STAT
OCTOBER 22, 2024
Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make. Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years.
pharmaphorum
OCTOBER 22, 2024
Otsuka is hoping to file for approval of its anti-APRIL antibody sibeprenlimab as a treatment for kidney disorder IgA nephropathy (IgAN) after the drug hit the target in a phase 3 trial.The Japanese drugmaker said that interim results from the 530-patient VISIONARY study showed that sibeprenlimab achieved a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatine ratio (uPCR) – a measure of how well the kidneys are working – after nine months of treatmen
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STAT
OCTOBER 22, 2024
Senators led by Sen. Dick Durbin (D-Ill.) on Monday demanded answers from Pfizer and Eli Lilly about their relationship with the telehealth prescribers they point patients to from their websites, seeking to determine whether the pharma giants are violating the federal anti-kickback statute. This year, both Pfizer and Eli Lilly launched websites that allow users to learn about their medications, follow links to “talk to a doctor now,” and fill their prescriptions through an online p
PharmaVoice
OCTOBER 22, 2024
Leaders advancing health advocacy, DEI initiatives and better medicine access for patients.
Speaker: Jennifer Hill
Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.
STAT
OCTOBER 22, 2024
There’s a fundamental barrier to scientific certainty in food science. People eat foods, not nutrients. The experts charged with advising federal health officials on the 2025-2030 Dietary Guidelines for Americans had to scale a mountain of research challenges like this basic impediment, starting with the impossibility of randomly assigning people to eat only x or y for 30 to 40 years.
PharmaVoice
OCTOBER 22, 2024
Pfizer’s proxy battle with Starboard has gotten messy. It’s the latest in a series of activist investor campaigns that have been on the rise in recent years.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
BioPharma Dive
OCTOBER 22, 2024
Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.
STAT
OCTOBER 22, 2024
Editas Medicine said Tuesday it will license out or partner its lead sickle cell treatment, the latest shift for a tarantella company that has repeatedly switched direction and leadership since first emerging as one of the first CRISPR biotechs a decade ago. Editas will now focus on a different, newly announced sickle cell program.
Pharma Times
OCTOBER 22, 2024
The company’s workforce will volunteer and fundraise for Team Jak throughout the year
STAT
OCTOBER 22, 2024
Michelle Tarver will be the new leader of the medical devices center at the Food and Drug Administration, according to an email reviewed by STAT and sent out to FDA device staff on Tuesday afternoon. Tarver has temporarily served in the role since veteran devices head Jeffrey Shuren announced his departure in July. The agency conducted a nationwide search for Shuren’s replacement, but Tarver quickly seemed to be the top pick, shadowing Shuren at conferences and town halls.
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
The Pharmacist
OCTOBER 22, 2024
EXCLUSIVE Any enforcement of sanctions against pharmacists for 'inadvertent dispensing' of puberty blockers outside the terms of legislation 'will be considered on a proportionate and case-by-case basis', the government has promised. This comes after the Royal Pharmaceutical Society (RPS) highlighted that pharmacists are the 'only' profession at risk of criminalisation in the government's changes to […] The post Sanctions for 'inadvertent dispensing' of puberty blockers will be &
STAT
OCTOBER 22, 2024
You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday. Will ‘responsible AI’ spawn a new market for tech? This year’s gathering features HLTH ‘s signature opulence and spectacle: as usual, a hair salon for attendees, an indoor puppy park, and a vast exhibit floor crammed with flashy booths, giveaways a
BioPharma Dive
OCTOBER 22, 2024
The gene editing company will focus on “in vivo” medicines, while seeking to license out or find a development partner for its clinical-stage treatment reni-cel.
STAT
OCTOBER 22, 2024
Genetics can be cruel. Lawrence Ingrassia, a longtime journalist, has learned that the hard way. A genetic mutation that runs in his family predisposes those who carry it to developing malignant tumors of all types. It’s why, at age 69 and 30 days, he became the longest living member of his family.
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pharmaphorum
OCTOBER 22, 2024
AstraZeneca and Ionis are on track for EU approval of ATTR polyneuropathy therapy Wainzua after the CHMP backs the drug
STAT
OCTOBER 22, 2024
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. Check out the latest promo we’re running, where you can get your first three months of a STAT+ subscription for $20.
The Pharmacist
OCTOBER 22, 2024
Men taking metformin can be reassured that there is no link with birth defects, say researchers who reviewed data from more than three million pregnancies. The study was done after Danish researchers reported a possible association in 2022 but for which there was ‘no plausible biological mechanism’. Now a careful analysis of national birth registries […] The post No link with metformin in dads and birth defects, finds review appeared first on The Pharmacist.
STAT
OCTOBER 22, 2024
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. Hello and happy Thursday! In a tense election season, my go-to feel-good show has been The Great British Baking Show. Feelings about Caramel Week and news tips are always welcome to rachel.cohrs@statnews.com.
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.
pharmaphorum
OCTOBER 22, 2024
Discover the seven essential pillars of GenAI for generating value at an enterprise level and leveraging artificial intelligence to drive innovation and growth.
vizient
OCTOBER 22, 2024
The report includes insights across key performance indicators and features programs and solutions Vizient implements to ensure a diverse, equitable and inclusive work environment.
Pharmaceutical Technology
OCTOBER 22, 2024
The European Union's CHMP has recommended the approval of AstraZeneca and Ionis Pharmaceuticals’ Wainzua to treat ATTRv-PN.
pharmaphorum
OCTOBER 22, 2024
Sanofi is now in exclusive talks with private equity company Clayton Dubilier & Rice over the sale of a controlling stake in its consumer health business Opella, as the French government seeks guarantees it will keep production and jobs in France.
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Express Pharma
OCTOBER 22, 2024
J.B. Chemicals & Pharmaceuticals (JB Pharma) has announced its Environmental, Social, and Governance (ESG) commitments with the release of its third Sustainability Report. The report highlights the company’s achievements in reducing its environmental impact and improving resource efficiency, marking a significant milestone in its dedication to sustainable growth.
pharmaphorum
OCTOBER 22, 2024
The proportion of commercially sponsored clinical trials run in Europe almost halved over the last 10 years and is now trailing China
PharmaTech
OCTOBER 22, 2024
As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.
pharmaphorum
OCTOBER 22, 2024
Starboard Value CEO Jeff Smith pulls no punches in his assessment of Pfizer failings, which he claims have resulted in at least $20bn in lost value
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.
Pharmaceutical Technology
OCTOBER 22, 2024
Eli Lilly sued three online vendors and medical spas earlier this week over improper copying of tirzepatide.
The Pharmacist
OCTOBER 22, 2024
The government has launched what it has described as a ‘major crackdown’ on waste in the NHS. The new strategy – the Design for Life Roadmap – sets out 30 actions to help the health service reduce the number of single-use medical devices and its reliance on product imports from overseas. The Royal Pharmaceutical Society (RPS) welcomed […] The post Government launches ‘major crackdown’ on NHS waste appeared first on The Pharmacist.
Pharmaceutical Technology
OCTOBER 22, 2024
Editas is partnering its CRISPR platform with Genevant’s LNP technology to develop novel gene editing medicines in a deal worth $283m.
European Pharmaceutical Review
OCTOBER 22, 2024
The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). This Statutory Instrument means that patients can access highly personalised medicines and medicines with a very short shelf life more quickly.
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