Thu.Jul 06, 2023

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Bernie Sanders proposes price caps on drugs developed with federal funds

Fierce Pharma

After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. | After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. Bernie Sanders, I-Vermont—a longtime opponent of Big Pharma—has become even more ubiquitous in his efforts to reduce drug prices.

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‘Hope Is Not a Business Model’: Digital Health Fundraising Advice from 2 VCs

MedCity News

Two VCs from Merck Global Health Innovation Fund recently offered fundraising advice for digital health companies. They told these firms to expect slower funding timelines, urged them not to be afraid of down or flat rounds, and advised them to spend time nailing down the specifics of their growth narrative.

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Teva weighs sale of $2B API business as CEO Richard Francis embarks on 'Pivot to Growth' strategy: reports

Fierce Pharma

Less than two months into its "Pivot to Growth" strategy under a new CEO, Israeli-American generics giant Teva Pharmaceutical could be weighing a major shake-up of its key drug ingredients business | Teva is looking at strategic options for its active pharmaceutical ingredient unit, with a potential sale on the table, BNN Bloomberg and Benzinga have reported.

Sales 326
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CareEvolution Webinar Highlights Healthcare Data Management Evolution [Sponsored]

MedCity News

Health tech experts explained the nuances of healthcare data management and ways in which patient data can be cleaned, converted, standardized and harmonized across systems

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest

Fierce Pharma

It’s official: Roughly half a year after the FDA granted an accelerated nod to Eisai and Biogen’s new Alzheimer’s disease med lecanemab, the companies have converted that green light into a full-fl | With a full approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s disease under the FDA's traditional approval pathway.

FDA 268
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AI Frontiers: Navigating the Risks, Rewards, and Regulations

PharmExec

Senior editor Fran Pollaro chats with Sharlene Jenner, vice president of engagement strategy, Abelson Taylor about the transformative impact and ethical considerations of AI in the pharmaceutical industry, emphasizing its potential in data analysis and marketing, while also highlighting the pioneering work of AI companies in advancing drug discovery.

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MA Beneficiaries Have Fewer In-Network Options for Psychiatrists Than Other Insurance Types

MedCity News

A Health Affairs study discovered that nearly two-thirds of Medicare Advantage psychiatrist networks, or 64.6%, were narrow in 2019. Comparatively, about 43.1% of Medicaid managed care networks were narrow and 39.5% of ACA Marketplaces were narrow.

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'The Top Line': New HIV therapies, plus this week's headlines

Fierce Pharma

In this episode of "The Top Line," we talk with ViiV’s head of R&D, Dr. Kimberly Smith, about new HIV therapies. | This week on "The Top Line," we discuss new HIV therapies, plus Humira's new biosimilar, foreign pharmaceutical investments, and the rest of the week's headlines.

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3 Predictions for Home-Based Care, Per 7WireVentures

MedCity News

The healthcare industry will continue to shift more toward more home-based care offerings in the coming years, 7WireVentures said in a new report. The venture firm also gave some other predictions — including that established healthcare stakeholders will be forced to partner with non-traditional digital health companies and that the greater use of home-based solutions will lead to more personalized care plans.

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Johnson & Johnson unloads eye drops line to acquisitive Bausch + Lomb as Brent Saunders' deal streak rolls on

Fierce Pharma

During the first earnings call Brent Saunders led since his return at Bausch + Lomb, the CEO laid out what he believes is the company’s biggest issue: underutilization of existing infrastructure. | During the first earnings call Brent Saunders led since his return at Bausch + Lomb, the CEO laid out what he believes is the company’s biggest issue: underutilization of existing infrastructure.

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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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Heart Valves Made in Minutes

Medgadget

Researchers at Harvard University have developed a technique that lets them create biomaterial heart valves in a matter of minutes. The approach, called ‘Focused Rotary Jet Spinning’, has been described by the researchers as ‘a cotton-candy machine with a hair dryer behind it.’ Essentially, the technique involves using jets of air to direct polymer strands onto a heart valve shaped frame.

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Improving the Patient Experience Through Research-Driven Design

Fierce Pharma

Digital technologies designed to support clinical trial management have evolved greatly over the years, spurred by increasing complexity in study design, emerging technologies in specific therapeut | Karl McEvoy, Product Director, Decentralized Trial Technology at YPrime discusses the importance prioritizing patient experience when updating and designing eClinical technologies.

