Search Results for “arthritis” – Page 11 – media

Amgen, J&J ink patent settlement

After the recent high-profile loss of exclusivity for AbbVie’s megablockbuster immunology drug Humira, industry watchers’ eyes moved to Johnson & Johnson’s Stelara as one of the next major drugs expected to face biosim competition. Tuesday, the industry got more information about when exactly that biosimilar clash might occur. In J&J’s patent case over Amgen’s proposed biosimilar to J&J’s Stelara, the companies have settled, according to a Tuesday filing in Delaware federal court. An Amgen spokesperson told Reuters the deal will allow the company to launch its Stelara biosimilar “no later than January 1st, 2025.” With that, the market exclusivity clock is ticking on J&J’s biggest drug by sales. Last year, the medicine pulled down $9.72 billion across its range of indications, including plaque psoriasis, psoriatic arthritis and Crohn’s disease. Amgen has yet to win FDA approval for its proposed biosimilar. The company filed its biosim application last November, so the ...
- Source: drugdu
- 106
- May 25, 2023
AbbVie’s Rinvoq scores its 7th FDA nod, this one for Crohn’s disease

In developing immunology treatment Rinvoq, AbbVie is employing the same game plan it used to make predecessor Humira a megablockbuster. And the company seems to be getting better at it.Thursday, AbbVie scored its seventh FDA approval for Rinvoq in a span of less than four years, getting the JAK inhibitor across the finish line as a treatment for Crohn’s disease. A look at Humira’s approval history shows that AbbVie has become more efficient in adding indications to its immunology blockbusters. After Humira was initially blessed in 2002, it took AbbVie 10 years to get the TNF blocker endorsed for its seventh disease type. Coincidentally, Rinvoq’s new FDA approval came hours after the U.K.’s National Institute for Health and Care Excellence signed off on the drug for Crohn’s disease. This is the second gastroenterology indication for Rinvoq after it won approval for ulcerative colitis in March of last year. Rinvoq’s first ...
- Source: drugdu
- 127
- May 21, 2023
AbbVie nabs seventh FDA approval for Rinvoq, adds Crohn’s disease indication

Beth Snyder Bulik Senior Editor AbbVie picked up another indication for blockbuster Rinvoq on Thursday, this time for Crohn’s disease. The seventh FDA approval for the JAK inhibitor is specifically for use in moderate to severe Crohn’s patients who have had inadequate response or intolerance of at least one TNF blocker. While there are several other biologics already on the market to treat moderately to severely active Crohn’s including J&J’s Stelara, Takeda’s Entyvio and AbbVie’s own Skyrizi, the FDA noted that Rinvoq is the first oral drug. The approval was based on results from three studies, the U-EXCEED and U-EXCEL initial trial and the U-ENDURE maintenance trial, determining statistical significance in the co-primary endpoints of endoscopic response and clinical remission. AbbVie consultant and gastroenterologist Edward Loftus, who was a U-EXCEL investigator, said in a news release, “Based on the clinical trial results, treatment with RINVOQ shows both early and long-term ...
- Source: drugdu
- 124
- May 21, 2023
Acelyrin follows Kenvue with largest IPO for a biotech startup since 2021

Acelyrin has raised $540 million in an initial public offering, the largest for a biotechnology startup since early 2021 and one of only a handful by young drugmakers this year. The company said Thursday it sold 30 million shares at $18 apiece, exceeding the projections it set earlier this week. It will start trading Friday on the Nasdaq under the ticker symbol “SLRN.” The pace of biotech IPOs has slowed considerably since 2021, when a record 104 startups flooded Wall Street, according to data compiled by BioPharma Dive. The following year, the number of new stock offerings fell by about 80%. Until this week, only five companies had priced a new offering in 2023, the sector’s slowest start in at least five years. The value of those offerings has also trended downwards. Prior to Acelyrin’s offering, nine of the last 15 biotech startups that went public raised $15 million or ...
- Source: drugdu
- 119
- May 6, 2023
AbbVie weathers first months of biosimilar challenge to top-selling Humira

