Sat.Oct 03, 2020 - Fri.Oct 09, 2020

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Pharmacquired: Splashy deals belie a shallow pool of heart drugs left to acquire

Bio Pharma Dive

Recent deals for MyoKardia and The Medicines Co. may be hard to follow, since venture investors and big pharma acquirers have largely ignored cardiovascular drugs.

Drugs 361
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New cancer drug clinical trials struggling

World of DTC Marketing

WHAT’S THIS ABOUT THEN : Researchers are rushing to launch clinical trials of experimental vaccines against the coronavirus, and treatments for COVID-19. But as hospitals brace for an onslaught of critically ill patients and laboratories worldwide are disrupted, researchers have had to shelve clinical trials of therapies for other illnesses. Eli Lilly recently announced that it would halt enrolment in ongoing studies and delay the launch of new trials.

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How is Cell Isolation Revolutionizing Medical Industry?

Pharma Mirror

One of the biggest medical advancements of recent times is the invention of the cell isolation method. Also known as cell sorting or cell separation, the cell isolation method has rapidly become an integral component of modern biological and medical research. In this method, a one-cell population or multiple cell types are isolated from a. The post How is Cell Isolation Revolutionizing Medical Industry?

Research 162
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EMA accepts filing for Biogen/Samsung Bioepis’ Lucentis biosimilar

Pharma Times

Biosimilar is an anti-VEGF therapy for retinal vascular disorders

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Moderna says it won't enforce coronavirus vaccine patents during pandemic

Bio Pharma Dive

The biotech, a frontrunner in the coronavirus vaccine race, said it won't tie up resources defending the intellectual property covering its experimental shot as long as the pandemic continues.

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Pharma’s digital transformation journey and the role of customer reference data

pharmaphorum

Better management of customer data could help pharmaceutical companies’ digital transformation, according to Veeva’s Rebecca Silver. pharmaphorum’s Richard Staines spoke to her about how the use of customer reference data can transform pharma companies, increase competitiveness, and benefit the bottom line during these challenging times. Precision medicine is emerging as a key approach for disease treatment and prevention, which makes it even more critical to get the right medicine to the

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Clinical trials have ‘much work to do’ in boosting diversity

Outsourcing Pharma

A veteran with more than 20 years of experience talks about the vitality of recruiting an inclusive patient population, and the perils of falling short.

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FDA releases coronavirus vaccine guidelines that White House resisted

Bio Pharma Dive

The review criteria outlined in the document, which the White House had held up for weeks, make the early approval of a coronavirus shot before the Nov. 3 election less likely.

Vaccine 341
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Neuroblastoma UK welcomes advancement of potential new treatment

Pharma Times

Fadraciclib has passed safety trials and shown early efficacy

Trials 130
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“Get the First Inch Right”: Oncology Combination Product First-in-class Treatment Success Story

Camargo

Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct…. Regulatory pathway, FDA center, Key Opinion Leaders (KOLs), Target Product Profile (TPP) inclusions, Data to rely on, Studies to conduct, Indication and patient population, Commercial strategy, and much more.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Romaco implements new sustainability strategy

Pharma Mirror

Romaco has appointed a Sustainability Officer and defined goals for the company’s climate-friendly development. Not only is the manufacturer seeking to enable more sustainable production by its customers; Romaco is also keen to improve its own carbon footprint. The Romaco Group has a new central corporate objective: sustainability. To enable climate protection measures to be.

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Lilly, with new data, seeks emergency clearance for COVID-19 antibody drug

Bio Pharma Dive

The pharma is the first to seek emergency approval for this kind of treatment, and may quickly follow up with a second request after reporting promising data for a two-drug combination.

Antibody 337
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ViiV’s two-drug HIV regimen demonstrates long-term efficacy

Pharma Times

Two-drug regimen continues to offer non-inferior efficacy compared to a three-drug regimen

Drugs 130
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Excel spreadsheet blamed for UK’s COVID-19 test and trace woes

pharmaphorum

An Excel spreadsheet was behind IT glitch that caused thousands of positive COVID-19 tests to be omitted from the UK’s official records, according to press reports. The issue that left almost 16,000 positive results going unreported has been blamed on the way Public Health England tracks results from mainly private labs that have been hired to add extra testing capacity.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Biocartis Announces Market Release of SeptiCyte® RAPID test on Idylla™

Pharma Mirror

Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the market release of SeptiCyte® RAPID on Idylla™ as a CE-marked IVD test. SeptiCyte® RAPID is a host-response test that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about one.

