Thu.Nov 09, 2023

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Takeda scores second FDA approval this week with green light for rare blood clotting disorder drug Adzynma

Fierce Pharma

Thanks to a Takeda approval Thursday, patients now have a drug to tackle a rare inherited blood clotting disorder. | The FDA has given a green light to Takeda’s Adzynma, the first recombinant protein product as a preventative or on demand enzyme replacement therapy in adults and kids with congenital thrombotic thrombocytopenic purpura.

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Glasses Provide Audible Prompts for Blind Wearers

Medgadget

A team at the University of Technology Sydney has developed an assistive technology for blind people and those with low vision. The system consists of glasses that can view their surroundings through an on-board camera, appraise the objects nearby using computer vision technology, and then play a sound that provides a cue for the wearer as to their surroundings.

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Fierce Pharma Asia—AstraZeneca's GLP-1 play; Takeda's cancer drug approval; BioNTech's bispecific deal

Fierce Pharma

AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene. Takeda won FDA approval for the Hutchmed-developed colorectal cancer drug Fruzaqla. | AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene. Takeda won FDA approval for Hutchmed-developed colorectal cancer drug Fruzaqla. BioNTech bought a PD-L1xVEGF bispecific antibody from Chinese biotech Biotheus.

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Food as Medicine Startup Launches With $3M in Funding

MedCity News

The Heali app, which launched Thursday, offers personalized nutrition plans for more than 200 chronic conditions, including diabetes, allergies, autoimmune issues and gastrointestinal issues. Users can also access nutrition studies that explain the benefits of certain foods, as well as recipes that fit their diet.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AstraZeneca chases another liver cancer nod for Imfinzi with early phase 3 win, scraps Imfinzi-Lynparza combo study in lung cancer

Fierce Pharma

AstraZeneca chases another liver cancer nod for Imfinzi with early phase 3 win, scraps Imfinzi-Lynparza combo study in lung cancer zbecker Thu, 11/09/2023 - 11:02

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AstraZeneca Pays $185M to Add Oral GLP-1 Drug Candidate to Pipeline

MedCity News

AstraZeneca gains global rights to an oral GLP-1 agonist on track to reach Phase 2 testing in 2024. Under China-based Eccogene, the small molecule’s Phase 1 data show reductions in glucose and body weight.

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More Trending

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AbelsonTaylor Group Receives the Healthcare Businesswomen’s Association ACE Aspire Award for its Employee Psychological Safety Initiative

PM360

Award-winning health and wellness advertising agency AbelsonTaylor Group received the inaugural ACE Aspire Award for its employee Psychological Safety Initiative from the Healthcare Businesswomen’s Association (HBA). The Award was presented yesterday at the HBA Annual Conference in Chicago. The HBA’s ACE (Advancement. Commitment. Engagement.) Awards recognize companies committed to ensuring that gender diversity and leadership opportunities for women are part of their organizational DNA.

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Takeda scores FDA green light for colorectal cancer drug Fruzaqla, 10 months after acquiring its rights in $1.1B deal with Hutchmed

Fierce Pharma

Takeda scores FDA green light for colorectal cancer drug Fruzaqla, 10 months after acquiring its rights in $1.

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Developing a first-in-class small molecule drug for inflammatory disease

European Pharmaceutical Review

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders. In July 2023, MyMD Pharmaceuticals released results from its Phase II study in sarcopenia evaluating potential of MYMD-1 ® , its first-in-class oral TNF-α inhibitor.

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Inside the Kaiser Contract That Ended the Biggest Healthcare Strike in US History

MedCity News

About 85,000 Kaiser Permamente workers voted to ratify a new contract, putting to end what was the largest strike in the history of the healthcare industry. The new contract includes terms for higher wages, more employee education, increased hiring and retention efforts, and greater involvement of frontline workers in the health system’s staffing decisions.

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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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Sandoz and Teva achieve first-of-a-kind manufacturing certification

European Pharmaceutical Review

Sandoz and Teva have become the first organisations to qualify for the new global Minimized Risk of Antimicrobial Resistance (AMR) certification. This programme was developed by the British Standards Institute (BSI) to verify companies that are taking the necessary steps in ensuring responsible antibiotic manufacturing in the global supply chain, helping to lower the spread of AMR.

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Magnetic Dressing Improves Diabetic Wound Healing

Medgadget

Researchers at the National University of Singapore have developed a magneto-responsive hydrogel wound dressing that also contains two different regenerative cell types. The hydrogel is also embedded with magnetic particles that can be stimulated using an external magnetic field. The action of the magnetic field on the gel-encapsulated particles causes mechanical stresses within the gel to act on the cells, stimulating them to grow and enhancing their regenerative potential.

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Report: The Average Medicare Beneficiary Will Choose From 43 MA Plans in 2024

MedCity News

In total, there are 3,959 Medicare Advantage plans being offered for individual enrollment in 2024, a 1% decrease from 2023, according to a new report from KFF.

