Drug Topics
MARCH 14, 2024
The approval, awarded to Madrigal Pharmaceuticals, was based on phase 3 data demonstrating that resmetirom achieved broad treatment effects in patients with MASH with liver fibrosis.
Pharmacy Times
MARCH 14, 2024
This finding was evident in both examined groups and regardless of the patients' B-cell maturation antigen-directed therapy status.
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Drug Topics
MARCH 14, 2024
With growing concerns around opioid use disorder, interventional pain management for patients with cancer can provide effective relief without the side effects associated with medication.
STAT
MARCH 14, 2024
A new study suggests the antiviral drug obeldesivir may be effective in curing Ebola Sudan infections, for which there are currently no approved vaccines or treatments. Scientists at the University of Texas Medical Branch in Galveston tested the drug, made by Gilead, in primates, starting treatment 24 hours after the animals were given what should have been a lethal dose of Sudan ebolavirus by intramuscular injection.
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
MARCH 14, 2024
The drug is indicated for patients 5 years of age and older with progressive familial intrahepatic cholestasis and cholestatic pruritus in pediatric patients with Alagille syndrome.
STAT
MARCH 14, 2024
WASHINGTON — Novo Nordisk’s newly won permission to market the heart benefits of its obesity drug Wegovy could provide a backdoor way to expand access to the drug for people on Medicare, experts told STAT. Currently, Medicare is prohibited by law from covering medications for obesity treatment alone. While companies that manufacture wildly popular anti-obesity medications and their allies haven’t been successful in lobbying Congress to change the law , the Food and Drug
Pharmacy Technician Pulse brings together the best content for pharmacy technicians from the widest variety of industry thought leaders.
STAT
MARCH 14, 2024
The Food and Drug Administration on Thursday approved the first medicine developed specifically to treat the serious liver disease known as MASH. The pill, called Rezdiffra, is made by Madrigal Pharmaceuticals. Metabolic dysfunction-associated steatohepatitis, or MASH, is often associated with obesity. The accumulation of fat in the liver causes inflammation, which leads to fibrosis, or liver scarring, and can progress in more advanced stages to cirrhosis, cancer, and the need for a liver transp
Pharmacy Times
MARCH 14, 2024
At 4 months, 75% of participants achieved remission and no longer showed signs of depression symptoms in a phase 2 clinical trial.
STAT
MARCH 14, 2024
LONDON — The U.K.’s cost-effectiveness watchdog said Thursday it is not yet recommending Vertex’s CRISPR-based therapy for sickle cell disease, saying in draft guidance it has questions about the medicine’s lasting benefits for patients. U.K. regulators approved the therapy , known as Casgevy or exa-cel, last year, granting it the world’s first authorization for any CRISPR-based medicine.
Pharmacy Times
MARCH 14, 2024
Results from the phase 3 RATIONALE 302 trial showed tislelizumab-jsgr prolonged survival compared to chemotherapy in patients who received prior systemic treatment.
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.
STAT
MARCH 14, 2024
Have you heard the news? I’m launching a weekly email newsletter starting on March 28. It’s called Adam’s Biotech Scorecard and it’s exclusively for STAT subscribers. One catch: We need you to sign up, which you can do here. What should you expect to see in my newsletter each week? Unfiltered, uncompromising, and (hopefully) valuable insight and analysis from the intersection of Wall Street and biotech.
Fierce Healthcare
MARCH 14, 2024
Providers are still feeling the pain brought on by the cyberattack on Change Healthcare, and they're continuing to push insurers and the feds to beef up their responses. | Providers are still feeling the pain brought on by the cyberattack on Change Healthcare, and they're continuing to push insurers and the feds to beef up their responses.
STAT
MARCH 14, 2024
LONDON — AstraZeneca said Thursday it would purchase the French firm Amolyt Pharma in a deal worth up to $1 billion, picking up a rare disease drug in a pivotal trial. The acquisition includes an upfront payment of $800 million in cash, plus another $250 million if regulatory milestones are met. AstraZeneca framed the deal for Amolyt, which has focused on treatments for rare endocrine diseases, as a boost for its own rare disease pipeline.
Fierce Healthcare
MARCH 14, 2024
Salesforce launched a new healthcare AI assistant within its customer relationship management system, marking the latest tech company trying to expand its reach in the healthcare market. | Salesforce launched a new healthcare AI assistant within its customer relationship management system, marking the latest tech company trying to expand its reach in the healthcare market.
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Fierce Pharma
MARCH 14, 2024
Just as BeiGene’s Brukinsa encroaches on C | Just as BeiGene’s Brukinsa encroaches on CAR-T territory, Bristol Myers Squibb has brought its CAR-T therapy Breyanzi into chronic lymphocytic leukemia, which is considered the BTK inhibitor class’s home turf.
