Wed.Sep 08, 2021

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Moderna expands mRNA vaccine supply in deal with new biotech producer

Bio Pharma Dive

The company has previously said it could make up to three billion vaccine doses in 2022, depending on how booster shots are authorized.

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In the News: August 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices.

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Venture capital pours more money into RNA medicines with the launch of Replicate

Bio Pharma Dive

The company, which focuses on self-replicating RNA, comes equipped with $40 million from Apple Tree Partners and a stamp of approval from the former research head at Biogen.

RNA 271
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Provepharm Life Solutions raises €120 million

Pharma Mirror

Marseille, France, Provepharm Life Solutions, a private French pharmaceutical company that finds new applications for well-known molecules, today announces a €120 million ($142.3M) strategic funding. Tikehau Capital will provide the funds and joins the group’s pool of banking investors, including Société Générale, BNP Paribas, Banque Populaire Méditerranée, Crédit Agricole Alpes Provence and Bpifrance.

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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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Autism drug fails in late-stage trials, Servier says

Bio Pharma Dive

The French drugmaker and its biotech partner Neurochlore agreed to end two Phase 3 studies early after finding no signs that treatment was effective.

Trials 259
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AI ‘could help diagnose lung cancer a year earlier’

pharmaphorum

An artificial intelligence algorithm was able to detect signs of lung cancer on CT scans a year earlier than with traditional methods, according to a new study. CT (computed tomography) scans are already used to spot signs of lung tumours, followed by a biopsy or surgery to confirm whether the tumour is malignant, according to Benoît Audelan, a researcher at France’s National Institute for Research in Digital Science and Technology.

Research 111

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MHRA cuts could affect UK regulatory decisions, say unions

pharmaphorum

A 20% to 25% reduction in staffing at the UK Medicines and Healthcare products Regulatory Agency (MHRA) risks undermining the ability of the authority to fulfil its role, according to trade unions. In an open letter to Health Secretary Sajid Javid, Prospect, Unite and three other unions say the decision to slash the MHRA’s current 1,200 workforce by up to 300 workers means that “regulatory decisions may suffer.” Fewer staff will therefore be asked to cover more ground with fewe

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New patent for Allergan Holdings drug VIBERZI

Drug Patent Watch

Annual Drug Patent Expirations for VIBERZI Viberzi is a drug marketed by Allergan Holdings and is included in one NDA. It is available from one supplier. There are fifteen patents…. The post New patent for Allergan Holdings drug VIBERZI appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 96
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NICE changes its mind on J&J’s Erleada in prostate cancer

pharmaphorum

NICE has reversed its position on Johnson & Johnson’s oral prostate cancer therapy Erleada in patients with hormone-relapsed or hormone sensitive tumours, backing NHS use of the drug. The change of heart comes after J&J’s Janssen pharma unit offered an improved discount on Erleada (apalutamide), according to the cost-effectiveness watchdog in its final appraisal determination, which makes the drug an option for around 8,000 patients in England and Wales.

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HilleVax Rakes in $135 Million to Rapidly Progress Norovirus Vaccine

BioSpace

?The funds will be used to support further clinical development of VLP based vaccine candidate, HIL-214, to prevent moderate-to-severe acute gastroenteritis caused by norovirus infection.

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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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Japan to take 150m doses of Takeda-produced Novavax shots, probe ongoing into deaths following inoculation with recalled Moderna vaccine lot

BioPharma Reporter

Japanâs health ministry is to secure 150 million doses of Novavaxâ vaccine candidate that Takeda is producing. The Japanese government's purchasing agreement is subject to regulatory approvals.

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COVID-19 Update: Super-Immunity, Booster Shots, Mu and Moderna

BioSpace

Heading into fall, with the COVID-19 pandemic surging again and researchers tracking new variants, there’s plenty of news. Here’s a look.

Research 115
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Positive interim data for Ixaka’s lead ‘multi-cell’ therapy

Pharma Times

The independent data monitoring committee (DMC) has recommended continuation of the Phase III trial

Trials 106
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Qualified mobile research nurses key to DCT success: Illingworth

Outsourcing Pharma

A leader from Illingworth Research Group outlines exactly what makes a good mobile research nurse and what their duties in decentralized trials are.

