Sat.Sep 18, 2021 - Fri.Sep 24, 2021

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CDC panel clears way for Pfizer booster shots, but divided on broader use

Bio Pharma Dive

Agency advisers supported giving a third Pfizer vaccine dose to older adults and those with medical conditions. But in a break with the FDA, they voted against recommending it for younger people in high-risk jobs.

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World Pharmacists Day 2021 Celebration

Pharma Mirror

25th September is celebrated as world pharmacists day, and it brings a new theme every year. The main motive behind this celebration is to give an excellent message to improve people’s health worldwide. And also, create an acceptance and encourage the role of a pharmacist in health. The pharmacist community from all over the world arranges different campaigns, exhibitions, lectures, etc., for serving this purpose.

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What is Biogen and can they repair their reputation?

World of DTC Marketing

SUMMARY: If I were to ask you, “what type of company is Biogen?” what would be your response? I tried asking that of several colleagues in the industry, and they couldn’t come up with an answer. Biogen has lost its way and is in desperate need of a corporate rebranding. This week two colleagues, who worked at Biogen, left the company because they knew that the ax was coming after the failure of Aduhelm.

Drugs 222
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Scientific study finds music can ‘tune out pain’

pharmaphorum

A study has found that listening to a specially composed music track can achieve “clinically significant” reductions in pain intensity and unpleasantness, according to the researchers behind the work. The All of Us track – composed by musician Anatole with the help of psychologist Dr Claire Howlin of University College Dublin and available via Spotify – reportedly showed a benefit in 286 people suffering from various types of acute pain, including headache, backache or period pain in

Hormones 135
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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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Novartis pushes further into gene therapy for the eye with deal for Swiss startup

Bio Pharma Dive

The large drugmaker has acquired Arctos Medical and its preclinical research into optogenetics, an area Novartis already showed interest in with its buyout of Vedere Bio last year.

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Telling it how it is: The need for plain language summaries in medical journals

BioPharma Reporter

Open Pharma wants to see articles in peer-reviewed medical journals provide plain language summaries: those written in everyday language that is easy to understand by anyone from patients to policymakers. It's now set out its recommendations on how to write a good plain language summary.

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Novavax files its COVID jab to WHO for emergency use listing

pharmaphorum

Novavax and its partner Serum Institute of India have applied to the World Health Organization for an emergency use listing for their COVID-19 vaccine, based on a conventional recombinant protein technology. Getting a WHO emergency use listing (EUL) is a requirement for approvals by many national regulatory authorities, as well as for participation in the COVAX mechanism, which has been set up to procure COVID-19 vaccines for lower-income countries.

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Pfizer says coronavirus vaccine is safe and spurs immune response in children

Bio Pharma Dive

The results position Pfizer and BioNTech to seek clearance in children as young as five years old. But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators.

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Pharma in the Courts: Takeda, AbbVie, RedHill, Pfizer and Gilead

BioSpace

Aside from the fraud trial of Theranos founder Elizabeth Holmes, other court-related cases are taking place, including between Takeda and AbbVie over cancer drug, Lupron.

Trials 133
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Dr. Daniel Pauly’s extraordinary life and work revealed in new book

Scienmag

Dr. Daniel Pauly is the world’s most-cited fisheries scientist, but life for the UBC professor has been far from easy. The biracial son of a French woman and an American GI, he was born in Paris and kidnapped as a child to be a live-in servant for a Swiss family. He escaped to Germany at […].

Scientist 110
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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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Study finds 10% of medicines in England are overprescribed

pharmaphorum

An alarming number of people in England are being prescribed medicines unnecessarily, which could harm their health, according to a UK government review. The study , led by the Chief Pharmaceutical Officer for England Dr Keith Ridge, estimates that 10% of items dispensed in primary care are inappropriate or could be better served with alternative treatments.

Medicine 122
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Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial

Bio Pharma Dive

Positive results from Clover's Phase 3 study could mean another coronavirus vaccine option for the many countries still grappling with short supplies.

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NHS patients gain access to COVID-19 treatment Ronapreve

Pharma Times

Ronapreve will be targeted at hospitalised patients who have not mounted an antibody response against COVID-19

Antibody 134
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Llama Nanobodies May be Missing Link in COVID-19 Therapeutics

BioSpace

Monoclonal antibodies play a key role in the treatment of COVID-19, but new research suggests that nanobodies derived from llamas could provide an alternative to monoclonal antibodies.

