Fri.Sep 10, 2021

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Biogen offered a window into what's holding up Aduhelm. Investors didn't like what they saw.

Bio Pharma Dive

At Morgan Stanley’s healthcare conference, executives detailed how the launch of their Alzheimer’s drug has been slower than expected, due in large part to lingering questions about clinical trial data and insurance coverage.

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Mandating vaccinations is the right decision

World of DTC Marketing

SUMMARY: Marci Hamilton, a professor at the University of Pennsylvania Constitution, said, “The Constitution is not a suicide pact guaranteeing a right to harm others. The government has the latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” We, as a nation, can not allow ignorance and stupidity to endanger us all.

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Cost, Confusion Proving Potentially Prohibitive in Aduhelm Rollout

BioSpace

Biogen CEO Michel Vounatsos admitted Thursday that the company’s rollout of Aduhelm (aducanumab) for Alzheimer’s disease has been “slower than we anticipated.

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Startup Neuroglee raises $10m for virtual neurology clinics

pharmaphorum

A digital health company focusing on neurodegenerative disorders – Neuroglee Therapeutics – has raised $10 million in first-round funding to roll out a virtual neurology clinics for people with cognitive problems caused by dementia. The Singapore startup, which is partnering with the Mayo Clinic on the clinics, said the cash injection will also go towards the development of its pipeline of digital therapeutics (DTx) for Alzheimer’s disease and other neurodegenerative conditions.

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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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Intelligent digitalization can maximize manufacturing ROI: ACG

Outsourcing Pharma

A leader from ACG Engineering shares insight on how âsmartâ drug manufacturing, accelerated by COVID-19, can best be put to work now and in months to come.

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Bharat's Intranasal Vaccine Speeds into Phase II on Heels of Strong Data

BioSpace

This marks the second vaccine against the novel coronavirus developed by the India-based company and brings a significant milestone for intranasal formulations.

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Intratumoral Cancer Therapy: A Potential Weapon To Fight the Battle Against Cancer

Delveinsight

Cancer is a leading cause of global death, accounting for nearly 10 million deaths in 2020. However, over the past years, the treatment paradigm of Cancer has transformed with several therapies such as chemotherapies, radiation therapies and immunotherapies available to treat cancer. Even then, there exists a large segment of the Cancer patient pool who do not get benefitted from the available therapies owing to severe side effects, resistance to available therapies, non-eligibility for a partic

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UK approval for Pfizer’s JAK inhibitor Cibinqo

Pharma Times

Treatment approved for adults and adolescents with moderate to severe atopic dermatitis

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Hormonal hazard: Chemicals used in paints and plastics can promote breast tumor growth

Scienmag

Photoinitiators are chemicals that release reactive molecules in response to UV radiation. Given these properties, photoinitiators are used in a wide range of products, including plastics, paints, inks, and adhesives. As a result, photoinitiators are present in several objects of everyday use as well as in medical products and instruments such as dental fillers and […].

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NICE OKs Xeljanz for individuals with juvenile idiopathic arthritis

Pharma Times

Xeljanz is the second drug to be recommended as part of NICE’s new approach to the cost comparison fast track appraisal process

Drugs 83
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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The vampire that doesn’t suck blood: New parasite-host relationships in Amazonian candirus

Scienmag

The Amazon River Basin is home to about 15% of all freshwater fish species known to science, and an estimated 40% yet to be named. These include some of the most bizarre fishes: the vampire fishes, locally known as candiru, members of the catfish subfamily Vandelliinae.). They survive by attaching themselves to the bodies of […].

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MHRA approves Amgen’s Lumykras under Project Orbis

Pharma Times

Project Orbis is an international collaborative programme between the FDA and worldwide regulatory agencies

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New technology designed to genetically control disease-spreading mosquitoes

Scienmag

Leveraging advancements in CRISPR-based genetic engineering, researchers at the University of California San Diego have created a new system that restrains populations of mosquitoes that infect millions each year with debilitating diseases. Credit: Akbari Lab, UC San Diego Leveraging advancements in CRISPR-based genetic engineering, researchers at the University of California San Diego have created a […].

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Entry deadline extended for the 2021 Marketer of the Year, Sales and Communications Awards!

Pharma Times

The entry deadline for the 2021 Marketer of the Year, Sales and Communications Awards has been extended to 22nd of October

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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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Personality matters, even for squirrels

Scienmag

Humans acknowledge that personality goes a long way, at least for our species. But scientists have been more hesitant to ascribe personality—defined as consistent behavior over time—to other animals. Credit: Jaclyn Aliperti, UC Davis Humans acknowledge that personality goes a long way, at least for our species. But scientists have been more hesitant to ascribe […].

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BioSpace Movers & Shakers, Sept. 10

BioSpace

Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.

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UK’S MHRA GRANTS MARKETING AUTHORISATION FOR PFIZER’S CIBINQO® (ABROCITINIB) FOR.

The Pharma Data

– Abrocitinib is a once-daily oral JAK1 inhibitor indicated in Great Britain for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and over, who are candidates for systemic therapy-. -This is the first marketing authorization globally for abrocitinib-. today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for CIBINQO ® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) i

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New patent expiration for Skyepharma Ag drug TRIGLIDE

Drug Patent Watch

Annual Drug Patent Expirations for TRIGLIDE Triglide is a drug marketed by Skyepharma Ag and is included in one NDA. There is one patent protecting this drug. This drug has…. The post New patent expiration for Skyepharma Ag drug TRIGLIDE appeared first on DrugPatentWatch - Make Better Decisions.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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AbbVie to Highlight Its Leadership in Movement Disorders at the.

