Wed.Nov 13, 2024

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Canadian teen’s bird flu infection is not the version found in cows

STAT

A Canadian teenager who is in critical condition after contracting H5N1 bird flu was infected with a version of the virus that is different from the one circulating in dairy cattle in the United States, Canadian authorities announced Wednesday. The National Microbiology Laboratory in Winnipeg confirmed the infection was indeed caused by the H5N1 virus.

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From Mr. Mucus to the Super Bowl, pharma tries offbeat marketing strategies

PharmaVoice

As the industry’s marketing dollars shift, companies are targeting potential patients in unique ways.

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U.S. drug overdose deaths on pace to fall below 100,000 this year 

STAT

U.S. drug overdose deaths are plummeting, putting the country on pace for its first year with fewer than 100,000 overdose deaths since 2020 — a powerful, if bleak, symbolic milestone. Reported drug deaths fell nearly 17% during the 12-month period ending in June, to 93,087,  according to new statistics released this week by the Centers for Disease Control and Prevention.

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BioNTech to buy Biotheus, gaining control of cancer bispecific

BioPharma Dive

Biotheus’ antibody drug targets PD-L1 and VEGF, a design that’s high on drugmakers’ radars after the success of Summit Therapeutics’ ivonescimab over Keytruda.

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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: How I addressed racial bias in my company’s AI algorithm

STAT

Several years ago, teams of scholars published groundbreaking research that pointed to racial biases in algorithms that helped direct patient care at major health systems in the U.S. Those algorithms, the studies found, adversely affected the care of Black and Latinx patients across multiple medical categories. For instance, the researchers uncovered racial biases in the prediction algorithms used by to identify more medically complex patients, such that Black patients were far less likely to qu

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Unauthorised ejaculation delay spray recalled by MHRA

The Pharmacist

A spray sold to delay ejaculation has been recalled after its manufacturer revealed it was not authorised by the Medicines and Healthcare Products Regulatory Agency (MHRA). The EXS Delay Spray Plus contains lidocaine, a local anaesthetic. But the product has not undergone the appropriate assessments related to safety, quality and efficacy, the MHRA said today. […] The post Unauthorised ejaculation delay spray recalled by MHRA appeared first on The Pharmacist.

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PTC gets FDA okay for first brain-delivered gene therapy

pharmaphorum

More than two years after its approval in Europe, PTC Therapeutics' gene therapy for rare genetic disorder AADC deficiency will soon be made available to patients in the US.The FDA has approved PTC's eladocagene exuparvovec – known as Upstaza in Europe – under the Kebilidi trade name in the US. It is cleared for both children and adults with AADC (aromatic L-amino acid decarboxylase) deficiency, a fatal disease that causes severe disability and suffering from the first months of life.

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STAT+: FDA is still struggling with a lack of inspectors, but doesn’t have a plan, watchdog finds

STAT

In the wake of the Covid-19 pandemic, the Food and Drug Administration continues to struggle with a lack of investigators needed to inspect domestic and foreign pharmaceutical manufacturing plants and has not yet developed a plan to keep needed staff, a U.S. government watchdog found. Between November 2021 and this past June, the vacancy rate among investigators increased to 16% from 9%.

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GP Awards shortlist: Orpington PCN Pharmacy Team

The Pharmacist

We caught up with the Pharmacist/Pharmacy Team of the Year Award shortlist ahead of this year’s General Practice Awards ceremony to be held on 6 December at the Novotel London West. The Orpington PCN Pharmacy Team has grown from a group of five to a thriving team of 13 over the past 18 months, comprising […] The post GP Awards shortlist: Orpington PCN Pharmacy Team appeared first on The Pharmacist.

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BioNTech acquires its Chinese cancer drug partner

STAT

This story first appeared in The Readout newsletter.  Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.  Good morning, lots of news this morning that we’ll get straight into.

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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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Pharmacy owners vote overwhelmingly in favour of collective action

The Pharmacist

Pharmacy owners in England, Wales and Northern Ireland have voted in favour of taking collective action, according to a ballot carried out by the National Pharmacy Association (NPA). Some 99% of participating pharmacy owners said they were willing to limit their services unless funding is improved. The NPA said that subject to agreement from its […] The post Pharmacy owners vote overwhelmingly in favour of collective action appeared first on The Pharmacist.

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STAT+: Buoyed by billion-dollar deals, its stock is up 50% this year. How did Boston Scientific get its mojo back?

STAT

The day after completing its latest billion-dollar deal, Boston Scientific dispatched food trucks to hand out fried chicken sandwiches and burritos to Silk Road Medical employees in California and Minnesota, before holding a town hall-style meeting to welcome them into the fold. That September day was a big one for the teams at  Silk Road , which makes stroke-prevention devices.

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Myth vs Fact: The Biosimilar Red Tape Elimination Act

Safe Biologics

Click here to download the Myth vs Fact Onepager.

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Sanofi wins appeal in spat with NICE over Sarclisa

pharmaphorum

Sanofi has taken a small step towards potentially overturning a recent rejection by NICE for NHS use of Sarclisa as a treatment for relapsed and refractory multiple myeloma (RRMM).The drugmaker has won an appeal against NICE's recent final draft guidance on Sarclisa (isatuximab) as a regimen alongside Bristol-Myers Squibb/Celgene's Imnovid (pomalidomide) and dexamethasone (Isa-Pd) for relapsed RRMM.

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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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Two Asthma Assessments That Pharmacists Should Know

Med Ed 101

Two tests are commonly used in asthma assessments to monitor symptom control and airflow and this blog post will discuss their use and how they determine appropriate treatment options. Important tests pharmacists should know include the Asthma Control Test and a Peak Expiratory Flow. We will discuss them below. Asthma Control Test The first of two […] The post Two Asthma Assessments That Pharmacists Should Know appeared first on Med Ed 101.

