Search Results for “arthritis” – Page 8 – media

IGM jettisons workforce and blood cancer programme to refocus pipeline

IGM Biosciences plans to axe 22% of its workforce, becoming the latest company to downsize in a bid to free cash resources. Amid the layoffs, the US-based biotechnology company will also reprioritise its pipeline, discontinuing operations for all haematologic oncology and targeted cytokine product development while doubling down on its efforts in the clinical development of T cell engagers for autoimmune diseases and a DR5 agonist for colorectal cancer. IGM expects the restructuring to extend the company’s cash runway into Q2 2026. The restructuring comes less than a month after the company said it anticipated an increase in headcount to support the research and development of its pipeline candidates, citing its intent to advance and expand its antibody product pipeline, in its 13 November 10-Q filing. In the same filing, the company acknowledged that it had significant net losses to date and that achieving profitability sufficient enough to offset the ...
- Source: drugdu
- 102
- December 8, 2023
Rising Cost of New Medications, Will the People Who Need Them Most be able to Afford them?

Americans can’t afford their medications. About 25% leave prescriptions unfilled, split pills, or skip doses. Seniors face challenges covering non-Medicare services, including prescriptions. Even those with commercial health insurance are not immune. One-third of insured adults worry about affording their premiums, and 44% must meet increasingly high deductibles before insurance even kicks in. As a result, 41% of adults carry substantial medical debt. At the same time, FDA approvals for therapeutics targeting rare diseases are on the rise, including those for cancer, Alzheimer’s, and many previously untreatable diseases. In fact, 54% of 2022’s novel drug approvals targeted rare diseases. They encompass groundbreaking therapies like the first acid sphingomyelinase deficiency treatment, a prurigo nodularis remedy, and an obstructive hypertrophic cardiomyopathy therapy. In 2023, the first enzyme replacement therapy for non-neurological alpha-mannosidosis effects gained early approval. Breakthroughs, though welcome, are staggeringly expensive. In fact, Hemgenix, a new treatment for hemophilia, is officially ...
- Source: drugdu
- 101
- December 5, 2023
Samsung Bioepis, J&J Ink Settlement and License Deal for Stelara Biosimilar

By Tyler Patchen Samsung Bioepis has inked a settlement and license agreement with Johnson & Johnson, which will settle all U.S. patent litigation and allow for the commercialization of a biosimilar for the arthritis drug Stelara, known as SB17. According to Thursday’s announcement, Samsung Bioepis’ license period for its Stelara biosimilar will kick in on February 22, 2025. However, all the other terms of the deal were labeled as confidential and no further details were revealed. The BLA for the SB17 drug is under review by the FDA. If the drug is approved, it will be commercialized by Sandoz.   The issues between J&J and Samsung Bioepis come from the South Korean biotech filing a petition for an Inter Partes Review of J&J’s Stelara, or ustekinumab patent. According to a legal intelligence website lexology, Samsung Bioepis stated that the claims of J&J’s patent were invalid.  Patent protections over the use of ...
- Source: drugdu
- 132
- December 4, 2023
Acelyrin claims errors by CRO Fortrea led to late-stage trial downfall

Immunology biotech Acelyrin has determined that its CRO partner Fortrea is responsible for the late-stage failure of its immunotherapeutic drug candidate for moderate to severe hidradenitis suppurativa (HS). The company says a programming blunder by a vendor recruited by the CRO resulted in two erroneously treated patient arms going undetected through the testing processes. Los Angeles-based Acelyrin was aiming to make waves in a fiercely competitive psoriasis market with a breakout $540m IPO in May and a steady stream of clinical data and patient enrolment updates on its izokibep clinical program. But in September, when the Phase IIb/III study (NCT05355805) failed to meet its endpoint of achieving a 75% reduction in total abscesses and inflammatory nodules, the company’s stock more than halved overnight and has not yet recovered to the levels seen before 11 September. While a press release issued by Acelyrin outlining the error did not identify Fortrea as ...
- Source: drugdu
- 246
- November 30, 2023
Smith+Nephew to buy CartiHeal and its knee cartilage healing tech

