Wed.Nov 18, 2020

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New coronavirus vaccine data back up Pfizer, BioNTech claims of strongly effective shot

Bio Pharma Dive

Reaching the main goal of their large trial, Pfizer and BioNTech reported 162 cases of COVID-19 among participants who received a placebo, and just 8 for those who were vaccinated.

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CPhI & P-MEC China 2020 adapts to customer needs with hybrid pharma event

Pharma Mirror

CPhI & P-MEC China returns as a hybrid event in Shanghai (16-18 December 2020), with a physical exhibition running alongside Virtual Expo Connect (18 November – 18 December 2020)for international audiences unable to attend. The physical exhibition will be held at the SNIEC (Shanghai New International Expo Center), with some 3,000 exhibitors present across three days, alongside exhibitor talks and conferences.

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Copycat to top-selling eye drug takes a step toward market

Bio Pharma Dive

The FDA is reviewing Samsung Bioepis and Biogen's biosimilar of Lucentis. If approved, it would be the first biosimilar for an eye disease drug to become available.

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Researchers Create Nasal Spray for COVID-19 That May Already Be Safe for Humans

BioSpace

Researchers from the University of Birmingham, UK, announced today that they have developed a nasal spray that can potentially provide protection against COVID-19. Additionally, it is formulated using materials that have already been cleared for use in humans.

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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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As US cases surge, FDA clears first fully at-home COVID-19 test

Bio Pharma Dive

The prescription test from Lucira Health can deliver results within 30 minutes, and could help boost U.S. testing capacity. Some experts, however, called for more guidance on proper use.

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One Step Forward for Hemophilia Patients – an Even Bigger Step for Gene Therapy

BioSpace

Positive top-line data from UniQure’s Phase III HOPE-B gene therapy trial of etranacogene dezaparvove, an investigational AAV5-based gene therapy, point to a potentially curative treatment for patients with moderate to moderately severe hemophilia B.

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Viking Therapeutics’ NASH Therapy Shows Major Reduction of Liver Fat and LDL Cholesterol

BioSpace

Results of Viking Therapeutics’ metabolic disease program exceed all other oral therapies in development in terms of reducing liver fat for nonalcoholic steatohepatitis (NASH) patients, according to Greg Zante, SVP of finance.

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FDA authorises first home self-testing kit for COVID-19

BioPharma Reporter

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Lucira COVID-19 All-In-One Test Kit: the first COVID-19 diagnostic test for self-testing at home.

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COVID-19: Helping to support momentum on antimicrobial innovation

pharmaphorum

To mark World Antimicrobial Awareness Week NovaBiotics’s Deborah O’Neil tells us why 2021 might be the year anti-infective drugs finally demonstrate their economic value. . COVID-19 has reminded the world how critical infectious disease is, from both a societal and economic standpoint. Cancer is rightly seen as one of the most pressing challenges of our time: but it has not yet caused a multi-trillion hole in the world’s finances.

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Sanofi Genzyme’s Bill Sibold Champions Diversity, Community Responsibility

BioSpace

Bill Sibold, executive vice president and head of Sanofi Genzyme, is passionate about fomenting programs that increase the diversity of the workforce in his company and the pharmaceutical industry as a whole.

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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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Pfizer prepares to file COVID-19 shot after reaching safety milestone

pharmaphorum

Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press reports. The company’s CEO Albert Bourla said that the company is preparing to submit its data to the FDA following last week’s announcement that the vaccine is more than 90% effective, according to an interim analysis of a phase 3 trial.

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SR One Completes GSK Spinout, Closes $500 Million Fund

BioSpace

Venture capital firm SR One, founded in 1985 as the venture capital arm of pharma giant GlaxoSmithKline, completed its spinout from its parent company and closed its first independent fun at $500 million.

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McDonald’s to Enter the Plant-Based Burger and Crispy Chicken Sandwich Markets

XTalks

McPlant is the new plant-based menu category at McDonald’s, a move that has been hinted at for a while as McDonald’s started exploring meatless menu options a few years ago. McPlant will debut in markets around the world early next year. McPlant will include a selection of meat alternative products that will initially feature plant-based burgers, and could eventually include chicken substitutes, breakfast sandwiches and other offerings, depending on the market interest. “We have a very fle

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Iceland to become centre for sleep research

Scienmag

Scientists at Reykjavik University (RU) to lead a research project receiving a 15-million Euro Horizon 2020 grant Credit: Golli / Reykjavik University Sleep Revolution, an interdisciplinary international research and development project, has been selected for a 15-million Euro grant from the EU’s Horizon 2020 Framework Programme for Health, demographic change and wellbeing.

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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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Pfizer and BioNTech Complete Phase III Analysis of COVID-19 Vaccine, Revealing it is 95 Percent Effective

XTalks

Pfizer and German partner BioNTech announced this morning that they have concluded the final efficacy analysis in an ongoing Phase III trial of their COVID-19 vaccine candidate (BNT162b2), results of which show that it is 95 percent effective. The observed efficacy in adults aged 65 and older was found to be 94 percent, which is an important and promising result for this high-risk population.

