February, 2024

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The Respiratory Disease Trifecta: What to Know About COVID-19, Flu, and RSV

Drug Topics

In order to provide the best care, it’s crucial that pharmacists stay up-to-date on the latest guidance and data for flu, COVID-19, and RSV—even when that information is constantly changing.

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Hyperbaric Oxygen Therapy May Be the First, Only Clinically Effective Treatment for Long COVID

Pharmacy Times

“I’m better than I was before I had long COVID, and in so many ways,” said a patient in an interview with Pharmacy Times.

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Trending Sources

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CDC advisory panel says people 65 and older should get a Covid spring booster shot

STAT

An expert panel advising the Centers for Disease Control and Prevention on vaccines on Wednesday recommended that people 65 and older should get an additional Covid-19 vaccine shot this spring. The recommendation was approved by CDC Director Mandy Cohen, allowing the United States to join Canada and the United Kingdom in offering a spring booster this year to people at high risk of severe disease if they contract Covid.

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Abridge clinches $150M to build out generative AI for medical documentation

Fierce Healthcare

Investors continue to pour money into generative AI startups and Abridge is riding this wave as it rapidly scales its technology across U.S. health systems. | Along with the funding round, Abridge also announced an enterprise agreement with Connecticut-based Yale New Haven Health System to give thousands of clinicians access to its AI-powered clinical documentation technology.

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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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FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

Fierce Pharma

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.

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Clinical research is about trial and error

pharmaphorum

Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.

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SGLT2 Inhibitors Are Underutilized for Inpatient Heart Failure Treatment

Pharmacy Times

Cardioprotective antihyperglycemic agents are underutilized for inpatient care in heart failure patients. Lack of use can lead to preventable patient deaths and hospital readmissions.

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Cholera vaccine shortage reaches worst point yet, with experts fearing deadly outbreaks

STAT

An unprecedented shortage of cholera vaccine has public health experts fearing that a recent surge of outbreaks across developing countries will only worsen, a situation they argue is as regrettable as it was avoidable. At least 16 countries in Asia, Africa, and the Caribbean are dealing with cholera outbreaks. According to the latest report from the European Centre for Disease Prevention and Control , between Dec. 23 and Jan. 23, nearly 50,500 people contracted cholera and nearly 500 died.

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As AI adoption in healthcare grows, Senate lawmakers weigh regulation, payment approaches

Fierce Healthcare

As the use of artificial intelligence technology in healthcare grows, federal lawmakers are weighing how to protect patients without hindering innovation and many in Congress are pushing for strong | As the use of artificial intelligence technology in healthcare grows, federal lawmakers are weighing how to protect patients without hindering innovation and many in Congress are pushing for stronger regulation.

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AstraZeneca finally drops roxadustat US rights after FDA rejection, trial failure

Fierce Pharma

AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat. | More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. Still, AZ left the partners' China pact intact.

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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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FDA says yes to Allecra, no to Venatorx UTI drugs

pharmaphorum

The FDA has approved Allecra Therapeutics' Exblifep, a combination antibiotic for complicated urinary tract infections (cUTIs) that will now launch later this year, but turned down a rival product from Venatorx.

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OTC Colon Cancer Screening Test Now Available in Pharmacies Across US

Drug Topics

Reese Pharmaceutical’s ColoTest has a suggested retail price of $19.99 and will also be sold on major retail shelves later this spring.

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California Passes First-in-Nation Law to Reduce Medication Errors, Address Pharmacy Staffing Concerns

Pharmacy Times

California's Stop Dangerous Pharmacies Act aims to improve patient safety by establishing new pharmacy staffing regulations and a medication error reporting system, arising from understaffed conditions.

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STAT+: White House to hold a listening session on reforming pharmacy benefit managers

STAT

In a bid to combat prescription drug costs, the White House will hold a listening session on Monday in search of ways to reform pharmacy benefit managers , according to people familiar with the plans. The list of attendees includes representatives from the federal government and industry, who are expected to provide insights into how the largest pharmacy benefit managers determine which medicines are covered by insurers and employers, as well as prices that are paid at pharmacy counters.

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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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ViVE 2024: Health systems are making big bets on AI. Here's how

Fierce Healthcare

LOS ANGELES — AI took center stage at the ViVE 2024 conference this week and health systems across the country are deploying the tech to tackle issues from easing the drudgery of medical docum | AI took center stage at the ViVE 2024 conference this week and health systems across the country are deploying the tech to tackle issues from easing the drudgery of medical documentation to making it easier for patients to get information about their medical care.

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FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

Fierce Pharma

People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods.

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Transforming drug development with AI

pharmaphorum

Discover how artificial intelligence (AI) is revolutionising the drug development process and transforming the way FDA-approved drugs are produced, ensuring compliance and optimising the supply chain. Learn more about the future of AI in pharmaceuticals.

