Drug Topics

AUGUST 13, 2024

Rejoyn, developed by Otsuka Pharmaceutical and Click Therapeutics, is only accessible with a prescription from a health care provider.

FDA

PharmaVoice

AUGUST 13, 2024

A series of executive turnovers at Gain Therapeutics this year precedes important early-stage Parkinson’s results that could change how the disease is treated.

Drug Topics

AUGUST 13, 2024

Two phase 3 trials evaluating nemolizumab found that 41% of patients treated with the therapy achieved at least a 4-point reduction in itch intensity at week 16.

FDA

PharmaVoice

AUGUST 13, 2024

Immunic’s treatment has anti-inflammation, neuroprotection and antiviral effects plus a ‘benign’ safety profile that even seems to lower the risk of COVID-19 infection.

Immunization

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

Drug Topics

AUGUST 13, 2024

The FDA approved imetelstat (Rytelo) in June 2024.

FDA

STAT

AUGUST 13, 2024

WASHINGTON — The idea for Todd Wagner’s new advocacy organization FoodFight USA, he says, came to him after visiting George Clooney in Lake Como. He’s recruited Morgan Freeman, who is “obviously” a friend. He personally lobbied Arnold Schwarzenegger and current California Gov. Gavin Newsom to support food makers’ nightmare scenario — a first-in-the-nation law banning certain food additives in the state, which was signed into law last year.

FDA

STAT

AUGUST 13, 2024

Two days into a cyberattack on his hospital system, Nate Couture reached the end of his cyber incident plan. “We make these incident response plans and we feel great about them,” Couture, the University of Vermont Health Network chief information security officer, told other heath care cyber professionals at a recent conference. “At the end of them, they have a box that usually says something like, ‘And then IT recovers the systems.

Medical Records

Fierce Pharma

AUGUST 13, 2024

When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing adverse events from a pivotal trial.

FDA

STAT

AUGUST 13, 2024

Cancer detection firm Grail announced sizable workforce cuts on Tuesday in a bid to save cash and concentrate resources on developing a blood-based test to spot early signs of dozens of cancers. The cuts will affect 30% of the biotech’s current and planned hires. Grail spokesperson Kristen Davis told STAT in an email that around 350 existing positions and 150 open roles have been eliminated.

Fierce Healthcare

AUGUST 13, 2024

Fifty-four percent of Medicare beneficiaries are enrolled in a private Medicare Advantage plan, and in seven states that figure tops 60%, according to a new report from KFF. | Fifty-four percent of Medicare beneficiaries are enrolled in a private Medicare Advantage plan, and in seven states that figure tops 60%, according to a new report from KFF.

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.

STAT

AUGUST 13, 2024

SAN DIEGO — The unwinding of Illumina’s ill-fated acquisition of Grail earlier this year left investors and the genomics community with a pressing question: What kind of company is Illumina going to be going forward? CEO Jacob Thaysen on Tuesday made clear that the sequencing firm, which controls about 80% of the current DNA-sequencer market, is essentially returning to its traditional role of creating instruments for researchers in academia, the biopharma industry, and health care

Fierce Healthcare

AUGUST 13, 2024

Steward Health Care has agreed to sell its physicians network, Stewardship Health, to Rural Healthcare Group, which is owned by a private equity group. | Steward Health Care has agreed to sell its doctors network, Stewardship Health, to Rural Healthcare Group, which is owned by a private equity group.

STAT

AUGUST 13, 2024

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, the FDA’s recent rejection of an MDMA therapy hasn’t seemed to deter some other companies from moving ahead with psychedelics studies. We discuss that, and also some big policy developments that are coming this week.

FDA

pharmaphorum

AUGUST 13, 2024

With the implementation of advancing technologies in industry comes the parallel need for suitable upskilling of the workforce – but this doesn’t as yet always pan out, and in today’s pharmaphorum podcast COO of Enthought Mike Connell discusses the growing skills gap in R&D in life sciences and the 80/20 rule with web editor Nicole Raleigh, as well as the need for correct education of people and machines, both.

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

STAT

AUGUST 13, 2024

Acelyrin, a California biotech focused on immunology and inflammatory disease, announced Tuesday that its experimental drug for a common skin disorder succeeded in a late-stage clinical trial. That’s the kind of news that’s usually accompanied by plans to apply for regulatory approval to market a new therapy. But the results didn’t show a clear edge over competing products on the market or in development.

Fierce Healthcare

AUGUST 13, 2024

In places like rural El Paso, Texas, community health workers (CHWs) help thousands of underserved individuals obtain the food, housing and medical services they need to survive. | While there’s no silver bullet to save VBC, community-based health workers are best positioned to protect it.

