Fri.Dec 15, 2023

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STAT+: European regulators endorse Casgevy, paving way for approval of CRISPR-based therapy

STAT

LONDON — The world’s first medicine based on the genome-editing technology CRISPR will almost certainly win approval in Europe in the coming months, following an endorsement Friday by a regulatory committee. The medicine, a treatment for sickle cell disease and beta thalassemia called Casgevy, received a positive review from a European Medicines Agency’s committee.

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Study suggests PBMs are gaming pharmacy system to overcharge for drugs

PharmaVoice

Markups for generics can be as high as 7,000%, the researchers said.

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NIH panel calls for fewer, better-paid postdocs in bid to halt loss of scientists to industry

STAT

A National Institutes of Health working group on Friday recommended a sizable increase in salaries of postdoctoral researchers and a cap on the length of the position in an effort to secure the future of academia’s research workforce amid an unprecedented exodus of young life scientists to industry. The group called for raising minimum postdoc salaries to $70,000 beginning next year — an increase of more than 20% — and adjusting wages for annual inflation, as well as limitin

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Positive results for mRNA vaccine in melanoma patients

European Pharmaceutical Review

Moderna and MSD have announced follow-up data from the Phase IIb clinical trial evaluating cancer vaccine mRNA-4157 (V940) in combination with MSD’s Keytruda in patients with resected high-risk melanoma. The randomised study, KEYNOTE-942, evaluated the treatment in patients with high-risk stage III/IV melanoma. Analysis shows that after three years, treatment with mRNA-4157 (V940) in combination with checkpoint inhibitor Keytruda reduced the risk of recurrence or death by 49 percent compared w

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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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FDA chastens pet companies over antibiotics

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hullo! Turns out Jay Bradner is moving from academia and Novartis to serve as Amgen’s new CSO. Also, the FDA has a new registry of trial sponsors and investigators who didn’t finish their paperwork. Have a nice weekend!

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CHMP issues positive option for first gene-editing medicine

European Pharmaceutical Review

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of Vertex’s gene-editing therapy Casgevy for the treatment of severe sickle cell disease and transfusion-dependent beta thalassemia. Casgevy (exagamglogene autotemcel) is a CRISPR/Cas9 gene-edited cell therapy.

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MSD, Moderna cancer vaccine aces melanoma study

pharmaphorum

MSD and Moderna’s individualised cancer vaccine mRNA-4157 has shown impressive efficacy in a phase 2b trial in skin cancer melanoma, leaving the partners speculating about a possible regulatory filing.

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AstriVax awarded €3m to develop therapeutic vaccine for hepatitis B

Pharma Times

The funding builds on AstriVax’s €30m in seed funding for its vaccine platform - News - PharmaTimes

Vaccines 129
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Alkermes to sell Irish manufacturing facility to Novo Nordisk

European Pharmaceutical Review

Alkermes has agreed to sell its pharmaceutical development and manufacturing facility in Athlone, Ireland to Novo Nordisk for $92.5 million. “The acquisition of the Athlone facility represents an expansion of Novo Nordisk’s global manufacturing setup and will provide Novo Nordisk with additional development and manufacturing capacity for current and future oral products,” commented Thilde G.

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Median Technologies partners with PASREL-Imagerie to deliver imaging biomarkers for oncology drugs

Express Pharma

The association aims to develop and implement smart imaging biomarkers to better understand the Mechanism of Action (MOA) of oncology drugs and collect more evidence of efficiency in early phase clinical trials Median Technologies (ALMDT) and PASREL-Imagerie has announced the signing of an agreement to deliver imaging biomarkers for the development of new oncology drugs in the era of precision medicine.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Pharmacist In Charge Shandra Bouzemann: When Life Gives You Lemons.

Proxsys Rx

Shandra Bouzemann did not start working with ProxsysRx’s Pharmacy At DeSoto by choice. “I was a senior at Ole Miss in 2021, and we were asked to choose the pharmacy where we’d like to do rotations. Well naturally, I picked the one at Baptist Oxford, which was a three-minute drive from campus, and less than 10 minutes from my apartment.” Needless to say, she was none too pleased to learn she’d been paired with a pharmacy an hour away, on the campus of Baptist Memorial Hospital in Southaven, Missi

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How Betaine with Pepsin Can Help with Hashimoto’s

The Thyroid Pharmacist

Many moons ago, I was chronically exhausted and needed to sleep for 11 to 12 hours to feel human. Things didn’t get much better, despite starting thyroid medications in 2010, and even going gluten- and dairy-free in 2011. The medication did reduce my cold intolerance, need for sleep by about one hour, and anxiety. Furthermore, eliminating dairy and gluten helped to stop my acid reflux, irritable bowel syndrome, and joint pain, as well as reduced my thyroid antibodies… but my symptoms of fatigue

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New filtering system to combat spread of infections in hospitals

Pharma Times

The combined system works to detect and eliminate airborne pathogens - News - PharmaTimes

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CDC Raises Urgent Alert for Low Vaccination Coverage for COVID-19, Influenza, RSV

PharmExec

CDC data show hospitalizations among all age groups spiked by 200% for influenza, 51% for COVID-19, and 60% for respiratory syncytial virus over the past four weeks, emphasizing the need for improved outreach efforts among at-risk populations.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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AstriVax awarded €3m to develop therapeutic vaccine for hepatitis B

Pharma Times

The funding builds on AstriVax’s €30m in seed funding for its vaccine platform AstriVax has announced that it has been awarded a total of €3m in funding from Flanders Innovation & Entrepreneurship (VLAIO) for its therapeutic vaccine targeting chronic hepatitis B. The new funding will bring the company closer to revolutionising therapeutic vaccine development and creating a long-lasting impact in the hepatitis B field.

