Tue.Jan 07, 2025

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STAT+: Generic GLP-1 drugs could help Medicare drive a harder bargain for Ozempic and Wegovy

STAT

The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide , according to experts familiar with the price-negotiation program and STAT’s review of documents from the first round of negotiations.

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Subcutaneous options offer convenience for patients — and a valuable window for drugmakers

PharmaVoice

New formulations for under-the-skin application of drugs give pharmas another opening in a crowded market.

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STAT+: Pharmalittle: We’re reading about FDA guidance on AI, meds releasing ‘forever chemicals,’ and more

STAT

Top of the morning to you, and a fine one it is, although we concede this may depend on your tolerance for frigid temperatures. Nonetheless, blue skies and a shiny sun are enveloping the Pharmalot campus, where the official mascots are hunting wildlife and we are engaged in the usual rituals — firing up the coffee kettle in order to brew a cup of stimulation (the choice today, hazelnut mocha) and foraging for items of interest.

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ALS drugs from Denali, Calico come up short, marking more failures for Healey trial

BioPharma Dive

Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the tally of failed drugs in the innovative “Healey platform trial” to seven.

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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 issues first recommendations on AI for drug development

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. The guidelines address the safety, effectiveness or quality of these medicines. FDA has previously published a discussion paper that was produced to inform its guidance on AI in pharmaceutical drug development.

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Metsera reveals study data supporting long-acting obesity shot

BioPharma Dive

The startup, which has already raised more than half a billion dollars, released Phase 2 results that could position its drug as a future threat to weight loss medicines from Novo Nordisk and Eli Lilly.

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PharmaVoice’s Crystal Ball: The industry’s AI future

PharmaVoice

How AI will further transform the business of drug discovery and development in 2025.

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Novartis gene therapy set to enhance SMA treatment

Pharma Times

OAV101 IT expands potential for type II SMA patients

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US reports its first fatal case of H5N1 bird flu

pharmaphorum

A man in Louisiana has become the first recorded fatality in the US attributed to the H5N1 strain of bird flu.

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Breakthrough drugs herald ‘new era’ in battle against dementia, experts predict

The Guardian - Pharmaceutical Industry

Medical advances make pills to treat Alzheimers disease viable, though challenges remain in sharing gains globally Pills that prevent Alzheimers disease or blunt its effects are on the horizon, as the fight against dementia enters a new era, experts have said. Scientific advances were on the cusp of producing medicines that could be used even in the most remote and under-resourced parts of the world, thereby democratising care, said Jeff Cummings, professor of brain science and health at the Uni

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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 bags breakthrough status for bone cancer drug

pharmaphorum

GSK has claimed its second breakthrough designation from the FDA for B7-H3-targeted ADC, this time in osteosarcoma.

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Merck unveils new cyber-physical trust platform at CES 2025

Pharma Times

M-Trust set to improve product safety and counterfeiting solutions

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Denali Therapeutics’ ALS drug fails to improve function and survival in phase 2/3 trial

Outsourcing Pharma

Denali Therapeutics' DNL343 fails to slow ALS progression in phase 2/3 trial but shows safety and offers insights for future analysis.

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Hub and spoke changes 'likely in late 2025' but supervision legislation 'not imminent'

The Pharmacist

Changes to allow hub and spoke dispensing between different legal entities are likely to come in late 2025, Community Pharmacy England (CPE) has said. But changes to supervision legislation are not imminent, although the General Pharmaceutical Society (GPhC) and the Royal Pharmaceutical Society (RPS) are expected to update their standards and guidance.

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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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Heart failure market to grow at 9.6 per cent CAGR in 7MM during 2022-32

Express Pharma

With pipeline approvals of varying mechanisms of action and an influx of newly diagnosed patients, the heart failure (HF) market is expected to grow at a 9.6 per cent compound annual growth rate (CAGR) from $13.5 billion in 2022 to $33.7 billion in 2032 across the seven major markets (7MM*), forecasts GlobalData. GlobalDatas report, Heart Failure: Seven-Market Drug Forecast and Market Analysis Update, reveals that the US will contribute the most to the growth of the HF market due to the higher

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Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

Generic drugs play a crucial role in providing affordable medication options to patients. However, many individuals still harbor misconceptions and doubts about the efficacy and safety of generic alternatives. As healthcare professionals, it’s our responsibility to educate patients about generic drugs and empower them to make informed decisions about their treatment options.

