Fri.Mar 01, 2024

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Breaking: CVS, Walgreens to Begin Mifepristone Dispensing This Month

Drug Topics

The decision comes a year after a group of conservative attorneys generals threatened the chains with legal action.

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Balancing Health Tech Innovation With Safety: Navigating the Intersection of AI and Patient Care

Pharmacy Times

Although regulation takes time, real safety concerns for patients in the rapid development of AI technology in health care are present today.

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Trending Sources

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CDC eases isolation guidance for Covid and other respiratory illnesses

STAT

The Centers for Disease Control and Prevention is “sunsetting” its advice that people sick with Covid-19 isolate themselves for five days. The agency published new guidance Friday for Covid and other respiratory illnesses, suggesting people who are sick should stay at home until they are fever-free for 24 hours and their symptoms have been improving for the same period of time.

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'Cybersecurity is patient safety': What the ransomware attack on Change Healthcare should teach the industry

Fierce Healthcare

As the disruption caused by the cyberattack at Change Healthcare stretches beyond its tenth day, cybersecurity experts say that the incident could spur greater emphasis on enhancing protocols | As the disruption caused by the cyberattack at Change Healthcare stretches beyond its tenth day, cybersecurity experts say that the incident could spur greater emphasis on enhancing protocols — and greater oversight from the feds.

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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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STAT+: Medical device lobby says it’s tired of waiting on Medicare to cover breakthrough devices

STAT

Medical technology lobby AdvaMed is fed up with the Centers for Medicare and Medicaid Services. In a letter sent to the agency and shared with STAT, the group urged CMS to act on finalizing a pathway that would make reimbursement for breakthrough devices easier.  CMS has been working on implementing the pathway since 2021. A CMS spokesperson told STAT the agency is working “expeditiously” to finalize it.

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Providers will need 'real support' to navigate Change Healthcare cyberattack's disruptions, experts say

Fierce Healthcare

Payers, providers and pharmacies are scrambling to keep up after a high-profile cyberattack against a UnitedHealth Group subsidiary took down critical systems. | Payers, providers and pharmacies are scrambling to keep up after a high-profile cyberattack against a UnitedHealth Group subsidiary took down critical systems.

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Pfizer’s new cancer unit sees eight new blockbusters by 2030

pharmaphorum

Pfizer says new oncology division will generate eight new blockbusters by 2030, in first R&D update after its $43bn takeover of Seagen.

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Moderna lays off parts of manufacturing team after resizing COVID footprint

Fierce Pharma

Moderna is laying off employees within its manufacturing unit, with the move tied to a resizing of its COVID production work. | Moderna is laying off some employees within its manufacturing unit after shaving COVID production costs. The company previously disclosed plans to rightsize its COVID vaccine production footprint.

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STAT+: RaDonda Vaught, nurse who accidentally killed patient, to speak at CommonSpirit event on patient safety

STAT

CommonSpirit Health is hosting an educational event this month featuring RaDonda Vaught, the Tennessee nurse who was criminally prosecuted for accidentally killing a patient by injecting the wrong medication. A registration page for the March 12 virtual event for all CommonSpirit employees says Vaught will discuss the human factors and system issues that led to the fatal error that killed a 75-year-old patient.

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Biologics Quality Control: The Growing Need for Accessible Proteomics

BioPharm

There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

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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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STAT+: Federal judge rules against AstraZeneca in lawsuit challenging Medicare drug price negotiation

STAT

WASHINGTON — A federal judge in Delaware on Friday ruled against AstraZeneca in a case challenging the constitutionality of Medicare’s new drug price negotiation program. Colm Connolly, chief judge of the U.S. District Court of Delaware, ruled against the company on all its major arguments. He wrote that AstraZeneca had not proved that Medicare’s new drug price negotiation program jeopardizes its constitutional property rights, and that the company didn’t have standin

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With Sanofi left as the lone supplier of tetanus shots in the US, CDC warns of shortage

Fierce Pharma

It’s time to add another vaccine to the shortage list in the U.S. | It’s time to add another vaccine to the shortage list in the United States as the CDC has urged healthcare providers to conserve their supply of tetanus shots. The warning from the national public health agency comes after one of the two providers of tetanus shots in the U.S., MassBiologics, discontinued production of its tetanus and diphtheria vaccine.

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Opinion: New federal guidance is hurting cancer patients, especially those in rural areas

STAT

I recently started a patient with metastatic triple-positive breast cancer patient on a targeted therapy regimen consisting of capecitabine and neratinib, both oral chemotherapy pills that are dosed on a 21-day cycle. Given that her cancer also thrives on estrogen, I chose to continue her monthly fulvestrant injections (which targets estrogen) in my clinic in Dickson, Tennessee, a small town 40 minutes outside Nashville.

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Planning strategies for transitioning to the Clinical Trials Regulation

pharmaphorum

There is a pressing need for companies to transition their EU clinical trials that are ongoing under the “old” regulatory framework of the Clinical Trials Directive to the Clinical Trials Regulation. The risk for those that don’t meet the 30th January 2025 deadline for transition is that they will lose their legal basis.

