Tue.Oct 29, 2024

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STAT+: Dreams of cancer vaccines are becoming more real. Here are 9 scientists making it happen 

STAT

Vaccines are the original immunotherapy, in the view of Ryan Sullivan, a cancer immunotherapy researcher and oncologist at Mass General Cancer Center. But many other modes of immunotherapy for cancer were approved first — checkpoint blockade drugs like Keytruda and engineered immune cell therapies like Yescarta. Shadowed by the successes of other therapies, the field of cancer vaccines was “seemingly dying,” Sullivan said.

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Guselkumab’s Promising Results as First Subcutaneous IL-23 Inhibitor to Treat Chron’s

Drug Topics

Johnson & Johnson announced results from its phase 3 GRAVITI trial exploring guselkumab’s results in subcutaneous (SC) induction and maintenance therapy for treating Chron’s disease.

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STAT+: VCs move to launch U.S.-based companies to develop drugs developed in China

STAT

As Chinese biopharma companies rise on the international stage, they are increasingly finding VC partners — in the United States. U.S. companies have long signed licensing deals with Chinese drugmakers. But increasingly American venture capitalists are building U.S.-based companies from scratch to test and ultimately seek to commercialize innovative drugs developed in China.

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Best Practices for Proactively Preventing PBM Audit Issues | NCPA 2024

Drug Topics

Trent Thiede, PharmD, MBA, president of PAAS National, discusses best practices that pharmacy teams can implement to proactively prevent audit issues before they arise.

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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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Walgreens lays off 250 support center employees as part of cost-saving strategy

Fierce Healthcare

Walgreens is conducting another round of layoffs as the drugstore giant looks to significantly cut costs and improve its financial performance. It's the third round of cuts in 2024. | Walgreens is conducting another round of layoffs as the drugstore giant looks to significantly cut costs and turnaround its financial performance.

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American Pharmacists Month: Stephanie Y. Crawford, PhD, MPH, on Mentorship, Health Equity, and the Expanding Role of Pharmacists

Pharmacy Times

Stephanie Y. Crawford, PhD, MPH, highlights the expanded roles of pharmacists in clinical and non-clinical settings and their increased role in patient care, sharing personal experiences where pharmacists have been instrumental in supporting her family's health needs.

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Researchers Begin Phase 3 Trial Assessing Adjuvant V940 With Pembrolizumab to Treat Non–Small Cell Lung Cancer

Pharmacy Times

The INTerpath-009 trial assessed a combination of V940 with pembrolizumab among individuals with stage II, IIIA, IIIB (N2) non–small cell lung cancer.

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MSSP ACOs saves Medicare $2.1 billion in 2023, the largest savings in program history

Fierce Healthcare

Accountable care organizations saved Medicare $2.1 billion, the largest yearly savings in program history, in 2023, the Centers for Medicare & Medicaid Services revealed on Tuesday. | Accountable care organizations (ACOs) saved Medicare $2.1 billion, the largest yearly savings in program history, in 2023, the Centers for Medicare & Medicaid Services (CMS) revealed Oct. 29.

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FDA Approves Abuse-Deterrent 10 mg Oxycodone Hydrochloride for Severe Pain

Drug Topics

The addition of a 10 mg oxycodone hydrochloride tablet improves dosing flexibility and precision.

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STAT+: Warren wants close FTC scrutiny of drug distributors buying cancer medical groups

STAT

Sen. Elizabeth Warren (D-Mass.) is urging the Federal Trade Commission to scrutinize recent deals from McKesson and Cardinal Health to buy oncology practices, saying those transactions pose “clear, anticompetitive risks.” McKesson, Cardinal Health, and Cencora are the three dominant wholesalers that distribute drugs and medical products.

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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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AMA panel changes reporting requirement for remote monitoring, removing barriers for the industry

Fierce Healthcare

The American Medical Association’s (AMA's) CPT Editorial Panel has removed the requirement for a patient to transmit 16 days’ worth of data for providers to bill remote physiologic monito | The American Medical Association's coding panel decided at its September meeting to eliminate the requirement for a provider to collect 16 days' worth of data from a connected device to bill the supply code.

