Sat.Feb 13, 2021 - Fri.Feb 19, 2021

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10 biotechs become 1: Centessa launches with $250M to prove unorthodox R&D model

Bio Pharma Dive

The new company will be led by Saurabh Saha, a former Bristol Myers executive, and Moncef Slaoui, who until recently led the U.S. government's coronavirus vaccine program.

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DTC Review: Nucala

World of DTC Marketing

THE SHORT: According to Medical News Today “in the United States (U.S.), an estimated 25.7 million people have some form of asthma , and 15 percent of these people have severe asthma that is difficult to control with standard medications. In the population as a whole, eosinophilic asthma is rare, affecting only 5 percent of adults with asthma or about 1.2 million people.

Doctors 205
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Haven: The strategy that didn’t fix healthcare

pharmaphorum

John Singer discusses the disbanding of Haven, the joint healthcare venture by Amazon, JP Morgan and Berkshire Hathaway, and the strategies that can help fix US healthcare. . “The market” was terrified when Warren Buffett, Jamie Dimon and Jeff Bezos got together to disrupt healthcare three years ago with the launch of Haven – in response to that news, healthcare stocks comprising a significant chunk of the $3.5 trillion health economy in the United States shed billions in value overnight.

Marketing 126
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University of Oregon Campus Could Be Cornerstone of New Biotech Hotspot

BioSpace

A new biotech hotspot could be on the horizon in Oregon thanks to a $500 million gift to the University of Oregon from Nike co-founder Phil Knight, an alumnus of the university.

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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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Lilly wagers almost $1B on Rigel's drugs for immune and nervous systems

Bio Pharma Dive

For $125 million up front, Lilly secures rights to a drug about to enter mid-stage testing for autoimmune and inflammatory diseases, as well as preclinical assets targeting the central nervous system.

Drugs 329
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Pharma running online ads on vaccine misinformation sites

World of DTC Marketing

SUMMARY: More than 42,000 programmatic ads from 4,315 brands are running on websites spouting misinformation about the vaccine and COVID over the past year. Included in the programmatic ad errors is Pfizer, who developed a leading COVID vaccine. When will pharma stop using programmatic online ads? Programmatic has been a thorn in online advertisers.

More Trending

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Alzheimer’s Research UK starts AI-based drug hunt with Exscientia

pharmaphorum

Medical charity Alzheimer’s Research UK has teamed up with artificial intelligence specialist Exscientia to find new drug treatments for the devastating neurodegenerative disease. . The alliance will see Exscientia work with the charity’s Oxford Drug Discovery Institute (ODDI) to find therapeutics that target the neuroinflammation associated with Alzheimer’s disease (AD), focusing in particular on the NLRP3 inflammasome pathway.

Research 119
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Pfizer set to double weekly production of coronavirus vaccine

Bio Pharma Dive

The drugmaker will use production lines at its plant in McPherson, Kansas to help fill vaccine vials, company CEO Albert Bourla said Friday.

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How much to spend on DTC TV

World of DTC Marketing

SUMMARY: By far, the biggest question I get as a consultant is, “how much should we spend on DTC ads?” It’s important to understand that no formula can be applied across all health conditions and products. It varies by the size of your audience and the number of diagnosed and undiagnosed patients. DTC marketers will do a lot of research on brand messaging, but what’s really important is what action your target audience will take due to being exposed to your message.

Branding 180
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South Africa starts administering Janssen COVID-19 vaccine to health workers

BioPharma Reporter

South Africa has started administering the Janssen COVID-19 vaccine to health workers this week after the first doses arrived in the country. Meanwhile, J&J has submitted an application for Conditional Marketing Authorisation in the EU, following its application for EUA in the US.

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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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Turning Point Therapeutics is ‘Cycling’ Toward a Precise Cure for Cancer

BioSpace

The company's lead drug candidate, Reprotrectinib, is currently in Phase I/II clinical studies to target non-small cell lung cancer (NSCLC) in patients with a ROS1 or NTRK metastatic mutation.

Drugs 117
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Bluebird stops studies of sickle cell gene therapy after new cancer cases

Bio Pharma Dive

The biotech is also suspending sales of its related treatment Zynteglo following a leukemia diagnosis in a clinical trial volunteer and a case of a cancer-like bone marrow disease in another.

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Pharma needs to give the boot to McKinsey

World of DTC Marketing

SUMMARY: This month, McKinsey agreed to pay nearly $600m to settle claims that its advice had exacerbated the deadly US opioid crisis, yet pharma views McKinsey as business gurus. This has to stop, and NOW! McKinsey is loaded with MBAs addicted to spreadsheets and PowerPoint presentations, so of course, they know about patients and pharma? McKinsey’s recommendations to Purdue were directly aimed at extreme sales improvement, and the analysis failed to address the potential of specific ince

Sales 154
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LSD biotech MindMed buys digital trial firm HealthMode

pharmaphorum

Psychedelic medicine biotech MindMed is to acquire digital medicine and therapeutics startup HealthMode for around $32.2 million, which uses artificial intelligence (AI) technology to speed up drug development. The move will also see ex-Pfizer digital medicine executive Dr Daniel Karlin join the MindMed executive team, along with former Google AI guru Bradford Cross.

