Fri.Jun 17, 2022

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FDA authorizes Pfizer, Moderna COVID-19 vaccines for young children

Bio Pharma Dive

The much-anticipated decision follows two days after a panel of independent experts unanimously recommended expanding the shots’ use. A CDC panel is meeting Friday and Saturday to develop specific recommendations.

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Six months after authorization, what do we know about Paxlovid?

pharmaphorum

It has now been over six months since the FDA authorized Paxlovid in December 2021 “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19.” . At the time of authorisation, the United States federal government had already purchased 10 million doses of the drug.

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Eli Lilly’s Olumiant Wins FDA Approval as First Systemic Treatment for Alopecia Areata

XTalks

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. Olumiant oral tablets — in 4 mg, 2 mg and 1 mg doses taken once daily — were approved for the treatment of adults with the rare hair loss condition.

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NICE recommends Eli Lilly’s breast cancer therapy

Pharma Times

Verzenios in combination with endocrine treats people with early breast cancer who are at high-risk of recurrence

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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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UMass Lowell leader honored as a champion of entrepreneurship education

Scienmag

Media contacts: Credit: Richard Pasley for UMass Lowell Media contacts: Emily Gowdey-Backus, Emily_GowdeyBackus@uml.edu Nancy Cicco, Nancy_Cicco@uml.edu UMass Lowell Chancellor Jacquie Moloney has been honored for her role in founding the Deshpande Symposium for Innovation and Entrepreneurship in Higher Education. Now in its 11th year, the international conference is dedicated to integrating entrepreneurship education and […].

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Novartis receives vital licence for Scemblix

Pharma Times

Therapy represents the first STAMP inhibitor for patients with chronic myeloid leukaemia

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Rumour mill says AstraZeneca may be eyeing a takeover of Mereo

pharmaphorum

AstraZeneca is rumoured to be considering a bid to take control of its longstanding partner Mereo BioPharma, according to a report in The Times, which doesn’t provide the source of the speculation. The UK-based but US-listed biotech licensed rights to AZ’s orally-active neutrophil elastase inhibitor alvelestat for the rare disease alpha-1 antitrypsin deficiency (AATD) five years ago, and has since advanced the project into a phase 2 trial which is due to read out in the second half o

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Accuracy of diagnostic mammograms may vary across racial and ethnic groups

Scienmag

Bottom Line: The accuracy of diagnostic mammograms differed across racial and ethnic groups, with variation in several measures of diagnostic performance. Journal in Which the Study was Published: Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research. Authors: Sarah J. Nyante, PhD, associate professor of radiology at the University of […].

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FTC Unanimously Agrees to Keep Close Eye on PBMs, Higher Drug Costs

BioSpace

The vote came just over one week after the FTC announced it would probe claims regarding the role the middlemen play in determining retail prices of prescription drugs.

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Training virtually can reduce psychosocial stress and anxiety

Scienmag

Previous research has described how virtual training produces acute cognitive and neural benefits. Building on those results, a new study suggests that a similar virtual training can also reduce psychosocial stress and anxiety. Credit: Tohoku University Previous research has described how virtual training produces acute cognitive and neural benefits.

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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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Technology that Supports Patients and Brands at Every Point of the Medication Access Journey

Drug Channels

Today’s guest post comes from Shawn Seamans, Chief Commercial Officer at CoverMyMeds. Shawn discusses how technology can be combined with human intervention to better help patients access, afford, and adhere to their therapies. He then describes how three patients benefited from support solutions. For more information about how CoverMyMeds’ solutions can support the patient journey for your brand, visit their digital commercialization experience.

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Gaia space telescope rocks the science of asteroids

Scienmag

The European Gaia space mission has produced an unprecedented amount of new, improved, and detailed data for almost two billion objects in the Milky Way galaxy and the surrounding cosmos. The Gaia Data Release 3 on Monday revolutionizes our knowledge of the Solar System and the Milky Way and its satellite galaxies. Credit: Reference and […].

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Decentralised trials gaining ground in oncology, says report

pharmaphorum

A survey of clinical research executives working in the cancer arena has found that nearly three quarters of them will include decentralised designs in trials due to start in the next 12 months. The report from Science 37 found that 73% of respondents were planning either a hybrid study – including both remote and traditional investigation site elements – or a fully decentralised study, up from 49% a year earlier.

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ACMG releases update to secondary findings gene list; SF v3.1 adds five genes, including one with variant linked to heart failure in underrepresented populations

Scienmag

The American College of Medical Genetics and Genomics (ACMG) has released an update to the recommended minimum gene list for the reporting of secondary findings (SF). In 2021, the ACMG Board of Directors and Secondary Findings Working Group (SFWG) declared that the College would update the list (SF v3.0) annually. Today’s update (SF v3.1) adds […].

