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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'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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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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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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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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Why do some women experience UTI pain with no clear infection? A mouse study offers clues

STAT

Each year, more than 400 million urinary tract infections occur in people around the globe. And researchers have long been puzzled by a medical mystery: Some women susceptible to recurrent UTIs experience symptoms without any signs of bacteria, or after an infection has supposedly been cleared with antibiotics. A new study provides a potential molecular mechanism behind the phenomenon.

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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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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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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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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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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’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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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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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+: 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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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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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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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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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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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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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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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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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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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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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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What you should know about prescription Adderall

The Checkup by Singlecare

Trying to describe the attention deficit hyperactivity disorder (ADHD) experience can be challenging. We’ve seen the my-brain-has-too-many-tabs-open memes. The TV characters flutter unfocused around the screen. But the condition is more complex than that, manifesting in ways that can affect daily life for both children and adults. For those people, Adderall could be a game-changer.

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Ahead of strategy reveal, Bayer taps activist investor Jeffrey Ubben for board seat

Fierce Pharma

In the latest shake-up amid waves of changes at Bayer, the company is planning to add new expertise to its board room, including a prominent activist investor. | The company's supervisory board proposed the appointments of activist investor Jeffrey Ubben, legal expert Lori Schecter and biotech leader Nancy Simonian, M.D. Bayer also swapped in a new head of its consumer health division.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Retail pharmacy in the age of AI

Drug Store News

At DSN’s 2023 Issues Summit, Sharon Gai’s keynote explored generative AI and its impact on health, wellness and beauty CPGs.

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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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Green granulation: Tracking energy efficiency in pharmaceutical granulation

Pharmaceutical Technology

Experts say that dry granulation is 10x more efficient than wet granulation, which could make substantial progress towards making this pharmaceutical process greener.

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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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CVS and Walgreens plan to start dispensing abortion pill mifepristone soon

STAT

The drugstore chains CVS Health and Walgreens plan to start dispensing an  abortion pill in a few states within weeks. CVS Health will start filling prescriptions for mifepristone in Rhode Island and neighboring Massachusetts “in the weeks ahead,” spokeswoman Amy Thibault said Friday.

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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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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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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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