Search Results for “arthritis” – Page 9 – media

FDA Approves Novartis’ New Rheumatic Disease Treatment

Cosentyx is the first intravenous formulation interleukin-17A antagonist to focus on disease. Image Credit: Adobe Stock Images/Seventyfour Novartis officially announced that the FDA approved n intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Currently, Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. “At Novartis, we are committed to ensuring healthcare providers and patients have treatment options available to meet their unique needs. With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and eight years of real-world experience,” said Christy Siegel, ...
- Source: drugdu
- 111
- October 11, 2023
Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 197
- October 10, 2023
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
- 128
- September 19, 2023
AbbVie shares positive results from head-to-head study of Skyrizi in Crohn’s disease

AbbVie has shared positive top-line results from a head-to-head study of its interleukin-23 inhibitor Skyrizi (risankizumab) in Crohn’s disease. The late-stage study, SEQUENCE, has been evaluating the drug against Johnson & Johnson’s Stelara (ustekinumab) in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Skyrizi was shown to match Stelara in terms of clinical remission at week 24, with remission rates of 59% in the Skyrizi group and 40% in the Stelara cohort. On the second primary endpoint of endoscopic remission at week 48, Skyrizi demonstrated superiority to Stelara, with remission rates of 32% and 16%, respectively. All secondary endpoints achieved statistical significance for superiority versus Stelara, AbbVie said, and safety results were consistent with the overall safety profile of Skyrizi. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. It is ...
- Source: drugdu
- 151
- 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
- 110
- September 15, 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
- 107
- September 14, 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
FDA Approves Sandoz Biosimilar to Biogen’s MS Therapy Tysabri

By Tristan Manalac Pictured: Novartis office in Switzerland/iStock, Michael Derrer Fuchs The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis. Tyruko is also indicated for inducing and maintaining clinical response and remission in patients with Crohn’s disease with evidence of inflammation, and who are either unable to tolerate or show an inadequate response to conventional therapies. Sandoz is the generics and biosimilars arm of Swiss pharma Novartis, which in August 2022 announced that it was spinning the division off into a standalone entity, scheduled for the fourth quarter of this year. With Thursday’s approval, Tyruko becomes “the first biosimilar product indicated to treat relapsing forms of multiple sclerosis,” Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said in a statement. The regulator’s decision will also contribute ...
- Source: drugdu
- 112
- August 29, 2023
Researchers publish early results with new interleukin-targeting antibody

An academic group has published preclinical results with a new antibody that has greater activity and fewer side effects than existing biological therapies for inflammatory conditions. This could translate into a clinical benefit for patients living with rheumatoid arthritis (RA), psoriasis, or inflammatory bowel disease (IBD). Researchers from the University of Birmingham in the UK and the University of Naples Federico II in Italy revealed promising results after designing an antibody that targets a 20-long amino acid sequence in interleukin-17 (IL-17) – a protein important in inflammatory pathways. According to the team, they demonstrated for the first time that this sequence activates the release of cyto-chemokines. The antibody, which has been called Ab-IPL-IL-17, targets this sequence in both IL-17A and IL-17F. In cell studies, it demonstrated an ability to reduce the production of cyto-chemokines and white blood cell migration to inflammation-primed tissue. When the researchers compared it to existing therapies ...
- Source: drugdu
- 229
- August 17, 2023
J&J signs Stelara biosimilar settlement deal with Formycon and Fresenius

Johnson & Johnson (J&J) has reached a settlement with Formycon and Fresenius over their Stelara biosimilar FYB202, setting its US launch date to 15 April 2025. The companies confirmed that they are on track to submit the biosimilar’s biologics license application (BLA) later this year, based on the 7 August announcement. This marks the third settlement reached by J&J and pharma companies that are trying to market Stelara’s biosimilars this year so far. In May, J&J settled its patent lawsuit with Amgen, setting the biosimilar’s launch to no later than 1 January 2025. A month later, J&J reached a settlement with the producers Alvotech and Teva Pharmaceuticals, with a US licence entry date for their Stelara biosimilar AVT04 of no later than 21 February 2025. Also known as ustekinumab, Stelara was first approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to ...
- Source: drugdu
- 192
- August 10, 2023

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