Search Results for “arthritis” – Page 10 – media

J&J Exceeds Q2 Expectations, Oncology and Immunology Top Pharma Drivers

Pictured: Johnson & Johnson Sign in Silicon Valley/Shutterstock, Michael Vi Johnson & Johnson exceeded Wall Street expectations in its second quarter performance. The healthcare products giant posted sales of $25.5 billion in its earnings report on Thursday. Worldwide sales numbers reflected a 6.3% growth for J&J with revenue close to $1 billion higher than analysts expected, thanks in particular to a nearly 10% increase in its medtech sales. Medtech has been on the rebound since patients have returned to non-emergent surgeries like knee and hip replacements, which saw a significant drop during the pandemic. Operational sales for the company’s pharma arm, suffering growth points due to dwindling COVID-19 vaccine sales, was up 3.9%. The second quarter posted no U.S. sales of J&J’s COVID vaccine, with no domestic revenue expected beyond the $747 million from outside the U.S. reported last quarter. Its government contracts are now complete. Primary growth drivers were J&J’s oncology and immunology ...
- Source: drugdu
- 111
- July 24, 2023
Bilateral total knee arthroplasty may increase risk of complications

Patients undergoing bilateral total knee arthroplasty (TKA) are at an increased risk of several types of complications, as compared with matched patients undergoing unilateral TKA, reports a study in The Journal of Bone & Joint Surgery. The journal is published in the Lippincott portfolio in partnership with Wolters Kluwer. “Patients who underwent simultaneous bilateral TKA were at higher risk of experiencing postoperative complications such as pulmonary embolism, stroke, blood loss anemia, and requiring a transfusion,” according to the report by Nathanael D. Heckmann, MD, and colleagues of Keck School of Medicine of USC, Los Angeles. Study in matched groups of patients clarifies risks of bilateral TKA TKA is a highly effective treatment for patients with advanced osteoarthritis of the knee, decreasing pain and improving function. When both knees are affected, bilateral TKA offers some advantages over sequential unilateral TKA, including less time in the hospital, a single rehabilitation period, and ...
- Source: drugdu
- 120
- July 10, 2023
Sandoz launches high-concentration biosimilar of AbbVie’s Humira in the US

Sandoz, a Novartis division, has announced the US launch of its citrate-free high-concentration formulation (HCF) of Hyrimoz (adalimumab-adaz) – a biosimilar version of AbbVie’s Humira (adalimumab). Hyrimoz HCF (100mg/mL) is approved to treat all indications that are no longer covered by the reference medicine regulatory exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are highly similar to an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs. Hyrimoz was approved by the FDA in 2018 at a concentration of 50mg/mL. The HCF offers a 50% reduction compared to the original concentration and can decrease the number of injections required for people who need at least 80mg ...
- Source: drugdu
- 116
- July 7, 2023
first interchangeable biosimilar to Humira rolls out across US

Boehringer Ingelheim’s new autoinjector pen administering Cyltezo (adalimumab-adbm) is now available to patients living with chronic inflammatory diseases in the US. The Cyltezo pen autoinjector, which is a biosimilar to AbbVie’s blockbuster Humira (adalimumab), received approval from the US Food and Drug Administration (FDA) in May 2023. Boehringer Ingelheim originally received FDA approval for the drug in 2017, and then further approval as an interchangeable biosimilar in 2021. The 40mg/0.8ml pre-filled Cyltezo Pen will be offered in two, four and six-pack options. AbbVie has enjoyed a prosperous monopoly of the adalimumab market with Humira generating $21.2bn in global sales in 2022. With several biosimilars likely to flood the market in 2023 and the company losing exclusivity, AbbVie said it expects its sales of the drug to decline 37% in 2023. Challengers to Humira are now vying for market share. Organon and Samsung Bioepsis launched an autoinjector pen on 1 July, ...
- Source: drugdu
- 134
- July 5, 2023
FDA rejects Alvotech’s Humira biosimilar for the third time

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Humira biosimilar AVT02, further delaying the company’s plans to launch the drug in a landmark year. The agency rejected the drug’s biologics licence application (BLA) over deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland, according to Alvotech’s press release on 28 June. While the FDA did not make a note of any other deficiencies in the BLA, issues related to the Reykjavik facility need to be resolved to facilitate the drug’s potential approval. This marks the second time that the FDA has rejected AVT02’s BLA this year. In April, the regulator issued a CRL to Alvotech, which also noted the deficiencies seen in the company’s Reykjavik plant. Prior to that, the company received a CRL from the FDA over deficiencies in the plant in September 2022. Alvotech plans to resubmit ...
- Source: drugdu
- 109
- July 1, 2023
Johnson & Johnson inks another Stelara patent settlement, this time with Alvotech and Teva

