Tue.Oct 29, 2024

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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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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+: 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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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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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: Fecal transplants are saving lives — but are now at risk

STAT

Twenty years ago, a respected colleague asked me to perform a “poop transplant” on a local schoolteacher with multiply recurrent C. difficile infection.  I was incredulous and skeptical, but my colleague (a friend but a forceful one) persisted until I ultimately acquiesced.  Soon I was in a hazmat suit blenderizing stool and performing my first (subsequently named) fecal microbiota transplant, or FMT.

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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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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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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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Oracle Health will offer next-gen EHR in 2025 embedded with AI and analytics tools

Fierce Healthcare

Oracle Health plans to release a new electronic health record platform in 2025, the company announced Tuesday. | Oracle Health executive Seema Verma stressed that the next-gen EHR platform is not a "refurbished Cerner EHR." "You can’t bolt new innovation onto something built in the 1990s," she said.

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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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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 Grants Accelerated Approval to Asciminib for Adult Patients With Newly Diagnosed Ph+ CML-CP

Pharmacy Times

The accelerated approval comes after 48-week major molecular response rate data.

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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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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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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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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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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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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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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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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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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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NHS funding boost confirmed ahead of tomorrow's Budget

pharmaphorum

UK government confirms £1.8bn funding boost to NHS to cut waiting lists, including £1.

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FDA Grants Approval to Oxycodone Hydrochloride Immediate-Release Tablets For Management of Severe Pain

Pharmacy Times

The approval marks the first and only abuse-deterrent immediate release oxycodone formulation.

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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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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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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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PHTI review of digital hypertension tools gives mixed results

pharmaphorum

An evaluation of digital health technologies for hypertension by the Peterson Health Technology Institute (PHTI) finds some provide a clinical benefit, while others are lacking.On the plus side, the health technology assessment (HTA) body has concluded that tools to help people manage their antihypertensive drug treatment can deliver benefits in reduced blood pressure.

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EC approves AstraZeneca’s Fasenra for EGPA treatment

Pharmaceutical Technology

The EC has approved AstraZeneca's Fasenra as an add-on therapy for adults with relapsing or refractory EGPA.

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Pfizer rebuffs Starboard criticism as it raises forecasts

pharmaphorum

Pfizer CEO Albert Bourla hit back at activist investor Starboard Value, saying measures to reset the pharma group are already well in hand

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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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AbbVie gets bigger in Alzheimer's R&D with Aliada takeover

pharmaphorum

AbbVie agrees a $1.4bn cash deal to acquire Aliada Therapeutics, adding another anti-amyloid antibody to its Alzheimer's pipeline.

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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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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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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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Drug pricing and the 2024 presidential election

Fierce Pharma

As the 2024 U.S. | This week on "The Top Line," we explore how each presidential candidate’s approach to drug pricing could shape future policy.

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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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