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?

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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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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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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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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.

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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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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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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.

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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.

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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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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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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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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.

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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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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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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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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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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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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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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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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?

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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.

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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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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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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!

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The Michigan supreme court set to decide whether voters see abortion on the ballot

NPR Health - Shots

Michigan's Board of Canvassers rejected an abortion rights initiative on Wednesday after its Republican board members voted against putting the proposed constitutional amendment on November's ballot.

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Incyte secures second approval for targeted cancer drug

Bio Pharma Dive

Sold as Pemazyre, the drug, which blocks well-known cancer proteins known as FGFRs, is now also cleared for use in certain patients with very rare and aggressive blood cancers.

Drugs 288
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Your questions on the new Covid vaccine boosters answered

STAT News

Sometime this weekend or early next week, pharmacies and doctors’ offices are going to start to receive Covid-19 boosters that have been reformulated to include protection against one of the sub-variants of Omicron. These boosters, from Pfizer and its partner BioNTech as well as from Moderna, are bivalent shots. They target two strains of the SARS-CoV-2 virus, both the original strain that all previous vaccines have protected against, and the Omicron sub-variants BA.4/BA.5.

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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. .

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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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With rare acquisition, Novo Nordisk makes $1B bet on sickle cell disease drug

Bio Pharma Dive

The target company, Forma Therapeutics, started as a developer of cancer drugs but has made the most progress in rare blood disorders, attracting Novo’s attention.

Drugs 289
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Texas reports death tied to monkeypox, a first in the U.S.

STAT News

Texas health officials on Tuesday reported the death of a person with monkeypox — what appears to be the first fatal case in the United States during the unprecedented global outbreak of the virus. The unidentified person was a resident of Harris County, which is home to Houston, and was “severely immunocompromised,” according to the state health department.

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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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Poll: One year after SB 8, Texans express strong support for abortion rights

NPR Health - Shots

One year after a restrictive abortion law took effect, a poll shows a majority of Texans surveyed say they support abortion access in most or all cases. Many say the issue will motivate them to vote.

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AstraZeneca, matching Lilly, reports positive heart failure data for diabetes pill

Bio Pharma Dive

The new data position AstraZeneca to significantly expand use of Farxiga in heart failure and compete with Lilly and Boehringer Ingelheim’s rival drug Jardiance.

Drugs 289