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Thermo Fisher Adds Real-World Evidence to Remit Via $912M CorEvitas Acquisition

MedCity News

Corvitas brings Thermo Fisher Scientific registries that gather data about how approved therapies are working in the real world. The acquisition will complement PPD, the contract research organization that Thermo Fisher purchased in 2021.

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Lifera, Sanofi and Arabio boost vaccine manufacture in Saudi Arabia

Pharmaceutical Technology

Lifera, Arabio and Sanofi have signed a memorandum of understanding (MOU) to bolster manufacturing of vaccines in Saudi Arabia.

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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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Eisai Alzheimer’s Drug Wins Full FDA Approval, But With Sterner Safety Alert

MedCity News

Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.

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BioNTech to support trial access for cancer immunotherapies

European Pharmaceutical Review

BioNTech SE and the UK government have jointly agreed to provide up to 10,000 patients with personalised cancer immunotherapies by 2030. Signing of this agreement builds on a memorandum of understanding signed in January. The partnership will provide cancer patients with improved access to the latest cancer trials and therapies currently being developed.

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Alfie Health Raises $2.1M for AI-powered Weight Loss Platform

MedCity News

Alfie Health’s $2.1 million seed funding was led by Y Combinator and Nina Capital. It included participation from Goodwater Capital, Phoenix Investment Club and several angel investors.

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Pharma’s strike-from-all-sides attack on the IRA could be decided by the Supreme Court

PharmaVoice

New lawsuits challenging the Inflation Reduction Act’s price negotiation program hit the government with multiple Constitution-based challenges.

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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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EMA-endorsed statement targets Covid-19 vaccine misinformation

Pharmaceutical Technology

The ICMRA says evidence from more than 13 billion global vaccine doses shows good safety amid “dangerous” false information.

Safety 98
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Surgical Patch Alerts to Intestinal Leaks

Medgadget

Scientists at the Swiss Federal Laboratories for Materials Science and Technology (EMPA) have developed an advanced surgical sealant that can alert clinicians to the presence of an intestinal leak after gastrointestinal surgery. Such leaks can be very dangerous, but until now clinicians had few ways to detect them before they start causing symptoms.

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SK bioscience and Thailand’s GPO enter MoU to boost vaccine response

Pharmaceutical Technology

SK bioscience and Thailand's GPO have entered a memorandum of understanding (MoU) to bolster vaccine infrastructure in Thailand.

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GeneCode receives record Parkinson’s funding

PharmaTimes

European Innovation Council Accelerator finances treatment development drive for condition - News - PharmaTimes

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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.

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Navigating the Recession and Patent Expirations

PharmExec

Pharma is built to overcome, but focus on fundamentals remains key.

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Novartis reveals five-year efficacy data for Kesimpta

PharmaTimes

Patients treated with Kesimpta experienced considerable decreases in relapse rates - News - PharmaTimes

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Chime Biologics Forms mAb Development and Manufacturing Deal with Leads Biolabs and BeiGene

PharmaTech

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

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MedRhythms Announces FDA Listing of InTandem™ (MR-001) to Improve Walking and Ambulation in Adults with Chronic Stroke

Legacy MEDSearch

MedRhythms announced that MR-001, the company’s evidence-based neurorehabilitation system to improve walking and ambulation in adults with chronic stroke walking deficits, has been listed as a Class II medical device with the U.S. Food and Drug Administration (FDA). The system delivers an intervention based on the principle of Rhythmic Auditory Stimulation (RAS), a well-researched clinical intervention utilizing the mechanism of auditory-motor entrainment, through which the motor and audit

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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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How do results from different dynamic light scattering instruments compare?

PharmaTech

Here, we explain how results from DLS instruments at different wavelengths and scattering angles are related using practical examples and established light scattering theory

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VBI Vaccines and Brii Biosciences expand Hepatitis B partnership

Pharmaceutical Technology

VBI Vaccines has announced the expansion of its HBV partnership with Brii Bio to address prevention and treatment of the disease.

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DeSpir Logistics Named ‘Fast 50’ Company

Pharmaceutical Commerce

Crain’s Chicago Business distinction—based on revenue performance—is the second honor in just as many years for the transportation 3PL.

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WCD 2023: better understanding skin of colour in atopic dermatitis patients

Pharmaceutical Technology

Atopic dermatitis (AD) manifests differently across White, Brown, Asian, and Black skin and this impacts how these patients are treated.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.