Wed.Dec 09, 2020

article thumbnail

Researchers of the Year: The RECOVERY team

Bio Pharma Dive

The U.K.'s RECOVERY trial proved a cheap steroid could keep COVID-19 patients from dying, and showed two other widely considered drugs didn't work — crucial findings in a sprawling and sometimes messy global hunt for coronavirus treatments.

Research 334
article thumbnail

In the News: November Regulatory and Development Updates

Camargo

Remote Document Review Leads to CRL: Be Careful What You Wish for? The FDA’s halt of onsite inspections has created a wealth of problems. Camargo is currently involved with no less than three product applications that are stalled because the FDA is requiring inspections before the application can be approved (assuming a satisfactory outcome). Needless to say, the sponsors of these applications are anxious to pursue all possible alternatives to simply waiting for an indeterminate period for inspe

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA advisers meet to review Pfizer, BioNTech's coronavirus vaccine

Bio Pharma Dive

A panel of vaccine and infectious disease experts will publicly vet the drugmakers' study results on Thursday. Follow the discussion along with BioPharma Dive reporters here.

article thumbnail

CO2 Safety Monitors for Dry Ice Vaccination

Pharma Mirror

Ormond Beach, FL – CO2Meter, Inc. has partnered with a national pharmacy chain to keep their customers and employees safe from the potential hazardous effects for CO2 exposure from the dry ice that is keeping the COVID-19 vaccines cold. A national pharmacy chain contacted CO2Meter on December 1st asking about devices to detect the release of CO2 when dry ice sublimates.

article thumbnail

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

article thumbnail

Armed with big pharma cash, another startup takes aim at mysterious clusters of molecules

Bio Pharma Dive

Faze Medicines, which launched Thursday with $81 million in funding, is among a handful of young drug companies focused on the emerging research field of biomolecular condensates.

Medicine 269
article thumbnail

SARS-CoV-2, the COVID-19 Virus, is Mutating, But So Far, Slowly

BioSpace

Viruses mutate, and SARS-CoV-2, the virus that causes COVID-19, is not different. Luckily, it appears to mutate relatively slowly. Meanwhile, researchers are beginning to get a grip on the virus’s evolution.

Research 145

More Trending

article thumbnail

What HCPs think about COVID-19’s impact on cancer

pharmaphorum

COVID-19’s knock-on effect on cancer patients is of concern by HCPs, with delayed or decreased diagnosis seen as a key worry. CREATION.co’s Lara Meyer explores why HCPs need more support. The COVID-19 pandemic has been mainstream headline news throughout 2020 and continues to have a profound impact on all our lives. A key concern that has emerged from the crisis is how COVID-19 will affect other areas of healthcare, particularly cancer diagnosis and treatment.

Nurses 122
article thumbnail

Biotech of the Year: SeaGen

Bio Pharma Dive

A billion-dollar deal with Merck followed quick approvals for the company's second and third drugs, pushing SeaGen's market value to over $30 billion.

Marketing 278
article thumbnail

Gilead’s CAR T therapy Yescarta shows potential in new indication

Pharma Times

ZUMA-12 phase II study is evaluating therapy as a first-line treatment for high-risk large B-cell lymphoma

147
147
article thumbnail

Vaccine Developers of the Year: BioNTech and Moderna

Bio Pharma Dive

Defying expectations, BioNTech and Moderna each designed and developed highly effective coronavirus shots far faster than previously considered possible.

article thumbnail

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.

article thumbnail

Winners shine bright at PharmaTimes Awards

Pharma Times

Meet the winners of the 2020 PharmaTimes Marketer of the Year, Communications Awards and Sales Awards

Sales 143
article thumbnail

Amgen readies KRAS-blocking cancer drug for FDA filing

Bio Pharma Dive

The agency agreed to assess sotorasib under a real-time review program that could speed up its evaluation of the closely watched therapy.

Drugs 252
article thumbnail

FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The gist of a briefing document published from FDA reviewers ahead of an expert advisory board meeting is that the vaccine is good to go.

article thumbnail

The BioPharma Dive Awards for 2020

Bio Pharma Dive

Vaccine developers and COVID-19 researchers took center stage in a year turned upside down by the pandemic.

article thumbnail

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.

article thumbnail

Novartis signs AI ophthalmology pact with RetinAI

Pharma Times

Agreement will utilise RetinAI's IT solutions and artificial intelligence tools to support projects in ophthalmology

133
133
article thumbnail

Gilead Snaps up Germany’s Myr GmbH and Its HDV Drug Hepcludex

BioSpace

Gilead Sciences bolstered its capabilities in treating Hepatitis and other liver diseases with the €1.15 billion ($1.4 billion) cash acquisition of Germany-based Myr GmbH, a company focused on developing therapies for treatment of chronic hepatitis delta virus (HDV), the most severe form of viral.

