Bio Pharma Dive

MAY 1, 2023

The cash influx extends Maze’s financial runway into 2025, giving the South San Francisco company time to advance other drug candidates into testing.

Drugs 351

Drugs 351

Pharmaceutical Technology

MAY 1, 2023

Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share. Both the companies’ Boards of Directors have unanimously approved the deal.

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Drugs Development 278

Bio Pharma Dive

MAY 1, 2023

Founded by Sam Waksal, Graviton Biosciences is developing drugs that block an enzyme called ROCK2, which drew the interest of neurology-focused Ovid.

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Development Drugs 319

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 1, 2023

Microscopic backpacks full of drugs designed to stick to troublesome immune cells have been shown to improve the health of mice with a condition similar to multiple sclerosis in humans.

Scientist 214

Scientist Development Drugs Research 214

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Clinical Supply

Bio Pharma Dive

MAY 1, 2023

The company was co-founded by, among others, Jamie Cate, husband of CRISPR pioneer Jennifer Doudna, and Kevan Shokat, a chemical biologist whose previous work helped lead to KRAS-targeting cancer drugs.

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Protein Drugs 287

Pharmaceutical Technology

MAY 1, 2023

Teva Pharmaceuticals and MedinCell have received approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone) extended-release injectable suspension to treat adult patients with schizophrenia, a chronic, progressive, and severely debilitating mental health disorder. Developed using MedinCell’s SteadyTeq copolymer technology, Uzedy is the first subcutaneous, long-acting formulation of risperidone.

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FDA Approval Clinical Trials Clinical Trials Trials 189

Pharmaceutical Technology

MAY 1, 2023

Nicox’s Chinese partner Ocumension Therapeutics has secured priority review status for the New Drug Application (NDA) for Zerviate (cetirizine ophthalmic solution), 0.24%, from China’s National Medical Products Administration (NMPA). This will expedite the regulatory approval process as well as the launch of Zerviate in the country, expected next year.

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Licensing Licensing Sales Packaging 162

Medical Xpress

MAY 1, 2023

Reports of near-death experiences—with tales of white light, visits from departed loved ones, hearing voices, among other attributes—capture our imagination and are deeply engrained in our cultural landscape.

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Pharmaceutical Technology

MAY 1, 2023

The California Institute of Regenerative Medicine (CIRM) has awarded $3.46m Clinical Stage Research Programme (CLIN1) grant to Ossium Health for advancing OSSM-007 development to treat steroid-refractory acute graft versus host disease (GVHD). OSSM-007 is the interferon-gamma primed mesenchymal stem cell product of Ossium Health. The grant will help in expediting pre-clinical and manufacturing activities of the product.

Development 162

Development Gene Therapy Gene Production 162

Medical Xpress

MAY 1, 2023

Gene-editing therapy aimed at two targets—HIV-1, the virus that causes AIDS, and CCR5, the co-receptor that helps the virus get into cells—can effectively eliminate HIV infection, new research from the Lewis Katz School of Medicine at Temple University and the University of Nebraska Medical Center (UNMC) shows. The study, published online in the journal Proceedings of the National Academy of Sciences (PNAS), is the first to combine a dual gene-editing strategy with antiretroviral drugs to cure a

Gene Editing 124

Gene Editing Gene Medicine Drugs 124

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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

Clinical Trials

Pharmaceutical Technology

MAY 1, 2023

The successful launch of mRNA vaccines during the Covid-19 pandemic has not only spurred mRNA-related research across interdisciplinary groups, but also further validated the use of lipid nanoparticles as delivery approaches. This issue’s cover story delves into how the interest around exploring nanotechnology for drug delivery solutions has recently grown.

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Drug Delivery Research Drugs Clinical Trials 130

Medical Xpress

MAY 1, 2023

The exercise was simple: inhale for a count of five, then exhale for a count of five. Do that for 20 minutes, twice a day, for four weeks.

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Pharmaceutical Technology

MAY 1, 2023

Australian biotechnology company Cartherics has granted licence for CTH-004 , its autologous CAR-T cell product, to Chinese company Shunxi. Under the deal terms, Shunxi will have licence to develop, manufacture, and commercialise CTH-004 to treat several solid tumours including ovarian cancer in Greater China, including Hong Kong, Taiwan, Mainland China, and Macao.

Gene Therapy 130

Gene Therapy Gene Development Clinical Trials 130

Medical Xpress

MAY 1, 2023

For many decades, neuroscientists believed there was a "critical period" in which the brain could learn to make sense of visual input, and that this window closed around the age of 6 or 7.

Scientist 119

Scientist 119

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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

Clinical Research

Pharma in Brief

MAY 1, 2023

On April 20, 2023, the federal government tabled legislation ( Bill C-47 ) that would amend the Patent Act to bring, for the first time, a system of general patent term adjustment ( PTA ) into Canada. Canada is required under the Canada-United States-Mexico Agreement ( CUSMA ) to adopt a PTA system by 2025. The PTA system is intended to compensate patentees for “unreasonable delays” by the patent office in issuing a patent.