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In the lab, St. Jude scientists identify possible COVID-19 treatment

Scienmag

Immunologists have determined the process driving life-threatening inflammation, lung damage and organ failure in patients with COVID-19, sepsis and other inflammatory disorders suggesting possible treatment using existing drugs Credit: St. Jude Children’s Research Hospital The COVID-19 pandemic continues to cause significant illness and death while treatment options remain limited.

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FDA COVID-19 news roundup this week

Outsourcing Pharma

The federal agency has offered updates, advice and action regarding the COVID-19 pandemic, helping life-sciences professionals stay on top of developments.

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Study finds health trade-offs for wildlife as urbanization expands

Scienmag

Research on tree swallows suggests city living may offer advantages, but not without risks Credit: Joseph Corra, Ohio State University COLUMBUS, Ohio – City living appears to improve reproductive success for migratory tree swallows compared to breeding in more environmentally protected areas, a new five-year study suggests. But urban life comes with a big trade-off […].

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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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University of Oxford links up with Evox Therapeutics

Pharma Times

Collaboration will focus on developing exosome therapeutics for rare diseases

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Synthesis study demonstrates phytoplankton can bloom below Arctic sea ice

Scienmag

Credit: Pierre Coupel Small photosynthetic marine algae are a key component of the Arctic marine ecosystem but their role for the ecology of the Arctic Ocean have been underestimated for decades. That’s the conclusion of a team of scientists who synthesized more than half a century of research about the occurrence, magnitude and composition of […].

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EU signs COVID-19 vaccine deal with CureVac

Pharma Times

Initial purchase includes 225 million doses of mRNA-based vaccine

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UIC launches three COVID-19 clinical trials for blood clot prevention

Scienmag

Researchers help design, implement all three national NIH studies Credit: UIC The University of Illinois Chicago will conduct three clinical trials for studying blood clot prevention in patients with COVID-19. “Blood clots are one of the leading complications of COVID-19,” said Dr. Jerry Krishnan, UIC associate vice chancellor for population health sciences. “Patients with COVID-19 […].

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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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ViiV’s cabotegravir scores breakthrough designation for HIV prevention

Pharma Times

Designation is based on results from phase IIb/III HPTN 083 trial

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UTHSC researchers identify three drugs as possible therapeutics for COVID-19

Scienmag

Credit: UTHSC Memphis, Tenn. (November 18, 2020)–Researchers at the University of Tennessee Health Science Center working with colleagues at the University of New Mexico have identified three drugs, already approved for other uses in humans, as possible therapeutics for COVID-19, the illness caused by the SARS-CoV-2 virus. Based on virtual and in vitro antiviral screening […].

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Weill Cornell Researchers ID Specific Lung Changes in COVID-19

BioSpace

Researchers at Weill Cornell Medicine identified a specific and unique kind of immune cell activity in the lungs of COVID-19 patients.

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Solving a mystery: How the TB bacterium develops rapid resistance to antibiotics

Scienmag

Credit: SDSU For a slow-growing microbe that multiplies infrequently, Mycobacterium tuberculosis, the pathogen that causes tuberculosis (TB) has long puzzled researchers as to how it develops resistance to antibiotics so quickly, in a matter of weeks to months. Now, TB researchers at San Diego State University have uncovered a crucial clue to the mystery: the […].

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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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COVID-19 Vaccine Rollout Timeline: Possibly Beginning Distribution in December

BioSpace

The looming question is: when will the public be able to start getting the vaccines?

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Dual brake on transport protein prevents cells from exploding

Scienmag

Credit: Membrane Enzymology group, University of Groningen A high concentration of salt or sugar in the environment will dehydrate microorganisms and stop them from growing. To counter this, bacteria can increase their internal solute concentration. Scientists from the University of Groningen elucidated the structure of a transport protein OpuA, that imports glycine betaine to counter […].

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NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis

pharmaphorum

UK cost-effectiveness agency NICE has said that Eli Lilly’s Emgality can be made available through the NHS for migraine prevention, the second drug in the CGRP inhibitor class to achieve that milestone. The decision means that with two CGRP antibodies now cleared for migraine prevention, the first drug in the class to be approved in Europe – Novartis’ Aimovig (erenumab) – has fallen further behind its rivals in getting access to the UK market.

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Scientists develop a magnetic switch with lower energy consumption

Scienmag

Credit: UAB Magnetic materials are ubiquitous in modern society, present in nearly all the technological devices we use every day. In particular, personal electronics like smartphones/watches, tablets, and desktop computers all rely on magnetic material to store information. Information in modern devices is stored in long chains of 1’s and 0’s, in the binary number […].

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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.