media – Page 391 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

In warning letters, FDA tells 8 companies to stop selling illicit eye drugs

Eight companies are finding themselves in hot water for allegedly churning out illicit eye drugs, the FDA said Tuesday. The drugs are unapproved and illegally marketed, the FDA said, which is especially risky considering that medications administered through the eye bypass some of the body’s natural defenses. The illegal therapies are purportedly used to treat diseases such as pink eye, cataracts, glaucoma and more, according to the agency’s release. The companies in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance. Consumers using the illicit products should talk to a doctor, according to the FDA. The companies, for their part, must respond within 15 days of receiving the FDA’s warning letters. CVS appears to be responding quickly. Reuters reports the company said it has stopped the sale of its Pink Eye Relief Eye Drops and that customers who ...
- Source: drugdu
- 186
- September 14, 2023
CancerVAX joins forces with UCLA to develop a universal CAR-T cell therapy

CancerVAX has announced the development of a universal chimeric antigen receptor (CAR) T-cell platform in partnership with a research team from the University of California, Los Angeles (UCLA). The company plans to adapt the nanoparticle technology developed by the UCLA team, which is currently being used for a universal cancer vaccine project to target T cells. The nanoparticle technology is inspired by the lipid nanoparticle and messenger RNA (mRNA) technology used to develop Covid-19 vaccines. Conventional CAR-T therapies rely on gene editing performed in the laboratory to transform the allogeneic T cells to induce CAR protein expression before reinfusion of these calls back into the patient. The universal CAR-T cell therapy would use injectable smart nanoparticles, which would be loaded with genetic information for specific cancer cell targeting. These nanoparticles would attach to the patient’s T cells and reprogram them to target specific cancer cells. CancerVAX has reported that preliminary ...
- Source: drugdu
- 227
- September 14, 2023
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
- 154
- September 14, 2023
Acelyrin’s Lead Asset Izokibep Fails in Late-Stage Hidradenitis Suppurativa Trial

By Tristan Manalac Pictured: Close-up of a skin lesion in a patient with hidradenitis suppurativa/iStock, krblokhin Top-line data from a Phase IIb/III trial showed that Acelyrin’s investigational IL-17A inhibitor izokibep fell short of its primary endpoint in patients with hidradenitis suppurativa, a chronic inflammatory skin condition, the company announced Monday. In patients who were being treated with 160-mg izokibep once-weekly, 39% demonstrated at least a 75% decrease in the hidradenitis suppurativa clinical response (HiSCR75) score at 16 weeks, while 29% of placebo comparators achieved a similar level of clinical response. This did not result in a significant treatment effect, with a p-value of 0.3278, according to the company’s announcement. Even the twice-weekly izokibep schedule was unable to significantly distinguish itself from placebo, with only 34% of patients achieving HiSCR75 at 16 weeks. These findings were calculated using a non-responder imputation (NRI) method. Acelyrin’s shares tanked 64% in after-hours trading in ...
- Source: drugdu
- 183
- September 14, 2023
FDA Questions Efficacy of Alnylam’s Drug in ATTR-CM Ahead of Adcomm Meeting

By Connor Lynch Pictured: FDA Sign in front of building with blue sky background/Adobe Stock, Grandbrothers Alnylam Pharmaceuticals’ push for patisiran to be expanded to a much larger pool of patients for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis has hit a significant hurdle. In a briefing document released ahead of the Sept. 13 meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, the agency called into question the efficacy of the drug in treating that pool of patients. The company has been seeking approval for its drug patisiran, sold under the brand name Onpattro, to be used to treat patients with cardiomyopathy induced by transthyretin amyloidosis (ATTR-CM). The disease typically affects the hearts and tendons of elderly people, causing an accumulation of proteins which can lead to severe cardiomyopathy. The APOLLO-B study was looking at one key primary efficacy endpoint and one key secondary ...
- Source: drugdu
- 173
- 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
- 162
- September 13, 2023
Gilead’s Trodelvy Shows Potential as First-Line Treatment in NSCLC

By Tristan Manalac Pictured: Gilead’s corporate headquarters in California/iStock, Sundry Photography Early data from the Phase II EVOKE-02 study showed that Gilead’s Trodelvy (sacituzumab govitecan-hziy), combined with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab), demonstrates promising efficacy in patients with metastatic non-small cell lung cancer, the company reported Sunday. However, the trial also detected worrying safety signals, with 18% of participants dropping out due to side effects. One patient died due to treatment-related sepsis. Nevertheless, the overall safety profile of Trodelvy in EVOKE-02 was generally consistent with what had previously been established. The most common treatment-emergent adverse events were diarrhea, anemia and asthenia. EVOKE-02 is an open-label, multi-cohort Phase II study with 224 patients enrolled. The trial assessed the combination of Trodelvy and Keytruda, with or without additional chemotherapeutic agents such as carboplatin or cisplatin. Advanced or metastatic non-small cell lung cancer (NSCLC) patients were enrolled regardless of PD-L1 expression status. The ...
- Source: drugdu
- 342
- 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
- 288
- September 13, 2023
Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Out with the old and in with the new: Monday, the U.S. FDA approved retooled mRNA shots against COVID-19 from Pfizer-BioNTech and Moderna, simultaneously bidding adieu to the companies’ bivalent shots in the U.S.The FDA has approved Pfizer-BioNTech and Moderna’s separate vaccine formulations that are more closely targeted to current variants of the disease, the agency said in a release. Specifically, each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old. The vaccines have been updated to include a monovalent component aimed at omicron variant XBB.1.5, according to the companies and the FDA. Meanwhile, Novavax’s revised shot is still pending regulatory approval. Moderna noted the COVID is “on the rise again” and warned of a “’tripledemic’” of COVID, flu and respiratory syncytial virus this winter and fall. Vaccines should remain “top of mind,” the company said. Following ...
- Source: drugdu
- 184
- September 13, 2023
Novo Nordisk enters new research alliance for diabetes and cardiometabolic diseases

Novo Nordisk and the Broad Institute of MIT and Harvard have announced a new research alliance to address ‘critical unmet clinical needs’ in diabetes and cardiometabolic diseases. The collaboration aims to identify disease-modifying interventions to improve the standards of care for people living with type 2 diabetes and cardiac fibrosis. The Novo side of the collaboration is secured through the Novo Nordisk Bio Innovation Hub, a research and development unit designed for life sciences innovation and focused on cardiometabolic, rare blood and rare endocrine disorders. Utilising state-of-the-art genetics and genomics methods, the collaboration aims to interrogate subtypes of diabetes. Along with the Broad’s Center for the Development of Therapeutics, using large-scale cell screens, the research will focus on the relationships between genes and pathways that could be therapeutic targets. Type 2 diabetes affects more than 37 million people in the US. Scarring of the heart, or cardiac fibrosis, is common ...
- Source: drugdu
- 211
- September 13, 2023

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