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Repeat Dosing Study Demonstrates Positive Data for Neffy Epinephrine Nasal Spray

Drug Topics

Manufacturer ARS Pharma will submit the data as part of a response to a CRL received in 2023.

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Biosimilars: Are They Delivering the Cost Savings Promised?

Pharmacy Times

Since the first FDA biosimilar approval of filgrastim-sndz (Zarxio) in 2015, a total of 44 biosimilars for 15 originator products have been approved and more than 20 are marketed.

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Opinion: Medicare Advantage is bad for patients and bad for investors

STAT

In 2023, enrollment in Medicare Advantage, the version of Medicare run by private insurers, surpassed 50% of eligible beneficiaries for the very first time. Going by this headline, or perhaps the predictable flood of advertisements for plans during the fall’s open enrollment period, you might be fooled into thinking 2023 was MA’s best year yet.

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Optum's Change Healthcare responding to 'cybersecurity issue'

Fierce Healthcare

Change Healthcare is mitigating a "cybersecurity issue" that began Wednesday, and details remain scant. | Change Healthcare is mitigating a "cybersecurity issue" that began Wednesday, and details remain scant.

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Perrigo plots hundreds of job cuts as it embarks on restructuring initiative

Fierce Pharma

Over-the-counter self-care specialist Perrigo is poised to leave hundreds of workers by the wayside as it embarks on the next leg of its corporate journey. | As part of a cost-cutting and restructuring initiative dubbed "Project Energize," Perrigo expects to trim roughly 6% of its total staff, the company said in a fourth-quarter earnings release Tuesday.

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Rare Disease Day 2024 – The importance of shining a light on rare diseases

pharmaphorum

Rare Disease Day 2024 is an important opportunity to raise awareness about rare diseases and the need for research, diagnosis, and treatment options like orphan drugs. Learn the significance of shining a light on rare diseases.

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FTC sues to block Kroger’s acquisition of Albertsons

Drug Store News

The FTC alleges that the largest supermarket merger in U.S. history will eliminate competition and raise grocery prices for millions of Americans, while harming tens of thousands of workers.

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Maternal Vitamin D, Multivitamin Supplementation May Reduce Risk of Autism in Offspring

Pharmacy Times

Supplementation during pregnancy also reduced communication warning behaviors in children who developed autism compared to the children of women who did not take supplements.

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STAT+: Congress punts on PBM reform efforts

STAT

WASHINGTON — Congress has abandoned its attempt to reform how pharmacy middlemen operate in an upcoming package to fund the federal government, 11 lobbyists and sources following the talks told STAT. It’s a missed opportunity to pass one of the health care priorities that has attracted the most bipartisan interest and activity this Congress, though lawmakers could revive the negotiations on the issues in the future.

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WSJ: Department of Justice conducting antitrust probe of UnitedHealth Group

Fierce Healthcare

Amid a tense week for UnitedHealth Group as the company continues to navigate a cyberattack against its Optum unit, the Wall Street Journal reports that the Biden administration is quietly launchin | Amid a tense week for UnitedHealth Group as the company continues to navigate a cyberattack against its Optum unit, the Wall Street Journal reports that the Biden administration is quietly launching an antitrust probe into the company.

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'The Top Line': Gene editing's next act

Fierce Pharma

Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. | This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.

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Roche’s Xolair is first medicine for food allergy in US

pharmaphorum

Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people with food allergies in the US.

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MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine

Pharmaceutical Technology

The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.

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FDA Accepts New Drug Application for MDMA-Assisted Therapy for PTSD

Pharmacy Times

If approved, this would mark the first MDMA-assisted therapy and psychedelic-assisted therapy approved, calling for a reschedule of MDMA from Schedule I. A PDUFA was set for this summer.

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STAT+: Obesity treatment from Boehringer Ingelheim, Zealand Pharma succeeds in study in liver condition MASH

STAT

LONDON — A drug in development as a weight loss treatment succeeded in a Phase 2 study in a serious liver condition, its developers said Monday, as the competition in the broader obesity medicine field pushes ahead. The drug, survodutide, is being developed by the privately held German firm Boehringer Ingelheim and the Danish biotech Zealand Pharma.

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CMS: Providers may now text patient info, orders to care teams

Fierce Healthcare

Providers working in hospitals and critical access hospitals may now text patient information and patient orders among care team members without landing on the wrong side of Medicare’s Conditions o | Texting patient info has been against Medicare's Conditions of Participations for over half a decade, due to concerns of insecure texting platforms.

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To BioMarin CEO Alexander Hardy, hemophilia A gene therapy Roctavian needs 3 stars to align

Fierce Pharma

Even Alexander Hardy, the former Genentech leader who managed the blockbuster hemophilia drug Hemlibra, can’t immediately bend the laggard launch trajectory of BioMarin’s gene therapy Roctavian.

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