Sat.Aug 19, 2023 - Fri.Aug 25, 2023

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Apellis finds faulty needles in probe of rare eye drug side effects

Bio Pharma Dive

The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.

Drugs 246
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Pfizer’s first-ever bispecific antibody Elrexfio holds promise in multiple myeloma

Pharmaceutical Technology

The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.

Antibody 246
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August 22, 2023: Distributed Research Network Shares Opportunities and Challenges for Pragmatic Research Embedded in Health Insurance Plans

Rethinking Clinical Trials

In an article published this month in Clinical Trials , researchers from the NIH Pragmatic Trials Collaboratory’s Distributed Research Network share opportunities for conducting pragmatic trials embedded in health insurance plans. “There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensing

Research 245
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Can Drinking Coffee Save You From Sleep Deprivation? A Psychologist Explains

AuroBlog - Aurous Healthcare Clinical Trials blog

There is no denying the importance of sleep. Everyone feels better after a good night of sleep, and lack of sleep can have profoundly negative effects on both the body and the brain. So what can be done to substitute for a lack of sleep?

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Foundery, a new biotech venture firm, sets out to speed early immune drug research

Bio Pharma Dive

Billing itself as both a scientific and investment partner, Foundery aims to provide research grants and drug development support to researchers developing new immunotherapies.

Research 246
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CVS Health enters biosimilar fray with launch of new subsidiary

Pharmaceutical Technology

The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.

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More Trending

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Your Body Can Be ‘Younger’ Than You Are. Here’s How That’s Possible.

AuroBlog - Aurous Healthcare Clinical Trials blog

The saying goes that money can’t buy you love. But can it buy you time? This is what US billionaire Bryan Johnson is hoping to find out. The 45-year-old reportedly spends millions each year in an attempt to reverse ageing and regain his 18-year-old body (presumably sans acne).

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FDA approves Novartis’ copycat of blockbuster Biogen drug

Bio Pharma Dive

According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.

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EC approves TECVAYLI’s reduced dosage frequency for multiple myeloma

Pharmaceutical Technology

The EC approved Janssen's Type II variation application for reduced dosing frequency of bispecific antibody TECVAYLI for multiple myeloma.

Antibody 246
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Pfizer’s RSV vaccine receives EC approval to protect infants and older adults

Pharma Times

The decision follows a recent recommendation from the European Medicines Agency’s human medicines committee - News - PharmaTimes

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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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Scientists Identify a Hidden Pattern of Consciousness in The Brains of Coma Patients

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists have used advanced imaging techniques to identify brain activity and regions linked to cognitive motor dissociation (CMD), or ‘hidden consciousness‘ CMD is a state in which a person appears comatose and unresponsive while inwardly showing signs of conscious brain activity.

Scientist 203
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Roche’s surprise study results spur new optimism for TIGIT drugs

Bio Pharma Dive

Data inadvertently published from a closely watched lung cancer study suggest a drug blocking the protein TIGIT may help extend survival, a finding that boosted shares of other developers.

Drugs 246
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Dizal receives approval in China for NSCLC therapy

Pharmaceutical Technology

Dizal has received approval from China’s NMPA for sunvozertinib to treat adult patients with locally advanced or metastatic NSCLC

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CVS Health Enters Biosimilars Market with Launch of Cordavis Subsidiary

BioSpace

The consumer healthcare brand is joining the growing biosimilars market in the U.S. with its new subsidiary Cordavis, which will market a Humira biosimilar as its first product.

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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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Microplastics Could Trigger Inflammation in Human Brain Cells

AuroBlog - Aurous Healthcare Clinical Trials blog

Mounting evidence suggests microplastics in our blood are likely capable of crossing our mammalian brain-blood barrier. Now preliminary experiments reveal the potential impact they can have once in there, finding weathered microplastics are far more toxic to human brain cells than fresh ones.

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Boehringer sues to block US drug price program

Bio Pharma Dive

The pharma’s suit, which claims Medicare’s new power to negotiate certain drug prices is unconstitutional, comes days before the agency will reveal the first 10 medicines to be included under the plan.

Drugs 243
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Japan grants patent for BioArctic’s Parkinson’s disease antibody

Pharmaceutical Technology

Japan has granted a new drug substance patent for BioArctic’s monoclonal antibody (mAb), BAN0805, to treat Parkinson’s disease.

Antibody 245
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Meet the researcher: Giusy Di Conza

Drug Discovery World

DDW’s Megan Thomas looks at a day in the life of Giusy Di Conza , Head of Research at iOnctura. MT: Where do you work, and can you tell us what you’re working on at the moment? GDC : I’m Head of Research for a young, dynamic biotech called iOnctura. We are pioneering research into new biological mechanisms for established drug targets. Whereas traditionally biotechs have studied the effect of a drug on a singular pathway, we are focused on targets that are involved in multiple independent tumour

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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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Experimental Probiotic Uses Microbes to Treat Multiple Sclerosis in Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

Our immune system is made up of multiple smart defenses built into our bodies – but if those defenses go haywire, it can lead to diseases such as multiple sclerosis (MS). Scientists may have found a new way to control potentially dangerous autoimmune responses.

Scientist 182
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J&J-backed startup raises another $150M for brain drug development

Bio Pharma Dive

The funding for Rapport Therapeutics saw participation from a series of so-called crossover investors, many of which have pulled back from biotech startups in recent years.

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FDA grants approval to Regeneron Pharmaceuticals’ EYLEA HD injection

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ EYLEA HD injection 8 mg.

Drugs 246
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Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America

FDA Law Blog

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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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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DCGI issues alert on suspected falsified GLP-1-RA products in the market

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. The alert follows the World Health Organisation (WHO)’s communication about a safety threat which has been identified with falsified versions of these products being available in the market.

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Startup Cellares adds $255M as investors pour cash into cell therapy production

Bio Pharma Dive

Bristol Myers Squibb is among those backing the startup, which claims the manufacturing capacity at its New Jersey plant can surpass that of conventional CDMO facilities.

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Revive begins development of next-generation Bucillamine formulation

Pharmaceutical Technology

Revive has begun the development of a next-generation formulation of Bucillamine to treat public health emergencies.

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Novo Adds Another Cardio Win for Wegovy, Shows Benefits in Heart Failure

BioSpace

Wegovy’s highest dose significantly improved physical function and quality of life in obese patients with heart failure, according to results published Friday in The New England Journal of Medicine.

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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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Cabinet approves National Policy on R&D and Innovation and PRIP Scheme

AuroBlog - Aurous Healthcare Clinical Trials blog

In a move to strengthen the research and development (R&D) and innovation efforts of Indian pharma industry and academia, the Cabinet has approved the National Policy on Research & Development and Innovation in the Pharma-MedTech Sector and the Scheme for Promotion of Research and Innovation in Pharma-MedTech (PRIP).

Research 146
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FDA expands use of Neurocrine drug to Huntington’s patients

Bio Pharma Dive

Analysts expect the approval of Ingrezza in Huntington’s patients with a movement disorder known as chorea to intensify a commercial battle between Neurocrine and Teva.

Drugs 242
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AstraZeneca scores its second paediatric approval for Soliris in Japan

Pharmaceutical Technology

Soliris is already approved to treat refractory generalised myasthenia gravis in adults in different regions.

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FDA Approves Sandoz Biosimilar to Biogen’s MS Therapy Tysabri

BioSpace

Amid one of the industry’s steepest patent cliffs, the regulator Thursday approved Sandoz’s Tyruko, the first biosimilar for treating relapsing multiple sclerosis in adults. Sandoz is a division of Novartis.

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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.