World of DTC Marketing
AUGUST 30, 2022
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?
Bio Pharma Dive
AUGUST 30, 2022
The biotech's drug prospect vopratelimab has become the latest member of a group of medicines targeting a molecule called ICOS to fall short of expectations in clinical testing.
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Pharmaceutical Technology
AUGUST 30, 2022
The US Food and Drug Administration (FDA) has accepted Sanofi ’s efanesoctocog alfa (BIVV001) Biologics License Application (BLA), to treat haemophilia A, for priority review. A decision from the regulatory agency on approval for the therapy is anticipated on 28 February next year. The application is based on findings from the open-label, non-randomised, interventional Phase III XTEND-1 clinical trial designed to evaluate the safety, efficacy and pharmacokinetics of efanesoctocog alfa given once
Bio Pharma Dive
AUGUST 30, 2022
The neuroscience-focused company has agreed to buy U.K.-based Diurnal for around $57 million, a move it expects to “accelerate the establishment of its clinical development and commercial activities” in Europe.
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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
Pharma Mirror
AUGUST 30, 2022
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.
Pharmaceutical Technology
AUGUST 30, 2022
RANKINGS 2022 Excellence Business Expansion Commended Excellence Innovation Commended Excellence Investments Commended. The Verdict. Verista is a Life Sciences business, technology and compliance firm specializing in systems, quality, and validation solutions throughout the product lifecycle. The company has been ranked in the 2022 Excellence Rankings in the areas of Business Expansion , Innovation and Investments.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 30, 2022
Moderna has obtaine d temporary authorisation from Swissmedic for its Omicron-targeting bivalent booster vaccine for Covid-19, Spikevax Bivalent Original/Omicron (mRNA-1273.214), for individuals aged 18 years and above. . The vaccine is indicated for active immunisation for the prevention of Covid-19. It comprises 25µg mRNA-1273 (Spikevax) and 25µg of a vaccine candidate that acts on the Omicron variant of concern (BA.1).
STAT News
AUGUST 30, 2022
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.
Pharmaceutical Technology
AUGUST 30, 2022
Zerion Pharma has entered a partnership with Insud Pharma for the development and marketing of drug products using Zerion Pharma's solubility-boosting Dispersome technology. . Under the deal, Zerion will handle the development of Dispersome formulations of marketed drugs. The finished product dosage form, clinical development and the final products’ marketing and sales across the globe will be handled by Insud. .
STAT News
AUGUST 30, 2022
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.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Rethinking Clinical Trials
AUGUST 30, 2022
The US Food and Drug Administration (FDA) will host a webinar on September 9 for industry, patient groups, and other interested stakeholders to discuss and answer questions about the draft guidance, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The draft guidance, known as “Guidance 3,” is the third of 4 methodological guidance documents for patient-focused drug development that describe how patients, caregivers, r
NPR Health - Shots
AUGUST 30, 2022
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.
BioPharma Reporter
AUGUST 30, 2022
AstraZeneca's long-acting antibody combination Evusheld has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection: marking the first global marketing approval of Evusheld as a treatment for COVID-19.
STAT News
AUGUST 30, 2022
When an obstetrician or midwife cuts the umbilical cord after a child is born, the room is filled with tense silence until the baby’s first cry is heard. I once heard this silence in an operating room where 32 people were bustling around, all awaiting the birth of a baby with a massive growth covering her neck and jaw that might make it difficult — if not impossible — for her to breathe on her own.
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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.
pharmaphorum
AUGUST 30, 2022
Neurocrine Biosciences has featured on lists of potential takeover candidates for years, but has now taken the lead on a buyout of UK biotech Diurnal that if consummated will extend its therapeutic focus further into hormonal disorders. The 27.5 pence-a-share cash deal values Diurnal at around £48.3 million ($57 million), a 144% premium to the biotech’s closing share price on Friday.
