Search Results for “EC” – Page 411 – media

FDA Indicates Potential Full Approval for Eisai & Biogen’s Leqembi Ahead of Adcomm

By Rosemary Scott Pictured: Three side-by-side scans of a human brain/iStock, semnic The FDA released briefing documents Wednesday that signal it is likely to grant Eisai and Biogen’s Leqembi (lecanemab) full approval to treat Alzheimer’s disease on its decision date in July. The documents come just two days before an advisory committee is scheduled to vote on whether to recommend the drug’s approval. The FDA has asked the six members of the advisory committee to answer the following question: Do the results of a pivotal trial dubbed Study 301 (CLARITY AD) verify the clinical benefit of lecanemab for the treatment of AD? But it appears the agency may have already decided for itself. Both the briefing documents and the committee’s decision will be based on the Study 301results. In the documents, the FDA stated that the data from the trial showed “consistently favorable results for the primary and secondary endpoints,” ...
- Source: drugdu
- 99
- June 10, 2023
Neurotic people are more likely to suffer from mood swings, study finds

In everyday life, our emotions often change from moment to moment, and people experience these fluctuations to varying degrees. Psychologists at Leipzig University have studied the relationship between the personality trait neuroticism—a potential risk factor for mental health—and emotional experiences. They found that neurotic people experience negative emotions not only more intensely, but also with more mood swings than others. They have just published their findings in the Proceedings of the National Academy of Sciences (PNAS). “Previous studies are in agreement that neurotic people experience stronger negative emotions in everyday life. Because of new, contradictory studies, there has been disagreement about whether this is also associated with increased variability in emotional experiences, i.e., mood swings,” says the study’s first author, Nina Mader from the Wilhelm Wundt Institute of Psychology at Leipzig University. Personality psychologists at Leipzig University have developed a new approach to modeling data that solves previous methodological problems. ...
- Source: drugdu
- 139
- June 9, 2023
New study shows certain blood pressure drugs could boost the efficacy of cancer immunotherapy

A Ludwig Cancer Research study has shown that some molecules previously used to treat hypertension might also help the immune system to better target cancer cells. Reported in the current issue of Nature, these findings could, in time, be applied to significantly improve the effectiveness and applicability of cancer immunotherapy. “Immunotherapy today can effectively fight only 30% to 40% of cancers,” said Benoît Van den Eynde, who is a member of the Ludwig Institute for Cancer Research, co-director of the de Duve Institute and professor of Tumor Immunology at the University of Oxford. “Many cancers are resistant, largely because their T lymphocytes are not reactive enough. We discovered that drugs once used to treat hypertension could have a very interesting effect in combating these forms of immunotherapy-resistant cancers.” The immune system protects against disease by destroying foreign substances and pathogens, such as bacteria and viruses. T lymphocytes, a type of ...
- Source: drugdu
- 140
- June 9, 2023
Study

The expected course of a patient’s cancer prognosis has traditionally been judged by its type, stage and microscopic aggressiveness, but patients with the same presentation can still have widely divergent outcomes. Researchers from Vanderbilt-Ingram Cancer Center have discovered that differences in tumor mutation burden are a major reason for this divergence. The study, published in JCO Precision Oncology, has revealed that mutation burden is a fundamental predictor of survival, independent of the clinical presentation metrics currently used. The researchers state in the study that mutational indices can be “used to predict disease course as effectively as (cancer) stage or grade.” William Dupont (Study Corresponding Author and Professor, Biostatistics, Health Policy, and Preventive Medicine, Vanderbilt University Medical Center) said, “A major insight of the study was the observation that survival was better at both low and high extremes of tumor mutation burden.” The study investigated the Pan-Cancer Atlas of 10,652 patents ...
- Source: drugdu
- 123
- June 9, 2023
FDA document outlines apparent agency support for full approval of Biogen, Eisai’s Leqembi

As Alzheimer’s disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug.In advance of a highly anticipated FDA advisory committee set for Friday, the agency released a briefing document that appears to support a full FDA approval for Leqembi. On efficacy, the agency said the drug’s treatment effect in its pivotal trial, called Study 301, is “supported by the consistently favorable results for the primary and secondary endpoints across the prespecified subgroups of interest.” In the study, investigators tested Leqembi against placebo in patients with mild cognitive impairment due to Alzheimer’s or mild Alzheimer’s dementia. The study measured the drug’s efficacy on an endpoint called the Clinical Dementia Rating-Sum of Boxes at 18 months of treatment. On ...
- Source: drugdu
- 176
- June 9, 2023
Johnson & Johnson, Legend file for expanded use of Carvykti after key trial win

