Fri.Mar 01, 2024

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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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SAEM Clinical Images Series: Two Pupils for the Price of One

ALiEM - Pharm Pearls

A 24-year-old female with no pertinent PMHx presents to the ED with a chief complaint of eye pain. She reported a 10-day history of worsening right eye pain following being punched in that eye. She had been managing her pain with ice and had not taken any OTC medications. Her mom convinced her to go to the ED and she first went to an outside hospital, but was referred to come to our institution.

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Trending Sources

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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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After ‘tragic’ bacterial outbreak, lawmakers press FDA to step up foreign inspections

PharmaVoice

Impatience to fix long-held challenges to overseas drug facility inspections is growing on Capitol Hill.

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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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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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CDC panel mulls changes to RSV vaccine recommendation

BioPharma Dive

The expert committee is discussing whether, for certain older adults, to make a universal recommendation for vaccination, rather than the current policy of “shared decisionmaking.

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More Trending

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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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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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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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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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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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Gritstone to lay off 40% of workforce after costly study delay

BioPharma Dive

The restructuring comes ahead of a key study readout for Gritstone, which, like Moderna, is developing a type of personalized vaccine for cancer.

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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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Researchers reveal COVID-19 could have small impacts on cognition and memory

Pharma Times

Different factors, such as illness duration and virus variant, impacted patients cognitive abilities

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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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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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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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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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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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ICL uses AI to help doctors assess lung cancer from ‘virtual biopsies’

Pharma Times

TMR-CT will help doctors select treatment and predict the spread of lung cancer in patients

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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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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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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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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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Cleveland Clinic researchers uncover how virus causes cancer, point to potential treatment

World Pharma News

Cleveland Clinic researchers have discovered a key mechanism used by Kaposi's sarcoma-associated herpesvirus (KSHV), also known as human herpesvirus 8 (HHV8), to induce cancer. The research points to effective new treatment options for KSHV-associated cancers, including Kaposi's sarcoma, primary effusion lymphoma, and HHV8-associated multicentric Castleman disease.

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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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New antibody drug formulation wins novel MHRA approval

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the first product via its new International Recognition Procedure (IRP). The approval was for a new formulation for XGEVA (denosumab), to prevent serious bone-related complications caused by bone metastasis in adults and to treat giant cell tumour of bone in adults and adolescents.

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GSK boss’s annual pay package jumps 50% to £12.7m

The Guardian - Pharmaceutical Industry

Emma Walmsley’s deal, with a high share bonus payout, makes her one of the highest-paid CEOs in the FTSE 100 The annual pay package of the boss of GlaxoSmithKline, Emma Walmsley, has jumped by 50% to £12.7m, mainly because of a higher share bonus payout reflecting the British drugmaker’s improved performance. Walmsley’s huge pay rise makes her one of the highest-paid executives in the FTSE 100 index of Britain’s leading shares, a week after it emerged her counterpart at Britain’s biggest pharmac

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Joint investment to accelerate UK sustainable biomanufacturing

European Pharmaceutical Review

A new £11.5 million investment is set to support the development of innovative solutions to drive advancements in sustainable biomanufacturing in the UK. The UK Research and Innovation ( UKRI ) is backing 21 cross-sector collaborations designed to generate innovation, commercialisation and growth in this area. UKRI highlighted that overall, these investments will “enhance the UK’s global competitiveness by supporting research and innovation that leads to new and disruptive biomanufacturing proce

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Pfizer, looking for a jumpstart, leans into cancer drug research

BioPharma Dive

Reeling from a difficult year financially, the pharma unveiled a new oncology division it says will produce eight billion-dollar medicines by 2030.

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Cresset and Enamine partner to develop virtual screening technology for drug discovery

Outsourcing Pharma

Cresset, a leading provider of integrated in silico solutions for drug discovery, announced last month (February 21) a global collaboration with Enamine, one of the front providers of chemical building blocks and drug discovery services.

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European Pharmaceutical Review Issue 1 2024

European Pharmaceutical Review

Articles included in Issue 1 of European Pharmaceutical Review include: FOREWORD Validation of analytical procedures – ICH Q2(R2) David Elder, David P Elder Consultancy REGULATORY INSIGHT The EU pharmaceutical reform: tweaks to marketing authorisation procedures Vladimir Murovec, Osborne Clarke SEPARATION & PURIFICATION IDF Fractionation, purification and downstream processing: the path to commercialisation Rob Abbenhuis, Ardena PAT Process analytics for the new era of continuous RNA manufac

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Metabolon introduces ‘groundbreaking’ bioinformatics platform

Outsourcing Pharma

Metabolon, Inc., a prominent figure in metabolomics solutions, has launched a seminal integrated bioinformatics platform, aiming to redefine metabolomics analysis in life sciences research.

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Cardiff Oncology doses first patient in colorectal cancer trial

Pharmafile

Cardiff Oncology has announced that it has dosed the first patient in its randomised first-line phase 2 trial, CRDF-004, for patients with RAS-mutated metastatic colorectal cancer (mCRC). The trial is intended to confirm dosage of onvansertib for use in a subsequent registrational trial, as well as providing safety and efficacy information for the addition of […] The post Cardiff Oncology doses first patient in colorectal cancer trial appeared first on Pharmafile.

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