Wed.Sep 18, 2024

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GSK Announces Positive Topline Data for Co-Administration of RSV, Shingles Vaccines

Drug Topics

A co-administration option for both vaccinations can increase the likelihood of older adults completing the vaccination series and improve health outcomes for the patient population.

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Study Finds Women With Asthma Are More Likely to Need Fertility Treatments

Pharmacy Times

The authors also found that there was a higher frequency of miscarriages compared with women who did not have asthma.

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Trending Sources

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Cigna’s PBM Express Scripts Files Lawsuit in Response to July FTC Report

Drug Topics

The health care giant’s pharmacy benefit manager subsidiary filed a lawsuit claiming that the FTC’s recent 6(b) report was false and misleading.

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Medication Nonadherence Poses Risks to Patient Safety

Pharmacy Times

Reasons include fear of adverse effects, lack of education, polypharmacy, and others

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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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Opinion: Tested in Africa, used in America

STAT

At the recent annual International AIDS Conference, a startling presentation about the newest wonder drug in HIV prevention brought a raucous standing ovation. Lenacapavir, a novel drug given as an injection under the skin every six months, was 100% successful in preventing HIV in adolescent girls and young women in two countries in Africa. It felt to many like a generational moment.

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RFID Technology and the DSCSA: Paving the Way for a New Standard in Patient Care

Pharmacy Times

The Drug Supply Chain Security Act (DSCSA) will soon mandate end-to-end tracking of pharmaceuticals throughout the supply chain, with numerous benefits for health systems.

More Trending

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Standardizing Infusion Pumps in Large Health Systems Enhances Safety

Pharmacy Times

Analyzing consolidation of 8 drug pump libraries into 1 IV infusion library in a 9-hospital system: from standardization to implementation.

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STAT+: Hospital giant Ascension recorded about $1.3 billion in losses from its cyberattack

STAT

The cyberattack that forced Ascension to shut off access to its electronic health records cost the nonprofit hospital system roughly $1.3 billion, according to STAT’s analysis of financial documents the health system released Tuesday evening.

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FDA Approves Pembrolizumab Plus Pemetrexed and Platinum Chemotherapy for Malignant Pleural Mesothelioma

Pharmacy Times

The approval is based on positive results from the phase 2/3 IND.227/KEYNOTE-483 trial.

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STAT+: Drugmakers rely on ‘use codes’ to vastly expand the nature of their patent claims, STAT analysis shows

STAT

Amid debate over potential abuse of the U.S. patent system by the pharmaceutical industry, moves by some drugmakers to expand their patent claims appear to be delaying the arrival of lower-cost generic medicines to the marketplace, according to a STAT analysis.  At issue are use codes, which are brief descriptions of a type of patent claim that focuses on the specific use of a medicine, or the “method of use” in legal vernacular.

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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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CVS' Oak Street to pay $60M to settle kickback allegations

Fierce Healthcare

CVS' Oak Street Health unit has agreed to pay a $60 million settlement to resolve kickback allegations, the Justice Department announced on Wednesday. | CVS' Oak Street Health unit has agreed to pay a $60 million settlement to resolve kickback allegations, the Justice Department announced on Wednesday.

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STAT+: In race to make gene therapy for age-related blindness, 4D Molecular announces positive results

STAT

A long-running race to develop a gene therapy for the most common cause of age-related blindness is heating up. On Wednesday, 4D Molecular Therapeutics announced new data from its program for the disease, known as wet age-related macular degeneration, or wet-AMD. In one 30-person Phase 2 study, patients’ need for standard-of-care injections fell by 89% after receiving gene therapy, and 73% did not need another standard-of-care shot for at least 32 weeks.

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FDA Approves Benralizumab for Eosinophilic Granulomatosis With Polyangiitis

Pharmacy Times

Eosinophilic granulomatosis with polyangiitis is a rare and immune-mediate vasculitis that can damage multiple organs and be fatal if left untreated.

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STAT+: Social media diss highlights high-stakes rivalry over colon cancer blood tests

STAT

Biotech companies routinely compete to develop and commercialize products. But these rivalries are seldom as publicly heated as what has played out on social media this week between two firms racing to develop new ways to screen for colon cancer. Over the weekend, during the leadup to Exact Sciences announcing data from a blood-based colon cancer test, Guardant Health co-CEO AmirAli Talasaz challenged Exact’s CEO, Kevin Conroy, in a LinkedIn post that was unusually confrontational.

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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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Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama

Fierce Pharma

With its latest acquisition, women’s health outfit Organon is bringing its dermatology business to the U.S. with a potential blockbuster in tow. | Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.

