Sat.Sep 05, 2020 - Fri.Sep 11, 2020

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How biotech and pharma companies pay their CEOs, and their workers

Bio Pharma Dive

The median CEO of 231 drug companies analyzed by BioPharma Dive earned 50% more last year than in 2017, a leap that far outpaced the more modest pay gains among employees.

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Prescription Digital Therapeutics: When Software Is the Active Ingredient

Camargo

With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms. The post Prescription Digital Therapeutics: When Software Is the Active Ingredient appeared first on Camargo.

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Honeybee venom kills aggressive breast cancer cells: Australian study

BioPharma Reporter

Venom from honeybees has been found to rapidly destroy triple-negative breast cancer and HER2-enriched breast cancer cells â with minimal effect on healthy cells, according to a study published this month.

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Preclinical Data Supports Efficacy for Pfizer, BioNTech Phase II/III COVID-19 Vaccine

BioSpace

Preclinical data for Pfizer and BioNTech’s Phase II/III COVID-19 mRNA vaccine candidate generated BNT162b2 strong anti-viral effects against an infectious SARS-CoV-2 challenge.

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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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Studies of AstraZeneca coronavirus vaccine put on hold for safety review

Bio Pharma Dive

A participant in a clinical trial of the experimental shot suffered from an unexplained illness, triggering an investigation and a pause in vaccinations.

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Non-vaccine nasal spray could protect against COVID-19

pharmaphorum

Two UK biotechs – Destiny Pharma and Sporegen – have joined forces to develop a nasal spray that they say could serve as a first line of defense against coronavirus infections. The nasal spray could provide protection from infection within a few days of administration, and would be easy to make in bulk at a low cost, say the partners. The programme is still in the early stages of development, but if it works in trials would provide another approach to prevent transmission of SARS-CoV-2, the viru

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Can High Blood Sugar Haunt People with Diabetes Even After it is Under Control?

BioSpace

In people with diabetes, periods of high blood sugar can negatively impact their health years later, even if they get their blood sugar under control. While this ‘metabolic memory’ phenomenon has been known for years, why it happens is poorly understood.

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The voice of the customer, and how pharma can respond

Bio Pharma Dive

ZS surveyed more than 500 physicians, 500 patients and 30 healthcare administrators to gather their current thoughts on care delivery, telemedicine and pharma's potential role during the COVID-19 pandemic.

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Ex-Allergan CEO Saunders pops up again in ‘blank cheque’ company

pharmaphorum

Brent Saunders has been out of the limelight for a few months since departing Allergan after its takeover by AbbVie, but now he is back in a leading role at Vesper Healthcare Acquisition, set up to acquire assets in the healthcare sector. Delaware-incorporated Vesper has filed a with a $400 million initial public offering (IPO) and plans to list on the Nasdaq under the symbol VSRU, with Goldman Sachs and JP Morgan acting as bookrunners.

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Spotlight on Moderna funding declarations in patent filings

BioPharma Reporter

Two US government agencies are investigating whether Moderna Therapeutics, the biotech company behind one of the leading Covid-19 vaccine candidates, was upfront about government funding in its filed or awarded patents, as required by federal law.

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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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CEOs Pledge to Stand Behind Science, Not Politics in Potential Vaccine Approval

BioSpace

The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Moderna, Novavax, Pfizer, Merck and Sanofi all signed the pledge promising to ensure that any vaccine put forth by one or more of the companies meets the rigorous standards for approval.

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Sanofi's hemophilia drug comes into focus as delays hit a key competitor

Bio Pharma Dive

With BioMarin's gene therapy sidelined, attention is turning to other drugs, including one Sanofi acquired when it paid $11.6 billion for Bioverativ.

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Pharma ‘must not dodge liability for harm in COVID-19 vaccine trials’

pharmaphorum

An EU consumer body has urged the European Commission to keep compensation measures in place for people who might be harmed in COVID-19 vaccine trials, responding to reports that the drug industry is lobbying to reduce liability. In a letter to the Commissioner for Health and Food Safety Stella Kyriakides, the BEUC says that even though the need for a coronavirus vaccine is urgent, access “must go hand in hand with adequate consumer compensation in case of harm.”.

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Europe lines up agreement with BioNTech-Pfizer for supply of coronavirus vaccine

BioPharma Reporter

The European Commission has concluded exploratory talks with BioNTech-Pfizer to purchase up to 300 million doses of a potential vaccine against COVID-19.

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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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Merck Makes Headway with V114 Vaccine Against Pneumococcal Disease

BioSpace

Merck, known as MSD outside of the U.S. and Canada, announced on Wednesday that it has seen positive results regarding the safety, tolerability and immunogenicity of V114 in two Phase III studies.