Another biosimilar product copying Johnson & Johnson’s top-selling drug Stelara may enter the U.S. market without a patent infringement challenge by early 2025 thanks to a new settlement.J&J has signed an agreement granting Alvotech and Teva a license for their proposed Stelara biosimilar, AVT04, in the U.S. The settlement allows the biosimilar makers to launch their version no later than Feb. 21, 2025, the companies said Monday. The new Stelara biosim deal follows another one J&J recently inked with Amgen, which gives the latter a license to launch its copycat no later than Jan. 1, 2025. Like Amgen, Alvotech and Teva haven’t gotten the FDA’s blessing for AVT04. The pair in January said the FDA had accepted its application with a decision targeted for the second half of this year. A verdict for Amgen’s version is expected by the end of the third quarter. Settling those biosimilar entry dates is ...
- Source: drugdu
- 124
- June 14, 2023
European Commission grants two new marketing authorisations for UCB’s Bimzelx

The European Commission (EC) has granted UCB’s Bimzelx (bimekizumab) two new approvals, with the inflammatory disease drug now authorised to treat certain adults with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). The marketing authorisations, which follow a pair of recommendations from the European Medicines Agency’s human medicines committee earlier this year, make Bimzelx the first and only IL-17A and IL-17F inhibitor approved in the EU for these two indications. The authorisation for PsA – a type of arthritis that affects some patients with psoriasis – specifically applies to those with active disease who have had an inadequate response or have been intolerant to one or more disease-modifying antirheumatic drugs. The approval was supported by results from two phase 3 trials in which Bimzelx showed improvements over placebo in joint and skin symptoms across biologic naïve and TNF inhibitor-inadequate responder populations. “The approval of [Bimzelx] in PsA provides rheumatologists and dermatologists ...
- Source: drugdu
- 112
- June 12, 2023
Freiburg researchers gain new insights into metabolic processes in the kidney

Researchers at the Faculty of Medicine at the University of Freiburg have gained significant new insights into metabolic processes in the kidney. The scientists from the Institute of Genetic Epidemiology at the Medical Center – University of Freiburg measured tiny molecules, so-called metabolites, which occur in blood and urine and reflect our metabolism, in samples from more than 5,000 study participants. They compared these with the genome of the test persons and were able to identify 1,299 genetic changes that are associated with metabolites and contribute to their production, degradation or transport. The findings provide a better understanding of processes throughout the body and particularly in the kidney, which produces urine from blood plasma. These discoveries, which appeared June 5, 2023, in the journal Nature Genetics, could lead to a better understanding of diseases and new approaches to their treatment. For example, a new class of therapies for treating diabetes, ...
- Source: drugdu
- 128
- June 7, 2023
Novartis receives EC approval for Cosentyx in hidradenitis suppurativa

Novartis’ Cosentyx (secukinumab) has been approved by the European Commission (EC) to treat adults with active moderate to severe hidradenitis suppurativa (HS). Cosentyx, which is now the first new treatment option for the inflammatory skin disease in nearly a decade, is specifically indicated for patients who have had an inadequate response to conventional systemic therapy. There are currently around 200,000 people in Europe living with moderate to severe stages of HS, which causes boil-like abscesses that can burst, creating open wounds and irreversible scarring. Until now, there has only been one approved biologic treatment for HS, with around half of patients potentially losing response to this. Surgery is usually considered in advanced cases to remove abscesses and prevent the disease from spreading further, which Novartis describes as an invasive procedure that frequently results in additional scarring. Currently approved to treat a range of inflammatory conditions such as psoriatic arthritis and ...
- Source: drugdu
- 129
- June 4, 2023
Common diabetes drug could be repurposed as a treatment for autoimmune disorders

Swansea University researchers have found that a drug commonly used to treat type 2 diabetes can potentially be used in the treatment of autoimmune disorders. Academics at the University’s Faculty of Medicine, Health and Life Science have found that the drug, canagliflozin (also known as Invokana), could be used to treat autoimmune disorders such as rheumatoid arthritis and systemic lupus erythematosus as it targets T-cells, which form an essential component of the immune system. Canagliflozin is a drug that controls blood sugar levels in people with type 2 diabetes, however researchers have found an unexpected role for the drug involving the human immune system. Existing research has reported that targeting T-cell metabolism in autoimmunity can lead to therapeutic benefits. T-cells are a type of white blood cell that help the body fight infections and diseases, but in autoimmune diseases they have been observed to attack healthy tissues. The new study, ...
- Source: drugdu
- 136
- May 26, 2023

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