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Opinion: I’m the director of the Center for Medicare. Here’s how we executed the first round of drug price negotiation

STAT

The historic Inflation Reduction Act of 2022 has fundamentally improved the affordability of and access to prescription drugs for millions of people with Medicare. The law laid out aggressive timelines for implementing the Medicare Drug Price Negotiation Program. As the director of Medicare, my team and I worked thoughtfully and diligently to stand up the program — on time and successfully.

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Novartis' Scemblix leaps into newly diagnosed leukemia—where winning over doctors may take time

Fierce Pharma

Exactly three years after an initial FDA green light for the third-line treatment of leukemia, Novartis’ Scemblix has won an accelerated approval to treat newly diagnosed patients. | Exactly three years after an initial FDA green light for the third-line treatment of leukemia, Novartis’ Scemblix has won an accelerated approval to treat newly diagnosed patients.

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STAT+: Pfizer beats earnings expectations in first report after criticism by activist investor

STAT

Pfizer released earnings Tuesday that handily beat analyst expectations in the company’s first quarterly report since an activist investor took a $1 billion stake in the drug giant and began putting pressure on its board and CEO. Pfizer reported adjusted earnings per share, a key metric watched by analysts at investment banks, of $1.06 per share compared to expectations of $0.60 per share among analysts surveyed by Visible Alpha.

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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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With Jakafi's patent cliff looming, Incyte looks to 2025 launches to bulk up revenue by decade's end

Fierce Pharma

Incyte’s blockbuster JAK inhibitor Jakafi has been driving the company’s sales for years now, with this quarter being no different. | Meanwhile, the company also scrapped plans to expand its topical JAK Opzelura into two other skin disorders.

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STAT+: Eli Lilly says modified dosing of its Alzheimer’s drug may be safer

STAT

A change in the dosing regimen of Eli Lilly’s Alzheimer’s drug Kisunla resulted in a lower rate of brain swelling among patients in a clinical trial, new data reported Tuesday show. But it’s unclear whether the new dosing schedule, if approved by regulators, will convince doctors that the treatment is safer for patients. At 24 weeks of a Phase 3b trial, 24% of those taking the standard regimen experienced a side effect called ARIA-E, a kind of brain swelling.

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A look at Aetna's new, more transparent health plan, SimplePay Health

Fierce Healthcare

Navigating the healthcare system and understanding benefits are a major pain point for patients, especially as costs continue to rise. | Navigating the healthcare system and understanding benefits are a major pain point for patients, especially as costs continue to rise. With that backdrop, Aetna has rolled out SimplePay Health, a new alternative insurance plan that seeks to add simplicity and transparency to the member experience.

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Q&A: Why drafting new rules on ultra-processed foods is so hard

STAT

Ultra-processed foods are part of daily life, filling 60% to 70% of the American diet. That umbrella term covers a wide variety of packaged foods, from snacks carrying added sugar, salt, and saturated fat combined with preservatives for shelf life, additives for flavor, colorants for eye appeal, and chemicals like bisphenols in the packages themselves.

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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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STRIPE Names Recipients of the Inaugural Double Helix Awards

Pharmacy Times

The STRIPE Double Helix Awards celebrate individuals and organizations that have made exceptional contributions to the field of pharmacogenomics.

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STAT+: Novartis raises profit guidance, pushes off myelofibrosis drug submission

STAT

LONDON — Novartis on Tuesday increased its earnings guidance for the third time this year, boosted by strong sales of its leading drugs.  The company said it anticipates full-year operating profit to grow by a percentage in the high teens, up from the previously forecasted mid- to high teens.  Separately, Novartis CEO Vas Narasimhan said it would be a “couple more years” before the company could submit to regulators an experimental drug for a rare bone marrow cance

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Pfizer bumps up revenue outlook by $1.5B in Paxlovid rebound amid criticism from activist investor Starboard

Fierce Pharma

Amid a looming standoff with activist investor Starboard Value, Pfizer fought back against accusations of underperforming by delivering double digit revenue growth over the third quarter and notchi | The company is projecting yearly sales of $61 billion to $64 billion in a $1.5 billion boost from previous forecasts.