Legend Biotech and Johnson & Johnson are moving fast in their efforts to forward their CAR-T standout Carvykti.Two days after presenting remarkable data from a phase 3 trial in multiple myeloma at the American Society of Clinical Oncology annual meeting, the companies have filed with the FDA for expanded use of the cell therapy. After gaining approval 16 months ago for Carvykti to treat multiple myeloma patients following four or more lines of therapy, the companies hope to get the U.S. regulator to sign off on its use at an earlier stage of treatment. Specifically, Legend and J&J submitted an application seeking an approval to treat patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a protease inhibitor, such as Takeda’s Velclade, and an immunomodulatory agent, such as Bristol Myers Squibb’s Revlimid. With such an approval, Carvytki could leapfrog BMS’ multiple ...
- Source: drugdu
- 104
- June 9, 2023
Merck sues US government over Medicare drug price negotiation programme

Merck & Co – known as MSD outside the US and Canada – has filed a lawsuit against the US government over the Medicare drug price negotiation element of President Biden’s Inflation Reduction Act (IRA). The IRA, which was enacted last year, allows Medicare – the government health plan for older adults – to negotiate lower prices for a selected group of prescription medicines. Merck argues that this violates the part of the Fifth Amendment to the US Constitution that requires the government to pay just compensation if it takes private property for public use. The lawsuit, filed in the US District Court for the District of Columbia, also argues that companies will be forced to sign agreements conceding that the prices are fair, which the drugmaker claims is a violation of the First Amendment’s protections of free speech. “These constitutional violations cannot be swept under the rug by pretending ...
- Source: drugdu
- 99
- June 9, 2023
Biosimilars ‘Fulfilling Their Promise’ of Lowering Biologic Prices

By Tristan Manalac Pictured: Cancer patient in bed looking out window / iStock, Ridofranz The entry of biosimilars promotes healthy market competition. It can reduce the prices of branded biologic medicines, according to a new study from the University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics. The study, published online Tuesday in the journal Health Affairs, focused on Genentech’s (Roche) breast cancer treatment Herceptin (trastuzumab) and its five biosimilar competitors that entered the U.S. market starting in 2019: Amgen’s Kanjinti, Viatris’ Ogivri, Pfizer’s Trazimera, Teva’s Herzuma and Organon’s Ontruzant. Study results showed that when Herceptin’s first biosimilar competitor—Kanjinti—hit the market, its average price dropped around 21%, from $101 to $80 per 10 mg. By the second quarter of 2022, toward the end of the study’s analysis period, biosimilars maintained an average sales price of 28% to 58% of Herceptin’s pre-competition average sales price. “Trastuzumab is ...
- Source: drugdu
- 196
- June 9, 2023
Moderna, Pfizer Hit with New COVID Vaccine Patent Lawsuits

By Tristan Manalac Pictured: Scales of justice/Kanizphoto, iStock Tuesday, New York-based Promosome filed separate lawsuits against Moderna and Pfizer, accusing both companies of violating patent protections related to mRNA technology, according to a report by Reuters. In the filings submitted to the Southern District Court of California, Promosome claims that in 2009 company-affiliated scientists “discovered a method for increasing protein expression by making small changes to the mRNA that could affect the amount of protein produced without altering the amino acid sequence encoded by the mRNA.” This method is protected by U.S. Patent No. 8,853,179, also known as the ’179 Patent. Promosome scientists, including Nobel laureate Gerald Edelman, gave the company exclusive license to the ’179 Patent. Promosome eventually disclosed the protected technology to Moderna—which ultimately declined to license it—and to Katalin Karikó, who served as senior vice president and top mRNA scientist at BioNTech at the time of the ...
- Source: drugdu
- 101
- June 9, 2023
Novo Nordisk says in talks to acquire French device-maker Biocorp for $165M

Dive Brief Novo Nordisk said it is in exclusive talks to buy French medical device company Biocorp. Novo Nordisk will buy out Biocorp’s main shareholder, Bio Jag, for 35 euros per share, and then make a tender offer for any outstanding shares at the same price, the companies said Monday. The offer would value all of the company at 154 million euros ($165 million). Denmark-based Novo Nordisk, which makes pharmaceutical products and insulin pens, has been collaborating with Biocorp since 2021 on a smart pen cap that tracks information on dose, date and time of injection. Dive Insight Novo Nordisk wants to innovate faster and develop new connected devices, and expects that Biocorp would complement its internal efforts, said Marianne Ølholm, Novo Nordisk’s senior vice president of devices and delivery solutions. Novo Nordisk will work with Biocorp to invest in new devices and drug delivery solutions for people with chronic ...
- Source: drugdu
- 128
- June 8, 2023

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