Antibody 107
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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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RwHealth, the Artificial Intelligence provider for the NHS, promises to transform healthcare

pharmaphorum

RwHealth , the leading provider of Artificial Intelligence to the healthcare industry, has today reported 160 per cent year-on-year growth as its data-led solutions are increasingly embraced by NHS trusts, private healthcare providers and major pharmaceutical companies. RwHealth’s unique Data Science Platform combines Artificial Intelligence (AI), Machine Learning and Data Science to give healthcare providers access to the best and most in-depth data available, helping them to make better decisi

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FDA green lights booster dose of Pfizer vaccine for older, more vulnerable Americans

Bio Pharma Dive

The authorization is more narrow than envisioned by the Biden administration last month, but still makes potentially millions of Americans eligible for a third Pfizer shot.

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Workshop and lecture on generic portfolio management

Drug Patent Watch

I’ll be leading a workshop on generic portfolio management, and also giving a talk, at the 14th annual Marcus Evans event on Portfolio Planning and Partnerships for Generics. The event…. The post Workshop and lecture on generic portfolio management appeared first on DrugPatentWatch - Make Better Decisions.

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Why Dash Water Uses “Wonky Fruit In Its Sparkling Water

XTalks

Victoria Beckham and Robbie Williams are among the celebrities seen spotted with Dash Water in hand, the UK’s latest sparkling water craze. The London-based brand has built a strong reputation as a better-for-you beverage that uses upcycled ingredients. So, how does Dash Water differentiate itself from the plethora of sparkling waters on the market, and how does it stack up to its competitors?

Branding 105
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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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EU panel rejects Pfizer’s tanezumab for osteoarthritis pain

pharmaphorum

Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor (NGF) inhibitor tanezumab looks to have been dashed after the EMA’s human medicines committee rejected the drug. A positive recommendation was already looking like a long shot for after FDA advisors voted 15 to one against approval of the drug in March.

Drugs 117
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'This is the time to double down': Top Vertex executives defend research plan as pressure builds

Bio Pharma Dive

A series of setbacks has led to criticism of the storied biotech's bid to diversify. But Vertex intends to stay the course, its CEO and top scientist say.

Scientist 310
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Touchlight extends funding round, sees hike in demand for synthetic DNA vectors

BioPharma Reporter

Synthetic DNA vector producer, Touchlight, has announced the extension of its fundraising round to a current aggregate total of US$125m (Â92m). The financing was led by Bridford Investments Limited and Novator Partners.

DNA 103
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UK trial to evaluate existing drugs for secondary breast cancer

Pharma Times

Trial will test if radium-223 plus avelumab can improve outcomes for metastatic breast cancer patients

Trials 135
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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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The benefits of being a family-run pharma company

pharmaphorum

The third generation of his family to hold a leadership role at Chiesi Group, Giacomo Chiesi reflects on the lessons he learned from his father and grandfather – and from his work as a former management consultant – about what it means to run a successful family business and its benefits. Family businesses across industries including the life sciences sector contribute significantly to the global economy – they represent about half of the world gross domestic product and global emplo

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Insurers sue Merck for 'monopolistic scheme' to delay generics of blockbuster cholesterol drug

Bio Pharma Dive

The suits allege an agreement between Merck and a generic manufacturer kept low-cost versions of the drugmaker's widely used Zetia off the market for years.

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COVID-19 Death Toll Surpasses 1918 Spanish Flu

BioSpace

In September 20, 2021, the United States marked a grisly milestone, recording more American deaths from COVID-19 than died from the 1918-1919 Spanish flu pandemic.

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Self-amplifying mRNA COVID-19 vaccine 'immunogenicity enhancer’ enters Phase 1 trial

BioPharma Reporter

Gritstone bio, Inc., has dosed the first volunteer in a Phase 1 trial for a self-amplifying mRNA second-generation COVID-19 vaccine booster.

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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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Amnesty says COVID jab producers are causing human rights crisis

pharmaphorum

Amnesty International has slammed the six pharma companies behind the bulk of COVID-19 vaccine supplies of for not agreeing to waive their intellectual property rights and share the technology behind them. The charity says AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax, and Pfizer are fuelling an “unprecedented human rights crisis” as a result and their failure to act “paints a dismal picture of an industry that is woefully failing to respect human rights.”

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Second dose of J&J's coronavirus vaccine increases protection, company says

Bio Pharma Dive

Long-awaited results from a Phase 3 study run by J&J could support use of a booster dose, although the drugmaker has not officially applied for FDA clearance yet.

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Researchers Turn Back the Clock on Heart Cells in Mice

BioSpace

?Researchers from the Max Planck Institute for Heart and Lung Research reportedly achieved positive results after returning adult cardiomyocytes to their fetal-like state in mouse models.

Research 101
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New patent for La Jolla drug GIAPREZA

Drug Patent Watch

Annual Drug Patent Expirations for GIAPREZA Giapreza is a drug marketed by La Jolla Pharma and is included in one NDA. It is available from one supplier. There are eight…. The post New patent for La Jolla drug GIAPREZA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 95
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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.