Sat.Feb 05, 2022 - Fri.Feb 11, 2022

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'The music stopped': Biotech rout leaves drug startups grounded as demand slumps for IPOs

Bio Pharma Dive

For the first time in years, biotechs no longer have an easy path onto Wall Street, a market reversal that could change what the next generation of young drugmakers looks like.

Drugs 364
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Biogen continues to sink

World of DTC Marketing

Board members and senior executives are bailing out of Biogen but will there be enough life vests? What has/is happening at Biogen is a train wreck, and the only way to correct this disaster is to tear it down and rebuild the company from the top down. According to Endpoint News” We’ve seen Biogen’s CSO exit under pressure in recent weeks, and senior marketing execs leave in an exodus as the company recoiled from a fierce backlash against the FDA’s ultra controversial app

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Simons Foundation gives $4 million to CUNY Graduate Center to diversify astrophysics education

Scienmag

NEW YORK, February 9, 2022– Astrophysics is one of the most popular science fields, igniting the imaginations of many as they learn about it from television shows or news of space exploration. Like many other STEM fields, though, it lags in attracting students of color. Studies have shown the benefits of diversity in STEM fields, […].

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Cancer vaccines: providing the edge in oncology

pharmaphorum

In this article, Ben Hargreaves looks into the promise of cancer vaccines and how this treatment modality may offer advantages over existing immunotherapies in the oncology sector. According to a report by IQVIA last year, there were 3,500 oncology-focused therapeutic candidates in the pipeline, which represents a 75% increase on figures seen in 2015.

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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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FDA sends signal with tough questions of Lilly at cancer drug meeting

Bio Pharma Dive

The agency criticized Eli Lilly for using a trial run in China to seek approval of an immunotherapy it licensed from Innovent Biologics. Outside advisers agreed in a decisive vote that could have repercussions for several other drugmakers.

Licensing 340
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Mental health apps can be useless

World of DTC Marketing

According to the Lancet, a medical journal, the incidence of depression and anxiety has soared in the pandemic—by more than 25% globally in 2020. That, combined with more people using online services, has led to a boom in mental-health apps. But are they safe and effective? Now that big companies prioritize employees’ mental health, some apps work with them to help entire workforces.

Marketing 241

More Trending

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Your microbiome shapes your life. But where did it come from?

Scienmag

Baltimore, MD— The gut microbiome is an ecosystem of hundreds to thousands of microbial species living within the human body. These populations affect our health, fertility, and even our longevity. But how do they get there in the first place? Credit: By Navid Marvi, courtesy of the Carnegie Institution for Science. Baltimore, MD— The gut […].

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Why the FDA is making a test case of a cancer drug from China

Bio Pharma Dive

In documents released Tuesday, FDA staff gave a cool review to an immunotherapy developed by Eli Lilly and Innovent Biologics. An advisory meeting this week to review it could have broader implications for cancer drug development in the U.S.

Drugs 312
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Does Pfizer have a conscience?

World of DTC Marketing

Pfizer has held a vaccine monopoly, blocking low-income countries from accessing its novel technology, while enriching shareholders at levels advocates for vaccine equity label “obscene.” The corporation is making as much as $1 million in profits every hour from vaccine sales, according to Oxfam, and its executives boast that revenues will expand exponentially in 2022. ( The Atlantic ).

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Valneva and Pfizer to take Lyme disease vaccine into Phase 3 trial this year

BioPharma Reporter

Valneva and Pfizer have reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15, with a Phase 3 trial set to start in Q3, 2022.

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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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AI Marketing for Pharma – The time to rise is Now!

pharmaphorum

The digitalisation that we all experience daily has affected the way we engage with stakeholders and patients. But how can we make Customer Engagement effective, and how can we leverage technologies like AI and Marketing Automation to their best potential? The key to success lies in implementing a digital health ecosystem , in order to support the shift from an organization-centric model to a customer-centric model by using digital platforms.

Marketing 105
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Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback

Bio Pharma Dive

Safety concerns, including the recent death of a patient in an early study, led the FDA to place a hold on the therapy and Pfizer to redesign its Phase 3 trial.

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Small biotech startups hurting

World of DTC Marketing

Biosplice, once the world’s most valuable biotech startup (reaching a $12 billion valuation in 2018), is laying off nearly a quarter of its workforce and has stopped internal development of one of its late-stage medicines, a treatment for hair loss in men, with hopes of licensing that program to another drug company. As VC funding for biotech companies becomes harder to obtain, patients are the real losers.

Sales 208
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ViiV Healthcare long-acting HIV treatment secures FDA approval

Outsourcing Pharma

The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.

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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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Novo Nordisk gets NICE okay for obesity drug Wegovy

pharmaphorum

Novo Nordisk’s new obesity therapy Wegovy has been recommended for routine NHS use by UK cost-effectiveness watchdog NICE, but in a narrower group of patients than is covered by its MHRA-approved label. NICE has backed use of the Wegovy (semaglutide) for people with a body mass index (BMI) of 35 kg/m2 or more and at least one weight-related ailment – such as high blood pressure, high cholesterol or diabetes – as part of a weight management programme involving exercise and a reduce-calorie

Drugs 105
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Pfizer forecasts $100B in sales, fueled by COVID-19 vaccine, pill

Bio Pharma Dive

The company estimated revenue from its COVID-19 vaccine and antiviral pill Paxlovid will total $54 billion this year. Curiously, its stock fell by more than 5%.

