Merck’s latest deal turns up the spotlight on immune system drugmakers
Bio Pharma Dive
APRIL 17, 2023
The buyout of Prometheus highlights pharmaceutical companies’ intense interest in medicines targeting inflammatory diseases, according to analysts.
Mon.Apr 17, 2023
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Merck agrees to acquire Prometheus Biosciences for $10.8bn
Pharmaceutical Technology
APRIL 17, 2023
Merck has signed a definitive agreement to buy clinical-stage biotechnology firm Prometheus Biosciences for $10.8bn, strengthening its immunology pipeline. The company will buy all of Prometheus Biosciences’ outstanding shares for $200 a share through a subsidiary. Prometheus Biosciences uses precision medicine to discover, develop and commercialise new therapeutic and companion diagnostic products to treat immune-mediated diseases.
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Vaxcyte strengthens case for experimental pneumococcal vaccine
Bio Pharma Dive
APRIL 17, 2023
The company reported positive results from a second Phase 2 study of a shot that’s meant to challenge vaccines from Pfizer, Merck and GSK.
NKGen Biotech signs agreement to merge with Graf Acquisition
Pharmaceutical Technology
APRIL 17, 2023
NKGen Biotech, a clinical-stage natural killer (NK) cell therapy firm, has signed a definitive agreement to combine its business operations with Graf Acquisition. NKGen Biotech will become a publicly traded company, while Graf will be rebranded as NKGen Biotech. Graf is also anticipated to be listed on the New York Stock Exchange, NYSE American and Nasdaq under the ticker symbol ‘NKGN’.
Biotech leader Vagelos to retire as Regeneron board chair
Bio Pharma Dive
APRIL 17, 2023
The former Merck CEO will step down from the role he’s held for nearly three decades later this year. Leonard Schleifer and George Yancopoulos, respectively Regeneron's CEO and CSO, will succeed him.
FDA AdCom votes in favour of Lundbeck’s/Otsuka’s Rexulti in AAD
Pharmaceutical Technology
APRIL 17, 2023
On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). Serving as a joint meeting of the Psychopharmacologic Drugs AdCom and the Peripheral and Central Nervous System Drugs AdCom, experts from the committees voted nine against one in support of Rexulti’s supplemental New Drug
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Health Canada accepts Pfizer Canada’s bivalent RSV vaccine for review
Pharmaceutical Technology
APRIL 17, 2023
Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The vaccine will be used to prevent lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in adults aged 60 and above. Immunising pregnant women will also prevent these diseases in infants from birth up to six months.
Brain images just got 64 million times sharper
Medical Xpress
APRIL 17, 2023
Magnetic resonance imaging (MRI) is how we visualize soft, watery tissue that is hard to image with X-rays. But while an MRI provides good enough resolution to spot a brain tumor, it needs to be a lot sharper to visualize microscopic details within the brain that reveal its organization.
Satsuma submits new drug application for STS101 to the US FDA
Pharmaceutical Technology
APRIL 17, 2023
US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. STS101 combines Satsuma’s nasal powder formulation and Shin Nippon Biomedical Laboratories’ (SNBL) delivery device technology, which was licensed by Satsuma.
No magic number for time it takes to form habits, finds new study
Medical Xpress
APRIL 17, 2023
Putting on your workout clothes and getting to the gym can feel like a slog at first. Eventually, you might get in the habit of going to the gym and readily pop over to your Zumba class or for a run on the treadmill. A new study from social scientists at Caltech now shows how long it takes to form the gym habit: an average of about six months.
The New Age of Decentralized Clinical Trials
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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
Akthelia and the University of Iceland receive funds for IN-ARMOR project
Pharmaceutical Technology
APRIL 17, 2023
Akthelia Pharmaceuticals and the University of Iceland have received a €6m European Union (EU) Horizon Grant for the IN-ARMOR project. The project aims to combat antimicrobial resistance (AMR), identified as one of the top 10 global health challenges by the World Health Organisation (WHO). AMR and multi-drug resistance are said to result in the deaths of more than five million people per year.
Navigate the complexities of cell and gene therapies
Bio Pharma Dive
APRIL 17, 2023
See how the effective use of CMC expertise helped guide a biopharma company’s development of a CGT product.
Incannex engages QPS for CannQuit and ReneCann
Pharmaceutical Technology
APRIL 17, 2023
Australian pharmaceutical company Incannex has appointed Quest Pharmaceutical Services (QPS) to advance CannQuit-N (Nicotine), CannQuit-O (Opioid) and Renecann Products in the USA and the European Union (EU). QPS was established in 1995 to provide bioanalytical LC-MS/MS contract services. The company will provide regulatory advice to Incannex, and manage clinical trials to develop CannQuit and ReneCann products to treat addiction and immune-disordered skin diseases.
Supreme Court looks at whether Medicare and Medicaid were overbilled under fraud law
NPR Health - Shots
APRIL 17, 2023
Arguments on Tuesday center on a powerful tool for fighting fraud in government contracts and programs. The case examines whether major pharmacies knowingly overcharged Medicare and Medicaid.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
US FDA approves label update for Horizon’s Tepezza TED drug
Pharmaceutical Technology
APRIL 17, 2023
The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. An insulin-like growth factor-1 receptor inhibitor, Tepezza is claimed to be the first and only medicine to receive approval from the FDA to treat TED, a rare progressive, debilitating and potentially vision-threatening autoimmune
Study links poor diet to 14 million cases of type 2 diabetes globally
Medical Xpress
APRIL 17, 2023
A research model of dietary intake in 184 countries, developed by researchers at the Friedman School of Nutrition Science and Policy at Tufts University, estimates that poor diet contributed to over 14.1 million cases of type 2 diabetes in 2018, representing over 70% of new diagnoses globally. The analysis, which looked at data from 1990 and 2018, provides valuable insight into which dietary factors are driving type 2 diabetes burden by world region.
