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

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Neumora, a richly funded brain drug developer, readies for an IPO

Bio Pharma Dive

Neumora’s filing late Friday, along with that of radiopharmaceutical startup RayzeBio earlier this week, could be an important test of the biotech IPO market.

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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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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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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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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.

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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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Agenus to lay off 25% of staff, trim pipeline in cancer drug push

Bio Pharma Dive

The job cuts are meant to preserve enough cash so the nearly three-decade-old company can potentially pursue its first drug approval next year.

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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August 23, 2023: PCT Grand Rounds to Highlight a Pragmatic Trial of an EHR Display of Real-Time PRO Data

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Gabriela Schmajuk of the University of California, San Francisco, will present “Pragmatic Trial of an EHR Application to Display Real-Time PRO Data: Successes and Challenges.” The Grand Rounds session will be held on Friday, August 25, 2023, at 1:00 pm eastern. Schmajuk is a professor of medicine at UCSF and the chief of rheumatology at the San Francisco VA Health Care System.

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

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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 243
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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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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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NICE recommends Amryt’s Filsuvez for rare skin disorder

Pharma Times

Around 670 people in England with epidermolysis bullosa will benefit from the treatment - 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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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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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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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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AstraZeneca’s Soliris approved in Japan for paediatric gMG patients

Pharma Times

The drug is the first to be approved in Japan to treat children and adolescents with& generalised myasthenia gravis - News - PharmaTimes

Drugs 112
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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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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 232
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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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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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FDA grants ODD to Nexcella's multiple myeloma treatment

Pharma Times

The drug is currently being assessed in a phase 1b/2a clinical trial - News - PharmaTimes

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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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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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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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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

Vaccine 106
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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).

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FDA approves Pfizer’s RSV vaccine for use in pregnancy

Bio Pharma Dive

The expanded approval follows the FDA’s May clearance of the shot, called Abrysvo, in older adults.

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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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GSK shares promising results from shingles vaccine trial

Pharma Times

The varicella zoster virus that causes shingles and chicken pox is typically present in over 90% of adults globally - News - PharmaTimes

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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.