Fierce Pharma

OCTOBER 25, 2024

Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem. | Iterum's Orlynvah was approved by the FDA Friday to treat certain uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative antibacterial treatment options.

FDA

Drug Topics

OCTOBER 25, 2024

As the H5 bird flu outbreak gradually impacts human health in the US, health care experts weighed in on possibilities of a future vaccine.

Vaccines

STAT

OCTOBER 25, 2024

For the nation’s largest health insurer, the evidence of abuse was stunning and unmistakable: UnitedHealth Group reaped billions from the federal Medicare program by diagnosing patients with serious chronic illnesses, and then delivering no follow-up care. The findings in the federal report reveal that UnitedHealth repeatedly sent clinicians into patients’ homes and pored over their medical charts to add diagnoses for illnesses such as vascular disease, heart failure, and diabetes.

Insurance

Drug Topics

OCTOBER 25, 2024

Don’t miss out on the latest pharmacy insights in the Total Pharmacy October issue.

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

Patient Care

Pharmacy Times

OCTOBER 25, 2024

Their expertise complements multidisciplinary teams in a variety of clinical settings.

Drug Topics

OCTOBER 25, 2024

The cost effectiveness of biosimilar denosumab for postmenopausal osteoporosis varies significantly based on factors like adherence, subsequent therapies, and treatment duration.

Drug Topics

OCTOBER 25, 2024

“As the first oral penem approved in the US, Orlynvah offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market,” according to the CEO of Iterum Therapeutics.

FDA

STAT

OCTOBER 25, 2024

A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans. Earlier this month, the FDA declared an end to the shortage of Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, after almost two years.

FDA

Drug Topics

OCTOBER 25, 2024

Analyzing outcomes from the COVID-19, influenza, and pneumococcal vaccines, researchers explored the effectiveness and patient hesitancy surrounding each vaccine.

Vaccines

STAT

OCTOBER 25, 2024

When Chelsea Smith met Jason Martin she knew right away that he was the one — so she refused to get his phone number. That’s because getting married would make Smith ineligible for Social Security benefits and Medicaid — financial support that she and many others with disabilities need to survive. Smith didn’t want to risk falling in love knowing she couldn’t get married.

Insurance

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.

Pharmacy Times

OCTOBER 25, 2024

Pharmacists are encouraged to leverage prescription drug monitoring programs connect patients to community-based resources to address the opioid crisis and pharmacy deserts.

STAT

OCTOBER 25, 2024

Michael Anne Kyle had just begun her Ph.D. in health policy and management at Harvard Business School when her friends started complaining about the health care system. Many of them were having children for the first time, and they’d never been to the doctor so much in their lives. They’d text Kyle, who is also an ICU nurse, with gripes.

Pharmacy Times

OCTOBER 25, 2024

The call follows the FDA’s sudden removal of tirzepatide from the drug shortage list, preventing compounding pharmacies from providing the drug.

Compounding Pharmacies

Fierce Healthcare

OCTOBER 25, 2024

UnitedHealth Group has officially disclosed that 100 million people were affected by the massive cyberattack on Change Healthcare earlier this year. | UnitedHealth Group has officially disclosed that 100 million people were affected by the massive cyberattack on Change Healthcare earlier this year.

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.

FDA

Pharmacy Times

OCTOBER 25, 2024

Orlynvah is approved for uncomplicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

FDA

STAT

OCTOBER 25, 2024

A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans. Earlier this month, the FDA declared an end to the shortage of Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, after almost two years.

FDA

Pharmacy Times

OCTOBER 25, 2024

Congenital muscular dystrophy type 1a is a severe, early-onset condition that currently has no treatment, but MDL-101 may serve as a 1-time, durable treatment option.

FDA

STAT

OCTOBER 25, 2024

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Fun fact: My Ph.D. dissertation was about destroying toxic “forever chemicals,” aka PFAS. This mostly means I am cursed with knowing too much about where these chemicals are used.

