Thu.Dec 17, 2020

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Novartis acquires a small biotech and its trio of brain drugs

Bio Pharma Dive

More active in neuroscience than most pharmaceutical firms, Novartis would gain three experimental drugs for depression, schizophrenia and movement disorders through the deal.

Drugs 322
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American healthcare is unsustainable

World of DTC Marketing

SUMMARY: (Axios) The U.S. spent $3.8 trillion on health care last year, accounting for about 18% of the entire American economy, according to new federal data. The U.S. has by far the most expensive health care system in the world, and every year it eats up a little more — from the federal government, states, employers, and individuals. This is unsustainable.

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FDA advisers meet to review Moderna's coronavirus vaccine

Bio Pharma Dive

Support from the advisory committee Thursday would likely result in an emergency authorization for the shot within days. Track the meeting's progress with BioPharma Dive's reporters here.

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Brain Fog Explained as Study Shows SARS-CoV-2 Crosses Blood-Brain Barrier

BioSpace

A study in Nature Neuroscience shows SARS-CoV-2, the virus responsible for COVID-19, is capable of crossing the blood-brain barrier, likely contributing to symptoms of brain fog and other cognitive effects reported by people infected with the virus.

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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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MacroGenics wins FDA approval of breast cancer drug

Bio Pharma Dive

Margenza, which bested Roche's Herceptin in a head-to-head study, offers a new option to patients with HER2-positive metastatic breast cancer who have already tried other regimens.

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Machine-learning, robotics and biology to deliver drug discovery of tomorrow

pharmaphorum

Biology 2.0: Combining machine-learning, robotics and biology to deliver drug discovery of tomorrow. Intelligent OMICS, Arctoris and Medicines Discovery Catapult test in silico pipeline for identifying new molecules for cancer treatment. Medicines discovery innovators, Intelligent OMICS, supported by Arctoris and Medicines Discovery Catapult, are applying artificial intelligence to find new disease ‘drivers’ and candidate drugs for lung cancer.

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More Trending

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New Zealand secures COVID-19 vaccines from Novavax and AstraZeneca

BioPharma Reporter

New Zealand now has enough COVID-19 vaccines for everyone in the country, says the government, as it announces two new supply agreements with Novavax and AstraZeneca today.

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Los países prósperos aseguraron sus vacunas, pero ‘han vaciado los estantes’ para el resto

NY Times

Estados Unidos, el Reino Unido, Canadá y otros países hicieron pedidos de vacunas que superan con creces a sus poblaciones, mientras muchas naciones pobres luchan por asegurarse las dosis que necesitan.

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Valneva’s inactivated COVID-19 vaccine candidate enters Phase 1/2 clinical trial

BioPharma Reporter

Valneva has started a Phase 1/2 trial of its COVID-19 vaccine: eying up potential regulatory approval in the fourth quarter of 2021. It champions a âtried and testedâ approach with its inactivated candidate.

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New patent for Paratek Pharms drug NUZYRA

Drug Patent Watch

Annual Drug Patent Expirations for NUZYRA Nuzyra is a drug marketed by Paratek Pharms Inc and is included in two NDAs. There are ten patents protecting this drug. This drug…. The post New patent for Paratek Pharms drug NUZYRA appeared first on DrugPatentWatch - Make Better Decisions.

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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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EUSA Pharma launches phase III COVID-19 study for siltuximab

Pharma Times

Study will enrol hospitalised COVID-19 patients with serious viral acute respiratory distress syndrome

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EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed

pharmaphorum

UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from Roche and Sanofi/Regeneron have failed. Hertfordshire-based EUSA said recruitment has begun in phase 3 trial involving patients with COVID-19 previously treated with corticosteroids and other respiratory viruses associated with serious respiratory complications.

Drugs 105
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AB Science's Masitinib Shows Unusually Good Data in Late-Stage Alzheimer's Trial

BioSpace

It has been said that late-stage clinical trials are where Alzheimer’s drugs go to die—there have been well over 130 failed clinical trials for Alzheimer’s in the last decade. Still, AB Science SA reported promising data from its Phase IIb/III trial of masitinib in patients with confirmed mild to.

Trials 111
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Trials of Valneva COVID-19 vaccine begin in UK

pharmaphorum

Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s Valneva begun the phase 1/2 clinical study of the inactivated vaccine candidate VLA2001 in sites across the UK, supported by the National Institute for Health Research (NIHR). It is the first publicly announced inactivated COVID-19 vaccine candidate to begin clinical development in Europe.

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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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Google/Alphabet’s Life Science Division, Verily, Raised $700 Million

BioSpace

Verily, Google/Alphabet’s life sciences company, raised $700 million in an invest round that included Alphabet, Silver Lake, Temasek, Ontario Teachers’ Pension Plan and others.

