Sat.May 28, 2022 - Fri.Jun 03, 2022

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BioMarin delays planned FDA filing for hemophilia gene therapy

Bio Pharma Dive

BioMarin now expects to resubmit its approval application to the FDA by the end of September, the latest regulatory setback for the company's closely watched treatment.

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Insurance companies putting profits ahead of patients

World of DTC Marketing

Five of America’s largest health insurers reported more than $11bn in profits in the second quarter – a decline from the same period last year when the Covid-19 pandemic helped drive sky-high profits yet they are having more of a say on patients’ treatments even when HCPs disagree. A vibrant 83-year-old man hurt his back while gardening. His neurologist diagnosed the problem as a disk issue that could be fixed with surgery.

Doctors 225
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Could virtual reality become an essential tool for healthcare education?

pharmaphorum

The technology behind virtual reality is rapidly advancing, allowing developers to create entire 3D hospitals for training purposes. In this article, Ben Hargreaves looks at how VR headsets are being used to better educate both healthcare professionals and the general public. Digital healthcare solutions are being talked about with increasing frequency.

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Monkeypox: The vaccine landscape

BioPharma Reporter

Interest in vaccines against monkeypox is growing as the outbreak spreads around the world. The arsenal includes existing smallpox vaccines and potential new monkeypox specific mRNA vaccines.

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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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Upstream Bio, a richly funded startup, reveals its lead drug and research plans

Bio Pharma Dive

Backed by $200 million in funding and led by biotech veteran Samantha Truex, Upstream is developing a clinical-stage inflammatory disease drug acquired from Astellas last year.

Drugs 335
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Why online marketing is so essential for pharma

World of DTC Marketing

There’s quite a debate in the CPG world about the investment in digital marketing. While some are increasing their digital budgets, does a pancake syrup company need to spend much money? However, with pharma brands, online is essential to a successful marketing strategy. According to Google search statistics, “health” and “wellness” topics are among the top searches.

Marketing 179

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mRNA tech ‘reason for hope’ on path to HIV vaccine

BioPharma Reporter

With mRNA tech achieving major success against COVID-19, the initiation of trials into vaccination against HIV is creating discussion amid a potential breakthrough in the prevention of the disease.

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Bristol Myers' autoimmune drug shows potential in lupus

Bio Pharma Dive

Positive Phase 2 results could help boost company executives' arguments that the drug, called deucravacitinib and under FDA review in psoriasis, will become a top-seller.

Drugs 335
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AstraZeneca CEO Knighted by Queen for COVID-19 Leadership

BioSpace

AstraZeneca CEO Pascal Soriot has been knighted in the Queen's Birthday Honours for his contribution to life sciences and leadership during the COVID-19 pandemic.

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At ESMO, three studies show promise of antibody-drug conjugates in breast cancer

pharmaphorum

The American Society of Clinical Oncology, or ASCO, conference is just around the corner, but one subgroup of cancer researchers just had their own gathering, as breast cancer researchers came together in person for the first time since the start of the pandemic at the ESMO Breast Cancer congress. pharmaphorum sat down with Sunil Verma, global head of oncology, medical, at AstraZeneca, to discuss three studies that were presented at the show, which demonstrate a few of the ways oncology is advan

Antibody 116
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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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Boosting innovation in antibacterials: Pitfalls and potential solutions

BioPharma Reporter

A well-funded and appropriately rewarded biotech ecosystem is needed for the next generation of antibacterials to reach the clinic and beyond, according to BIOâs State of Innovation in Antibacterial Therapeutics report.

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GSK wagers $2.1B on Affinivax and its next-generation pneumonia vaccine

Bio Pharma Dive

The deal is the second acquisition for GSK since April and gives the company access to an experimental shot that’s meant to surpass new products from Pfizer and Merck & Co.

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J&J and BMS Drugs Reduce COVID-19 Deaths in Moderate-to-Severe Population

BioSpace

Bristol Myers Squibb’s Orencia and Johnson & Johnson’s Remicade improved survival rates for people hospitalized with COVID-19 according to a new report by the National Institutes of Health.

Drugs 111
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Blood drawing robot heading for pivotal trials

pharmaphorum

In future, blood samples may be taken by an autonomous robot rather than a healthcare professional – if Dutch developer Vitestro can get its prototype approved for marketing. Vitestro’s blood drawing (phlebotomy) robot is designed to offer a solution to what the company says is a growing shortage of healthcare personnel, coupled with rising demand for blood tests with billions carried out every year worldwide.

Trials 116
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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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Lilly invests $2.1bn in new Indiana manufacturing sites

BioPharma Reporter

Eli Lilly and Company plans to expand its manufacturing footprint in Indiana by investing $2.1bn in two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.