STAT News
AUGUST 30, 2022
“N ovel.” “Exciting.” “Incredible.” “Devastating.” “Unprecedented.” You name the adjective, and a scientist has probably stuck it into a grant application to score funding. In semi-official scientific parlance, they’re known as “hype.” And adjectives like these are becoming more common in grant applications, according to a new study.
NPR Health - Shots
AUGUST 30, 2022
The Food and Drug Administration is planning to authorize a new generation of COVID-19 boosters this week that for the first time will target the omicron variant. (Image credit: FREDERIC J.
STAT News
AUGUST 30, 2022
Five years ago today , the Food and Drug Administration issued a landmark approval for Kymriah, the first gene therapy available in the United States. Cell and gene therapy products can transform how certain diseases are treated, offering life-extending and potentially curative benefits for patients living with life-threatening or debilitating diseases.
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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.
Drug Discovery World
AUGUST 30, 2022
The Phacilitate Advanced Therapies Europe 2022 conference will take place from 30 August to 1 September at the Royal Lancaster in London, UK. The conference is the European twin to Phacilitate Advanced Therapies Week, an event held in January in Florida, US. The event is tailored to a European audience looking to commercialise ATMPs globally, as well as a global audience looking to understand and expand into the European market.
STAT News
AUGUST 30, 2022
You’re reading the web edition of Health Care Inc., STAT’s weekly newsletter following the flow of money through the health care system. Sign up here to get it in your inbox. A different way for physicians to get recertified. Doctors dislike renewing their specialty certifications, also known as “maintenance of certification” in industry jargon.
XTalks
AUGUST 30, 2022
When you’re planning a webinar, one of the most important things to do is create a survey for attendees to partake in. This survey will help you gather information about your audience and their needs. In order to create an effective survey, you need to ask the right questions. We will discuss five tips for crafting successful webinar survey questions!
STAT News
AUGUST 30, 2022
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday. A giant leap for data access?
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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.
pharmaphorum
AUGUST 30, 2022
Bayer is pressing ahead with a phase 3 trial of its oral Factor XIa inhibitor asundexian, a new anticoagulant, despite missing efficacy targets in two mid-stage studies. The OCEANIC trial programme will investigate the potential of asundexian in up to 30,000 patients with atrial fibrillation (AF) as well as patients with a non-cardioembolic ischaemic stroke or high-risk transient ischemic attack (TIA), said Bayer.
XTalks
AUGUST 30, 2022
An initial public offering (IPO) refers to the process of offering shares of a private corporation to the public in a new stock issuance for the first time, allowing a company to raise equity capital from public investors. Meanwhile, it also allows public investors to participate in the offering. Food IPOs offer exciting opportunities for investors, with 2021 seeing the likes of Oatly and Krispy Kreme go public.
Pharma Times
AUGUST 30, 2022
Therapy is a biosimilar of Lucentis which treats several serious retinal diseases across the European Union
BioPharma Reporter
AUGUST 30, 2022
Applied StemCell is expanding its cGMP facility to increase its cell banking and cell product manufacturing capacity.
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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.
pharmaphorum
AUGUST 30, 2022
New practical guide walks digital health entrepreneurs through the patient and public involvement and engagement process. . Digital transformation could revolutionise healthcare, making for happier, healthier populations – but only if solutions are designed and deployed with patients at the heart. . That’s why a newly published, evidence-based guide for digital innovators, from the Academic Health Science Networks (AHSN) Network, the University of Plymouth, and Boehringer Ingelheim, aims to s
Pharma Times
AUGUST 30, 2022
It is estimated that every year more than 6,300 people will be diagnosed with CML in Europe
BioPharma Reporter
AUGUST 30, 2022
Thermo Fisher Scientific has opened its new viral vector manufacturing facility in Plainville, Massachusetts.
NPR Health - Shots
AUGUST 30, 2022
The Food and Drug Administration is planning to authorize a new generation of COVID-19 boosters this week that for the first time will target the omicron variant.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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