Smart Immune secures funding from Bill & Melinda Gates Foundation
Pharmaceutical Technology
APRIL 17, 2023
Clinical-stage biotechnology company Smart Immune has secured $5m in equity investment from the Bill & Melinda Gates Foundation for expediting the development of its thymus-empowered ProTcell platform for the treatment of cancer and infectious diseases. Smart Immune’s T-cell therapy platform, ProTcell is designed to ensure early immune reconstitution following allogeneic haematopoietic stem cell transplantation.
Teen with life-threatening depression finally found hope. Then insurance cut her off
NPR Health - Shots
APRIL 17, 2023
Despite laws that say mental health care should be paid for on a par with other medical care, health insurance stopped covering the care a suicidal teen needed before she was stable.
The New Age of Decentralized Clinical Trials
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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.
Telix revives Olaratumab development with positive preclinical data
Pharmaceutical Technology
APRIL 17, 2023
Telix has announced the successful preclinical development of radiolabelled olaratumab, an antibody licensed by Eli Lilly and Company. Telix has demonstrated proof-of-concept (PoC) and will now progress to first-in-human clinical studies. After Telix secured exclusive global rights to develop and commercialise radiolabelled forms of olaratumab for human cancer treatment, the Australia-headquartered company has demonstrated proof-of-concept (PoC) of using the drug to radiopharmaceutically deliver
Opinion: OTC naloxone is a baby step toward making the life-saving medication accessible
STAT News
APRIL 17, 2023
In an attempt to make naloxone more accessible amid the massive human toll of the opioid crisis, the FDA recently approved over-the-counter naloxone. Naloxone is the one solution that has remained constant through the evolving opioid crisis. A safe and effective medication that can quickly reverse an overdose, it is a critical tool in the public health response to the opioid crisis.
Progress in search for alopecia areata treatment for adolescents
Medical Xpress
APRIL 17, 2023
A medication that has been found to effectively treat the skin disease alopecia areata in adults is also successful in treating adolescent patients, according to a Yale-led clinical trial.
Q&A: What does it mean when a clinical trial is delayed? More than you think
STAT News
APRIL 17, 2023
Frank David was just starting an independent research program on cell signaling in cancer and kidney development at a lab in Boston when he realized he’d rather be doing something else. “I figured out I was more interested in how science turned into medicine than I was in actually making and discovering new science,” he recalled.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Long COVID smell loss linked to changes in the brain
Medical Xpress
APRIL 17, 2023
People living with long COVID who suffer from loss of smell show different patterns of activity in certain regions of the brain, a new study led by UCL researchers has found.
Jamil was struggling after his daughter had a stroke. Then a doctor pulled up a chair
NPR Health - Shots
APRIL 17, 2023
In 2015, Dr. Mark Petersen shared difficult news about the treatment plan for Jamil Zaki's fragile newborn daughter. But instead of delivering the news and getting back to work, he pulled up a chair.
Details of how the gut microbiota changes in the first months of life revealed by Italian study
Medical Xpress
APRIL 17, 2023
Details of how the gut microbiota changes during the first three months of life will be presented at this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen, Denmark (15-18 April).
Opinion: Where are the guidelines for the production of animals with intentional genomic alterations?
STAT News
APRIL 17, 2023
Genetic engineering has the potential to transform how we raise animals for meat and other products, making food safer, improving animal health and welfare, and shrinking animal agriculture’s environmental footprint. Pigs that are less likely to induce allergic reactions in humans. Cows with short hair that are better adapted to a changing climate or others that lack horns , preventing injury to other cows or farmhands.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Depression found to affect the care and survival of patients with breast cancer
Medical Xpress
APRIL 17, 2023
In a recent study, having depression before or after a breast cancer diagnosis was associated with a lower likelihood of survival. The findings are published in the journal Cancer.
Free Uber rides helped patients keep their prenatal appointments. Now the company wants insurers to pay for it
STAT News
APRIL 17, 2023
For patients of the Community of Hope and Mary’s Center clinics in Washington, D.C., getting to their medical appointments can be a challenge — many live far from public transit or lack cars. If they’re pregnant, the fallout can be especially harmful if they miss prenatal doctor visits, risking the baby’s and mother’s health.
An early study of fecal transplant to help slow early-stage motor neuron disease progression
Medical Xpress
APRIL 17, 2023
A randomized clinical trial is looking at whether fecal microbiota transplantation (FMT) from healthy donors into adults with early-stage amyotrophic lateral sclerosis (ALS—one of the most common forms of motor neuron disease) can modulate the immune reaction during inflammation responses that characterize disease progression, and aims to investigate the relationship between specific gut bacteria and their action on immune system cells.
What to know about homocystinuria
Antidote
APRIL 17, 2023
Homocystinuria, an inherited disorder, is a rare metabolic condition that impacts 1 in 335,000 people worldwide and is present from birth. Often abbreviated as HCU or HCY, homocystinuria is a genetic disorder that inhibits the body from processing certain amino acids found in proteins, causing a harmful buildup of homocysteine and methionine.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
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