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Opinion: The U.S. should follow California’s lead on banning toxic chemicals in IV bags and tubes

STAT

In 2017, at the age of 42, Susan Whitehead was diagnosed with an early form of breast cancer after discovering a lump in her breast. She embarked on a challenging path of treatment, including a recurrence with stage 2 cancer four years later. Susan underwent two lumpectomies, a mastectomy, radiation, and chemotherapy. Throughout this process, she was steadfast in her resolve to seek the best possible care, which included demanding a controversial full-body scan that led to an unexpected discover

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Bipartisan telehealth extension bill passes in House committee

Fierce Healthcare

A critical telehealth extension bill passed in a House markup hearing Wednesday, but it's far from the only activity in Congress this week.

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STAT+: House panel passes pediatric rare disease bill, setting it up for government funding bill

STAT

A House committee on Wednesday passed a bill to renew a program aimed at aiding development of drugs for rare diseases in children , putting it in a better position to be added to government funding legislation.  The pediatric rare disease priority review voucher program is set to end on Sept. 30. The legislation would extend the program until Sept. 30, 2029.

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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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GSK touts co-administration data for RSV, shingles vaccines as narrowed CDC guidance threatens sales

Fierce Pharma

This summer, GSK cut its yearly vaccine sales projection o | In the study, co-administration of GSK's RSV vaccine Arexvy and shingles shot Shingrix elicited non-inferior immune responses compared with separate administration of the vaccines.

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Healthy.io, National Kidney Foundation team up to promote early disease detection, using tech to reach at-risk people

Fierce Healthcare

Healthy.

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AstraZeneca's Fasenra plays catch-up with GSK's Nucala, gaining FDA nod for rare autoimmune disease

Fierce Pharma

Since GSK’s Nucala and AstraZeneca’s Fasenra were approved two years apart to treat patients with severe asthma, the IL-5 inhibitors have engaged in a spirited market battle, with one key differenc | Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off on its use to treat the rare autoimmune condition of eosinophilic granulomatosis with polyangiitis.

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PBM strikes back at FTC over drug pricing report

pharmaphorum

PBM Express Scripts has sued the FTC, claiming its recent report on the sector's role in drug pricing is defamatory and should be retracted

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STAT+: Roivant strikes another deal, selling dermatology spinoff to Organon in deal worth $1.2 billion

STAT

Roivant Sciences continues its dealmaking hot streak, announcing Wednesday that it would sell one of its subsidiaries to pharma company Organon in a deal worth $1.2 billion. Organon is buying Roivant subsidiary Dermavant and its topical treatment Vtama. The drug is currently approved to treat various forms of the skin condition plaque psoriasis. But analysts and Organon see the real potential in Dermavant’s standing application with the Food and Drug Administration to expand the drug

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Theratechnologies warns of Egrifta supply disruption after third-party plant shutdown

Fierce Pharma

Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could | Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could soon run short.

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STAT+: House panel advances bill to extend Medicare’s telehealth flexibilities, setting up December talks

STAT

A House committee on Wednesday advanced legislation that would extend Medicare telehealth flexibilities and a home hospital program adopted during the pandemic, the final step before the bills face a vote by the full House of Representatives. Congress in 2022 extended pandemic-era flexibilities about where and what kinds of care Medicare enrollees could receive over telehealth.

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Solution Spotlight: Aktiia Blood Pressure Technology

pharmaphorum

In a new solution spotlight, learn more about the Aktiia Medical Grade Wearable, a clinically validated device engineered to deliver precise blood pressure readings passively, irrespective of the user's position—be it sitting, lying down, or standing.

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Bernie Sanders keeps the heat on Novo’s high prices

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. My colleague Ed Silverman, who I view as the foremost expert on drug patents (and coffee flavors), has been taking a closer look at patent claims to bring us an exclusive analysis. We get into all of that today.

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Ribociclib Plus Aromatase Inhibitor Approved as Adjuvant Therapy for HR+/HER2- Early Breast Cancer

Drug Topics

This approval offers an additional treatment option for a disease that can commonly return.

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STAT+: Pharmalittle: We’re reading about pharma patent maneuvers, the U.S. warning J&J, and more

STAT

Hello, everyone, and how are you today? We are muddling along, but the middle of the week is upon us, so we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy. So we are digging about the pantry and firing up our coffee kettle to get things started.

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FDA Clears First 1-Year CGM for Diabetes

Drug Topics

The Eversense 365 is the world’s first long-term CGM that provides 1 year of use and should be available by the fourth quarter of 2024.

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Organon makes dermatology play with $1.2bn Dermavant buyout

pharmaphorum

Organon has agreed a $1.

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FDA Approves Benralizumab for Eosinophilic Granulomatosis with Polyangiitis

Drug Topics

The approval was based on data from the phase 3 MANDARA trial, where the therapy met the primary endpoint of proportion of patients in remission at weeks 36 and 48.

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FDA Grants Fast Track Designation to ICT01 in Combination With Azacitidine and Venetoclax for Acute Myeloid Leukemia

Pharmacy Times

The humanized anti-butyrophilin 3A monoclonal antibody selectively activates Vγ9Vδ2 T-cells.

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