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The decentralized clinical trials market will grow to $25 billion by 2032

Outsourcing Pharma

Driven by the effects of the COVID-19 pandemic, the market for decentralized clinical trials has seen a push that will lead it to more than triple in size within the next decade.

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CPHI & PMEC India expo to be held from Nov 26-28, 2024

Express Pharma

The 17th edition of CPHI & PMEC India, organised by Informa Markets in India, returns in an advanced format, scheduled from November 26-28, 2024, at the India Expo Centre, Greater Noida, Delhi-NCR. Renowned as a comprehensive, one-stop destination for innovative, cost-effective solutions, the expo will be showcasing the pharmaceutical industry’s modernisation, innovation, and sustainability.

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Pharmacogenetics pilot in general practice suggests 25% of patients change medication

The Pharmacist

A pharmacogenetics pilot supported by pharmacists working within general practice has resulted in medicines changes for 25% of participating patients so far, Royal Pharmaceutical Society (RPS) conference attendees heard last week. Jessica Keen, pharmacy lead at the NHS North West Genomic Medicines Service Alliance, shared an update on the NHS England-funded Pharmacogenetics Roll Out – Gauging Response to Service (PROGRESS) […] The post Pharmacogenetics pilot in general practice suggests 25

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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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CAR T cell therapies to promote drug-free remission in lupus care

Express Pharma

Bristol Myers Squibb and Cabaletta Bio are set to present promising Phase I data on CD19-directed CAR T therapies for severe, refractory lupus at the American College of Rheumatology 2024. BMS’s CC-97540 and Cabaletta Bio’s CABA-201 showed significant efficacy, offering new hope for severe, refractory lupus and other challenging autoimmune diseases.

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J&J seek approval for first drug to treat high-risk smoldering myeloma

Pharmafile

Earlier in November, Johnson & Johnson innovative medicine have applied to the US Food and Drug Agency (FDA) and the European Medicines agency (EMA) for the approval of a new indication for DARAZALEX FASPRO (daratumumab and hyluronidase-fihj). DARAZLEX FASPRO would be used as a monotherapy for the treatment of high-risk smoldering multiple myeloma in adult […] The post J&J seek approval for first drug to treat high-risk smoldering myeloma appeared first on Pharmafile.

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Pfizer considers divestiture of hospital drugs business

Pharmaceutical Technology

Pfizer is currently assessing the potential divestiture of its hospital drugs unit, a division mainly focused on antibiotics and sterile injectables used in hospitals and clinics, Reuters reported.

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UCB and Biogen’s dapirolizumab pegol paves path for systemic lupus erythematosus treatment

Express Pharma

UCB and Biogen’s Phase III PHOENYCS GO trial results signal a pivotal development for systemic lupus erythematosus (SLE) treatment, as dapirolizumab pegol met its primary endpoint and demonstrated enhanced disease control and safety at Week 48. With a novel CD40L-targeting mechanism and favourable efficacy outcomes, this therapy has the potential to challenge established SLE treatments and address unmet needs in an increasingly competitive therapeutic landscape, according to GlobalData.

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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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Medable and Google Cloud partner to deliver digital clinical trials technology

Outsourcing Pharma

The partners will work together to make Medableâs digital and decentralized clinical trial platform available on Google Cloud Marketplace.

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Vivolta and Neurochase to produce brain therapy catheters

Pharma Times

New long-term partnership to address neurological disorder treatments

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Spinal cord stimulator with AI technology receives CE Mark certification

Pharmafile

The HFC iQ, a personalised spinal cord stimulation (SCS) system developed by Nevro that leverages AI technology to manage chronic pain , has received CE Mark certification in Europe. Following on from US Food and Drug Administration (FDA) in 2022, the HFX iQ has received CE mark certification. The CE mark signifies that the product […] The post Spinal cord stimulator with AI technology receives CE Mark certification appeared first on Pharmafile.

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Amgen shares sink on obesity drug concerns; AstraZeneca to spend $3.5B on manufacturing

BioPharma Dive

An analyst note raising questions about Amgen’s MariTide triggered a stock sell-off Tuesday. Elsewhere, Roche and Novartis struck drug discovery deals.

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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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London "is number one European city in life sciences"

pharmaphorum

London is the top city in Europe for the life sciences industry, and ranks third worldwide after Boston and New York in the US, says MedCity report

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TRex Bio raises $84M to compete in crowded immune drug field

BioPharma Dive

The California biotech has drawn partnerships with Eli Lilly and J&J on the promise of its approach to rebalancing the immune system.

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Amgen plays down safety concern with obesity candidate

pharmaphorum

Amgen has rebuffed claims made by an analyst suggesting that its obesity drug MariTide is associated with reductions in bone mineral density

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Aptar pharma inaugurates new plant in Taloja

Express Pharma

AptarGroup announced the inauguration of its new pharma plant in Taloja, India, near Mumbai. The facility will help Aptar continue to meet the growing demands of the pharmaceutical industry in India. The new facility will expand the company’s existing footprint in the region while adding additional local production of several technologies including Aptar’s pressurised metered-dose inhaler (pMDI) valve, as well as breath-actuated devices and single-dose nasal sprays.

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Gilead data lends insight into transforming HIV prevention landscape

European Pharmaceutical Review

New clinical trial findings show that twice-yearly lenacapavir for HIV pre-exposure prophylaxis (PrEP) had high efficacy and safety in a diverse group of participants. This data provides the first in-depth insight into full results of Gilead Sciences pivotal Phase III PURPOSE 2 trial. In the oral PrEP study group, adherence to the small molecule injectable HIV-1 capsid inhibitor and placebo injections was 91.0 percent with on-time injections at week 26, the results showed.