Sat.Aug 27, 2022 - Fri.Sep 02, 2022

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Psychedelic clinical trials: What sponsors should know when designing new protocols

Bio Pharma Dive

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

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The futility of banner ads

World of DTC Marketing

Digital ad spending in the industry will reach $15.84 billion in 2022. Although growth in digital budgets is slowing, we estimate the category will see nearly $20 billion in spending in 2024. For every $1 million invested in online banner ads, just 0.1%, or $1,000, derives value for brands, resulting in $999,000 wasted by brands. So why is pharma wasting so much money?

Branding 270
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Novo Nordisk agrees to acquire biopharma firm Forma for $1.1bn

Pharmaceutical Technology

Novo Nordisk has signed a definitive agreement for the acquisition of clinical-stage biopharmaceutical firm Forma Therapeutics for $20 for each share in cash or a total equity price of $1.1bn. Forma focuses on researching, developing and marketing new therapies for patients with sickle cell disease (SCD), rare hematologic diseases and cancers. Through the acquisition, Novo Nordisk plans to boost its presence in sickle cell disease and rare blood disorders.

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Whatever happened to the new no-patent COVID vaccine touted as a global game changer?

NPR Health - Shots

The inventors of Corbevax said it was cheap, easy to make, effective and safe. They hoped it could bring vaccine equity to countries that can't access costlier shots. Has it lived up to its promise?

Vaccine 145
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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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Sangamo presses ahead with Fabry disease gene therapy

Bio Pharma Dive

Preliminary results from a Phase 1 study show Sangamo’s treatment to be safe and suggest it is working as intended, leading the biotech to move into the trial’s next phase.

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DTC as part of an integrated strategy

World of DTC Marketing

DTC marketers spend a lot of time and money gaining insights into patients and caregivers. That information should be shared with HCPs and insurers to understand better the barriers and opportunities of treating patients. A sales representative for a biotech company shared information with oncologists about patients’ attitudes towards treatment options, including the company’s brand.

Branding 203

More Trending

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Life expectancy in the U.S. continues to drop, driven by COVID-19

NPR Health - Shots

Americans' life expectancy dropped for the second year in a row and is now the lowest it's been since the 1920s. COVID-19 is driving the downward trend, according to CDC data.

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Biotech startup Ocean pivots from IPO to SPAC merger

Bio Pharma Dive

The blank-check deal gives Ocean another route to public markets after it struggled to price an initial public offering it revealed back in June 2021.

Marketing 342
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Life expectancy declines again

World of DTC Marketing

According to STAT News, “Americans born in 2021 can expect to live for just 76.1 years — the lowest life expectancy has been since 1996, according to a new government analysis published Wednesday. This is the biggest two-year decline — 2.7 years in total — in almost 100 years.” It’s only going to get worse too. The Covid-19 pandemic is the primary cause of the decline, but we are ignoring another statistic.

Nurses 176
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Moderna files lawsuits against Pfizer and BioNTech over mRNA technology

Pharmaceutical Technology

Moderna has f iled patent infringement lawsuits in the US District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany against Pfizer and BioNTech over messenger ribonucleic acid (mRNA) technology. Pfizer and BioNTech’s Covid-19 vaccine, Comirnaty, is said to have infringed patents filed by Moderna between 2010 and 2016 for its mRNA technology.

Vaccine 246
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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U.S. life expectancy drops sharply, the second consecutive decline

STAT News

Americans born in 2021 can expect to live for just 76.1 years — the lowest life expectancy has been since 1996, according to a new government analysis published Wednesday. This is the biggest two-year decline — 2.7 years in total — in almost 100 years. The Covid-19 pandemic is the primary cause of the decline. However, increases in the number of people dying from overdoses and accidents is also a significant factor.

Research 145
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Atlas Venture’s Bruce Booth on testing the IPO waters and putting the ‘tech’ in biotech

Bio Pharma Dive

In a wide-ranging conversation with BioPharma Dive, Booth, a prolific builder of new biotechs, said he’s starting to see positive signs for startups considering an IPO or private financing.

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Arcturus announces $63m award from US government to support development of self-amplifying mRNA vaccine

BioPharma Reporter

Arcturus Therapeutics has obtained an award for up to $63.2m from the Biomedical Advanced Research and Development Authority (BARDA): allowing the company to expand its current influenza vaccine program to include development of a pandemic influenza vaccine based on its proprietary self-amplifying mRNA platform.

Vaccine 142
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Brazil: untapped market for big pharma manufacturing

Pharmaceutical Technology

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region. Brazil has a unified healthcare system known as Sistema Único de Saúde (SUS), the largest government-run public healthcare system in the world by number of beneficiaries.

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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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10 key questions about monkeypox the world needs to answer

STAT News

Just over three months ago, public health authorities in the U.K., Europe, and the U.S. began to sound the alarm on the arrival of monkeypox. Since then, this long-neglected tropical disease — which until this year was mostly limited to periodic spillovers in the areas of Western and Central Africa where the virus is endemic — has gone global.

