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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Digital health is overrated but there is a future

World of DTC Marketing

The continued emphasis on digital health is overrated but digital health will become an integral part of total patient care. To become a vital part of patient care, digital health providers need to provide the medical community with studies that show their value to patient outcomes. The rapid advancement in the digital healthcare field brings many advantages and a few problems that shouldn’t be ignored.

Doctors 291
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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.

Vaccine 145
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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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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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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 340
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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

More Trending

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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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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 339
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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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Sandoz launches new global health inequalities initiative

Pharma Times

‘Act4Biosimilars’ will improve patient access and increase adoption in over 30 countries by 2030

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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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Azelis inaugurates state-of-the-art Regional Innovation Center for Food & Nutrition in Singapore 

Pharma Mirror

SINGAPORE, Azelis, a leading innovation service provider in the specialty chemicals and food ingredients industry, announces the opening of its Regional Innovation Center (RIC) for Food & Nutrition (F&N) in Singapore, further demonstrating the Group’s commitment to continuously invest in its innovation capabilities. The RIC will generate a wealth of possibilities for food innovation towards healthier and tastier solutions through pioneering, ready-to-use formulations with advance

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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.

Vaccine 336
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?A Parent’s Story: Supporting Families Through Palliative Care

Worldwide Clinical Trials

By: Kerri Padgett, Courageous Parents Network. This year, I will celebrate the life of my son, Kai, for the 10th time since his passing from hypothalamic optic glioma at the age of two. I feel immense gratitude for the support we received during his cancer journey, but there are also moments when I wish I’d had more support. I know there are many families out there needing more, too.

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NICE recommends UCB’s Fintepla for Dravet syndrome

Pharma Times

The drug is used to treat seizures caused by this rare syndrome that is a form of epilepsy

Drugs 123
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA grants speedy review to Dupixent rare skin disease

pharmaphorum

Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare skin disease prurigo nodularis (PN). The US regulator has granted Dupixent (dupilumab) a six-month priority review in PN and is due to deliver a verdict by 30 September, offering patients hope of a first-approved therapy for the highly-debilitating disease.

Sales 116
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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 304
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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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Memo Therapeutics initiates pioneering BK virus therapy trial

Pharma Times

Antibody addresses high unmet medical need in rapidly growing kidney transplant market

Antibody 123
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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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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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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 296
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Bio International Convention 2022: Program highlights

BioPharma Reporter

From the future of RNA to the applications of AI in drug development, hereâs 10 of the top sessions for biopharma pros at BIO in San Diego this month.

RNA 105
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NICE approves Merck’s Keytruda for adult patients with rare triple negative breast cancer

Pharma Times

The injection is given in combination with chemotherapy and administered once every three weeks

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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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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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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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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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NRG receives £2.68m funding boost for neurodegenerative disorders

Pharma Times

NRG Therapeutics announces multi-million Innovate UK Award to develop treatments for Parkinson’s and motor neurone disease

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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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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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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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Pfizer opens access to portfolio for low-income countries

BioPharma Reporter

The company will provide its current and future portfolio of patented medicines to 45 lower-income countries, but the move is not without controversy.

Medicine 104
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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time