FORE Biotherapeutics closes $75M financing to accelerate development of plixorafenib

Outsourcing Pharma

FORE Biotherapeutics yesterday (August 23) announced the closing of its $75 million (Â59 million) series D financing, led by the SR One and co-led by Medicxi and joined by existing investors.

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‘Eris’ and other new COVID strains accelerate vaccine push from Pfizer, Moderna, Novavax

PharmaVoice

New variants drive a need for another round of shots, and biopharma companies are stepping up to the plate.