STAT

AUGUST 13, 2024

There are few things more exciting for researchers than to mount and complete a clinical trial that could change the practice of medicine and save lives. That’s what we experienced when The New England Journal of Medicine published our findings in January 2023 that aspirin was as effective at preventing life-threatening blood clots after surgery as was a far more expensive and more painful injectable blood thinner.

Hospitals

pharmaphorum

AUGUST 13, 2024

Learn how real-world evidence platforms use real-world data (RWD) to advance precision medicine, bridging the gap between clinical trials and real-world patient outcomes.

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Pharmacy Management Software

STAT

AUGUST 13, 2024

Otsuka Pharmaceutical has started selling Rejoyn, its Food and Drug Administration cleared prescription app that treats the symptoms of major depressive disorder. And it’s hitting the market at a low price that Otsuka hopes will entice many people to give it a try. Otsuka will make the 6-week treatment available to patients through a prescription from their existing provider or through the treatment’s website where they can connect with a clinician from Wheel Health who can prescri

Insurance

pharmaphorum

AUGUST 13, 2024

Our longtime Finance Director Paul Bannister was a part of the fabric of pharmaphorum almost from the beginning and an integral part of keeping the publication running. And, most importantly, he was the soul of the place and a friend to all.

STAT

AUGUST 13, 2024

Rise and shine, everyone, another busy day is on the way. Our mascots, for instance, got off to a particularly busy start, having spotted a feline creature nearby that sent them into a tizzy. Such is life on the campus. As for us, we are reaching for the ever-trusty coffee kettle and brewing another cup of needed stimulation. Our choice today is the oh-so smooth butter pecan.

Pharmaceutical Companies

Pharmacy Times

AUGUST 13, 2024

The treatment is indicated to improve and maintain visual acuity in individuals with neovascular age-related macular degeneration.

FDA

STAT

AUGUST 13, 2024

Want to stay on top of health news?  Sign up  to get our Morning Rounds newsletter in your inbox. We’ve got some nice awards news this morning. Yesterday, my colleague and friend Jason Mast won the the 2024 Evert Clark/Seth Payne Award , for his reporting at the intersection of medical science, business, and human lives. I asked Jason if there was a STAT story he was most proud of and he shared this heart-wrenching one from last summer when the first gene therapy was approved fo

Hospitals

Pharmaceutical Commerce

AUGUST 13, 2024

The latest news for pharma industry insiders.

Fierce Pharma

AUGUST 13, 2024

Despite winning an FDA approval in 2023 and gaining clarity in May on the regulatory path forward for its Type 1 diabetes prospect sotagliflozin, Lexicon Pharmaceuticals hasn’t had an easy go of it | As part of a restructuring initiative, Lexicon Pharmaceuticals will lay off more than 75 staffers, or approximately 50% of its current field force, by the end of September.

FDA

The Checkup by Singlecare

AUGUST 13, 2024

Read any articles on the latest strategies for losing weight or ask any friends who have been trying to shed a few pounds, and you’ll likely notice a trend: The class of weight-management drugs known as glucagon-like peptide-1 (GLP-1) agonists are having a moment. Among these is the brand-name drug Saxenda (liraglutide). This prescription medication is FDA approved to regulate appetite and promote weight loss in adults with a body mass index (BMI) of 30 or higher and those with a BMI over 27 who

Compounding

Fierce Pharma

AUGUST 13, 2024

CORRECTED: After icodec rejection, Novo Nordisk won’t file application for once-weekly insulin and semaglutide combo in US fkansteiner Tue, 08/13/2024 - 13:42

PioneerRx

AUGUST 13, 2024

The back-to-school rush is in full swing. Vacations now have to wait for cozy autumns and icy winters to happen. Once class is in session, however, the rush.

pharmaphorum

AUGUST 13, 2024

Novartis' attempt to stop MSN Pharma from launching a generic version of heart failure blockbuster Entresto is blocked in a US court

Outsourcing Pharma

AUGUST 13, 2024

Driven by personal loss and inspired by the progress in disease management, Elaine has dedicated more than 20 years to the clinical trial technology industry.

Pharmacy Times

AUGUST 13, 2024

The study may serve as a foundation for future investigation regarding dietary recommendations to support the treatment of Alzheimer disease.

Outsourcing Pharma

AUGUST 13, 2024

In the rapidly evolving pharmaceutical industry, the process of evaluating outsourcing partners is critical to ensuring quality, efficiency, and innovation.

Pharmaceutical Technology

AUGUST 13, 2024

Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.

FDA