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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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STAT+: Many costly generic drugs are unavailable at Amazon, Cuban, and other alternative pharmacies

STAT

A growing number of alternative pharmacies — such as those run by Costco, Amazon, and Mark Cuban Cost Plus Drugs — may be increasingly popular with American consumers, but a new analysis finds many of the most expensive generic medicines are unavailable, prices vary widely, and savings can be modest. Of 100 expensive generics used to treat such diseases as cancer, HIV, or multiple sclerosis, 20% were not available at one or more of these pharmacies.

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After PhRMA loss, AstraZeneca's challenge to IRA price negotiations is rejected

Fierce Pharma

Less than three weeks after a Texas judge tossed a lawsuit b | Less than three weeks after a Texas judge tossed a lawsuit by industry lobbying group PhRMA that challenged the constitutionality of the Inflation Reduction Act, a federal court in Delaware has done the same with a similar action brought by AstraZeneca.

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STAT+: Biotech FogPharma raises $145 million in anticipation of more clinical trials, pharma partnerships

STAT

Oncology startup FogPharma just closed a $145 million Series E round, the company confirmed, reaching a late stage of financing that few other biotechs have hit in recent years. FogPharma, which is headquartered in Cambridge, Mass., is developing cancer treatments using corkscrew-shaped peptides called helicons that could possibly better breach cells.

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Abrysvo Demonstrates Continued Efficacy in Older Adults Through Second RSV Season

Drug Topics

Pfizer's RSV vaccine received FDA approval on May 31, 2023.

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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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Q&A: AMA’s chief health equity officer on ridding medicine of racial essentialism

STAT

In the aftermath of the police murder of George Floyd and subsequent Black Lives Matter protests across the U.S. in 2020, many institutions confronted their own histories of racism, lack of diversity, and failures to consider the impact of structural inequities on public health. That process was already underway at the American Medical Association, spearheaded in large part by Aletha Maybank, who was hired in 2019 to launch the organization’s Center for Health Equity.

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4SC files maintenance CTCL therapy Kinselby in EU

pharmaphorum

German biotech 4SC has filed its oral HDAC inhibitor Kinselby as a maintenance therapy for rare cancer CTCL in the EU

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Biotech funding optimism rises as 44% predict recovery in 2024

Pharmaceutical Technology

During 2023, funding decreased by 43.2% compared to 2022 and by 52.3% compared to 2021, attributed to macroeconomic pressures.

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This week in clinical trials: 5th Feb to 9th Feb 2024

pharmaphorum

Stay up to date with the latest news in the life sciences industry with highlights from clinical trials involving CSL, Arcturus, Sanofi, Nexviazyme, and REGENXBIO from the week of 5th to 9th February 2024.

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Garnier aims to reverse hair damage via Fructis Hair Filler collection

Drug Store News

Consisting of three collections, Garnier is rolling out the launches with a campaign starring TikTok personality Charli D’Amelio.

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MHRA okays first drug under new mutual recognition scheme

pharmaphorum

A new formulation of Amgen’s cancer treatment Xgeva is the first to be approved in the UK under a new procedure designed to speed up access to new therapies.

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Fine’ry celebrates 1st anniversary with 7 new fragrances

Drug Store News

Each scent is developed by renowned master perfumers, crafted from the highest quality ingredients and designed to evoke emotion with every spray, the company said.

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New film aims to raise awareness of rare disease cALD

pharmaphorum

Rare Disease Day saw the debut of a film that aims to raise awareness of cerebral adrenoleukodystrophy (cALD), a devastating and fatal condition with no pharmacological treatments available.

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Guayakí Yerba Mate debuts summer inspired flavor

Drug Store News

The lemon and strawberry flavored beverage contains 150 mg of caffeine, 20 calories and 2 g of sugar per serving.

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CAR-T boxed warnings: What comes next?

Fierce Pharma

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. | The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This week on "The Top Line," Fierce Pharma’s Angus Liu talks with regulatory experts to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T c

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Kiss Products’ latest lashes channel edgy glam, minimalist beauty looks

Drug Store News

The company said it is rolling out new lash collections featuring edgy glam and minimalist beauty trends.

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Despite good data, Ironwood’s shares plummet 

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Today, we’ll discuss how the U.S. government is cracking down on Chinese biotechs, and how that might affect the industry stateside. Also, a positive clinical trial for Ironwood Pharmaceuticals still causes a stock slump, and more.

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Rx Roundup: Quiz of the Week

Drug Topics

Test your pharmacy news knowledge with our weekly quiz: February 26 to March 1

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2024 Pharmaceutical industry trends – discover the latest pharma quality and manufacturing trends

European Pharmaceutical Review

Technology trends Current technology trends are influencing consumer behaviour and reshaping the way industry operates. Although pharma companies are working steadily to leverage the power of data and become more agile and resilient, there is still room for improvement. The post 2024 Pharmaceutical industry trends – discover the latest pharma quality and manufacturing trends appeared first on European Pharmaceutical Review.

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FDA Approves Amivantamab-vmjw for Locally Advanced, Metastatic NSCLC With EGFR Exon 20 Insertion Mutation

Drug Topics

The FDA granted accelerated approval to amivantamab-vmjw in May 2021.

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