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Coronavirus vaccine makers vow to wait for data before seeking approval

Bio Pharma Dive

In an unusual letter, the heads of nine top vaccine developers pledged to "stand with science" and only move forward with approval applications if warranted by clinical results.

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Digital success for pharma services in a uncertain world

pharmaphorum

Laura Morrill from ECI Partners looks at why data and technology are the keys to success in pharma services post-COVID. The pharmaceuticals industry has, for some time, been behind the curve when it comes to the adoption of technology. High barriers to entering the sector and high levels of regulation are just two factors that have meant that there has often been an “innovation lag” when it comes to implementing new technologies and embracing technological and digital change in the pharma indust

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NICE turns down Celgene's Revlimid as multiple myeloma maintenance treatment

Pharma Times

The drug's cost-effectiveness estimate when used in the maintenance setting is uncertain, the Institute has concluded

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Feline Antiviral Therapy Shows Promise Against SARS-CoV-2 in Human Cells

BioSpace

A study published in Nature Communications on August 27 shows that a feline antiviral drug was effective at inhibiting the replication of human coronaviruses in cell cultures infected by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

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FDA wants more details on Sarepta gene therapy, potentially delaying final test

Bio Pharma Dive

A new request from the regulator could tighten the race between Sarepta and Pfizer to prove out a gene therapy for Duchenne muscular dystrophy.

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How companies can encourage more diversity and inclusion in pharma

pharmaphorum

September is Global Diversity and Inclusion month – David Peacock, managing director of MSD in the UK shares with us his insights on why diversity and inclusion is so important and why it is critical to the future success of the life sciences sector. Taking diversity and inclusion seriously, supported by robust policies and accountability for implementation, creates success for everyone, fostering happy, healthy and invested employees, new ways of thinking and opportunities for growth, learning

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Pfizer, BioNTech could supply EU with 300m doses of SARS-CoV-2 vaccine

Pharma Times

The proposed deal covers the initial supply of 200 million doses and an option to purchase an additional 100 million, with deliveries starting by the end of 2020, if the vaccine is approved

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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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Poll: Trust in Fauci and the CDC is Declining Ahead of the November Election

BioSpace

Six months into a global pandemic and public trust is waning in its support for public health officials in charge of the nation’s response to the novel coronavirus, according to a new poll.

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NIH starts broad set of studies testing blood thinners against COVID-19

Bio Pharma Dive

The trials, which involve Bristol Myers and Pfizer's Eliquis as well as other anticoagulants, follow mounting evidence of blood clotting in COVID-19 patients.

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Diseases Don’t Discriminate, So Why Aren’t Clinical Trials More Diverse?

XTalks

COVID-19 isn’t one tragedy, but many. An underreported consequence of the pandemic is the outsized harm done to communities of color. In New York City — an early COVID-19 hotspot, and one of the most diverse communities in the world — 92 black residents died per 100,000 people. For white New Yorkers, the rate was less than half that, at 45 per 100,000 people.

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Delivering COVID-19 vaccines safely will be the ‘mission of the century’ for air cargo industry

BioPharma Reporter

Transporting a COVID-19 vaccine to 7.8 billion people around the world would fill 8,000 jumbo jets â illustrating the enormity of the distribution challenge. The International Air Transport Association (IATA) warns of potential capacity constraints, saying planning must begin now.

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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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NeuroOne’s Thin-Film Electrode Technology Offers Less Invasive Solution for Brain Surgery

BioSpace

For patients with epilepsy, the diagnosis and treatment process can be long, arduous, and filled with lengthy hospital stays. The medical device company NeuroOne Medical Technologies Corporation hopes to change that.

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Blueprint's cancer drug approval puts it up against Lilly

Bio Pharma Dive

Gavreto is cleared to treat certain lung cancer patients who have so-called RET mutations. Partners Blueprint and Roche will now compete with Eli Lilly and its rival drug Retevmo.

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Early data shows Russia’s Sputnik V COVID-19 vaccine produces immune response

pharmaphorum

A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immune response, although the study was too small to produce conclusive findings, particularly on safety. Preliminary results published in The Lancet are from a non-randomised phase 1/2 trial of 76 people aged 18-60, which found an antibody response within 21 days and no serious adverse events after 42 days.

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Pandemic Schmandemic – Intouchers Keep Creativity, Company Culture Alive

Intouch Solutions

In this post, we showcase just a few of Intouch's talented employees who are making the most of the pandemic. From content creation to painting, plant-raising and house-flipping, and more, there's something for everyone! The post Pandemic Schmandemic – Intouchers Keep Creativity, Company Culture Alive appeared first on Intouch Solutions.

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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.