Ned PagliaruloLead Editor Dive Brief: AbbVie withstood the first months of U.S. copycat competition to its lucrative arthritis drug Humira about as Wall Street had expected, conceding on price to maintain insurance coverage in response to Amgen launching the country’s first biosimilar rival in January. U.S. Humira sales totaled nearly $3 billion, a decline of 26% from the same period one year ago and just over analysts’ consensus forecasts. AbbVie executives told investors on a Thursday conference call that most of that impact was driven by price changes. Amgen, which recorded $51 million in U.S. revenue for its biosimilar Amjevita, is selling its Humira rival at two different prices: a 5% discount to Humira’s nearly $90,000 annual list price, and a 55% discount. The approach is meant to address the unique demands of the U.S. healthcare system, in which insurers rely on manufacturers providing rebates off of a drug’s sticker ...
- Source: drugdu
- 166
- April 30, 2023
Positive CHMP opinion for UCB’s bimekizumab

by John Pinching Therapy concerns the treatment of adults with axial spondyloarthritis and psoriatic arthritis UCB has revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted marketing authorisation for bimekizumab in the EU. It concerns the treatment of adults with active axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA). AxSpA is an indication that covers both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) – also known as radiographic axSpA (r-axSpA). In active PsA, the CHMP recommended approval of bimekizumab alone or in addition to methotrexate, for the treatment of adults who have had an inadequate response to one or more disease-modifying antirheumatic drugs. Furthermore, in active axSpA, the CHMP recommended approval of bimekizumab for treating adults with active nr-axSpA with objective signs of inflammation. Throughout all four relevant studies – BE OPTIMAL, BE COMPLETE, BE MOBILE 1 and BE MOBILE 2 ...
- Source: drugdu
- 117
- April 30, 2023
Selecta, Sobi rout gout in pair of phase 3 trials that could challenge Horizon

On March 21, Selecta Biosciences and Sobi announced positive pivotal results from two phase III studies (DISSOLVE I and DISSOLVE II). These two placebo-controlled, randomized clinical trials were designed to evaluate the safety and efficacy of two different dose levels of SEL-212 in adult patients with chronic refractory gout. Gout is an autoinflammatory disease in which patients experience severe pain and debilitating inflammatory arthritis due to deposits of pro-inflammatory sodium urate (MSU) crystals. Patients with chronic refractory gout often have a high tissue MSU burden, which can lead to frequent gout attacks and chronic arthritis. Gout is the most common inflammatory arthritic disease in the United States. SEL-212 has the potential to reduce serum uric acid and MSU deposition in patients with chronic refractory gout. Recombinant uricase is highly immunogenic in the human body. Through Selecta’s proprietary ImmTOR platform, SEL-212 has the potential to alleviate the formation of anti-drug antibodies, ...
- Source: drugdu
- 157
- March 24, 2023
Molecular component of caffeine may play a role in gut health

Brigham researchers studying how and why certain cell types proliferate in the gut found that xanthine, which is found in coffee, tea and chocolate, may play a role in Th17 differentiation. Insights may help investigators better understand gut health and the development of conditions such as inflammatory bowel disease. The gut is home to a cast of microbes that influence health and disease. Some types of microorganisms are thought to contribute to the development of inflammatory conditions, such as inflammatory bowel disease (IBD), but the exact cascade of events that leads from microbes to immune cells to disease remains mysterious. A new study by investigators from Brigham and Women’s Hospital explores exactly what leads to the generation of Th17 cells—an important subtype of cells in the intestine—and uncovers some of the underappreciated molecular players and events that lead to cell differentiation in the gut. One of those players is the purine metabolite xanthine, which is found ...
- Source: drugdu
- 263
- March 15, 2023
Wright Medical and Orthopaedic Devices Manufacturer Cartiva sign $435m Deal

Medical Devices companies Wright Medical Group and Cartiva signed a $435 million cash-based contract wherein the Netherlands-based firm will avail all the outstanding shares of the Osteoarthritis focused US-based firm.
- Source: The Verdict
- 915
- August 29, 2018
Company Insight medical device Orthopaedics
Immunovia’s IMMray Test for RA Shows Promising Results

Rheumatoid arthritis (RA) gets a new parameter to be detected via the IMMray blood test developed by Immunovia, a Swedish company which observed promising findings in a clinical study conducted in conjunction with Linköping University.
- Source: The Verdict
- 693
- August 29, 2018
Researches rheumatoid arthritis

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