Thu.Sep 12, 2024

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With another phase 3 win, Gilead races toward 2025 launch for long-acting PrEP drug

Fierce Pharma

Gilead Sciences is no stranger to making history in HIV. | In a study of more than 3,000 participants, Gilead's twice-yearly lenacapavir delivered a 96% reduction in HIV infections compared with background HIV incidence.

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The Human Touch: Why Human Transcriptionists Still Outperform AI in Healthcare

MedCity News

While AI continues to advance, the healthcare industry requires a level of accuracy, understanding, and confidentiality that only well-trained human transcriptionists can consistently provide. The post The Human Touch: Why Human Transcriptionists Still Outperform AI in Healthcare appeared first on MedCity News.

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ESMO: Even after unique trial win, Incyte CEO views PD-1 drug Zynyz as pipeline aide

Fierce Pharma

Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. | Incyte’s late PD-1 entrant Zynyz has chalked up a unique clinical win. Yet company CEO Hervé Hoppenot views the antibody molecule not necessarily as a major revenue driver but as an aide to the company’s oncology pipeline.

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Sanofi Jumps Into Radiopharmaceuticals, Paying €100M for Therapy That Could Rival a Novartis Drug

MedCity News

Sanofi is licensing a RadioMedix radiopharmaceutical in development for neuroendocrine tumors. The French pharmaceutical giant is responsible for global commercialization of the therapy, a potential competitor to the Novartis radiopharmaceutical Lutathera. The post Sanofi Jumps Into Radiopharmaceuticals, Paying €100M for Therapy That Could Rival a Novartis Drug appeared first on MedCity News.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Bridging research and clinical care in a new era of psychiatry

Fierce Pharma

By Dr. L. Alison McInnes and Jimmy Qian | We’re finally moving towards a causality-based nosology for psychiatry: specific symptoms with defined biological underpinnings can now be targeted by new therapies. But how do we bridge clinical development with real-world care? How do we ensure trial endpoints are synchronized with real-world measures, payer requirements, and clinical society guidelines?

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Our Next Generations’ Health Depends on the Oral Health of Moms

MedCity News

This starts with viewing specialties such as oral health, maternal health, endocrinology, and cardiology — among others — as interconnected practices, not as separate areas. It also requires combining education, innovation, and investment to truly see — and feel — positive change and interconnected care The post Our Next Generations’ Health Depends on the Oral Health of Moms appeared first on MedCity News.

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More Trending

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Starmer says no extra NHS funding without big reforms

pharmaphorum

Keir Starmer has promised the biggest 'reimagining' of the NHS in its history but said there will be no more funding without sweeping reforms

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Bavarian Nordic eyes external partnerships in bid to produce tens of millions of mpox vaccine doses

Fierce Pharma

As mpox continues to cause illness and claim lives in Africa, Bavarian Nordic is retooling certain vaccine supply pacts to ensure its vaccine goes to the regions that need it most. | Facing high demand, Bavarian Nordic is retooling certain supply pacts to ensure its mpox shot Jynneos goes to the regions that need it most. It's also looking at partnerships to dramatically boost supply.

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Addressing Key Challenges in U.S. Healthcare System

Referral MD

The U.S. healthcare system faces several key challenges that significantly affect providers and patients, making it harder to deliver high-quality care while managing costs. Rising healthcare expenses strain providers and complicate patient access to affordable treatments. Simultaneously, the patient experience is becoming a major focus as healthcare organizations strive to meet the growing expectations of consumer-driven care.

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Fierce Pharma Asia—Akeso, Summit's Keytruda-beating data; BIOSECURE's House passage; Candid's $370M debut

Fierce Pharma

Akeso and Summit Therapeutics' ivonescimab showed strong efficacy against Merck's Keytruda in a phase 3 trial in China. The BIOSECURE Act sailed through a full House vote despite some objections. | Akeso and Summit Therapeutics' ivonescimab showed strong efficacy against Merck's Keytruda in a phase 3 trial in China. The BIOSECURE Act sailed through a full House vote despite some objections.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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New Entity Aims to Help Payers Improve Payment Integrity

MedCity News

A private equity firm announced the merger of three assets that can reduce payers’s headaches when it comes to making sure that provider-submitted claims are accurate. In turn providers can get paid quickly. The post New Entity Aims to Help Payers Improve Payment Integrity appeared first on MedCity News.

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Medicare drug pricing negotiations: What comes next?

pharmaphorum

Explore the ins and outs of Medicare drug pricing negotiations with Alice Valder Curran on this insightful podcast. Learn more about what comes next in this crucial healthcare sector.

