Search Results for “EC” – Page 365 – media

TB deaths prompt FDA warning on reducing transmission risk

Dive Brief The Food and Drug Administration has issued advice on how to mitigate the risk of cell and tissue products transmitting tuberculosis. The recommendations follow a report from the Centers for Disease Control and Prevention that showed two recipients of bone matrix products died. In July, Aziyo Biologics, now rebranded as Elutia, recalled its viable bone matrix (VBM) products after two patients developed post-surgical infections. Elutia withdrew all of its VBM products and pivoted to drug-eluting biomatrices in response to its second link to tuberculosis since 2021. The FDA’s advice covers the role of the responsible person and donor screening. While the FDA has yet to authorize a donor screening test, it is “evaluating the risks and appropriate mitigation strategies including testing.” Dive Insight Elutia, then called Aziyo, found itself at the center of reports of tuberculosis cases in June 2021. At the time, the company voluntarily recalled a ...
- Source: drugdu
- 172
- September 15, 2023
Alnylam Wins Adcomm’s Support for Heart Disease Drug Despite FDA Concerns

By Hayley Shasteen Pictured: FDA headquarters, iStock, GrandbrothersT he FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday voted 9-3 in favor of Alnylam Pharmaceuticals’ patisiran on whether its benefits outweigh its risks for the treatment of adults with cardiomyopathy induced by transthyretin amyloidosis. In the company’s announcement on Wednesday, Alnylam CMO Pushkal Garg said the “positive outcome” of the adcomm meeting is “supported by the efficacy and safety data observed in the APOLLO-B Phase III study and is another step toward bringing patients with the cardiomyopathy of ATTR amyloidosis a novel treatment option that addresses the underlying cause of disease and has the potential to meaningfully benefit patients’ functional capacity and quality of life.” The decision came after the panel’s day-long meeting in which adcomm members discussed whether the treatment effects demonstrated by data from Alnylam’s Phase III APPOLLO-B clinical trial were clinically meaningful for patients with cardiomyopathy induced ...
- Source: drugdu
- 113
- September 15, 2023
AbbVie’s Skyrizi Outperforms J&J’s Stelara in Late-Stage Crohn’s Disease Trial

By Tristan Manalac Pictured: AbbVie headquarters in California/iStock, Michael Vi Topline data from the Phase III SEQUENCE trial showed that AbbVie’s Skyrizi (risankizumab) matched, and could potentially even outpace, Johnson & Johnson’s Stelara (ustekinumab) in patients with Crohn’s disease. SEQUENCE was designed to establish the non-inferiority of Skyrizi compared to Stelara in terms of clinical remission. AbbVie’s IL-23 inhibitor not only met this bar, but also demonstrated signals of superiority: 59% of Skyrizi-treated patients achieved remission, as opposed to only 40% among Stelara comparators. Remission, the study’s primary endpoint, was defined as scores lower than 150 in the Crohn’s Disease Activity Index, measured at week 24. “These head-to-head data reinforce SKYRIZI is an effective treatment option for patients living with Crohn’s disease,” Roopal Thakkar, AbbVie’s chief medical officer and senior vice president of development and regulatory affairs, said in a statement. SEQUENCE’s results also highlight the role Skyrizi can play ...
- Source: drugdu
- 106
- September 15, 2023
Kuano closes £1.8M seed funding round to validate quantum simulation platform for drug discovery

Kuano, a drug discovery company combining quantum mechanics with AI to design the next generation of medicines, today announced the close of its £1.8M seed funding round, led by Mercia Ventures, and including ACF Investors, Ascension Ventures, o2h Ventures, Meltwind Advisory LLP, and other Angel investors. The investment will facilitate further validation of Kuano’s quantum simulation platform for the design of more effective drug candidates targeting enzymes, as well as continued Company growth through strategic partnerships and recruitment. Dysfunctional enzymes are implicated in many human diseases and are therefore a prevalent target in today’s drug market. However, until now scientists have only been able to view enzymes in their ‘resting’ state, and not in their fully functioning ‘dynamic’ states. As different enzymes may appear very similar in a resting state, drugs designed to target one may also affect others, potentially impacting drug safety and efficacy. Kuano’s quantum simulation platform enables ...
- Source: drugdu
- 139
- September 14, 2023
Bausch + Lomb seeks funding for $1.75B eye drop acquisition from Novartis

Dive Brief Bausch + Lomb is seeking to raise almost $2 billion to fund the planned acquisition of Xiidra eye drops from Novartis. The eye health company struck a deal in June to buy the dry eye disease treatment Xiidra and other assets for $1.75 billion upfront, and followed up by agreeing to pay Johnson & Johnson $107 million for a line of eye and contact lens drops. It has the cash to fund the J&J deal but needs to arrange financing to close the larger acquisition of the Novartis assets. Fitch Ratings, in a note to investors, said the Xiidra deal will boost Bausch + Lomb’s ophthalmic pharmaceutical market presence while the company’s R&D efforts help drive revenue growth and support margins longer term. Dive Insight Bausch + Lomb, which split from parent company Bausch Health last year, has identified two ways to strengthen its balance sheet ahead of ...
- Source: drugdu
- 120
- September 14, 2023
Seagen and Nurix announce oncology partnership worth over $3.4bn

Seagen and Nurix Therapeutics have entered into a multi-year, multi-target strategic collaboration agreement worth more than $3.4bn, to advance a new class of medicines for use in cancer. The companies will work to combine antibody-drug conjugation (ADC) and targeted protein degradation (TPD), aiming to create drugs with new mechanisms of action and improve specificity and anti-cancer activity. Under the terms of the agreement, Seagen will provide an upfront payment of $60m to Nurix, with the potential to receive up to approximately $3.4bn in research, development, regulatory and commercial milestone payments across multiple programmes, as well as mid-single to low double-digit tiered royalties on future sales. As part of the collaboration, clinical-stage biopharmaceutical company Nurix will utilise its proprietary DELigase platform to develop targeted protein degraders against multiple targets nominated by Seagen that are suitable for antibody conjugation. Seagen will conjugate these degraders to antibodies to make a new class of ...
- Source: drugdu
- 103
- September 14, 2023
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
- 102
- 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
- 148
- 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
- 106
- 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
- 129
- September 14, 2023

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