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FDA Approves Padcev/Keytruda Combo for Locally Advanced, Metastatic Urothelial Cancer

PharmExec

In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer.

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Volunteer to help homeless this Christmas, pharmacists urged

The Pharmacist

A London pharmacist has encouraged members of the profession to help the homeless this Christmas by volunteering for the charity Crisis. The charity will be providing accommodation to more than 590 people who would otherwise be sleeping rough in London this Christmas, as well as opening three-day centres for hundreds of people stuck in insecure […] The post Volunteer to help homeless this Christmas, pharmacists urged appeared first on The Pharmacist.

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Waters Corporation opens new Global Capability Center in Bengaluru

Express Pharma

The Global Capability Center will enable Waters to accelerate technology and software development, digitization, operational excellence, and productivity Waters Corporation has inaugurated its new Global Capability Center (GCC), a strategic investment to accelerate technology adoption, innovation, digital transformation, and business efficiencies through a concentrated hub of talent that will operate across the Waters global enterprise.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Pfizer declares first-quarter 2024 dividend

World Pharma News

Pfizer Inc. (NYSE: PFE) announced that its board of directors declared an increase in the quarterly cash dividend on the company's common stock to $0.42 for the first-quarter 2024 dividend, payable March 1, 2024, to holders of the Common Stock of record at the close of business on January 26, 2024.

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Cipla to further invest Rs 42 crore in GoApptiv

Express Pharma

Strengthens investment in channels of the future to expand patient reach Cipla has announced that it has agreed to further invest Rs 42 crore (approx.) in digital tech company GoApptiv. With the completion of this deal, Cipla’s total stake in GoApptiv will increase to 22.99 per cent on a fully diluted basis. This is Cipla’s third investment in GoApptiv, which will be made in a combination of equity shares and compulsorily convertible preference shares.

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Vitamin D3 and Bone Health: Strengthening Naturally

Welltopia Pharmacy

Vitamin D3 and Bone Health: Building Stronger Bones Naturally Vitamin D3 and Bone Health One of the essential vitamins

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Influenza antivirals made available to pharmacists at NHS expense

The Pharmacist

The Department of Health and Social Care (DHSC) has made two influenza antivirals available to pharmacists at NHS expense due to rising flu levels in the community. According to a letter published via the DHSC’s central alerting system, oseltamivir and zanamivir can now be supplied by community pharmacists and prescribed by pharmacists working in primary […] The post Influenza antivirals made available to pharmacists at NHS expense appeared first on The Pharmacist.

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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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New patent expiration for Biocryst drug RAPIVAB

Drug Patent Watch

Annual Drug Patent Expirations for RAPIVAB Rapivab is a drug marketed by Biocryst and is included in one NDA. It is available from one supplier. There are three patents protecting… The post New patent expiration for Biocryst drug RAPIVAB appeared first on DrugPatentWatch - Make Better Decisions.

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EXCLUSIVE: The 340B Program Reached $54 Billion in 2022—Up 22% vs. 2021 (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for today’s Drug Channels Outlook 2024 live video webinar. My topic #9 for 2024: The Battle Over 340B Gets Even Messier. Click here to see the original post from September 2023. Drug Channels has just obtained new details on the size of the 340B Drug Pricing Program. I couldn’t wait to share the news, hence this special Sunday post.

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New tentative approval for Teva Pharms drug dasatinib

Drug Patent Watch

Dasatinib is the generic ingredient in two branded drugs marketed by Apotex and Bristol Myers Squibb and is included in three NDAs. There are two patents protecting this compound. Drug… The post New tentative approval for Teva Pharms drug dasatinib appeared first on DrugPatentWatch - Make Better Decisions.

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New filtering system to combat spread of infections in hospitals

Pharma Times

The combined system works to detect and eliminate airborne pathogens A new air-filtering system developed by the University of Glasgow and Pinpoint Medical aims to detect and eliminate airborne pathogens to combat the spread of infections in hospitals. Funded by the UK Research and Innovations’ (UKRI) Engineering and Physical Sciences Research Council (EPSRC), the platform will decontaminate the air of pathogens and measure air quality to ensure a safer and healthier environment.

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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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New tentative approval for Ascent Pharms drug icosapent ethyl

Drug Patent Watch

Icosapent ethyl is the generic ingredient in two branded drugs marketed by Apotex, Dr Reddys, Hikma, Strides Pharma, Teva Pharms Usa, Zydus, and Amarin Pharms and, and is included in… The post New tentative approval for Ascent Pharms drug icosapent ethyl appeared first on DrugPatentWatch - Make Better Decisions.

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FDA widens use of cancer drug Merck acquired for $1B

BioPharma Dive

Welireg, which Merck got through its purchase of Peloton Therapeutics, can now be used to treat an advanced form of kidney cancer, adding to an earlier clearance in a rare genetic disease.

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MSD claims 2nd FDA approval for Welireg, in kidney cancer

pharmaphorum

MSD claims 2nd FDA approval for Welireg, in kidney cancer Phil.

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European regulators push Biogen, CRISPR drugs toward approval

BioPharma Dive

While a positive recommendation for the gene editing treatment Casgevy was expected, a clearance for Biogen’s Skyclaris, acquired through a recent acquisition, was no sure bet.

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Merck gets FDA approval for WELIREG to treat advanced renal cell carcinoma

Pharmaceutical Business Review

This drug is intended for adult patients with RCC after a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). The FDA has given approval to the drug is based on statistically significant and clinically meaningful results from LITESPARK-005. LITESPARK-005 is said to be the only trial in advanced RCC to particularly analyse patients who have advanced after a PD-1 or PD-L1 inhibitor and a VE