The Pharma Data

–Final results from PROviDE, a long-term, real-world study, evaluating the effectiveness of DUODOPA® (levodopa-carbidopa intestinal gel) in patients with advanced Parkinson’s disease –Additional poster presentations planned on the real-world efficacy and safety of BOTOX® (onabotulinumtoxinA) for the treatment of spasticity and cervical dystonia –Research highlights AbbVie’s continued focus on advancing the management of movement disorders.

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Arizona State legislature approves $4 million in ongoing yearly funding for school of mining and mineral resources

Scienmag

About 45,000 jobs in Arizona are connected to mining in some way. Further, many top industries, such as aerospace, manufacturing, technology, health care and renewable energy rely on Arizona’s minerals, particularly copper. Copper is used everywhere, from electronics and electric vehicles to building materials, and it is constantly in high demand worldwide.

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MHRA clears third doses of AZ, Pfizer COVID jabs

pharmaphorum

The UK medicines regulator has cleared the use of a third dose of both the AstraZeneca and Pfizer COVID-19 vaccines, in readiness for a possible booster campaign ahead of the winter months. The decision means there is now no impediment to starting a booster drive – assuming the Joint Committee on Vaccination and Immunisation (JCVI) recommends such a programme and the government takes its advice.

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Catalyst study advances carbon-dioxide-to-ethanol conversion

Scienmag

UPTON, NY – An international collaboration of scientists has taken a significant step toward the realization of a nearly “green” zero-net-carbon technology that will efficiently convert carbon dioxide, a major greenhouse gas, and hydrogen into ethanol, which is useful as a fuel and has many other chemical applications. The study reports a “roadmap” for successfully […].

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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.

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NHS fast tracks access to Amgen’s just-approved KRAS cancer drug

pharmaphorum

Amgen’s first-in-class KRAS inhibitor Lumykras has been approved in Great Britain and arrives already armed with an agreement to allow early access while its cost-effectiveness is appraised by NICE. The MHRA has approved Lumykras (sotorasib) for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation, and according to Amgen patients in England, Wales and Scotland will be the first in Europe to receive the drug.

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GW wins contract to develop antidote-bearing organisms to protect against biological, chemical threats

Scienmag

WASHINGTON (Sept. 10, 2021) – The George Washington University has been awarded a $3.6 million contract to genetically modify commensal organisms to produce antidotes for harmful biological and chemical agents, such as anthrax, Ebola, and even COVID-19. Credit: Paul Brindley/GW WASHINGTON (Sept. 10, 2021) – The George Washington University has been awarded a $3.6 million […].

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What Data Can Clinical Research Sites Collect About Themselves To Remain Relevant Next Decade?

Clinical Trial Gurus

In the era of digitization and data analytics, progressive clinical research sites can make themselves indispensable by controlling their own data.

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UC San Diego leads a $12.25M grant to improve epilepsy treatment

Scienmag

The National Institutes of Health has awarded a $12.25 million grant to the University of California San Diego to develop and enhance brain-sensing and brain-stimulating platform technologies to enable treatment of drug-resistant epilepsy. The project is led by UC San Diego electrical engineering professor Shadi Dayeh who leads the Integrated Electronics and Biointerfaces Laboratory and brings together expertise from […].

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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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Improving the Provider Experience to Accelerate Patients’ Access to Specialty Therapy

Drug Channels

Today’s guest post comes from Vicki Muscarella, Vice President of Specialty Product at CoverMyMeds. Vicki discusses the value of a centralized patient support services solution. She argues that such a solution improves the provider experience, enhances the patient experience, and accelerates speed to therapy. To learn about CoverMyMeds’ integrated patient support services solution, download the free Medication Access Report: Healthcare Technology.

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Following the bouncing eyeball in AR

Scienmag

The eyes have it. They are constantly on the move when viewing scenes in augmented reality (AR). Credit: Jianbo Zhao et al., doi 10.1117/1.OE.60.8.085101. The eyes have it. They are constantly on the move when viewing scenes in augmented reality (AR). Now, developers of AR headsets and mixed reality systems have become increasingly interested in […].

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Bristol Myers Squibb Shares Research Supporting Correlation Between New York Heart Association Functional Class (NYHA class) and Mortality in Obstructive Hypertrophic Cardiomyopathy

BioTech 365

Bristol Myers Squibb Shares Research Supporting Correlation Between New York Heart Association Functional Class (NYHA class) and Mortality in Obstructive Hypertrophic Cardiomyopathy Bristol Myers Squibb Shares Research Supporting Correlation Between New York Heart Association Functional Class (NYHA class) and Mortality … Continue reading →

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Do a mom’s medications affect her breast milk and baby? New center investigates

Scienmag

More than 70 percent of breastfeeding women take some form of medication, but 90 percent of those medications are not appropriately labeled for pregnant or lactating women. This means the drugs are taken “off-label” or without Food and Drug Administration (FDA) approval, largely because they have never been tested in this population. Even less is […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.