Search Results for “Johnson ” – Page 18 – media

Sanofi Issues Update on Shortages of Beyfortus for Respiratory Syncytial Virus

Pharmaceutical Executive Editorial Staff Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus. Sanofi has announced that a higher than expected demand for nirsevimab-alip (Beyfortus) 50 mg and 100 mg injection to protect infants against respiratory syncytial virus (RSV) has caused a change in the company’s distribution plan. Sanofi said it developed an aggressive supply plan to outperform prior launches of pediatric vaccines, but the demand exceeded the supply. Image credit: MargJohnsonVA | stock.adobe.com “We previously communicated that new orders for the 100 mg dose were no longer being accepted, as the demand exceeded the available supply for the season,” Sanofi said in a statement.1 “Currently, due to demand, we are carefully managing distribution of the ...
- Source: drugdu
- 98
- November 9, 2023
Amgen scores FDA approval for Stelara biosimilar

Amgen’s interchangeable biosimilar version of Johnson & Johnson’s (J&J) Stelara, dubbed Wezlana (ustekinumab-auub), has received an US Food and Drug Administration (FDA) approval. The interchangeable biosimilar was approved for use in multiple inflammatory diseases, including for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe active Crohn’s disease and moderate to severe active ulcerative colitis. The agency approved Wezlana after a comprehensive review of scientific evidence, which showed that Wezlana was highly similar to ustekinumab and there were no clinically meaningful differences between the products in regard to safety, purity, and potency. Stelara was first approved by the FDA for the treatment of adult patients with moderate to severe plaque psoriasis in September 2009. The FDA later approved the IL-12/IL-23 inhibitor’s use in moderate to severe Crohn’s disease in November 2016, and later for active psoriatic arthritis and ulcerative colitis. ...
- Source: drugdu
- 99
- November 3, 2023
AbbVie announces positive results from head-to-head study of Skyrizi in Crohn’s disease

AbbVie has shared detailed results from a head-to-head study comparing its IL-23 inhibitor Skyrizi (risankizumab) to Johnson & Johnson’s Stelara (ustekinumab) in Crohn’s disease. The late-stage SEQUENCE study has been evaluating the drugs, both given as a subcutaneous injection every eight weeks after a lead-in period of intravenous infusions, in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. Despite the availability of a range of treatments, not every patient achieves long-lasting remission, and the progressive damage from disease flare-ups can result in some patients requiring surgery. The results from SEQUENCE, which were presented at the United European Gastroenterology Week, showed that Skyrizi was superior to J&J’s IL-12 and IL-23 inhibitor at achieving endoscopic remission after 48 weeks of treatment, with 32% and ...
- Source: drugdu
- 112
- October 19, 2023
Lilly’s Mirikizumab Shows Long-Term Remission in Phase III Crohn’s Trial

By Kate Goodwin Pictured: Eli Lilly world headquarters/iStock, jetcityimage A 52-week study finds Eli Lilly’s mirikizumab to be effective for long-term remission in over half of patients with Crohn’s disease. The company announced Thursday plans to submit a marketing application to the FDA for approval in 2024, followed by submissions to other global regulatory agencies. In the Phase III trial, moderately to severely active Crohn’s disease patients on mirikizumab demonstrated clinical remission as well as endoscopic response at the one-year mark. Over 54% of the patients in the treatment arm achieved clinical remission at week 52, versus 19.6% of those receiving placebo. The endoscopic response was seen in 38% of those on mirikizumab versus 9% on placebo. Safety was consistent with the known profile of the therapy with the frequency of serious adverse events greater in the placebo arm than the treated group, according to Lilly. The interleukin-23p19 antagonist demonstrated ...
- Source: drugdu
- 110
- October 14, 2023
After FDA snub, Lilly’s mirikizumab looks to regain momentum with phase 3 Crohn’s win

After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 Crohn’s disease study. The interleukin-23p19 antagonist achieved both primary endpoints and all of its major secondary endpoints in the VIVID-1 study, Lilly said in a Thursday release. The trial results will serve as the basis of regulatory submissions in the disease next year, the company added. In the study, Lilly’s drug helped 54.1% of participants achieve clinical remission at week 52, compared with 19.6% for those on placebo. However, the drug couldn’t prove superiority in the endoscopic response measure when pitted against Johnson & Johnson’s star immunosuppressant Stelara (ustekinumab). Still, mirikizumab’s results were “numerically higher” than its J&J counterpart, Lilly said. Lilly will pursue approval in Crohn’s in 2024, when it will submit a marketing application ...
- Source: drugdu
- 116
- October 13, 2023
Salipro partners with Icosagen to develop monoclonal antibody therapies

