Sat.Nov 26, 2022 - Fri.Dec 02, 2022

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Genentech starts phase 2 trial to optimize delivery of eye disease cell therapy

Fierce Pharma

Genentech starts phase 2 trial to optimize delivery of eye disease cell therapy. ntaylor. Mon, 11/28/2022 - 10:11.

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How “Lung Intelligence” is Accelerating New Therapies

MedCity News

Thanks to the convergence of cloud technologies, AI, and refined lung data, we are in a new era for those with chronic lung disease. In this new world, lung intelligence provides fast, precision measures of treatment efficacy so new drugs can blaze through the trial pipeline.

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NHS expedites rollout of Bayer’s darolutamide for prostate cancer

Pharmaceutical Technology

The National Health Service (NHS) in England, UK, has expedited the rollout of Bayer ’s new life-extending drug, darolutamide, to treat the most advanced kinds of prostate cancer that have spread to other body parts. With the latest development, NHS will become the first healthcare system in Europe to offer this drug to prostate cancer patients. Nearly 9,000 men with prostate cancer will be eligible to receive this treatment.

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5 enduring mysteries of the Barry and Honey Sherman murders

PharmaVoice

After nearly five years, the homicide case involving pharma billionaires continues to perplex investigators.

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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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With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker

Fierce Pharma

With buyout on Horizon, Amgen and Sanofi eye cash plays for rare disease drug maker. fkansteiner. Fri, 12/02/2022 - 09:51.

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A Dose of Innovation

MedCity News

As gene sequencing, machine learning, powerful imaging, sensors, gene and cell therapies make their way out of academic labs into everyday healthcare, our approach to healthcare is changing. For the first time, not only can we pinpoint the molecular and genetic causes of disease, but we also have the technologies to access them. On the back of this, prevention and cures are becoming possible.

More Trending

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Steps to building a more patient-centric industry

pharmaphorum

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. In 2021, a CISCRIP Perceptions and Insights Study reported more disruption to daily routines compared to previous years, citing length of visits, travel, and diagnostic tests as top burdens

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Eli Lilly dumps Innovent's PD-1 after FDA rebuff, nixing high-profile Chinese cancer drug

Fierce Pharma

Eli Lilly dumps Innovent's PD-1 after FDA rebuff, nixing high-profile Chinese cancer drug. aliu. Thu, 12/01/2022 - 15:03.

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How Patient Care Is Being Improved by Technology Everyday

MedCity News

From streamlining long-held manual processes to creating entirely new diagnostic devices, new tech is cropping up all over the medtech industry—resulting in a real-world impact on patients’ quality of life.

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Expanding ketamine’s horizons to treat rare neurological disorders

Pharmaceutical Technology

For several decades, researchers have been investigating the role of ketamine in treating depression. Now, efforts are underway to study ketamine’s effects in Parkinson’s disease, fibromyalgia, and Rett syndrome. On November 14, the Canadian developer PharmaTher announced positive data from a Phase I/II study where ketamine was used to treat levodopa-induced dyskinesia in Parkinson’s disease.

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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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How automation can help to address supply chain challenges in pharma

pharmaphorum

Supply chain issues have been rife in pharmaceuticals for a while, but current socio-economic challenges such as the conflict in Ukraine and the COVID-19 pandemic have led to extended wait times and higher prices for thousands of products. Incidents such as the hormone replacement therapy drug shortage in early 2022 have shown the damaging impact supply chain issues can have on people who depend on these drugs.

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With FDA nod for its fecal microbiome therapy, Ferring becomes No. 1 in No. 2

Fierce Pharma

With FDA nod for its fecal microbiome therapy, Ferring becomes No. 1 in No. 2. kdunleavy. Thu, 12/01/2022 - 10:14.

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Nvidia Aims to Simplify AI Adoption Process for Cincinnati Children’s, UCSF

MedCity News

Nvidia unveiled new tools designed to make it easier for hospitals to integrate AI models related to medical imaging into their clinical workflows. The tools have been adopted by major cloud infrastructure providers, as well as healthcare providers and AI software companies. Some of these include Cincinnati Children’s Hospital, University of California San Francisco, England’s National Health Service and Qure.ai.

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C4XD and AstraZeneca enter $402m deal to develop respiratory disease therapy

Pharmaceutical Technology

C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. The deal has been signed to develop the C4X NRF2 Activator programme for these ailments. Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD).

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Supporting the era of green pharmaceuticals in the UK

pharmaphorum

According to a report by the Office of Health Economics (OHE), commissioned by the Association of the British Pharmaceutical Industry (ABPI), immediate action must be taken by governments, health systems, and companies to secure the era of green pharmaceuticals. ‘Supporting the era of green pharmaceuticals in the UK’ highlights that, while Britain can play a leading role in the sustainability agenda for pharmaceuticals, action must also be taken on a global scale to ensure impact.