Trials 114
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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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Project Farma: Manufacturing Skills Gap Creates Bottleneck for Cell and Gene Therapy

BioSpace

The skills gap in cell and gene therapy is creating a bottleneck that is slowing the abilities of innovative therapies to reach patients, delaying manufacturing scaleup and increasing learning and development costs.

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Novartis expects sales lift from expanded heart drug approval

Bio Pharma Dive

The Swiss drugmaker's pill Entresto is now cleared in the U.S. for use in patients with stronger hearts, expanding the eligible population by two-thirds.

Sales 268
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Avacta: Rapid COVID-19 antigen test shows ‘very good sensitivity’ and generates ‘no false positive’ results

BioPharma Reporter

Avacta says data for its SARS-CoV-2 rapid antigen test from ongoing clinical studies in Europe and the UK show excellent performance of the test in identifying patients with an infectious viral load and no false positive results.

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North Korea ‘launched cyber-attack on Pfizer for COVID-19 jab data’

pharmaphorum

A news agency is claiming that North Korea launched a cyber-attack on Pfizer in a bid to steal information about its BioNTech-partnered COVID-19 vaccine, citing South Korea’s National Intelligence Service (NIS). The Yonhap agency said the revelation was made during a closed-door meeting of the intelligence committee of South Korea’s National Assembly.

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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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NKarta Therapeutics’ NKT Cells Elicit Better Response than CAR-T Cells Alone

BioSpace

NKarta Therapeutics is using engineered chimeric antigen receptor natural killer T cells (CAR-NKT cells) for allogeneic therapy, showing substantial benefits both in vitro and in vivo, according to James Trager, CSO, speaking Wednesday at the virtual CAR-TCR Summit – Europe.

In-Vivo 106
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GSK returns to Vir with expanded deal to develop drugs for flu, other viruses

Bio Pharma Dive

The British drugmaker will pay the San Francisco-based biotech $225 million upfront, while also investing another $120 million in Vir shares.

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Scientific breakthroughs, approvals: Latest CAR T-cell therapy related developments

BioPharma Reporter

From new research offering promise for children's cancer to FDA registrations, we track the progress made in the past few weeks in terms of advancing CAR T-cell therapy in a number of markets.

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Could CRISPR cure HIV? US biotech Excision raises $60m to find out

pharmaphorum

US biotech Excision BioTherapeutics has raised $60 million to test a potential HIV cure in the clinic, which would use CRISPR technology to snip out the viral code from human cells and tissues. Once someone is infected with HIV it stays with them for life thanks to the retrovirus’s ability to inject its DNA code into the host. Snipping out this viral code with powerful CRISPR gene editing technology, which last year won Drs Emmanuelle Charpentier and Jennifer Doudna the Nobel Prize for chemistry

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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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CureVac’s COVID-19 vaccine begins rolling review with EMA

Pharma Times

CureVac’s CVnCoV is currently being investigated in a randomised, placebo-controlled Phase IIb/III clinical trial

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Pfizer, BioNTech ask FDA approval to ease temperature requirements for coronavirus shot

Bio Pharma Dive

Testing showed the vaccine could be safely stored at normal freezer temperatures, rather than the roughly minus 70 degrees Celsius now specified. The change, if cleared by the agency, will help distribution.

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Charles River Dives Deep Into Cell and Gene Therapy With Cognate BioServices Acquisition

BioSpace

Charles River Laboratories will acquire Cognate BioServices in an $875 million cash deal that will significantly expand the company’s capabilities in the high-growth cell and gene therapy sector.

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Roche and PatchAi partner on digital tool for cancer patients

pharmaphorum

Roche’s Italian subsidiary has joined forces with digital health startup PatchAi to roll out an app that aims to support people diagnosed with cancer. Roche and PatchAi have been working together on the Smart Health Companion (SHC), which was launched to oncology and haematology patients in July 2020, and will now step up their collaboration to offer it more widely.

Doctors 105
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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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Flow Acquires Halo Neuroscience to Develop Brain Stimulation Technology to Treat Depression

XTalks

Neurotech company Flow Neuroscience has acquired the rights to Halo Neuroscience’s brain stimulation technology in an effort to further its research goals of developing treatments for depression and other mental health disorders. The company will use and further build upon Halo’s research on neuromodulation technology to enhance its current medically certified transcranial direct current stimulation (tDCS) headset for depression.

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eReconciliation tool: A new software to facilitate Safety Data Reconciliation between clinical and safety databases

Bio Pharma Dive

Simplify serious adverse events reconciliation operations with a customizable and GxP validated platform solution.

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Amgen Moves One Step Closer to First Approved KRAS Inhibitor for Lung Cancer

BioSpace

The U.S. FDA granted Amgen Priority Review for sotorasib for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), after at least one previous systemic therapy.

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UK will start first COVID-19 challenge study “within a month”

pharmaphorum

Sometime within the next few weeks, young and healthy volunteers will be deliberately exposed to the COVID-19 coronavirus in the UK in what looks set to be the first study of its type worldwide. . The human challenge study has just secured ethics committee approval and will recruit up to 90 volunteers aged 18-30 years, according to the UK government, which is backing it with £33.6 million ($47 million) in funding.

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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.