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Bristol Myers bets $4B on Turning Point and its targeted cancer drugs

Bio Pharma Dive

Dive Brief: Bristol Myers Squibb is buying biotech Turning Point Therapeutics, announcing Friday a $4.1 billion deal that will give the pharmaceutical company an experimental drug that targets mutations found in lung cancer and other solid tumors. The deal values Turning Point at $76 a sh.

Drugs 291
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How to Attract and Keep Top Talent in the Pharma Industry

BioSpace

The increased resignation of employees is making it difficult for companies to keep up with production and meet deadlines. Here are the best ways to attract and keep top talent in the pharma industry.

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Pfizer will exit GSK consumer health JV after spinout

pharmaphorum

GlaxoSmithKline is due to complete the split from its consumer health decision – now renamed Haleon – next month, with a listing for the new company on the London Stock Exchange set for 18 July. GSK said it has now filed a prospectus for the submission of Haleon’s ordinary shares to the stock market with the Financial Conduct Authority (FCA), and is awaiting approval for the move.

Sales 105
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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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Jubilant wins US government $150m funding into vaccine manufacture

BioPharma Reporter

The agreement, which was made in coordination between the US army and BARDA, will see Jubilant expand its injectable filling production capacity to prepare for future pandemics.

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Roche SMA drug approved in youngest infants, challenging Novartis and Biogen

Bio Pharma Dive

Evrysdi, the only oral drug for the neurodegenerative disorder, can now be used to treat babies younger than 2 months who have been identified through newborn screening.

Drugs 283
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Numinus CEO: Psychedelic-assisted Psychotherapy Still Driven by Perceptions

BioSpace

BioSpace spoke with Payton Nyquvest, co-founder and CEO of Numinus about changing perceptions around psychedelic-assisted psychotherapy and the company's work in this space.

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As cases rise, WHO says monkeypox risk is “moderate”

pharmaphorum

The World Health organisation’s latest assessment of the monkeypox outbreak is that it poses a moderate threat to public health, as cases of the infection continue to rise. In an update posted yesterday, the WHO said it had received reports of 257 confirmed cases of monkeypox from 23 countries, 106 of them from the UK and 49 from Portugal, with another 120 suspected cases being investigated.

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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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How Xook is Modernizing the Cafeteria Landscape

XTalks

Xook , a developer of robotic fresh food kiosks, recently raised $1.3 million in a pre-seed funding round from a group that includes SRI Capital, Pitchright Ventures, a handful of angel investors and tech accelerators. The food tech startup is now eyeing the US for the rollout of its “food courts in a box.”. Xook created automatic cafeterias, similar to the size of vending machines or kiosks, that make snacks and simple foods based on pre-fed ingredients.

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Former AbbVie executive Severino joins Flagship-backed startup as CEO

Bio Pharma Dive

Severino left the pharma company in April after eight years as its chief scientist and then president. He'll lead Tessera Therapeutics, a well-funded genetic medicine startup.

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Outbreak Updates: Monkeypox Highlights Animal-to-Human Interface, Dogs Sniff Out COVID-19

BioSpace

Monkeypox is not COVID-19, but both are viral diseases that are front-and-center in the world of public health and epidemiology. Here's a look at the latest news on both outbreaks.

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GSK said to be close to finding partner for science cluster in UK

pharmaphorum

GlaxoSmithKline is reportedly close to finding a development partner for a major new investment project in the UK that will see a new bioscience cluster built near its research centre in Stevenage. The pharma group said last year it was looking for a collaborator to develop a 33-acre block of land in the Hertfordshire town into a hub for life science companies, creating up to 5,000 jobs over the next decade.

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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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Freestyle Libre 3 By Abbott Gets FDA Clearance and Becomes the Affordable Continuous Glucose Monitor

XTalks

A person riding an exercise bike while wearing the FreeStyle Libre 3 and using the phone app with Bluetooth connection to this continuous glucose monitor. © Abbott. All rights reserved. The circular shape of the sensor, housing, FreeStyle, Libre, and related brand marks are marks of Abbott. In this fast-paced world, the dietary changes of the human population have led to the rise of diet-related diseases such as diabetes, obesity, cardiovascular diseases and more.

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FDA extends review of Amylyx ALS drug, delaying approval decision

Bio Pharma Dive

The agency said it wanted more time to assess additional clinical trial data submitted by Amylyx, and set a new decision date of Sept. 29 for the closely watched treatment.

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Roche, Repare Ink $1.2B Deal for Development of Cancer Therapy

BioSpace

Repare Therapeutics announced a global cancer collaboration valued at up to $1.2 billion with Swiss pharma giant Roche for the development and commercialization of camonsertib.

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How Lithuania aims to become a leading European biotech hub

BioPharma Reporter

Lithuaniaâs life sciences industry is growing at one of the fastest rates in Europe. Ahead of BIO, Innovation Agency Lithuania explains what the countryâs plans are for future growth in the area and how this is built upon students heading into STEM studies.

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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.