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What if a CRISPR cure isn’t such an easy choice?

PharmaVoice

A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

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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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Payers and Providers Are at War, Atlantic Health System CEO Says

MedCity News

Brian Gragnolati, CEO of Atlantic Health System, said that “there’s a war going on between providers and payers right now.” In his view, payers “are doing everything they can” not to pay providers for the care they deliver. He said insurers have greatly increased their rate of denials and are extremely reluctant to take on risk in value-based contracts.

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Cloud in pharma: Q&A with GlobalData thematic analyst

Pharmaceutical Technology

GlobalData analyst Jemima Walker discusses key topics around cloud computing for the pharmaceutical industry.

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Investor Appetite For Telehealth Post-Pandemic: Opportunities Based on Medicaid and Commercial Insurance Markets

MedCity News

Notwithstanding the end of PHEs and corresponding loss in many waivers and policies that allowed for increased telehealth adoption during the pandemic, the recent actions of state governments and private payers indicate that interest in telehealth remains strong.

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European Pharmaceutical Review Issue 5 2023

European Pharmaceutical Review

Issue 5 of European Pharmaceutical Review features articles on manufacturing, development and quality control of biopharmaceuticals from antibodies to mRNA and cell and gene therapies. In this issue, Peter Stenico, Biosimilar Global Platform Head at Sandoz, highlights how emerging technology platforms such as nanobodies, ADCs and cell and gene therapies are “on course to revolutionise medicine,” with significant growth anticipated over the next decade.

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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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Fulfilling the Quadruple Aim of Healthcare with AI

MedCity News

Putting all the AI pieces into place effectively requires clarity of what organizations want to accomplish – and for much of healthcare, the Quadruple Aim remains at the very top. Although how to get there will look different, clarity on principles and values that will guide the development of what comes next is paramount to setting us up for years to come.

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Ten Ways to Think Differently About Small-to-Mid-Sized Pharma Launches

Eversana Intouch

Back in 2003, drugs from large pharma companies made up 36% of the late-stage R&D pipeline. By 2018, that share had fallen by about half. Meanwhile, the number of companies launching their first drug during the decade preceding 2018 more than tripled. These data are astonishing, given the perception that Big Pharma is the main driver of biopharma innovation.

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New womb cancer test could prevent need for invasive diagnostic procedures

PharmaTimes

The WID-qEC test successfully identified 91% of womb cancer cases - News - PharmaTimes

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Fighting Against Antimicrobial Resistance With Phage: Q&A With Jonathan Solomon, CEO of BiomX

PharmExec

Solomon discusses new ways that researchers are fighting against bacterial resistance to medications.

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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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NIHR launches phase two of its Shape the Future campaign

PharmaTimes

The campaign was first launched to coincide with the 75th anniversary of the NHS - News - PharmaTimes

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Psychedelic Medicine: Developments, Evaluations, and Political Enthusiasm

PharmExec

A look into the potential effect of psychedelic drugs on various illnesses, such as mental health conditions.

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Takeda bags FDA okay for Fruzaqla in colorectal cancer

pharmaphorum

Takeda bags FDA okay for Fruzaqla in colorectal cancer Phil.

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Abbott’s Food as Medicine Program Reports Clinical Improvements in Patients with Diabetes

PharmExec

Healthy Food Rx provides home-delivered medical prescriptions of healthy food to help address diabetes.

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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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Patient Acquisition as a Competitive Advantage

Penrod

The patient intake experience is a patient’s first impression of your clinic, hospital, or practice. Certainly, many providers have lackluster intake processes…but you don’t have to. By approaching the intake experience as a competitive advantage, you will attract more patients, decrease patient leakage, and drive more revenue. Let’s explore how to make your intake process a competitive advantage.

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Is a Medical Mobility Scooter Right for Me?

Happy Living Medical Sales

Medical mobility scooters provide enhanced mobility for those with physical mobility issues. These devices can improve the quality of life and safety of people who can't get around as well as they used to. According to a report from the ClinMed International Library, it's estimated that 1.7 million people in the U.S. have mobility scooters or wheelchairs.

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Is patient recruitment out of control?

Pharmaceutical Technology

Every year, the patient recruitment landscape is getting larger and more multi-faceted. The good news is that sponsors now have a wide range of options at their fingertips; the challenge is that it’s becoming harder to oversee the flow of patients and understand what is and isn’t working – and therefore hard to make meaningful decisions that improve the trajectory of recruitment for your trial.

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FDA Approves New Chemotherapy-Free Treatment Option for Metastatic Colorectal Cancer

PharmExec

Fruquintinib (Fruzaqla) is the first novel chemotherapy-free treatment option approved for metastatic colorectal cancer in more than a decade.

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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.