Scientist 142
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Beam details reasons for FDA hold on base editing cancer therapy

Bio Pharma Dive

The regulator has asked Beam for a range of technical data before it can start testing the blood cancer treatment in humans.

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The U.S. diet is deadly. Here are 7 ideas to get Americans eating healthier

NPR Health - Shots

The way many Americans eat is fueling chronic disease. Here are seven big ideas from the White House's upcoming nutrition conference for how to improve Americans' diets. (Image credit: FREDERIC J.

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Merck and Guardant expand partnership to develop cancer therapies

Pharmaceutical Technology

Guardant Health has extended a partnership with Merck KGaA, Darmstadt, Germany, to aid in expediting precision oncology therapeutics development. Under the collaboration, the companies will use the GuardantINFORM real-world evidence (RWE) platform to boost works for developing Merck’s precision cancer pipeline. The development of therapies for key oncology indications with substantial unmet needs will be the expanded partnership’s focus.

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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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September 1, 2022: HCSRN Calls for Abstracts and Panel Presentations for 2023 Annual Conference

Rethinking Clinical Trials

The Health Care Systems Research Network (HCSRN) is accepting abstract submissions and panel presentation submissions for its 2023 Annual Conference until October 7, 2022. This year’s meeting will be held in Denver, Colorado, from February 21 to 23, 2023. The HCSRN is a 19-member research network focused on supporting research institutes aligned with healthcare delivery systems.

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CDC backs updated COVID shots from Pfizer, Moderna

Bio Pharma Dive

One day after the FDA’s authorization, the CDC recommended the companies’ omicron-targeted vaccines for most adults and children over 12 years old.

Vaccine 305
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Marijuana use is outpacing cigarette use for the first time on record

NPR Health - Shots

Cigarette use has been declining for decades, while marijuana use has been on the rise, according to a new Gallup survey in the U.S.

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An increasing impact of BCMA-targeting biologics in multiple myeloma

Pharmaceutical Technology

Multiple myeloma (MM) therapeutics comprise a multi-billion dollar market, among the most valuable in oncology. This is a result of intensive research efforts that have produced regimens that have prolonged patient survival, most of which are a combination of a proteasome inhibitor + an immunomodulatory drug (ie. lenalidomide) + a steroid ± an anti-CD38 antibody.

Antibody 147
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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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Testing Facility Called “Game Changer” in Regenerative Medicine

Pharma Mirror

The RegeneratOR Test Bed is an exciting game changer. The testing facility, located in North Carolina, provides supportive technology at no cost allowing companies to test and prove their cell-based products at various stages of development. The Test Bed utilizes Cytocentric principles, an innovative philosophy of putting the needs of the vulnerable cells front and center while growing and manipulating them in vitro.

Medicine 130
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Novartis’ Bradner steps down as research head amid company shake-up

Bio Pharma Dive

A well-known physician-scientist who joined Novartis from Harvard, Jay Bradner spent over six years steering the company’s research hub. He will be replaced by Merck executive Fiona Marshall.

Research 296
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There's no bad time to get a new COVID booster if you're eligible, CDC director says

NPR Health - Shots

People can get the Moderna booster if they're 18 or older, and the Pfizer-BioNTech version if they're 12 and up. In both cases, they must wait at least two months since their last COVID vaccine.

Vaccine 133
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EMA CHMP recommends expanded CMA for Novavax’s Covid-19 vaccine as booster

Pharmaceutical Technology

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting expanded conditional marketing authorization (CMA) for Novavax ’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), as a booster in adults aged 18 years and above. According to the recommendation, the vaccine is intended for usage as a homologous and heterologous booster for active immunisation for the prevention of Covid-19 in people of this age group in the EU. .

Vaccine 147
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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August 29, 2022: Special Grand Rounds Series on Ethics in Pragmatic Trials Begins September 9th

Rethinking Clinical Trials

Dr. Steven Joffe will give a keynote presentation on September 9th. The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Over the past decade, the program’s Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems.

Trials 130
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Finch to lay off 37% of staff after Takeda ends microbiome drug deal

Bio Pharma Dive

The company will cut 50 full-time positions and halt preclinical work on a pill for symptoms of autism in its second restructuring effort since April.

Drugs 293
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When does life begin? As state laws define it, science, politics and religion clash

NPR Health - Shots

For decades, the U.S. medical system has adhered to a legally recognized standard for death, one embraced by most states. Why is a uniform standard for the start of human life proving so elusive?

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FDA approves Incyte’s Pemazyre for treating myeloid/lymphoid neoplasms

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Incyte ’s Pemazyre (pemigatinib) to treat adults with relapsed or refractory (r/r) myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement. The approval was based on findings from the multicentre, open-label, single-arm Phase II FIGHT-203 clinical trial that assessed the safety and efficacy of Pemazyre in 28 adult patients with r/r MLNs with FGFR1 rearrangement.

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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.