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D.C. Diagnosis: Could RFK Jr. go ‘wild’ on health and medicine?

STAT

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine.  Sign up here  to receive it in your inbox on Tuesdays and Thursdays. Hello and happy Tuesday, D.C. Diagnosis readers! We are one week from Election Day; I probably don’t need to remind you.

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Novartis' Pluvicto enters FDA orbit for expansion bid as agency requests 'flexibility'

Fierce Pharma

As expected, Novartis’ radioligand therapy Pluvicto crossed the blockbuster sales threshold with one quarter still left of 2024. | Novartis didn't use a priority review voucher for Pluvicto's key application in an earlier treatment setting of prostate cancer. The company made the decision in response to the FDA's request for "flexibility" in its review timeline, Novartis CEO Vas Narasimhan explained.

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Leveraging US Prescription Market Insights to Drive Pharmacy Innovation

Drug Topics

Scott Biggs, Director of Supplier Services at IQVIA, discussed pharmacy trends within the industry and how pharmacists can stay ahead of them.

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Bristol Myers partner Zai Lab plots KarXT filing in China after trial win

Fierce Pharma

After the recent FDA approval for the promising schizophrenia drug Cobenfy (xanomeline and trospium chloride), Bristol Myers Squibb and its partners are moving fast to expand the global reach of th | In a phase 3 bridging study run by Zai Lab in China, Bristol Myers Squibb's KarXT helped schizophrenia patients chart a 9.2-point total-score reduction on the Positive and Negative Syndrome Scale versus placebo at week 5, teeing up a forthcoming regulatory filing.

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GSK acquires autoimmune drug candidate

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning, it’s a busy earnings week this week. Let’s get straight into reports from Pfizer and Novartis this morning.

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Athenahealth debuts ambient scribe choose-your-player product with Suki, iScribe

Fierce Healthcare

Athenahealth will release a product that allows clinicians in the same practice to choose which AI ambient scribe they want to use and easily use it in their workflow. | Athenahealth partnered with Suki AI and iScribe to let clinicians choose their preferred scribe without locking them into a long-term contract.

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Lassa fever, eviction lawyers, ultra-processed foods, and poop transplants

STAT

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.  Sign up here. Today’s First Opinion on poop transplants taught me a new word:  fulminant. According to Merriam-Webster, the adjective describes something that comes on “suddenly and with great severity.” Scroll all the way down for context.

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Joy as NICE lifts restrictions on myeloma drug Elrexfio

pharmaphorum

Patients in England and Wales with multiple myeloma are celebrating a decision by NICE to relax strict restrictions on eligibility to receive Pfizer's Elrexfio.In June, the cost-effectiveness agency cleared the use of the BCMAxCD3 bispecific antibody with 'optimised guidance' that allowed it to be used for a narrower range of patients than was covered by the approved label for the drug.

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How Participating in Pharma-Sponsored Programs Can Benefit Your Pharmacy

Drug Topics

A.J. Lipka, Business Development Lead of Network Growth at Outcomes, discussed the impact of pharmacy-sponsored programming.

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Modified dosing regimen of Eli Lilly's Alzheimer's drug leads to significant reduction in brain swelling

Fierce Pharma

Modified dosing regimen of Eli Lilly's Alzheimer's drug leads to significant reduction in brain swelling kdunleavy Tue, 10/29/2024 - 15:25

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Epinephrine Auto-Injectors May Not Be Reliably Effective in Preventing Fatal Anaphylaxis

Pharmacy Times

Though auto-injectors are still considered an appropriate first-line treatment for anaphylaxis, limited evidence exists surrounding their effectiveness in preventing fatal anaphylaxis.

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Protega scores FDA nod for new dosage of abuse-deterrent opioid Roxybond

Fierce Pharma

The FDA has approved the first abuse-deterrent, immediate-release, 10 mg opioid tablet for pain management. The drug, Roxybond, has been approved in other dosages.

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