Sat.Oct 02, 2021 - Fri.Oct 08, 2021

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Relay's targeted cancer drug could be safer than its competitors. Is it more effective?

Bio Pharma Dive

Initial study results for Relay's experimental treatment offer some support for the biotech's protein motion technology, but raise some questions, too.

Protein 359
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Open Source “Wikipedia” for Drug Discovery

Pharma Mirror

By Kambiz Shekdar, Ph.D. Open source drug discovery was proposed in the past in connection with third-world diseases like tuberculosis and malaria, but it is in the context of first-world indications where it is needed most. Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation.

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Pharma is “big business” that uses excuses to keep prices high

World of DTC Marketing

SUMMARY: Americans spend twice as much per capita on drugs as residents of other wealthy nations, because ours is the only country that lets drugmakers set any price they want for their products. Seventy-nine percent of Americans think the price of prescription drugs is “unreasonable,” according to a 2019 Kaiser Family Foundation poll , and about 9 in 10 say they support the idea of the government negotiating prices.

Sales 241
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Generic Portfolio Management, Partnering with Brands, and Staying Competitive

Drug Patent Watch

This is my talk from the 14th Annual Portfolio Planning and Partnership for Generic Conference. I discuss: Identifying generic entry opportunities at the earliest stages Discovering opportunities that avoid litigation…. The post Generic Portfolio Management, Partnering with Brands, and Staying Competitive appeared first on DrugPatentWatch - Make Better Decisions.

Branding 144
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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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Intergalactic Therapeutics launches with $75M to build a new type of gene therapy

Bio Pharma Dive

Founded by former Biogen executive Michael Ehlers and backed by Apple Tree Partners, Intergalactic aims to create non-viral gene therapies delivered via an advanced form of electroporation.

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CPhI Worldwide: 9-11 November 2021 in Milan, Italy

Pharma Mirror

“In a year when literally hundreds of our exhibitors have contributed to overcoming COVID, the greatest healthcare challenge of recent times, we are delighted to be welcoming back the pharma community. CPhI Worldwide is an essential conduit in helping pharma supply chains work, partners meet, empowering the industry with learning. But this year, more than ever, the event will also be a celebration of everything pharma has achieved.

Branding 246

More Trending

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Twin Health raises $140m for “digital twin” diabetes reversal app

pharmaphorum

The developer of a toolkit that promises to create a “digital twin” of individuals with chronic metabolic diseases like diabetes to help model the impact of lifestyle changes has secured $140 million in funding to develop the technology. US and India-based Twin Health says the Whole Body Digital Twin platform uses Internet of Things (IoT) sensors and self-reported data within an artificial intelligence-driven software platform to generate a virtual copy of a person’s unique met

Insulin 135
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Allogene cell therapy trials halted by FDA after safety finding

Bio Pharma Dive

Researchers found evidence of a "chromosomal abnormality" in one patient treated with Allogene's CAR-T cell therapy, spurring the clinical hold and an investigation.

Trials 317
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Medical Writing — An Outsourcing Competency

Pharma Mirror

The history of medical writing began with the rise of the modern clinical trial. A medical writer can be your most pivotal ally in a clinical trial. While clinic directors, data managers, and investigators in the pharmaceutical industry are required for clinical trials, medical writers are the glue that holds clinical trials together. The increase in volume of clinical trials has already put a tremendous strain on journal editors and reviewers.

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Merck gives taxpayers the middle finger

World of DTC Marketing

SUMMARY: Via Axios – The antiviral pill that showed promising results against severe COVID-19 was initially developed at Emory University with $35 million of taxpayer grants. And while it costs $17.74 to produce, according to a report issued last week by drug pricing experts at the Harvard School of Public Health and King’s College Hospital in London.

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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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Fungus-derived cancer killing drug by Oxford University shows promise

Pharma Times

A chemotherapy drug, NUC-7738, which is derived from a Himalayan fungus has been found to have 40 times greater potency in killing cancer cells than its original parent compound.

Drugs 135
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How a busy year for biotech IPOs measures up at the three-quarter mark

Bio Pharma Dive

Drugmaker initial public offerings could break records set just a year ago. But valuations and stock performance have slipped from historic highs.

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The ‘patient of the future’ is driving radical innovation in healthcare

pharmaphorum

Digital data collection, utilisation of real-word data and patient-centric thinking will all contribute to the rapid development of a new healthcare landscape, says Debiopharm Innovation Fund’s Tanja Dowe. In recent years, we have seen thinking shift from focusing on a disease’s treatment to seriously considering the wider potential for its prevention, enabled by dramatic advances in data science and supported by a pressing need to reduce healthcare costs.

Doctors 131
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Just how bad is Facebook health information? Really bad

World of DTC Marketing

SUMMARY: The health information on Facebook is a danger to anyone who reads it. Experiences from current patients do provide some context but too often contain lousy advice. Facebook should post a warning on every page that deals with health issues that informs people that their physician is still their best source of information. I joined some “private” healthcare condition pages on Facebook and was taken back by the amount of misinformation and bad advice.