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ICEXPO announces Pharma Live Expo 2025 in Mumbai from April 17-19

Express Pharma

The 3rd edition of Pharma Live Expo & Summit will be held from April 17 to 19, 2025, at the Bombay Exhibition Centre, Mumbai. Organised by ICEXPO Consults in collaboration with the Indian Drug Manufacturers Association (IDMA), the event is supported by, Federation of Pharmaceutical and Allied Products Merchant Exports (FPME) & Federation of Pharma Entrepreneurs (FOPE) along with key industry stakeholders.

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FDA issues first guidance on AI in medicine development

pharmaphorum

The FDA has placed the credibility of AI's 'context of use' in pharma development at the heart of its first guidance in this area

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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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Deal value declined by 86.4 per cent in Dec 2024, compared to Dec 2023

Express Pharma

In December 2024, the pharma industry reported 82 deals worth $5.2 billion, compared to the last 12-month (December 2023 to November 2024) average of 100 deals worth $16.8 billion. Goldman Sachs Asset Management, to acquire a majority stake in Synthon International Holdings BV, a company engaged in developing, manufacturing, and out-licensing complex generic medicines, for a consideration of approximately $2.1 billion; AlpInvest Partners B.V. and Sixth Street Specialty Lending, investing $945.6

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Vertex, startup Orna to partner on gene editing research

BioPharma Dive

The three-year partnership is another example of Vertex’s interest in improving on Casgevy, its CRISPR medicine for sickle cell and beta thalassemia.

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Association leaders share their expectations from Budget 2025-26

Express Pharma

Anil Matai, Director General, OPPI “To strengthen India’s healthcare ecosystem and drive inclusive growth, the upcoming budget must prioritise increased public spending on health initiatives. This includes expanding coverage under the Ayushman Bharat scheme to the missing middle, upgrading existing Centers of Excellence, establishing new ones, and enhancing primary healthcare infrastructure.

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FDA Publishes Two Guidance Documents, One in Final Version

PharmaTech

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

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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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Zydus signs agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR (Sitagliptin | Sitagliptin and Metformin Hydrochloride) to its template formulary

Express Pharma

Zydus Lifesciences has entered into an agreement with CVS Caremark, a CVS Health company to add Zituvio, Zituvimet and Zituvimet XR (Sitagliptin | Sitagliptin and Metformin Hydrochloride) tablets to its template formulary. CVS Caremark added Zydus Zituvio and combination products to its template formulary starting January 1, 2025. Zituvio and combination products include Zituvio (sitagliptin), Zituvimet (sitagliptin and metformin hydrochloride) and Zituvimet XR (sitagliptin and metformin hydroch

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Molex, Phillips Medisize Close Acquisition of Vectura Group

PharmaTech

The transaction, which was first announced in September 2024, expands Phillips Medisizes inhalation drug delivery capabilities.

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How GenAI will transform life sciences in 2025

pharmaphorum

The life sciences industry is in a position to help humanity, perhaps more than ever, with the introduction of generative AI (GenAI).

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Variant Bio and Novo Nordisk to identify targets for metabolic disease treatment

Pharmaceutical Technology

Variant has entered a multi-year research partnership with Novo Nordisk to identify new targets to treat metabolic conditions.

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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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FDA Requires Warning for Guillain-Barré Syndrome in Prescribing Information for RSV Vaccines

Pharmacy Times

Despite these concerns, experts have emphasized that the benefits of RSV vaccination outweigh potential risks for older adults, who are at heightened risk of severe RSV-related illness.

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FDA accepts Sentynl’s Menkes disease therapy NDA for priority review

Pharmaceutical Technology

The FDA has accepted for filing and priority review Sentynl Therapeutics CUTX-101 NDA for the treatment of Menkes disease.

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Beyond Amorphous Solid Dispersions: Novel Applications in Pharmaceutical Spray Drying

PharmaTech

Webinar Date/Time: Wed, Feb 5, 2025 11:00 AM EST

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WuXi Biologics to sell Ireland-based vaccine site to MSD for $500m

Pharmaceutical Technology

The transaction is expected to close in the first half of 2025, subject to the satisfaction of customary closing conditions.

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Klick Health Acquires Peregrine Market Access

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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