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Obesity is a public health problem

World of DTC Marketing

( Washington Post ) Obesity turned out to be a major risk factor for covid hospitalization and death, especially non-elderly. According to the CDC, it is linked to impaired immune function and decreased lung capacity; it can make ventilation more difficult. Once again, obesity indicates that it’s killing us. The United States might well have gotten through the pandemic at far lower cost, economic and human, without the decades-long obesity epidemic that preceded it.

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Rutgers researchers discover security vulnerabilities in virtual reality headsets

Scienmag

New Brunswick, N.J. (Feb. 10, 2022) – Researchers at Rutgers University-New Brunswick have published “Face-Mic,” the first work examining how voice command features on virtual reality headsets could lead to major privacy leakages, known as “eavesdropping attacks.” Credit: Shutterstock New Brunswick, N.J. (Feb. 10, 2022) – Researchers at Rutgers University-New Brunswick have published “Face-Mic,” the first work examining how […].

Research 100
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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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Do skills gaps and the COVID brain drain threaten digital transformation?

pharmaphorum

With staff shortages and digital skill gaps being experienced across the spectrum of healthcare, from CROs and pharma to providers, the people-led sector is facing a personnel challenge that could threaten the potential of digital transformation. The healthcare ecosystem may be the natural beneficiary of recent advances in data collection and analysis, but that’s no use without the staff to develop and implement solutions.

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FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift

Bio Pharma Dive

The FDA pushed back plans to expedite review of the shot in children under 5, seeking more data on a third dose. An advisory meeting scheduled for next week has been postponed as a result.

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InBody’s New At-Home Blood Pressure Machine Allows for Real Time Monitoring

XTalks

Health technology company InBody has released its new BP170 consumer at-home blood pressure monitor that allows individuals to track their blood pressure in real time. This is important because blood pressure can significantly fluctuate throughout the day. Inbody’s BP170 real time blood pressure monitoring device can capture these oscillations and generate reports that the individual and their healthcare provider can assess.

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Lack of COVID-19 testing availability can increase potential for risky behavior, survey shows

Scienmag

BLOOMINGTON, Ind. — A research survey of more than 1,100 people in the United States found that when COVID-19 testing wasn’t available in their community, participants showed significantly greater intentions to engage in risky behavior, possibly leading to increased transmission of the virus. Credit: Indiana University Kelley School of Business BLOOMINGTON, Ind. — A research […].

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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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Empowering rare disease patient advocacy organisations with data

pharmaphorum

Komodo Health’s president and co-founder, Web Sun, tells us about his company’s new partnership with the Chan Zuckerberg Initiative (CZI) to improve early diagnosis and advance research of rare diseases by providing CZI’s Rare as One Network healthcare data and software. Though 7,000 rare diseases exist that affect 400 million people globally, a lack of understanding of these diseases can cause a delay in diagnosis and, in turn, treatment.

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US buys up supply of new Lilly antibody meant to work versus omicron

Bio Pharma Dive

Distribution of Lilly's earlier antibody treatments was halted as testing showed them ineffective against omicron. Bebtelovimab appears able to neutralize the variant, and was authorized by the FDA on Friday.

Antibody 268
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Top 3 Things to Know About Engaging Oncologists in 2022

Pharma Marketing Network

Experts from top life sciences companies discussed strategies for more effectively engaging oncologists at the Pharma Marketing Network’s 2022 Future Forecast on January 25 th. Here are the top three things to know about engaging oncologists in 2022: 1. Lead with clinical education. It’s no longer enough to build brand awareness, according to the panelists.

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New Report Finds Whopping Increase in Pharma Cybersecurity Threats

XTalks

A new report shows that cybersecurity risks in pharma run a lot deeper and wider ranging than once thought. Findings from an analysis conducted by Constella Intelligence , a digital risk protection company, show widespread cybersecurity vulnerabilities that are costing pharma companies significantly. Constella released their Pharma Sector Exposures Report: 2018–2021 Digital Risk Findings and Trends , which focused on analyzing digital risks to the top 20 pharma companies on the Fortune Global 50

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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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GSK gets £1.4bn sales lift from COVID-19 products in 2021

pharmaphorum

GlaxoSmithKline’s COVID-19 products – antibody drug Xevudy and a vaccine adjuvant – helped drive a 5% increase in 2021 revenues to £34 billion ($46 billion), ahead of what chief executive Emma Walmsley says will be a “landmark year” for the company. Xevudy (sotrovimab), which was developed with Vir Biotech and has seen its use rise after it was shown to be effective against the Omicron strain of SARS-CoV-2, brought in £958 million, £828 million of that in the last quarter of th

Sales 105
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Sanofi's Bioverativ deal begins to pay dividends with first new drug approval

Bio Pharma Dive

The FDA's clearance of Enjaymo for cold agglutinin disease means Sanofi has a new marketed product to show for its 2018 buyout of Biogen's former spinoff.

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Online event to address disparities in cancer research, care

Outsourcing Pharma

The latest in the Diversity in Oncology series, taking place February 9, will discuss ways academia and community collaboration can narrow representation gaps.

Research 105
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Here are Some Food and Beverage Ads to Look Out for During Super Bowl LVI

XTalks

With only a few days to go before Super Bowl LVI, food and beverage brands are beginning to build buzz for their big game ads. On February 3, NBCUniversal announced that it was officially sold out of commercial time, with 30-second ad slots commanding a price tag of as much as $7 million in some cases. . Super Bowl commercials have become a cultural phenomenon of their own alongside the game itself, as many viewers only watch the game to see the commercials.

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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.