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UK regulators warn of ocular side effects after treatment with Sanofi's Dupixent

Fierce Pharma

UK regulators warn of ocular side effects after treatment with Sanofi's Dupixent. zbecker. Wed, 11/30/2022 - 10:55.

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What Should Health Systems’ Patient Access Strategies Be Heading into 2023?

MedCity News

Health system leaders believe that improving patient access should be their top priority when strategically planning for 2023, according to a new report from the KLAS Research and UPMC’s Center for Connected Medicine. To improve patient access, respondents agreed that their health systems will need to make changes in three key areas — people, process and technology.

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Diabetes Management Tech for Type II patients: Interview with Jeffrey Brewer, CEO of Bigfoot Biomedical

Medgadget

Bigfoot Biomedical , a medtech company based in California, has developed the Bigfoot Unity System, a diabetes management technology for patients on multiple daily injection therapy. The system uses continuous glucose monitoring data and doctor recommendations to provide insulin dose recommendations, helping patients to avoid uncertainty. The company argues that type 2 diabetes patients have been historically underserved by the medtech industry, in part because such patients typically tend to be

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Introduction to Pharmaceutical QMM Model: QMM Assessment to Promote Pharmaceutical Operational Excellence

PharmaTech

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.

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Roche, having shared data with regulators, unwraps results of subcutaneous Tecentriq phase 3 trial

Fierce Pharma

Roche, having shared data with regulators, unwraps results of subcutaneous Tecentriq phase 3 trial. ntaylor. Thu, 12/01/2022 - 09:45.

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CinCor Hypertension Drug Flunks Study, But the Biotech Still Sees a Phase 3 Path

MedCity News

Cincor Pharma drug baxdrostat failed its Phase 2 test, falling short of the goal of reducing blood pressure in patients with uncontrolled hypertension. But results in a subgroup of patients showed double-digit declines, which the company said could inform the design of a Phase 3 clinical trial.

Pharma 127
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The Top 10 Clinical Research Companies in the USA

Medico Reach

To bring effective medicines and Innovations in healthcare industry , a Clinical Research Organization or Contract Research Organization (CRO) are a must for the Biotech, Medtech, and pharma industries. A CRO offers comprehensive support to their efforts to test, examine, refine and market the latest medicines and devices that help in improving Healthcare Industry.

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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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The Animal Health Portal: A Veterinary Lifesaver

Celeritas

In America, the percentage of households that own or adopt animals is rising every year. A survey conducted by the APPA in 2021-22 showed that 70% of households owned a pet. Additionally, as knowledge of potential threats spreads, veterinary appointments are now part of a pet owner’s routine. The demand for and willingness to spend on extensive care, pet health plans, etc. are also on the rise.

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UPDATED: GSK, with new trial win, looks to expand PD-1 Jemperli in endometrial cancer

Fierce Pharma

UPDATED: GSK, with new trial win, looks to expand PD-1 Jemperli in endometrial cancer. zbecker. Fri, 12/02/2022 - 11:22.

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What Should Tech Companies do to Navigate Privacy Concerns in Post-Dobbs Era?

MedCity News

Patient privacy is evolving rapidly in the post-Dobbs era, according to healthcare and life science lawyers in a webinar hosted by the American Bar Association on Wednesday. .

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Improving trial predictability: leveraging AI-powered analytics to guide trial design, strategy, and operations

pharmaphorum

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. This emphasises sponsors’ need for enrolment predictability. The challenge the industry faces, however, is that operational certainty is exacerbated by the impact of global disruptions, such as the effect of COVID-19, natural disasters, and regional conflicts.

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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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Current pipeline developments could bring new hope for patients with PPMS

Pharmaceutical Technology

Multiple sclerosis (MS) is an autoimmune disease causing chronic inflammation and demyelination of the nerves, affecting around 2.5 million people worldwide. While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options.

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GSK unveils Keytruda head-to-head data in lung cancer—and they look good at first glance

Fierce Pharma

GSK unveils Keytruda head-to-head data in lung cancer—and they look good at first glance. aliu. Wed, 11/30/2022 - 16:32.

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DTC Metabolic Tracker Company To Expand Personalized Nutrition Guidance With $62M

MedCity News

Lumen sells a handheld device that measures users’ metabolism through breath and connects to an app that helps track goals and provides nutrition coaching. The funding round was led by Pitango Venture Capital, and included participation from Hanwha Group and Resolute Ventures.

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How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels

PM360

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. To overcome these barriers, organizations are increasingly looking to technology such as natural language processing (NLP) to reduce the manual, repetitive steps of acquiring regulatory intelligence.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.