Fierce Healthcare
MARCH 14, 2024
Despite challenges with compensation, staffing shortages, safety and more, most nurses want to remain in the field until retirement, a new report found. | The report, which also covered nurses' thoughts on healthcare AI, included Incredible Health’s proprietary data from the 1 million nurses using its platform and the findings of a survey that reached more than 3,300 nurses working in the hospital setting.
Fierce Pharma
MARCH 14, 2024
Twenty months after the FDA’s original target decision date on cancer drug tislelizumab, BeiGene has finally received the U.S. go-ahead. | Twenty months after the FDA's original target decision date, BeiGene has finally received the U.S. go-ahead for its PD-1 inhibitor Tevimbra.
Pharmacy Times
MARCH 14, 2024
Raj Gupta, DC, discusses holistic approaches to managing type 2 diabetes without medication by addressing root causes like diet, toxins, and stress.
STAT
MARCH 14, 2024
What happens when an approved drug doesn’t work? Why don’t patients want gene therapy? And is MASH still a big deal? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Bioethicist Holly Fernandez Lynch joins us to discuss the case of Amylyx Pharmaceuticals’ treatment for ALS and what its failure means for drug development.
Fierce Pharma
MARCH 14, 2024
Ever since Vertex and CRISPR therapeutics scored a groundbreaking U.K. | In its draft guidance, the U.K.'s cost effectiveness watchdog recognized the need for the sickle cell therapy but needs more data from Vertex on its effectiveness in an updated managed access proposal.
pharmaphorum
MARCH 14, 2024
Researchers have developed an artificial intelligence algorithm to assist in the diagnosis of lymph node cancer from medical images that has an accuracy of around 90%. The team carried out a retrospective study on the deep learning model, using PET-CT scans from more than 5,000 patients treated for lymphoma at Memorial Sloan Kettering Cancer Centre in the US and the Medical University of Vienna in Austria.
Pharmacy Times
MARCH 14, 2024
The tool consolidates and highlights key features that would be considered when choosing a biosimilar adalimumab.
STAT
MARCH 14, 2024
Rise and shine, everyone, another busy day is on the way. We can tell because the official mascots are especially enjoying the Pharmalot grounds now that spring is springing and various work crews are dotting the nearby environs. This is an especially busy day for us, in fact, since we are hosting a session later on biosimilars — mark your calendar for 1 p.m.
pharmaphorum
MARCH 14, 2024
AstraZeneca adds a late-stage rare disease therapy to its pipeline, buying Amolyt Pharma and hypoparathyroidism drug eneboparatide for $800 million upfront.
STAT
MARCH 14, 2024
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello, everyone. Damian here with a reminder that my colleague Ed Silverman is hosting a discussion today about the long-awaited arrival of Humira biosimilars and all they portend for drug costs, insurance coverage, and pharma revenues.
pharmaphorum
MARCH 14, 2024
Munich-based antibody-drug conjugate (ADC) specialist Tubulis has completed a sizeable Series B2 financing that shows sustained investor appetite for the ADC category, particularly for companies with technologies that can enhance the safety of these drugs.
Fierce Pharma
MARCH 14, 2024
After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy pact—this time centered on an adeno-asso | After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy pact—this time centered on an adeno-associated virus 9 (AAV9) candidate meant to serve as a non-opioid alternative for rare disease patients li
pharmaphorum
MARCH 14, 2024
Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.
The Checkup by Singlecare
MARCH 14, 2024
First approved by the U.S. Food and Drug Administration (FDA) in 2021, more people may be eligible to take the popular weight loss drug Wegovy (semaglutide) thanks to a recent expanded use approval. On Mar. 8, the FDA announced that it had approved a new indication for the injectable medication: reducing the risk of cardiovascular death, heart attack, and stroke in adults who are either obese or overweight and have cardiovascular disease.
STAT
MARCH 14, 2024
Editor’s note: A livestream of this event will be embedded below at 1 p.m. ET. Several biosimilar versions of Humira, which for years has been the world’s best-selling medicine, entered the U.S. market over the past year. What has that meant for insurance coverage and the way drugmakers are marketing these medicines? Join leading experts to discuss the impact on the industry and patients.
European Pharmaceutical Review
MARCH 14, 2024
In recent months there have been important development in the kidney disease treatment space. For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).
Pharmaceutical Technology
MARCH 14, 2024
The EMA raised concerns about the lack of long-term data for Novartis Vijoice in its initial bid, as the Swiss company prepares for a new regulatory submission.
European Pharmaceutical Review
MARCH 14, 2024
In recent months there have been important development in the kidney disease treatment space. For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).
Pharmacy Times
MARCH 14, 2024
Antimicrobial stewardship is crucial for all health care professionals—not just those in a hospital setting
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