Wed.May 15, 2024

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My rendezvous with the raw milk black market: quick, easy, and unchecked by the FDA

STAT

WASHINGTON — It’s Friday May 10, and I’m on my way to what feels like the world’s weirdest drug deal. I received a text the day before from a man named Karl. My order would be arriving from Maryland between 2 and 4 p.m. at the northwest D.C. drop site. It’ll be safely wrapped in ice packs, he assured me.

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As Lilly surges, headwinds against its weight loss drugs are growing

PharmaVoice

After missing analysts’ earnings expectations for Mounjaro sales in the first quarter due to overwhelming demand, Lilly is also dealing with a legal loss and incoming pricing questions from lawmakers.

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Drug overdose deaths fell for first time in five years, though still exceeded 100,000

STAT

U.S. drug deaths decreased slightly in 2023, according to new data, the first decrease in five years. Last year saw 107,543 U.S. drug overdose deaths, according to preliminary statistics released Wednesday by the Centers for Disease Control and Prevention, roughly a 3% drop from 2022.

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Ten pharmacies closing every week, NPA analysis suggests

The Pharmacist

The equivalent of 10 local pharmacies are closing their doors each week, according to analysis by the National Pharmacy Association (NPA). And the number of bricks and mortar pharmacies closing between January and April 2024 is nearly 50% higher than in the same period last year, the NPA said. The association’s analysis of NHS Business […] The post Ten pharmacies closing every week, NPA analysis suggests appeared first on The Pharmacist.

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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: Cutting-edge insulin is good. But it’s the ‘trailing edge’ of older versions that can keep it affordable

STAT

Physicians Frederick Banting and John MacLeod declined to be listed on the patent for insulin in 1923; their co-inventors Charles Best and James Collip sold the patent to the University of Toronto for $1. But despite the discoverers’ efforts to make insulin available and cheap for everyone, it has today become the poster child for soaring pharmaceutical prices.

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Eisai sets new revenue target for Alzheimer’s drug Leqembi

BioPharma Dive

The annual forecast, which comes as Eisai and Biogen have begun submitting a more convenient form of Leqembi for approval, looks “more realistic” than previous guidance, according to Jefferies analysts.

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More Trending

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LogiPharma Europe 2024: World Courier President Talks Mitigating Supply Chain Risks

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno at LogiPharma Europe, Nick Porter, President, World Courier discusses mitigating supply chain risks, the future of artificial intelligence in pharma logistics, and more.

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STAT+: Galapagos, in makeover mode, strikes deal to make CAR-T therapies at blood centers across U.S.

STAT

Seeking to differentiate itself from other makers of CAR-T cancer therapies, Galapagos NV on Wednesday announced it had struck a deal with Blood Centers of America to open up dozens of manufacturing sites for its cell-based medicines around the U.S. Galapagos said it will rely on the partnership, the financial terms of which were not disclosed, as it moves its CAR-Ts for different cancers into pivotal studies and could also help launch those medicines should they win approval.

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FDA approves Roche’s HPV self-collection screening option

Pharmafile

Roche has announced that the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV) self-collection solution. This makes the solution one of the first available in the US, allowing more women to utilise an accessible screening option. The post FDA approves Roche’s HPV self-collection screening option appeared first on Pharmafile.

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Opinion: Listen: Free medical tuition alone isn’t enough to close gaps in primary care

STAT

In 2018, New York University became the first U.S. medical school to go tuition free. Since then, a handful of others have followed with many more considering similar programs. One hope for free tuition endeavors is that lower post-graduation debt will increase the number of med students who choose lower-paying, desperately needed careers in primary care and pediatrics.

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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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GSK, UK govt put £130m into antimicrobial resistance fight

pharmaphorum

GSK has become the first founding partner of the new Fleming Initiative, which aims to tackle the rising threat of antimicrobial resistance (AMR) and is also backed by the UK government.

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STAT+: Pharmalittle: We’re reading about fake studies, AbbVie investing in psychedelics, and more

STAT

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the sobering possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is maple bourbon.

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FDA clears Roche self-collection system for HPV screening

pharmaphorum

The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer

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Leqembi gets closer to being offered as an injection

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. A bunch of my colleagues are traveling to San Francisco (without me) for our  Breakthrough West Summit  happening tomorrow. If you have FOMO like me, you can still  register  to get a virtual pass.

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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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Ensuring sterility of a novel anti-VEGF bispecific antibody

European Pharmaceutical Review

Research has demonstrated a cost-effective storage solution for compounded faricimab kept for a maximum of 28 days. Authors of the paper stated that it provides off-label use of the anti- vascular endothelial growth factor (VEGF)/angiopoietin-2 (Ang-2) biologic , “while maintaining safety in the treatment of patients”. Their study compared the stability, sterility, and binding affinity to VEGF and Ang-2 of faricimab.

