Search Results for “EC” – Page 86 – media

2seventy bio fires 40% of staff after reduced Abecma sales forecasts

2seventy bio will be reducing its workforce by 40% and firing 176 employees in an effort to cut costs. One of the main reasons cited for restructuring was the decreased 2023 sales forecasts of Abecma (idecabtagene vicleucel), the company’s only approved therapy. The chimeric antigen receptor (CAR) T-cell therapy, developed in partnership with Bristol Myers Squibb, is expected to generate $470m-$570m less in sales than previously projected, as per 2seventy bio. Still, the company was quick to note that it remains hopeful Abecma sales may improve, considering the expected label expansion for a third indication. The therapy is currently under review with the US Food and Drug Administration (FDA) for the treatment of triple-class exposed relapsed and/or refractory multiple myeloma, with the Prescription Drug User Fee Act (PDUFA) date set for 16 December. Multiple pharma companies have announced staff layoffs this year following FDA rejections and as a general cash ...
- Source: drugdu
- 94
- September 14, 2023
NIH grants support Kessler Foundation scientists to advance research on neglect dyslexia and autism

Three Kessler Foundation research scientists, Timothy Rich, PhD, OTR/L, and Co-Principal Investigators Helen Genova, PhD, and Heba Elsayed, MD, have been awarded $777,325 in federal grants by the National Institutes of Health (NIH) to expand research in the fields of neglect dyslexia and autism. These studies may provide major steps towards finding innovative solutions for individuals affected by these conditions. Dr. Rich, research scientist in the Center for Stroke Rehabilitation Research, was awarded $626,889 to conduct research on “Gaze, Head Rotation, and Neuroanatomic Correlates of Reading Errors in Neglect Dyslexia.” Neglect dyslexia, a reading impairment associated with post-stroke spatial neglect, presents a significant obstacle to achieving functional independence in daily activities. Dr. Timothy Rich (research scientist, Center for Stroke Rehabilitation Research) said, “We aim to delve deeper into understanding the mediating role of gaze in neglect dyslexic errors. By collecting biometric, behavioral, and neuroimaging data, this research will provide valuable ...
- Source: drugdu
- 111
- September 13, 2023
Moderna, Pfizer-BioNTech’s Updated COVID-19 Vaccines Approved by FDA

By Hayley Shasteen Pictured: Syringe drawing up vaccine/iStock, Diy13 The FDA approved two updated COVID-19 booster shots from Pfizer-BioNTech and Moderna Monday afternoon, just in time for the fall vaccination season. The reformulated mRNA vaccines are specifically tailored to provide protection against circulating Omicron-related variants, including subvariant XBB.1.5, which the FDA had recommended vaccines be updated to cover in June 2023. The CDC is anticipated to release its recommendation guidance on the boosters Tuesday. A positive endorsement by the agency could see boosters available at pharmacies and doctors’ offices by the end of the week, The New York Times reported. CDC Director Mandy Cohen is expected to recommend the updated vaccines and sign off on their use, having previously made remarks favoring an updated booster. The approval for both boosters covers individuals ages 12 years and up, with Emergency Use Authorization granted for individuals ages six months to 11 years. ...
- Source: drugdu
- 229
- September 13, 2023
AstraZeneca Signs AI-Powered Drug Discovery Pact with Verge

By Tristan Manalac AstraZeneca, through its rare disease division Alexion, has entered into a multi-target agreement with Verge Genomics to discover and develop drugs against novel targets in rare neurodegenerative and neuromuscular diseases, the companies announced Friday. Under the agreement, Alexion will make a $42 million payment in upfront fees, as well as equity and near-term investments. Counting milestones, the four-year collaboration can yield up to $840 million for Verge, plus potential royalties down the line. Alongside the drug discovery pact, AstraZeneca will also take an equity position in Verge. In return, Alexion will gain access to the California biotech’s proprietary full-stack CONVERGE platform, which applies machine learning to human tissue data in order to identify novel disease targets that have a high probability of yielding clinical success. Friday’s partnership will apply the AI-driven approach to several yet-undisclosed rare neurodegenerative and neuromuscular conditions. Alexion will have the option to select ...
- Source: drugdu
- 189
- September 12, 2023
NICE recommends Lilly’s tirzepatide to treat T2D

The UK National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s tirzepatide (Mounjaro) for the treatment of adult patients with inadequately controlled type 2 diabetes. According to NICE’s final draft guidance, the injection is indicated for weekly usage in combination with diet and exercise. Clinical trials show that tirzepatide usage resulted in a substantial decline in both blood sugar levels and body weight, in comparison with insulin therapy, semaglutide or a placebo. Data also showed that tirzepatide aided between 81% and 97% of individuals in attaining improved glucose control, and 54% to 88% also showed a 5% or greater reduction in body weight. These figures were substantially higher than the comparators. The independent NICE committee provided a positive recommendation for tirzepatide after conducting additional assessments and modelling on clinical and cost-efficiency data provided by Lilly. NICE noted that 180,000 individuals with poorly managed type 2 diabetes will ...
- Source: drugdu
- 103
- September 12, 2023
analysts