Swedish company Salipro Biotech has entered into a multi-target antibody research agreement with biotech company Icosagen. The agreement leverages Salipro’s proprietary platform technology for membrane proteins to identify drugs that target specific G protein-coupled receptors (GPCRs) and solute carrier (SLC) transporters, as per a 10 October announcement. These membrane proteins play a role in different areas such as oncology and autoimmune diseases. Estonian company Icosagen has CRO [contract research organisation] and CDMO [contract development and manufacturing organisation] capabilities, with expertise in protein production and analytics, which contributes to the drug development of monoclonal antibodies. Icosagen will utilise its QMCF technology to advance the project, based on the 10 October press release. The company’s QMCF technology is based on a proprietary mammalian expression system for producing recombinant proteins. Monoclonal antibodies have been identified by GlobalData as a key innovation area for cancer therapy, with Johnson & Johnson being the leading patent ...
- Source: drugdu
- 107
- October 12, 2023
J&J’s DePuy Synthes wins FDA clearance for TriAltis tech

BY SEAN WHOOLEY [Image courtesy of DePuy Synthes] Johnson & Johnson MedTech announced today that its DePuy Synthes unit won FDA 510(k) clearance for two TriAltis technologies. The FDA cleared the company’s TriAltis Spine system and the TriAltis navigation-enabled instruments. TriAltis Spine is a next-generation posterior thoracolumbar pedicle screw system. It offers a comprehensive implant portfolio and advanced instrumentation for integration with enabling technology. DePuy Synthes’ TriAltis navigation-enabled instruments include drills, taps and screwdrivers. These offer manual operation or power operation for navigated and non-navigated use. The company said combining its implants with a digital ecosystem can address unmet clinical needs. Its TriAltis Spine system could help surgeons achieve more consistent outcomes in treating complex spine conditions, too. That includes degenerative tumor, trauma and deformity pathologies. DePuy Synthes built its TriAltis system on what it calls a legacy of thoracolumbar solutions and expertise. It features a “hyperfocus” on performance and ...
- Source: drugdu
- 109
- October 12, 2023
analysts

Dive Brief Johnson & Johnson’s spinoff of its consumer health business has positioned the company to achieve top-tier medtech growth and profitability, according to analysts at RBC Capital Markets. J&J recently split off its consumer health unit to make a standalone company, turning itself into the only global healthcare company with pharma and medtech in a single portfolio. RBC analysts expect the new structure to support the growth of a “bellwether” healthcare stock. On the medtech side, the analysts identified J&J’s leadership position in 11 categories, shift to fast-growing markets, investment in robotics and capacity for M&A as factors that position it to outperform its peers. Dive Insight The RBC analysts praised J&J’s current medtech portfolio, noting that the company is a leader in 11 categories and has 12 platforms with sales of more than $1 billion. The portfolio is the result of a “clear winning strategy,” they wrote in ...
- Source: drugdu
- 165
- 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
Catheter ablation beats drugs in J&J retrospective study of AFib heart failure risk

Dive Brief Catheter ablation is better than antiarrhythmic drugs at cutting heart failure risk as a second-line treatment for atrial fibrillation patients, according to a retrospective study funded by Johnson & Johnson. The study, which was published in Heart Rhythm O2, compared the incidence of heart failure in a claims database to evaluate whether patients who have previously tried an antiarrhythmic drug should receive catheter ablation or a different medicine. Across a dataset of more than 18,000 patients, people who received catheter ablation had a 57% lower risk of developing heart failure than their counterparts on antiarrhythmic drugs. Dive Insight In 2019, a randomized clinical trial funded by the National Institutes of Health and medtech companies including J&J’s Biosense Webster found catheter ablation is no better at reducing the composite risk of death and major cardiovascular events than antiarrhythmic drugs. However, the trial linked ablation to a lower risk of ...
- Source: drugdu
- 143
- October 9, 2023

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