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Regulation Life Science Development Research 98

Medical Xpress

MAY 1, 2023

Paramedics summoned to an Arizona retirement community last summer found an 80-year-old woman slumped inside her mobile home, enveloped in the suffocating 99-degree (37 C) heat she suffered for days after her air conditioner broke down. Efforts to revive her failed, and her death was ruled environmental heat exposure aggravated by heart disease and diabetes.

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XTalks

MAY 1, 2023

It has been a little over a year since Axonics released its “Find Real Relief” TV ad campaign for overactive bladder and incontinence issues, and the company’s annual performance numbers are in. Axonics reported a 2022 revenue of $273.7 million, an increase of 52 percent compared to 2021. The company’s CEO Raymond W. Cohen said in a recent news release that “We continue to make progress on several key initiatives, including our direct-to-consumer advertising campaign.

Drugs 98

Drugs FDA Approval Doctors Doctor 98

Medical Xpress

MAY 1, 2023

What if your physician could predict if—or when—you might experience a heart attack, cardiac arrest or another heart-related problem?

Cardiology 131

Cardiology 131

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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.

Clinical Trials

XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This makes Qalsody the first approved treatment to target a genetic cause of ALS. Qalsody is administered intrathecally by healthcare professionals experienced in conducting lumbar punctures.

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FDA Approval Gene Genetics Protein 89

Medical Xpress

MAY 1, 2023

The bone density of many people decreases as they get older. This process, which is known as osteoporosis, often goes unnoticed, even if there are fractures to the vertebral bodies. These fractures could be detected by means of X-rays or computed tomography (CT), but this does not always occur. For example, because the CT is done for a different reason, a vertebral fracture can be overlooked in the stress of everyday life in the clinic.

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Radiology 111

Fierce Pharma

MAY 1, 2023

Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy kdunleavy Mon, 05/01/2023 - 07:35

FDA Approval 103

FDA Approval Drugs 103

Medical Xpress

MAY 1, 2023

Epilepsy affects approximately 1-in-26 people and the most common form, known as temporal lobe epilepsy (TLE), often cannot be adequately treated with anti-seizure medications. Patients with this form of epilepsy may require neurosurgery to provide relief from seizures. The condition's origins and progression are not well understood, and it has been unclear if genetic mutations may contribute to TLE.

Genetics 111

Genetics 111

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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.

Clinical Supply

Fierce Pharma

MAY 1, 2023

Struggling Biogen paid its 2 CEOs more than $57M last year, including $30.

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Medical Xpress

MAY 1, 2023

A new study on herpes infections of the eye from University of Illinois Chicago researchers helps shed light on the question of viral reinfections by identifying a key protein involved in viral reinfections that could be targeted by antiviral drugs.

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Protein Drugs Research 111

Fierce Pharma

MAY 1, 2023

Pfizer, Astellas build case for Xtandi in early-stage hormone-sensitive prostate cancer aliu Mon, 05/01/2023 - 09:56

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Hormones 89

Medical Xpress

MAY 1, 2023

It's generally accepted we will lose muscle strength and slow down as we age, making it more difficult to perform simple tasks such as getting up, walking and sitting down.

Research 111

Research 111

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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.

Clinical Trials

ACRP blog

MAY 1, 2023

While questions about what decentralized clinical trials (DCTs) are may have been largely resolved in the minds of most clinical research professionals by now, the reactions to several polling questions on Sunday (April 30) from attendees at the ACRP 2023 conference in Dallas, Texas, suggest strongly that opinions in the field on some aspects of how, when, and why they should be implemented remain divided.

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Clinical Research Research Clinical Trials Clinical Trials 59

Medical Xpress

MAY 1, 2023

A team of 87 researchers from multiple institutions led by the University of Michigan School of Public Health have published a paper in Science Advances—"The genetic determinants of recurrent somatic mutations in 43,693 blood genomes"—which challenges some long-held assumptions about non-oncogenic somatic mutations.

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Genome Genomics Genetics Research 105

WCG Clinical

MAY 1, 2023

CNS researchers have been using the EDSS (Expanded Disability Status Scale) for years to quantify the severity of disability in patients with multiple sclerosis and other neurological conditions. However, with more than 130 data points, this scale can be cumbersome to complete on paper, leaving it vulnerable to inaccuracies, including interrater and intrarater variability. 1 To address this, WCG collaborated with Neurostatus-UHB Ltd., to develop a digital version, the electronic EDSS (eEDSS).

Clinical Trials 52

Clinical Trials Clinical Trials Trials Dermatology 52

Medical Xpress

MAY 1, 2023

Glioblastoma multiforme (GBM) is the most aggressive and common malignant type of brain tumor, accounting for 16% of all primary brain tumors. Andrea Olsen from Oslo, Norway; Zachary Harpaz from Boca Raton, Florida; and Chris Ren from Shanghai, China have conducted a study in which they used a generative artificial intelligence (AI) engine for target discovery to identify new therapeutic targets for GBM.

Engineer 105

Engineer Research Drugs 105

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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.

Clinical Supply