Doctors 197
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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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Medtronic Expands Two Insulin Pump Recalls, Including One Over Cybersecurity Concerns

XTalks

Medtronic has expanded a Class I recall of remote controllers used with the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps over potential cybersecurity risks. The affected remote controller models are MMT-500 and MMT-503. The medtech giant has also expanded another Class I recall of the retainer rings on its 600 series insulin pumps.

Insulin 128
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Sarepta embarks on late-stage clinical trial of Duchenne gene therapy

Bio Pharma Dive

Initiation of the Phase 3 trial is an important milestone for the biotech after earlier setbacks, as well as for patients with the inherited muscle disease.

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MSD: Antiviral COVID-19 pill can halve the risk of hospitalisation and death

Pharma Times

MSD and Ridgeback Therapeutics announced that their investigational anti-viral medicine reduced the risk of hospitalisation and death by approximately 50% in non-hospitalised adult patients with mild-to-moderate COVID-19.

Medicine 121
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Transform patient experience with intelligent hyper-personalisation

pharmaphorum

Since 2019, pharmaceutical companies have been speeding to integrate digital channels and processes into their marketing efforts and patient outreach, to prepare for the wave of digitisation in the healthcare industry. As part of these efforts, customer experience (CX) became a key focus area to ensure customer engagement and loyalty. Significant strides have been made by the industry when it comes to embedding forward-thinking practices into its strategic marketing goals with healthcare profess

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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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Rejuvenate Bio is Reversing Age-Related Diseases to Increase Healthspan

BioSpace

Unlike most companies addressing the diseases associated with aging, Rejuvenate Bio tackles multiple cardiac, metabolic and renal issues at once.

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Gene therapy developer gets chance at a comeback with Pfizer deal

Bio Pharma Dive

Voyager Therapeutics recently scrapped much of its pipeline and replaced top executives. Now, a Pfizer deal on new technology gives investors hope.

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AstraZeneca pursues approval for COVID-19 antibody cocktail

Pharma Times

AstraZeneca has submitted an emergency approval to the US drug regulators for its COVID-19 antibody cocktail, which would be the first non-vaccine protection from the virus to be granted approval.

Antibody 116
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NHSX backs 14 digital health projects after funding round

pharmaphorum

NHSX, the government agency tasked with digitally transforming NHS England, has granted funding to 14 projects in its first digital health award competition. The Digital Health Partnership Award opened for applications in July and is aimed at projects that can help NHS organisations in England support patients with long term conditions focusing on supporting people at home.

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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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Absci and EQRx in tie-up to accelerate production of cheaper, protein based therapeutics

BioPharma Reporter

Absci Corp, a synthetic biology firm, is partnering with pharma company, EQRx, to jointly engineer and develop several clinical candidates across multiple therapeutic areas, including oncology and immunology.

Protein 102
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Armed with half a billion dollars, a startup aims to change how brain drugs are made

Bio Pharma Dive

Neumora Therapeutics launched Thursday with a $100 million investment from Amgen and another $400 million from a long list of venture capital firms, including Arch, which is taking another shot at building a neuroscience company.

Drugs 294
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UK’s first ‘asthma bus’ to support NHS respiratory service

Pharma Times

The UK’s first ‘asthma bus’ is set to begin its journey around the country, aiming to offer crucial support to pressured NHS respiratory services, as asthma sufferers have admitted to delaying care during the pandemic to avoid the risk of catching COVID-19.

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Pfizer agrees $630m deal to harness Voyager’s gene therapy tech

pharmaphorum

Voyager Therapeutics has just landed a new gene therapy alliance with Pfizer that could go some way towards easing the pain of losing three other partners in the space of a couple of years. Pfizer is paying Voyager $30 million upfront to get access to its TRACER adeno-associated virus (AAV) vector technology, which aims to improve the safety of gene therapies – a field that has suffered a string of safety scares in the last few months.

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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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World Egg Day 2021: What’s New in Egg Innovation?

XTalks

Held each year on the second Friday in October, World Egg Day is meant to celebrate the significance of eggs as one of the world’s oldest sources of protein. This year’s theme , “Eggs for all: Nature’s Perfect Package,” highlights eggs’ versatility and benefits to people at every stage of life. First observed in 1996, this year’s World Egg Day marks its 25 th anniversary.

Protein 98
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Gilead wins approval of CAR-T therapy in adult leukemia

Bio Pharma Dive

Tecartus, Gilead's second cell therapy on the market, is the first CAR-T treatment to be cleared for use in people older than 18 with ALL.

Marketing 317
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First subject given COVID-19 vaccine candidate in UK-based Scancell’s COVIDITY trial

Pharma Times

UK-based Scancell Holdings has announced that its first subject has been dosed in its COVIDITY clinical trial in South Africa.

Trials 122
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GSK’s malaria vaccine gets WHO okay for mass rollout

pharmaphorum

The WHO has given a green light to widespread use of GlaxoSmithKline’s malaria vaccine in Africa, in what could be a major turning point in the fight against the disease. The RTS,S/AS01 vaccine – also known as Mosquirix – will be administered to children living in sub-Saharan Africa and other regions with moderate to high malaria transmission in what WHO Director-General Dr Tedros Adhanom Ghebreyesus described as “a historic moment.” Initial clinical trials of the vaccine only

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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.