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STAT+: WuXi Biologics execs register to lobby as Congress comes for the company

STAT

WASHINGTON — WuXi Biologics executives have joined the lobbying fray in the lead-up to a move by Congress to add the company to a blacklist meant to prevent certain biotech firms from doing business in the United States. Legislation proposing that blacklist, known as the BIOSECURE Act, was passed in a 40-1 bipartisan vote on Wednesday by the House Oversight and Accountability Committee.

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Home testing devices for sleep apnoea backed for NHS use

pharmaphorum

Five home-testing devices to diagnose sleep apnoea, which can affect the health of around 2.5 million adults in the UK, have been recommended for NHS use by NICE.

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STAT+: Abbott’s dissolvable stent, which failed in heart disease patients, may help vascular patients

STAT

An Abbott device that failed in heart disease patients is getting a new life in patients with severe vascular disease. The device is a below-knee stent that widens clogged blood vessels, and then vanishes into the vessel’s walls over the course of three years. It also delivers a drug that prevents scar tissue from forming — a common risk factor with traditional metal stents that further narrow the vessel.

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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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Eisai, Biogen start delayed subcutaneous Leqembi filing

pharmaphorum

Eisai and Biogen have filed a rolling biologics license application in the US for a subcutaneous formulation of Alzheimer’s disease therapy Leqembi that was delayed by the FDA on procedural grounds.

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Bristol Myers Squibb’s cell therapy gets USFDA nod for relapsed or refractory follicular lymphoma

Express Pharma

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.

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Updated BIOSECURE Act draft clears House committee

pharmaphorum

House Oversight Committee passes BIOSECURE Act, which would restrict US companies from contracting with Chinese biotechs including WuXi AppTec, MGI and BGI

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Indica Labs'platform cleared by FDA, enhancing pathologists' diagnostic capabilities

Outsourcing Pharma

Indica Labs, a leader in digital pathology solutions, has announced that it has received FDA clearance for its enterprise digital pathology platform, HALO AP Dx, for primary diagnosis.

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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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Case Study: MHRA

pharmaphorum

MHRA's innovative regulatory approach enables Nuwiq's accelerated clinical trial timeline for haemophilia patients. Learn how their flexible approach is speeding access to new treatments.

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NIHR and TJBCM announce new funding initiative for novel brain tumour research

Pharma Times

The condition is the ninth most common cancer in the UK and affects 12,300 people annually

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FDA clears BMS’ Breyanzi for follicular lymphoma

pharmaphorum

BMS gets another FDA approval for its CD19-directed CAR-T Breyanzi, this time as a third-line or later therapy for follicular lymphoma

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Ecolab Life Sciences to unveil bioquell qube and more at BIO 2024

Outsourcing Pharma

Ahead of Bio 2024, we caught up with Matt Cokely, global technical consultant strategic leader, and Helen Gates, marketing director, at Ecolab Life Sciences to find out what the company is planning for the event and how it is navigating current challenges in the industry.

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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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AbbVie takes option on Gilgamesh CNS drugs in $2bn deal

pharmaphorum

AbbVie has agreed to pay $65 million on an option deal with start-up Gilgamesh Pharma, lining up rights to neuroplastogen compounds that can improve neuroplasticity - the ability of the brain to respond to changes. The two companies will work together on the development of a “next-generation” of psychiatric medicines, although – for now – the drugs themselves and the target indications are being kept under wraps. other than to say they include mood and anxiety disorders.

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Ecolab Life Sciences to unveil bioquell qube and more at BIO 2024

Outsourcing Pharma

Ahead of Bio 2024, we caught up with Matt Cokely, global technical consultant strategic leader, and Helen Gates, marketing director, at EcoLab Life Sciences to find out what the pharmaceutical manufacturing firm is planning for the event and how it is navigating current challenges in the industry.

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FDA rejects label expansion for Dynavax’s hepatitis B vaccine

Pharmaceutical Technology

The US agency rejected the expanded use of Dynavax’s vaccine for adults on haemodialysis, citing insufficient efficacy and safety data.

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New patent for Mallinckrodt Hosp drug INOMAX

Drug Patent Watch

Annual Drug Patent Expirations for INOMAX Inomax is a drug marketed by Mallinckrodt Hosp and is included in one NDA. It is available from one supplier.

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Cresset establishes new HQ in Bengaluru

Express Pharma

Cresset, a provider of solutions for Computational Drug Discovery and Development that accelerate research outcomes, is expanding its existing Asia Pacific presence by creating a new headquarters in Bengaluru, one of India’s leading centers for biotechnology and pharmaceutical research. The press release states that the new India site will support the growing demands of Cresset’s APAC customer base, and increase its reach in a range of markets across the region, including South Korea, Japan, Ch

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