Agili-C is a porous, biocompatible, and resorbable scaffold for cartilage regeneration in the knee. [Image courtesy of CartiHeal and Smith+Nephew] Smith+Nephew (LSE:SN, NYSE:SNN) announced today that it has agreed to acquire CartiHeal and its novel sports medicine technology. CartiHeal’s Agili-C is an off-the-shelf, porous, biocompatible, and resorbable scaffold. Approved by the FDA in 2022, it promotes natural regeneration of the articular cartilage — and restoration of its underlying subchondral bone. Under the acquisition agreement, Smith+Nephew will pay an initial $180 million for CartiHeal. There’s also the potential for CartiHeal’s present owners to receive a further $150 million contingent on financial performance. “The acquisition of this disruptive technology supports our strategy to invest behind our successful Sports Medicine business,” S+N CEO Deepak Nath said in a news release. “Agili-C’s superior clinical performance makes it highly complementary to our existing knee repair portfolio, and with our proven commercial expertise in high-growth biologics, ...
- Source: drugdu
- 140
- November 25, 2023
Alfasigma opens new doors in the US with Intercept acquisition

Alfasigma has expanded its drug portfolio for treating rare and serious liver diseases after completing its acquisition of US-based Intercept Pharmaceuticals. The completed acquisition comes just over a month after Intercept agreed to a $794m (€751.76m) buyout by Alfasigma. Any remaining common shares of Intercept were bought at $19.00 per share. Now being owned by the leading Italian pharmaceutical company, Intercept will no longer be traded on the Nasdaq exchange. In acquiring Intercept, Alfasigma has gained access to Ocaliva, the only US Food and Drug Administration (FDA)-approved second-line therapy for primary biliary cholangitis (PBC). Ocaliva, in combination with bezafibrate, also has orphan drug designation for PBC that was granted by the FDA in May. As per Alfasigma CEO Francesco Balestrieri, the company seeks to expand its gastroenterology and hepatology market presence and will benefit from Intercept’s innovation and R&D pipeline. Though Intercept’s Ocaliva has had its victories, the drug has ...
- Source: drugdu
- 120
- November 10, 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
- 101
- November 3, 2023
Shorla acquires methotrexate solution from Therakind in the US

Shorla Oncology has acquired the oncology and autoimmune drug Jylamvo (methotrexate) from Therakind, for commercialisation in the US market. Jylamvo was approved by the US Food and Drug Administration (FDA) approval in November 2022, to treat adults with acute lymphoblastic leukaemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis. Shorla is headquartered in Ireland and has operations in the US. The company had raised $35m earlier this month to advance its oncology pipeline. Jylamvo is an oral solution, making the treatment accessible to patients who may struggle taking tablets or other dosage forms. Commercialisation is set to begin immediately in the US. Chief Technical Officer and founder of Shorla Oncology Orlaith Ryan said: “This acquisition will provide a much-needed treatment to patients in need. It brings a crucial oral treatment to a larger patient population who suffer from cancer and other debilitating illnesses.” In March, Shorla ...
- Source: drugdu
- 107
- November 2, 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
- 113
- October 19, 2023
Novartis Wins FDA Approval for Intravenous Cosentyx Formulation

By Tristan Manalac The FDA on Friday approved an intravenous formulation of Novartis’ IL-17A antagonist Cosentyx (secukinumab) for the treatment of rheumatic diseases. This latest approval covers existing indications of Cosentyx, including ankylosing spondylitis (AS), psoriatic arthritis (PsA) and non-radiographic axial spondyloarthritis (nr-axSpA). Previously, Cosentyx was only authorized as a subcutaneous treatment for these conditions. With Friday’s approval, Cosentyx has become the first intravenous (IV) treatment that specifically targets and inhibits IL-17A and currently the only non-TNF-α IV therapy for these indications, according to Novartis’ announcement. The IV route of administration will improve treatment access for “a significant portion of patients” with AS, PsA and nr-axSpA, who are not comfortable with self-injections or simply prefer to receive treatments in their healthcare provider’s office, according to Philip Mease, clinical professor at the University of Washington School of Medicine. “The approval of Cosentyx as an IV formulation is an important milestone for ...
- Source: drugdu
- 178
- October 11, 2023

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