Search Results for “antibody” – Page 48 – media

Novartis Shareholders Approve Sandoz Spin-Off as Product Plans Increase

By Connor Lynch Pictured: Novartis office in Germany/iStock, TBE Sandoz is finally nearing the end of its path towards independence. Over a year after Novartis finalized its plans to spin off its generics and biosimilars division, the Swiss pharma’s shareholders on Friday approved the move, which is expected to take effect on or around Oct. 4. The Novartis board of directors also approved the move back in July, paving the way for it to go ahead once the shareholders had signed off. The deal will see Novartis shareholders receive one Sandoz share for every five Novartis shares they hold, and the same ratio of American Depository Receipts (ADRs). Board of Directors Chair Joerg Reinhardt said in a statement that with “this step, both Sandoz and Novartis will be able to optimize management focus, allocate capital on business priorities, and be in a better position to create sustainable shareholder value in ...
- Source: drugdu
- 129
- September 19, 2023
Bristol Myers Squibb reveals plans to double number of drugs in registrational trials

Bristol Myers Squibb (BMS) has revealed plans to double the number of drugs in registrational trials over the next 18 months. The drugmaker currently has six candidates in clinical trials, including an anti-IL-13 monoclonal antibody under development to treat eosinophilic oesophagitis and an LPA1 antagonist being evaluated in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. The pipeline update includes a CD19-directed cell therapy expanding into clinical trials for immunologic diseases, a GPRC5D-targeting cell therapy starting a registrational trial in relapsed/refractory multiple myeloma (RRMM), and a BCMA x CD3 T-cell engager advancing into a phase 3 trial, also for RRMM. The company will also be progressing a protein degrader to a late-stage trial in first-line large B-cell lymphoma, moving an androgen receptor degrader into pivotal studies in metastatic castration-resistant prostate cancer, and is expecting proof-of-concept data for a BET inhibitor in myelofibrosis. In addition to its growing registrational portfolio, the company ...
- Source: drugdu
- 101
- September 19, 2023
ICON partners with US Government for clinical trials of Covid-19 vaccines

US Biomedical Advanced Research and Development Authority (BARDA) has partnered with Ireland-based ICON to conduct clinical trials of Covid-19 vaccine candidates selected as part of “Project NextGen”. A part of the US Government’s Strategic Preparedness and Response division, BARDA has launched Project NextGen to develop Covid-19 vaccines and therapies for current and future strains. To achieve this, BARDA plans to leverage its public-private partnerships. The government has plans to invest more than $5bn in the Project NextGen programme. In June, the European Medicines Agency (EMA) identified the need to update the Covid-19 vaccines to include the XBB Omicron variant. The US Government seconded that sentiment, and last month, BARDA partnered with Regeneron to develop a Covid-19 monoclonal antibody vaccine candidate. ICON’s government and public health solutions team will conduct a Phase IIb active comparator clinical trial to evaluate the efficacy of the next-generation Covid-19 vaccine, selected by BARDA, compared to ...
- Source: drugdu
- 123
- September 18, 2023
BMS Culls Two Mid-Stage, Four Early-Stage Clinical Programs

By Connor Lynch Pictured: Bristol Myers Squibb in New Jersey/iStock, arlutz73 Bristol Myers Squibb has trimmed its development pipeline, announcing at an R&D Day on Thursday that the company would be cutting two mid-stage and four early-stage clinical programs for efficacy and safety reasons. Two Phase II clinical programs were on the BMS chopping block, including an investigational asset targeting heat shock protein 47 (HSP47), a small interfering RNA (siRNA) for nonalcoholic steatohepatitis (NASH), which was licensed from Nitto Denko for an upfront payment of $100 million in 2016. The compound inhibits expression of the heat shock protein, which is associated with excessive collagen buildup such as occurs in NASH, which is the most severe form of fatty liver disease. In 2019, BMS completed a Phase II trial investigating two different doses of the siRNA in 61 patients with scar tissue buildup post-hepatitis C infection. Neither dose performed better than ...
- Source: drugdu
- 206
- September 16, 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
- 110
- September 15, 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
- 107
- September 14, 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
- 254
- 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
- 233
- 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
- 207
- 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
- 103
- September 13, 2023

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