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Ardelyx’s ambition to revolutionise kidney treatment

pharmaphorum

A therapy to treat hyperphosphatemia is moving closer to the market after years of development by California-based company Ardelyx. The company’s lead candidate Tenapanor is a targeted, small molecule therapy currently under FDA review. As the pandemic surged this year, the disruption of healthcare systems posed a significant challenge for patients receiving kidney care.

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F.D.A. Panel Endorses Moderna's Coronavirus Vaccine

NY Times

An advisory group’s recommendation will mean millions more Americans can be inoculated, extending protection against Covid beyond major urban areas into rural and suburban regions.

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Daiichi Sankyo’s Mirogabalin Displays Significant Reduction in Post-SCI Neuropathic Pain

BioSpace

A phase 3 study from Daiichi Sankyo Company conducted in Japan, South Korea and Taiwan found that mirogabalin, an orally administered gabapentinoid, was associated with a significantly greater improvement in pain among patients with central neuropathic pain after spinal cord injury compared with.

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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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Mitochondria destruction for Cancer Treatment; Atsena raises USD 55 Million financings; Novartis and Cadent Therapeutics collaboration; Neuron23’s strategy to tackle CNS disorders

Delveinsight

Mitochondria destruction can help in Cancer Treatment . Human cells require structures known as mitochondria for the generation of energy for their biochemical activities. Researchers at the Karolinska Institutet in Sweden thought that destroying these could be a strategy for cancer treatment. Following that hypothesis, scientists designed oral inhibitors, which could target mitochondrial DNA (mtDNA).

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Vir and GSK Dose First Patient in COVID-19 Monoclonal Antibody Study and Other Pandemic Updates

BioSpace

Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study assessing the monoclonal antibody VIR-7831 as a potential treatment of hospitalized adults diagnosed with COVID-19.

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VC fund dedicated to psychedelic meds launches in UK

pharmaphorum

In the last few years, biopharma companies focusing on psychedelic medicines have been springing up like mushrooms – magic or otherwise – and venture capital money is starting to follow. Today sees the launch of the first investment fund in the UK devoted to psychedelic healthcare, with plans to invest in “revolutionary mind-altering medicines to treat illnesses including depression, addiction, anxiety and inflammation.”.

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Valneva starts UK-based early-stage COVID-19 vaccine trial

Pharma Times

French biotech will test vaccine candidate on 150 volunteers across four sites

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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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Scientists and medics turn to TikTok to reassure public on vaccine safety

pharmaphorum

Tik Tok is unlikely to spring to mind as a source of reliable information about complex issues, but scientists are using it to fly the flag for COVID-19 vaccines and other health topics. The social media platform, which allows users to share short and often frivolous video clips, has a growing number of experts using it to communicate important information to a broad audience, and particular teenagers and young adults.

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And Then There Were 2: Moderna Set to Join Pfizer-BioNTech with an Authorized COVID-19 Vaccine

BioSpace

It seems like history is repeating itself from just a week ago. Yesterday, the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the agency grant Moderna’s COVID-19 vaccine emergency use authorization (EUA).

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Novartis buys neurology biotech Cadent for up to $770m

pharmaphorum

Novartis is to buy neuroscience drugs firm Cadent Therapeutics in a deal worth up to $770 million. The big Swiss pharma already has a presence in neurology with its multiple sclerosis drug Gilenya (fingolimod) and the more recently approved Aimovig (erenumab). With the acquisition of Cambridge, Massachusetts-based Cadent, Novartis gains rights to a portfolio of neurology drugs.

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Going siteless can lead to clinical trial troubles: AiCure

Outsourcing Pharma

A leader from the clinical trial solutions firm talks about the drive toward conducting trials without sites, and why that idea might lead to problems.

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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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FDA Approvals: Therapies for Lupus, MS, Cancer and a Genomic Alteration in Pigs

BioSpace

The U.S. Food and Drug Administration (FDA) had several approvals this week. Read on to see what the regulatory agency gave the go-ahead to.

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International consortium creates ‘open platform’ for COVID-19 drug discovery

Pharma Times

Consortium is led by Cambridge Medical Research Council (MRC) researchers

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Sackler Family Side-Step Personal Responsibility for Opioid Crisis

BioSpace

In their first appearance in years, the notorious Sackler family, who previously headed OxyContin maker Purdue Pharma, apologized to victims of the opioid crisis but stopped short of admitting personal responsibility during a nearly four-hour grilling from the U.S. House Oversight and Reform Comm.

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The Covid-19 Vaccine Doesn't Mean Big Pharma Is Your Savior

NY Times

Heroic work went into the development of the coronavirus vaccines. But that doesn’t mean this industry deserves your affection.

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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.