Drugs 120
article thumbnail

Roche reveals new bispecific antibody data in blood cancers

Pharma Times

'Encouraging' data for investigational candidates across a range of blood cancers

Antibody 146
article thumbnail

Sanofi/Regeneron on notice as FDA reviews GSK’s Nucala for nasal polyps

pharmaphorum

Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala is now breathing down its neck. The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps in the nose that can obstruct airflow and cause mucus discharge, sometimes requiring surgical intervention.

Sales 91
article thumbnail

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.

article thumbnail

$2 million NIH grant to develop Zika virus vaccine

Scienmag

Credit: Virginia Tech Flaviviruses — a group of viruses transmitted by ticks or mosquitoes — infect an estimated 400 million people annually with diseases like yellow fever, Dengue fever, West Nile virus, and, most recently, Zika virus. Outbreaks of Zika virus, a flavivirus originating in Africa, were once rare and isolated events. But in 2015, […].

article thumbnail

17 creams to STOP ITCHING FAST

Druggist

Several factors can cause skin itchiness (also known as pruritus). Skin itch is commonly associated with eczema (dermatitis), psoriasis, chickenpox, insect bites, hives and other conditions. Several effective creams to stop itching can be purchased from supermarkets, pharmacies and online. Sale of some anti-itch creams is restricted to pharmacies only.

article thumbnail

New patent for Celator Pharms drug VYXEOS

Drug Patent Watch

Annual Drug Patent Expirations for VYXEOS Vyxeos is a drug marketed by Celator Pharms and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Celator Pharms drug VYXEOS appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 97
article thumbnail

COVID News Alert: At-Home Test Approved, FDA Panel Meets on Pfizer Vaccine and More

BioSpace

All eyes on the FDA as they review a COVID-19 vaccine, FDA approval of an Emergency Use Authorization to LabCorp’s home test kit for COVID-19, the first testing device that does not require a prescription and more news.

article thumbnail

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.

article thumbnail

How soil fungi respond to wildfire

Scienmag

Credit: Gabriella Selva In the wake of the 2017 North Bay fires, the golden hills of Santa Rosa, California, were unrecognizable. Smoky, seared and buried under ash, the landscape appeared desolate, save for some ghostly, blackened – but still alive – oak trees. For Stanford University graduate student, Gabriel Smith, whose family lives in Santa […].

96
article thumbnail

Innovative Companies Diving into The Neuro Market Ahead of 2021

BioSpace

With the expected Emergency Use Authorization (EUA) of Pfizer-BioNTech and Moderna’s COVID-19 vaccines providing hope that the COVID-19 pandemic will soon be resolved, 2021 is going to need a new primary healthcare campaign. Could it come from the field of neuroscience?

Marketing 106
article thumbnail

PhD thesis introduces new possibilities of electronic warfare to Estonian Defence Forces

Scienmag

Credit: TalTech Modern warfare is day by day shifting away from man-to-man combat towards electronic warfare. The end result of military operations is increasingly dependent on the high-tech equipment available to the military and the ability to use the equipment. Recently Martin Jürise defended his doctoral thesis “Hyperspectral Signatures of Military Objects in Battlefield, Radiation […].

Doctors 93
article thumbnail

Pfizer’s pneumococcal disease vaccine scores FDA priority review

Pharma Times

Vaccine candidate previously scored fast-track and breakthrough therapy designations

article thumbnail

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.

article thumbnail

Artificial intelligence finds surprising patterns in Earth’s biological mass extinctions

Scienmag

The idea that mass extinctions allow many new types of species to evolve is a central concept in evolution, but a new study using artificial intelligence to examine the fossil record finds this is rarely true, and there must be another explanation Credit: J. Hoyal Cuthill and N. Guttenberg. Charles Darwin’s landmark opus, On the […].

article thumbnail

Filtration Efficiency of Face Masks Used by the Public During the COVID-19 Pandemic

JAMA Internal Medicine

In November 2020, the US was averaging more than 1 million new coronavirus disease 2019 (COVID-19) cases per week, an astounding number. To make progress against the pandemic, routine and universal use of face masks throughout society is essential.

76
article thumbnail

A balancing act: Improved water treatment technique using ‘energy matching’

Scienmag

Scientists in Japan and China develop an innovative system to treat water using direct solar steam generation Credit: PS Photography on Pexels Today, a large number of people worldwide suffer from shortage of fresh drinking water, especially in remote rural regions, causing a significant threat to human life and society. While techniques such as membrane […].

article thumbnail

Bolstering Cancer Platform, Boehringer Acquires NBE for $1.4B USD

BioSpace

Pharma giant Boehringer Ingelheim strengthened its immuno-oncology portfolio this week by inking an acquisition deal with NBE Therapeutics for a tidy $1.4 billion US.

94
article thumbnail

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.