A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs. The cancer cell therapy Carvykti dramatically outperformed standard drugs in a late-stage clinical trial testing its use in earlier treatment of the blood cancer multiple myeloma, according to data from a study abstract that was briefly posted online Tuesday. The abstract showed Carvykti, which is made by Johnson & Johnson and Legend Biotech, reduced the risk of disease progression or death by 74% compared to standard of care — a degree of benefit that analysts who viewed it described as “stellar” and “highly encouraging.” J&J and Legend had previously said in late January that the study met its main goal, but did not disclose any specific data at the time. The abstract, which is no longer available online, was for presentation ...
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. In a decades-long technical tour de force lead by Duke’s Center for In Vivo Microscopy with colleagues at the University of Tennessee Health Science Center, University of Pennsylvania, University of Pittsburgh and Indiana University, researchers took up the gauntlet and improved the resolution of MRI leading to the sharpest images ever captured of a mouse brain. Coinciding with the 50th anniversary of the first MRI, the researchers generated scans of a mouse brain that are dramatically crisper than a typical clinical MRI for humans, the scientific equivalent of going from a pixelated 8-bit graphic to the hyper-realistic detail of a Chuck Close painting. A single ...
After decades under Johnson & Johnson, a massive plant that once cranked out over-the-counter mainstays like Pepcid and Imodium is poised to hit the market. The plant handover comes after last month’s news that Johnson & Johnson would cut 57 positions at the Lancaster County facility, as detailed in a local Worker Adjustment and Retraining Notification Act notice. High Properties acquired J&J’s Greenfield, Pennsylvania, consumer health facility for $14 million, local news outlet Lancaster Online first reported. Fierce Pharma has viewed a copy of the deed confirming the sale, which went through in late March. J&J and High Properties did not immediately respond to Fierce Pharma’s request for comment on the matter. Reference: https://deal.town/questex/041223-takeda-hit-with-another-pay-for-delay-lawsuit-after-layoff-warning-jandj-inks-14m-plant-sale-F34YGQUSL
Dive Brief: The Food and Drug Administration told Merck KGaA not to give an experimental drug for multiple sclerosis to new patients and to pause treatment for study participants who have been on it for less than 70 days amid concerns about possible liver damage. Regulators acted after laboratory tests suggested the livers of two patients might have been adversely affected by the drug, known as evobrutinib. However, neither patient exhibited symptoms and their liver enzyme levels returned to normal after they stopped taking the medicine, Merck KGaA said Wednesday. The German drugmaker had already fully enrolled a Phase 3 study known as Evolution, and that program will continue as planned because all the patients have already had received the medication for at least 70 days. Results are still expected in the fourth quarter. Dive Insight: Evobrutinib is part of a class of drugs known as BTK ...
Kerry Dooley Young April 05, 2023 US regulators may soon clear blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening. Most recently, Guardant Health, Inc, announced the completion of its US premarket approval application for its Shield blood test to screen for CRC. Approval by the US Food and Drug Administration (FDA) would position Guardant to later secure Medicare coverage for its test. Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC. If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years. “They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, ...
This is fourth installment in my series on progress toward the elimination of Hepatitis C infection and disease. Read more about Hepatitis C in part one, part two and part three. Figure 1. The direct-acting antiviral targets in the hepatitis C virus replication cycle. NS3/4A … [+] In the previous articles of this series, I’ve outlined the seriousness and uncontrolled nature of hepatitis C. In the absence of a vaccine, the control and treatment of hepatitis C, much like that of HIV/AIDS, depends on the use of antiviral medications. Recent progress in the development of several highly active, anti-hepatitis C drugs has been a triumph of modern medicine. These drugs usher in an era of effective treatment and even elimination of hepatitis C both nationally and globally. Later in this series I will describe how these drugs have been used to eliminate hepatitis C from some countries and discuss how that success may be ...
[Before the Sartorius buyout, Polyplus had itself been expanding through multiple acquisitions. (Sartorius)] As the biopharma industry struggles with a dire shortage of viral vectors to make cell and gene therapies, contract manufacturers are busy beefing up their capabilities. In the latest example of biopharma’s ongoing investment in cell and gene therapy production, Sartorius has agreed to acquire French company Polyplus for 2.4 billion euros ($2.6 billion), the German CDMO said Friday. The deal gives Sartorius additional know-how in nucleic acid delivery, including transfection reagents and plasmid DNA design, all of which are key elements in the production of viral vectors for building cell and gene therapies. Formed in 2001, Polyplus employs about 270 people in several locations in France, Belgium, the U.S. and China. Before the Sartorius buyout, Polyplus had itself been expanding through M&A deals. In 2021, Polyplus bought Asia-Pacific-focused reagent supplier Biowire. ...
The US government announced a plan Wednesday to overhaul the country’s organ transplant system. The US Department of Health and Human Services’ Health Resources and Services Administration said it will focus on accountability and transparency by seeking more contracts to operate the Organ Procurement and Transplantation Network and sharing data more transparently. The system has only ever been managed by the nonprofit United Network for Organ Sharing, which has been recently criticized for its handling of organs, long waitlists for transplants and the number of deaths among people waiting: about 6,000 per year. There are currently more than 100,000 people in the United States waiting for an organ transplant. In a statement, HRSA Administrator Carole Johnson said that oversight of organ transplants is a “top priority.” “That is why we are taking action to both bring greater transparency to the system and to reform and modernize ...
Unhealthy food cravings in adulthood can be traced all the way back to fetal development, according to new research from Rutgers University. The study, published this week in Molecular Metabolism, shows that exposure to excess calories while in the womb can alter one’s brain and spur adult overeating. The researchers made the connection by studying 6 pregnant mice, then their combined litters of nearly 50 mice pups through adulthood. They began by letting 3 mice become obese on unlimited high-fat foods during pregnancy and breastfeeding, while keeping the other 3 pregnant mice slim from a diet of healthy food. The team found that the mice pups born to the obese mothers overate more than the mice pups born to the lean mothers when given access to unhealthy chow. The findings suggest that children who are born to mothers who were overweight during pregnancy and nursing may similarly struggle later in life to moderate ...
Medtech’s resilience and flexibility have been clear to see during the COVID-19 pandemic. In this forward-looking view for 2022, CEOs from some of the Top 50 global medtechs share their perspectives on the present and the future, from company and health care system standpoints.
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