Nurses 99
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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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Roche Bolsters Diagnostics Division with Acquisition of Longtime Partner

BioSpace

The procurement will expand its PCR-test portfolio capabilities in the ongoing fight against existing and emerging infectious diseases, including new COVID-19 variants of interest.

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Gates Foundation ramps up funding to Exscientia in COVID project

pharmaphorum

The Bill & Melinda Gates Foundation must have liked what it saw in an initial collaboration with Exscientia to find new antivirals for COVID-19 and related diseases. Two months after providing initial funding of $1.5 million to get the ball rolling, the philanthropic organisation has now pledged $35 million in funding to a four-year project at the UK artificial intelligence-driven drug discovery company.

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Precision Signs Another Collab for ARCUS Genome Editing Platform

BioSpace

Durham, N.C.-based Precision BioSciences announced a license and collaboration deal with Philadelphia-based iECURE and described its clinical development plans.

Genome 97
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NICE changes its mind on Janssen’s Erleada

Pharma Times

Prostate cancer therapy now recommended for two indications within its marketing authorisation

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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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Where AI and Immunotherapy Converge to Reprogram Immunity

BioSpace

Recently launched biotech company Immunai is pairing artificial intelligence and machine learning in an attempt to tailor treatments and improve patient outcomes.

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Drug Channels Update: Buy-and-Bill Market Trends (NEW Live Video Webinar)

Drug Channels

Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for his latest video webinar: Drug Channels Update: Buy-and-Bill Market Trends. Friday, September 24, 2021, from 12:00 p.m. to 1:30 p.m. ET This page describes the event and explains how to purchase a registration. This event is part of The Drug Channels 2021 Quarterly Video Webinar Series.

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Investors Pour $360 Million into Cutting-Edge Biotechs

BioSpace

Obsidian Therapeutics and three other pharmaceutical companies announced successful Series B raises to propel pipeline candidates further down the track toward clinical studies and approvals.

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AZ CEO Soriot urges caution on COVID booster doses

pharmaphorum

The UK should think twice before backing widespread use of COVID-19 booster vaccinations, as to do so could place unnecessary burden on the NHS over the winter, according to AstraZeneca chief executive Pascal Soriot. In a letter to The Daily Telegraph newspaper with AZ’s head of biopharma R&D Mene Pangalos, Soriot write that the UK is only a few weeks away from having a definitive answer on whether two doses of COVID-19 vaccines can provide “continued, protective immunity.”

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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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Moderna’s mRNA Pipeline Shows No Sign of Slowing Down on R&D Day

BioSpace

This week, the mRNA leader followed up its announcement of a collaboration with the Institute for Life Changing Medicines (ILCM), with an update on several programs advancing in its pipeline.

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Prepping for success can streamline transition to decentralized trials: Oracle

Outsourcing Pharma

According to an Oracle Health Sciences leader, companies looking to take on decentralized trials should keep a few things in mind before taking the plunge.

Trials 84
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Could Lab-Grown Mini Brains Hold the Key to Parkinson's Disease?

BioSpace

Scientists from different agencies and research facilities have turned to laboratory manufactured human mini-brains to study the onset and progression of Parkinson's disease.

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Sanofi adds to transplant portfolio with Kadmon buy

Pharma Times

Sanofi will acquire Kadmon for $9.50 per share in cash, representing a total equity value of around $1.

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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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Humanigen Stock Craters After FDA Rejects COVID-19 Therapeutic

BioSpace

The FDA stated that it could not determine if the use of lenzilumab in COVID patients outweighs the known and potential safety risks.

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Getting the right tech tools vital to decentralized trial transition

Outsourcing Pharma

A representative from Cmed explains how taking stock of existing tech and adding the right new tools can help when switching to virtual clinical studies.

Trials 73
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Global Roundup: ProQR Licenses Axiomer RNA Editing Platform to Eli Lilly

BioSpace

Biopharma and life sciences companies from across the globe provide updates on their pipelines and businesses.

RNA 98
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Why CRA is Such a Great Role

ECRG Media's Clinical Research Podcast

Why CRA is Such a Great Role Comment on the full interview for a chance to win a 1:1 with Tiffany herself. Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education El

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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.