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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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AstraZeneca Rumored to Have Set Sights on Mereo BioPharma Buyout

BioSpace

AstraZeneca appears to have taken an interest in Mereo BioPharma and may be considering a buyout, according to speculations published by The Times UK.

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New research to help address blood shortages in Ireland

Scienmag

Friday, 17 June 2022: A study by RCSI University of Medicine and Health Sciences has identified barriers and motivators to blood donation for people from ethnic minority groups in Ireland. Credit: Maxwell Photography Friday, 17 June 2022: A study by RCSI University of Medicine and Health Sciences has identified barriers and motivators to blood donation […].

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Addex Ends Trials Evaluating Parkinson's Treatment Due to Slow Recruitment

BioSpace

Addex Therapeutics announced it is canceling its Phase IIb/III study evaluating its drug dipraglurant due to patient recruiting, staffing and pandemic-related issues.

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How stock market inefficiencies can affect the real economy

Scienmag

Mutual fund investors are known to be vulnerable to fluctuating market conditions. What is less well understood is how corporate managers are affected by waves of investor optimism. A Luxembourgish researcher has published a study in the SpringerNature journal Financial Innovation, where he argues that corporate managers and investors are jointly caught up in market euphoria. […].

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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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Antibodies Contract Manufacturing Market Size and Market Analysis

BioTech 365

The global antibodies contract manufacturing market is expected to reach from USD 13.4 billion in 2022 to USD 35.9 billion by 2030, registering a CAGR of 13.1% from 2022 to 2030.

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Dutch Research Council NWO Stevin Prize for expert on Parkinson’s disease Bas Bloem

Scienmag

Neurologist Bas Bloem of Radboud university medical center receives this year’s Stevin Prize of the Dutch Research Council (NWO). The Stevin Award is the highest distinction in science for a researcher in the Netherlands who has achieved particular success in the area of knowledge utilization for society. Bas Bloem is an expert in the field […].

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Covid Vaccine and Fisheries Deals Close a ‘Roller Coaster’ W.T.O. Meeting

NY Times

Members of the global trade group were forced to scale back plans for more ambitious agreements, but they were ultimately able to reach several deals at a meeting in Geneva.

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Launch of a materials open platform for permanent magnet by NIMS and four magnet makers

Scienmag

Since 2017, NIMS has been operating materials open platforms (MOPs): collaborative frameworks under which NIMS facilitates industry-specific joint basic research by private companies and academia. The new Magnet MOP, with four participating magnet manufacturers, will carry out magnetic materials basic research to achieve common goals. Credit: Office for the Materials Open Platform for Permanent […].

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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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F.D.A. Authorizes Moderna and Pfizer Shots for Young Children

NY Times

The Food and Drug Administration authorized both the Moderna and Pfizer-BioNTech coronavirus vaccines for use in children as young as six months. Doses would be rolled out after a final recommendation from the Centers for Disease Control and Prevention director.

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Scientists serendipitously discover rare cluster compound

Scienmag

Scientists at Kyoto University’s Institute for Cell-Material Sciences have discovered a novel cluster compound that could prove useful as a catalyst. Compounds, called polyoxometalates, contain a large metal-oxide cluster carry a negative charge. They are found everywhere, from anti-viral medicines to rechargeable batteries and flash memory devices.

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Broadly neutralizing antibodies could provide immunity against SARS-CoV-2 variants

The Pharma Data

Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published June 15 in the Journal of Experimental Medicine (JEM). The antibodies were effective against all SARS-CoV-2 variants of concern tested and could be used alone or in an antibody cocktail to diminish the risk of infection.

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Maike Sander named to lead the Max Delbrück Center

Scienmag

On November 1, 2022, Prof. Maike Sander will take the reins as Scientific Director and Chair of the Board of the Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC). The Supervisory Board of the MDC formally appointed her to the post on Thursday, June 16, 2022. The MDC, which is celebrating its […].

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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.

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Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

The Pharma Data

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe. Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formul

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Electrons take the fast and slow lanes at the same time

Scienmag

Imagine a road with two lanes in each direction. One lane is for slow cars, and the other is for fast ones. For electrons moving along a quantum wire, researchers in Cambridge and Frankfurt have discovered that there are also two ‘lanes’, but electrons can take both at the same time! Credit: Research Team, Cavendish […].

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Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

The Pharma Data

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety profile similar to placebo in young children ages 6 months through 4 years in Phase 2/3 clinical trial Pfizer-BioNTech COVID-19 Vaccine now authorized in the U.S. for all individuals 6 months of age and older.

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Integrated tool allows better tracking of clinical trial metrics

Scienmag

Before new treatments can reach the clinic, they must be tested in clinical trials to see if they are safe and effective. Trials that do not enroll enough participants present roadblocks for advancing care to the clinic because they offer no scientific insight, waste money and time and inflate the costs of new treatments. Credit: […].

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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.