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Pharma Pulse 9/12/24: AI Will Force a Transformation of Tech Infrastructure, Obesity Drug Market to be Worth $200 Billion by 2031 & more

Pharmaceutical Commerce

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

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AI Can Help Better Manage Polypharmacy Patients, Study Shows

MedCity News

New research was published this week analyzing how AI can be used to better manage medications for senior patients who use multiple medications simultaneously. It analyzed FeelBetter’s AI platform, which pinpoints patients at high risk of deterioration and preventable hospitalization due to suboptimal medication management. The post AI Can Help Better Manage Polypharmacy Patients, Study Shows appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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EASD 2024: Innovent shows off mazdutide’s efficacy in diabetes and obesity

Pharmaceutical Technology

The data from two Phase III trials demonstrated GLP-1/glucagon agonist’s efficacy in reducing blood glucose and weight.

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CCC to Host Town Hall on AI & Copyright: Essential Information for Global, Cross-Border Business

Copyright Clearance Center

September 12, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, will host the Town Hall event “AI & Copyright: Essential Information for Global, Cross-Border Business” via LinkedIn Live on Tuesday, 24 September, 10:00 am EST/4:00 pm CET. A panel of legal experts, including Prof. Daniel Gervais , Vanderbilt University Law School; Eleonora Rosati , Stockholm University; Karyn Temple , Motion Picture Association; and Atsushi Okada ,

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How Lilly’s sustainability goals come face to face with massive growth

PharmaVoice

Eli Lilly’s head of ESG is maintaining a focus on sustainability even as the company’s expansion plans in weight loss drive a larger footprint and more social scrutiny.

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New webinar series: Portfolio benchmarking, patent searching and FTO

Clarivate

57% of organizations struggle to implement their patent strategy due to insufficient staff, data, budget and time. Leaders can help their teams overcome these challenges by arming IP and R&D departments with the right patent intelligence software and the know-how to use them properly. In a new on-demand webinar series, Clarivate provides valuable insights and practical tools designed specifically for patent attorneys and patent researchers at corporations and law firms.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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FDA Approves Tremfya for Moderately to Severely Active Ulcerative Colitis

PharmExec

Tremfya is the first and only fully-human, dual-acting monoclonal antibody targeting IL-23 and CD64 to be approved for the treatment of moderately to severely active ulcerative colitis.

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Enzyme replacement therapy: improving outcomes in rare disease

European Pharmaceutical Review

In 2022, Xenpozyme ® (olipudase alfa) became the first and only approved ASMD therapy. Enzyme replacement therapy Xenpozyme has been evaluated in children and adults to treat non-central nervous system (CNS) manifestations of ASMD type A/B and type B. According to Sanofi, the treatment is “designed to replace deficient or defective acid sphingomyelinase (ASM), an enzyme that allows for the breakdown of the lipid sphingomyelin”.

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HDA 2024 Traceability Seminar: The WEE Request Process

Pharmaceutical Commerce

In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Elizabeth A. Gallenagh, General Counsel and Senior Vice President, Supply Chain Integrity, Healthcare Distribution Alliance, discusses the WEE request process itself, while also providing her thoughts on other sessions that have garnered her attention.

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How UpScriptHealth Guarantees Authenticity & Prevents Counterfeit Drugs from Entering Their Supply Chain

PharmExec

In this part of their Pharmaceutical Executive video interview, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, explain how their company guarantees the authenticity of the medications it dispenses, and the measures are in place to prevent counterfeit drugs from entering their supply chain.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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HRT linked to reduced psychosis relapse risk in menopausal women

PharmaTimes

New study highlights potential benefits of menopausal hormone therapy

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The Impact of the 21st Century Cures Act

Pharmaceutical Commerce

A cross-sectional study investigates changes in Medicare Advantage enrollment among Medicare beneficiaries with end-stage renal disease in the first two years of the Act.

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Why Sales & Marketing Should be Friends

Zymewire

We see it far too often… Even though sales and marketing have the same fundamental goal of generating new revenue, teams are frequently disconnected and working in silos.

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Dupixent delivers in two skin disease trials

pharmaphorum

Sanofi and Regeneron's Dupixent is effective in two skin disorders, bullous pemphigoid and chronic spontaneous urticaria

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Centessa reports positive phase 1 clinical data for ORX750

PharmaTimes

Promising results for novel orexin agonist in sleep-deprived volunteers

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GSK drops HSV jab, leaving rival mRNA shots in pole position

pharmaphorum

GSK drops clinical-stage HSV vaccine after a disappointing phase 1/2 trial in genital herpes, leaving rivals Moderna and BioNTech out in front.

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Sartorius Introduces New TFF Cassette that Offers Streamlined Workflow in the Lab

PharmaTech

Sartorius' new Vivaflow SU tangential flow filtration cassette offers better flexibility in lab workflows and is designed to be more user-friendly.

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Dupixent Demonstrates Reduced Symptoms of Chronic Spontaneous Urticaria

PharmExec

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

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.