Marketing 130
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Achieving success in pharma marketing: The need for a personalized, omnichannel approach

Bio Pharma Dive

Personalized, insight-driven omnichannel marketing has never been more beneficial or important.

Marketing 318
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BMS’ Opdivo plus Yervoy misses the mark in high-risk melanoma

Pharma Times

Combination treatment did not achieve statistical significance in all-comer population

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Your.MD secures $30m to expand self-care app Healthily

pharmaphorum

Digital health firm Your.MD has secured $30 million in a Series A round investment led by the consumer health giant Reckitt Benckiser (RB). Your.MD is the company behind the medical-grade, augmented intelligence self-care app Healthily, and will use the funding to accelerate the platform through a series of clinically-validated “health hubs”. Following a seed funding round led by RB and existing shareholders, the now completed Series A funding round will allow the app to reach other markets incl

Doctors 124
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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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Full CPhI & Pharmapack Europe schedule returns in 2021 with live & hybrid events

Pharma Mirror

Informa Markets announces its complete listing of pharma event dates for 2021 at the opening of the first CPhI Festival of Pharma (05 – 16 October 2020) – the largest ever virtual pharma event. The pharma schedule includes one further event in 2020: CPhI China, 16-18 December (hybrid event, combining “live” in-person with “virtual”). In. The post Full CPhI & Pharmapack Europe schedule returns in 2021 with live & hybrid events appeared first on Pharma Mirror Magazine.

Marketing 130
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From no drugs to 3: Patients with spinal muscular atrophy now face hard choices

Bio Pharma Dive

The availability of three vastly different, cutting-edge medicines for the rare disease has put patients, families and doctors in an unfamiliar position.

Doctors 318
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Janssen/MeiraGTx showcase nine-month data for sight loss gene therapy

Pharma Times

Gene therapy demonstrated improvement in retinal sensitivity

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Finding and Evaluating Generic Drug Market Entry Opportunities

Drug Patent Watch

Here is a copy of the talk I gave at the recent Marcusevans 13th Portfolio Management and Pipeline Optimization for Generics. I cover: How to find and evaluate generic entry…. The post Finding and Evaluating Generic Drug Market Entry Opportunities appeared first on DrugPatentWatch - Make Better Decisions.

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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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CRISPR Pioneers Doudna and Charpentier Win Nobel Prize in Chemistry

BioSpace

There is little doubt that CRISPR gene editing is and will continue to revolutionize biology and medicine. The Nobel Committee confirmed their belief in that by awarding the Nobel Prize in Chemistry to Emmanuelle Charpentier and Jennifer A. Doudna for their discovery and development of CRISPR.

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FDA told coronavirus vaccine makers of stricter standards for early approval

Bio Pharma Dive

Blocked by the White House from issuing new vaccine guidelines, the FDA made its criteria for an emergency authorization clear anyway, publishing requirements it had previously communicated to drugmakers.

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London universities join forces to ramp up COVID-19 testing

Pharma Times

Testing Alliance created to offer 20,500 extra coronavirus tests a day

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Axovant pushes on with Parkinson’s gene therapy, despite investor cynicism

pharmaphorum

Axovant has said it plans to continue developing its Parkinson’s Disease gene therapy after reporting supportive data from a small cohort of patients from a phase 2 trial. However shares in Axovant were down sharply after the announcement because of market sentiment that the New York biotech had been selective with the data it had shared in its update.

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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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White House Reverses Course, Approves New FDA COVID-19 Vaccine Guidelines

BioSpace

The new guidelines posted Tuesday by the FDA, call for vaccine developers to follow patients dosed with the experimental medication for at least two months before seeking Emergency Use Authorization.

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Regeneron follows Lilly in asking for emergency approval of COVID-19 antibody drug

Bio Pharma Dive

The two antibody treatments are now being reviewed by the FDA, although limited supply could mean their impact won't be felt for months, even if they are cleared for use.

Antibody 306
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ABPI calls on UK government to create non-COVID clinical research strategy

Pharma Times

New report finds UK is leading on early-stage clinical trials but needs strategy to restart non-COVID research

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Why intelligent automation is the future for regulation

pharmaphorum

There are a host of new, previously unimaginable tools and techniques – from analytics to robotic process automation (RPA) and artificial intelligence (AI) – available to help speed up processes and increase data accuracy. But for many life sciences organisations, these tools are either not yet fully adopted or are not being put to good use within their regulatory functions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time