PharmaFocus Today – Page 292 – media

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
- 139
- 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
- 121
- 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
- 261
- 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
- 241
- 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
- 116
- 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
- 117
- September 13, 2023
Coherus acquires immuno-oncology company Surface

Coherus BioSciences has concluded the acquisition of clinical-stage immuno-oncology (I-O) company Surface Oncology in a deal totalling nearly $66.9m. The deal value comprises $40m, along with Surface’s net cash at deal closing of $26.9m. Surface Oncology focuses on the development of immunotherapies that act on the microenvironment of the tumour. With the deal closing, Surface became a completely owned Coherus subsidiary. Following the takeover, Coherus expanded its I-O pipeline by adding clinical-stage antibody immunotherapy candidates of Surface, Casdozokitug (SRF388 / casdozo) and CHS-114 (SRF114). These product candidates can boost the innate and adaptive immune responses to facilitate a strong immunologic response and disease outcomes in cancer patients. Casdozokitug is a new antibody targeting IL-27 and is presently being analysed in Phase I/II clinical trials for lung and liver cancer. An anti-CCR8 antibody, CHS-114 is being evaluated in Phase I/II study as a single agent in advanced solid tumour patients. Coherus ...
- Source: drugdu
- 211
- September 13, 2023
Sandoz partners with Samsung Bioepis to license Stelara biosimilar

Sandoz has partnered with Samsung Bioepis to develop and market a Stelara (ustekinumab) biosimilar in the US, Canada, and Europe. Stelara is an interleukin (IL)-12/IL-23 inhibitor monoclonal antibody developed by Janssen Pharmaceutical Companies of Johnson and Johnson (J&J). It was first approved by the US Food and Drug Administration (FDA) for treating moderate to severe plaque psoriasis in adults in 2009. Its approval was later expanded to include Crohn’s disease, active psoriatic arthritis, and ulcerative colitis. With Stelara being a high-grossing drug for J&J, generating $3.2bn in sales in H1 2023, as per the company’s Q2 financial report, multiple companies are developing biosimilars. J&J has already settled three lawsuits with multiple companies, including Amgen, to push the launch of the Stelara biosimilar’s release date to 2025. Samsung Bioepis is expected to present Phase III trial data with the Stelara biosimilar, SB17, by the end of 2023. The Phase I trial ...
- Source: drugdu
- 111
- September 13, 2023
Click Expands to Substance Use Disorder With Indivior Digital Therapeutics Pact

Click Therapeutics, a developer of prescription digital therapeutic products, is adding substance use disorder to its pipeline through a new partnership with addiction medicines maker Indivior. Like other products in the Click pipeline, the new substance use disorder treatment, codenamed CT-102, will be a mobile software app. This app will be designed to work alongside drugs used to treat addiction. The Indivior portfolio includes the opioid addiction products Sublocade and Suboxone. Click said the partnered app will combine evidence-based behavioral therapy with tailored interventions intended to have an effect on the brain. Privately held Click is part of a cohort of companies developing software as treatments for various medical conditions. The company has mapped the entire brain to discover faulty brain circuits that are implicated across a variety of diseases. To treat these diseases, the company designs apps that present users with tasks that have the effect of retraining and ...
- Source: drugdu
- 187
- September 12, 2023
Seagen, Nurix Team to Create New Class of Antibody Conjugates for Cancer

By Tristan Manalac Pictured: Illustration of an antibody molecule/iStock, Dr_Microbe Seagen on Thursday inked a strategic collaboration agreement with San Francisco-based Nurix Therapeutics to develop a potentially new class of therapies—called degrader-antibody conjugates—that selectively kill cancer cells. Under the terms of the agreement, Seagen will make an upfront payment of $60 million and pledge up to $3.4 billion in research, development, regulatory and commercial milestone payments. Nurix will also be entitled to receive mid-single to low-double digit tiered royalties on future sales. The California biotech will also have the option for profit-sharing and co-promotion in the U.S., applicable to two products that emerge from the partnership. Seagen and Nurix will combine their respective expertise and produce degrader-antibody conjugates (DACs), which combine the “tissue and tumor specificity of antibodies with highly potent and catalytic targeted degradation of cancer driver proteins,” Nurix CEO Arthur Sands said in a statement. To achieve this, ...
- Source: drugdu
- 236
- September 12, 2023

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