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Pharmacy Management Software

Pharmacy Times

OCTOBER 25, 2024

Nathan Vanderford, PhD, MBA speaks about barriers to cancer care access experienced by patients in rural communities.

Fierce Pharma

OCTOBER 25, 2024

Key drugs from Johnson & Johnson and Eli Lilly stand to bolster their respective cases in competitive dermatology markets with new data readouts. | Johnson & Johnson tested Tremfya in patients with plaque psoriasis involvement in "sensitive or highly visible areas," while Lilly weighed Ebglyss in atopic dermatitis patients who've previously tried Dupixent.

Pharmacy Times

OCTOBER 25, 2024

Findings highlight the need for health care providers to continue to educate patients on the risk of scurvy, ensuring proper vitamin C intake.

Fierce Pharma

OCTOBER 25, 2024

Despite Merck & Co. | Despite Merck & Co. homing in on approval for its infant respiratory syncytial virus antibody clesrovimab, Sanofi thinks Beyfortus can hold its own. On a Friday call with analysts, Sanofi execs pointed to an efficacy edge for its preventive and stressed that more competition in the space is a net positive.

Pharmacy Times

OCTOBER 25, 2024

In postmenopausal women, the gel can reduce moderate to severe hot flashes as well as menopausal changes and symptoms.

FDA

Fierce Pharma

OCTOBER 25, 2024

A senior executive at BeiGene is under investigation by Chinese authorities, multiple local media outlets report. | A senior executive at BeiGene is under investigation by Chinese authorities, multiple local media outlets report. The company said it believes the investigation is not related to its activities.

Pharmacy Times

OCTOBER 25, 2024

NCCN recommends ribociclib as a preferred CDK4/6 inhibitor adjuvant therapy for patients with HR+/HER2- EBC in combination with an aromatase inhibitor.

Pharmaceutical Technology

OCTOBER 25, 2024

At the Outsourcing in Clinical Trials Conference, key opinion leaders shared predictions for workflow changes due to AI.

Fierce Healthcare

OCTOBER 25, 2024

Shares in Centene were up premarket Friday after the company beat Wall Street analysts' expectations on both profit and revenue for the third quarter. | Shares in Centene were up premarket Friday after the company beat Wall Street analysts' expectations on both profit and revenue for the third quarter.

pharmaphorum

OCTOBER 25, 2024

Intellia reports a big reduction in hereditary angioedema attacks in patients treated with its one-shot CRISPR drug, but its share fall sharply

Fierce Healthcare

OCTOBER 25, 2024

HCA Healthcare took a $50 million financial hit in the third quarter due to the impacts of the back-to-back hurricanes Helene and Milton, which slammed facilities in North Carolina, Georgia and Flo | HCA Healthcare took a $50 million financial hit in the third quarter due to the impacts of the back-to-back hurricanes Helene and Milton, which slammed facilities in North Carolina, Georgia and Florida.

pharmaphorum

OCTOBER 25, 2024

MSD buys Modifi Bio in a $1.3bn deal, getting rights to a new class of drugs for difficult-to-treat cancers, including glioblastoma.

STAT

OCTOBER 25, 2024

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We plan to manicure the Pharmalot grounds, promenade with the official mascots, and sample some natural wonders. We also hope to hold another listening party, where the rotation will likely include this , this , this , this , and this.

FDA

PharmaVoice

OCTOBER 25, 2024

After a slow start, the novel esketamine nasal spray for depression is now J&J’s fastest-growing medication.

European Pharmaceutical Review

OCTOBER 25, 2024

New clinical data has shown a potential best-in-class next-generation antibody-drug conjugate (ADC) can offer promising response rates in extensive-stage small cell lung cancer. The biologic ZL-1310 is being investigated in an ongoing Phase Ia/Ib study in these patients who have had at least one platinum-based chemotherapy regimen. Overall response rate was 74 percent in individuals with at least one post-treatment evaluation.

Chemotherapy