Biopharma M&A is on an uptick compared to the post-pandemic doldrums of the last two years. Analysts anticipate that the trend will continue in 2023 and into 2024 as companies attempt to beef up their portfolios.During second quarter earnings calls, many heavy-hitters—including Johnson & Johnson, Bristol Myers Squibb and Merck—expressed urgency in their quest for deals. With so many buyers in competition, sellers are finding offers that are more attractive. For example, Merck’s $10.8 billion proposal to acquire Prometheus in April came at a 75% premium. In July, Biogen’s $7.3 billion deal for Reata represented a 59% markup. “There’s been such a consistent pick up in momentum in anything above a billion [dollars],” Cody Powers, an M&A expert with ZS Principal, said in an interview. “I think we’re back on the gravy train of where we were a couple of years ago in terms of premiums.” In 2019, the industry ...
- Source: drugdu
- 113
- September 11, 2023
Janssen’s patient programme becomes latest victim of data breach

IBM has announced a data breach of Janssen’s CarePath platform and has started informing affected customers. The Janssen CarePath portal provides patients and healthcare professionals in the US with information regarding insurance coverage, out-of-pocket costs, and prescribing information at no cost to the users. The number of highest grossing Janssen drugs are included in the platform such as Darzalex (daratumumab) and Stelara (ustekinumab) which generated $2.5bn and $3.2bn in US sales in H1 2023, respectively, as per the company’s Q2 2023 financial report. Data breaches at the top pharma companies are nothing new, as companies such as Merck & Co (MSD), Roche, and AstraZeneca have all been hacked in the past. Data breaches cost the companies an average of $5m to remediate, as per IBM’s 2020 data breach report. The Janssen CarePath systems provider, IBM, indicated that the stolen data may have contained information provided as part of the Janssen ...
- Source: drugdu
- 103
- September 11, 2023
Wearable technology emerges as a potential game-changer in early detection of COVID-19 among athletes

In a groundbreaking study conducted by Florida State University, wearable technology has emerged as a potential game-changer in the early detection of COVID-19 among NCAA Division I female student-athletes. The research by FSU Professor Michael Ormsbee, Assistant Athletic Director of Sport Performance Elisa Angeles and doctoral candidate Liliana Rentería in the Institute of Sports Sciences and Medicine (ISSM) focused on the use of WHOOP bands, which use optical sensors to measure and predict how fast your heart beats, how often you breathe, how you sleep and then use that information to calculate your strain and recovery. The ISSM research team, which works closely with athletes, monitored 113 NCAA Division I female student-athletes in soccer, golf, softball, indoor volleyball, beach volleyball and tennis. The athletes were equipped with WHOOP bands over a 10-month period, from August 2020 to May 2021. The project started when Angeles, who is also the associate director ...
- Source: drugdu
- 199
- September 11, 2023
CymaBay’s Liver Disease Candidate Hits Phase III Primary, Secondary Endpoints

By Connor Lynch Pictured: Illustration of a human body with the liver highlighted/iStock, magicmine CymaBay Therapeutics’ liver disease candidate, seladelpar, hit its primary and key secondary endpoints in the Phase III RESPONSE trial, the company announced Thursday. The clinical-stage biopharma was testing its selective PPARδ agonist in adult patients with primary biliary cholangitis (PBC), a disease in which the bile ducts in the liver are slowly destroyed. The year-long, double-blind study was looking at 193 PBC patients that either had an inadequate response or an intolerance to the main treatment for PBC, ursodeoxycholic acid. The study’s primary composite endpoint was related to serum alkaline phosphatase (ALP), a key indicator of liver damage and/or bone disorders. CymaBay said in Thursday’s announcement that 61.7% of patients met this endpoint, versus 20% of patients taking a placebo. The study also met a second primary endpoint of ALP normalization and another related to itching. ...
- Source: drugdu
- 110
- September 11, 2023
Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq.The FDA was supposed to dole out a verdict on subcutaneous Tecentriq by next week. But Roche now needs to update the therapy’s manufacturing processes, the Swiss pharma’s drug delivery technology partner Halozyme Therapeutics said in a securities filing Thursday. “These updates are expected to be completed in 2023 and are expected to support a potential launch of Tecentriq SC in the U.S. in 2024,” Halozyme said. Roche is making the changes in response to the FDA’s evolving requirements, a spokesperson with the company’s Genentech unit told Fierce Pharma. The spokesperson confirmed that the company now expects to receive an FDA approval in 2024. Roche filed the under-the-skin formulation to both the FDA and the European Medicines Agency in November. It’s targeting all existing indications of the original intravenous Tecentriq. Last ...
- Source: drugdu
- 162
- September 9, 2023

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