Search Results for “AbbVie” – Page 7 – media

Otsuka Commits $800M in M&A Deal Bringing a Phase 3-Ready Metabolic Disorder Drug

Otsuka Pharmaceutical is acquiring Jnana Therapeutics, whose lead drug is a potential treatment for the rare metabolic disorder phenylketonuria (PKU). Jnana’s drug could provide an alternative to two FDA-approved PKU medicines from BioMarin Pharmaceutical. By Frank VinluanOtsuka Pharmaceutical is broadening its scope in rare disease, striking a deal to acquire Jnana Therapeutics and its lead drug candidate, a small molecule on track for pivotal testing in a metabolic disorder with few treatments. Per deal terms announced Thursday, Otsuka is paying $800 million up front to buy Boston-based Jnana. The Japanese pharma company could shell out up to $325 million more if the lead drug candidate of privately held Jnana achieves development and regulatory milestones. Jnana’s lead program, JNT-517, is in development for phenylketonuria (PKU), an inherited disorder that leads to deficiency of an enzyme needed to break down phenylalanine, an amino acid found in certain foods. Buildup of phenylalanine in ...
- Source: drugdu
- 91
- August 5, 2024
FDA approves Sun Pharma’s JAK inhibitor for alopecia

Sun Pharmaceutical Industries has secured the US Food and Drug Administration (FDA) approval for its oral Janus kinase (JAK) Inhibitor Leqselvi (deuruxolitinib) to treat severe alopecia areata. Originally developed by Concert Pharmaceuticals, Sun Pharma inherited the asset when it purchased Concert Pharmaceuticals in January 2023 for $576m. Alopecia areata is an autoimmune condition where the immune system attacks hair follicles, leading to sudden, patchy hair loss. JAK inhibitors such as Leqselvi block the activity of Janus kinase enzymes, which are involved in the signalling pathways that drive inflammation and immune responses. The FDA approval is based on data gathered from two Phase III studies—THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650)—where Leqselvi restored scalp hair coverage by at least 80% in more than 30% of patients after 24 weeks. The 1,220 patients enrolled across the two studies had alopecia areata with at least 50% scalp hair loss as measured by Severity of ...
- Source: drugdu
- 120
- July 29, 2024
NICE recommends Ebglyss for atopic dermatitis patients

England’s National Institute for Health and Care Excellence (Nice) has recommended Almirall’s Ebglyss (lebrikizumab) for patients with moderate to severe atopic dermatitis, giving NHS patients another biological therapy option. In line with NICE guidelines, the NHS will now have 90 days to make the treatment available to patients. Patients over 12 years of age who have not responded to or are not able to take systemic immunosuppressants will be eligible for the therapy, as per a 10 July press release. Monoclonal antibody Ebgylss will join Sanofi / Regeneron’s Dupixent (dupilumab) and Leo Pharma’s Adbry (tralokinumab) as interleukin-targeting options for treating the skin condition. The Janus kinase (JAK) inhibitors Cibinqo (abrocitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) developed by Pfizer, Eli Lilly, and AbbVie, respectively, are also recommended by NICE. Atopic dermatitis, also known as atopic eczema, is an inflammatory skin condition characterised by intense itching. It has an estimated prevalence of ...
- Source: drugdu
- 61
- July 12, 2024
Study finds headache drug could prevent overuse of acute migraine medications

Chronic migraine is a neurological condition estimated to affect up to 2.2% of people globally A study led by researchers at King’s College London (KCL) and funded by AbbVie has revealed that a headache drug helps to prevent the overuse of acute migraine medication. Published in Neurology, AbbVie’s Qulipta (atogepant) was shown to be effective in decreasing migraine days in adults living with chronic migraine. Estimated to affect up to 2.2% of the global population, chronic migraine is a debilitating neurological disease where people regularly experience at least 15 days a month of headaches. Most often, headaches can be intensified by the overuse of acute migraine medications such as triptans, ergots and simple analgesics, leading to worse pain relief outcomes over a 24-hour period. Funded by AbbVie, the study assessed the efficacy of Qulipta in preventing chronic migraine in patients who met the criteria for acute medicine overuse as well ...
- Source: drugdu
- 68
- July 5, 2024
Study shows cholesterol-lowering drug reduces diabetic retinopathy risk

A study conducted by Oxford Population Health has demonstrated that a cholesterol-lowering drug could help reduce the risk of eye disease in people living with diabetes. The Lowering Events in Non-proliferative retinopathy in Scotland (LENS) trial has been investigating the effect of fenofibrate on retinopathy in patients living with diabetes and early retinopathy. Estimated to affect around 415 million people worldwide, diabetes is a chronic, metabolic disease that is characterised by elevated levels of blood glucose, which can lead to serious damage to the heart, blood vessels, eyes, kidneys and nerves. Globally, the prevalence of diabetic retinopathy among diabetic patients is estimated to be 27%. As part of the national routine diabetic eye screening programme, the LENS trial compared the effects of fenofibrate with a placebo in 1,151 adults with type 1 or type 2 diabetes in Scotland who had early-to-moderate diabetic retinopathy. Sold under several brand names, including Tricor ...
- Source: drugdu
- 93
- June 29, 2024
RINVOQ® (upadacitinib) Now Available in the U.S. for the Treatment of Pediatric Patients Two Years of Age and Older with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis

On June 4, AbbVie announced that the U.S. FDA approved the use of RINVOQ® (upadacitinib) for the treatment of pediatric patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who have had an insufficient response to, or are intolerant of, one or more tumor necrosis factor (TNF) inhibitors. In addition, a new dosage form of RINVOQ® LQ (upadacitinib) oral solution, based on weight-based dosing, is now available in the U.S. for the pediatric population. Dr. Roopal Thakkar, Senior Vice President, Global Therapeutic Areas and Chief Medical Officer of AbbVie, said: “RINVOQ has always been an important addition to the treatment of a wide range of rheumatic diseases, helping adult patients achieve meaningful disease control. Now, AbbVie is proud to offer RINVOQ in tablets and oral solution for our younger patients. Nearly 300,000 children and adolescents in the U.S. have some form ...
- Source: drugdu
- 105
- June 11, 2024
Insmed’s Trial Results Pave Way for FDA Filing in a Lung Disease With No Approved Therapies

Brensocatib, a drug Insmed licensed from AstraZeneca, met the main goal of a Phase 3 test in non-cystic fibrosis bronchiectasis. Insmed plans to seek regulatory approvals in this indication while also continuing to develop the small molecule for other inflammatory disorders. By Frank VinluanAn Insmed drug developed for a serious chronic lung disorder with no FDA-approved therapies handily beat a placebo in a pivotal clinical trial, preliminary results that set the stage for a regulatory submission planned for later this year. It could be the first of several. The drug is also in development for other inflammatory conditions, giving the drug multiple opportunities to achieve its blockbuster potential. The first disease target of the Insmed drug is non-cystic fibrosis bronchiectasis (NCFB), a chronic lung disease characterized by excess production of sputum that’s persistently coughed up from the respiratory tract. Patients who have NCFB also experience frequent respiratory infections. There’s no ...
- Source: drugdu
- 98
- May 30, 2024
Strides receives USFDA approval for Sucralfate Oral Suspension, 1gm/10 mL

Sucralfate is used to treat stomach ulcers,GERD, radiation proctitis, and stomach inflammation and to prevent stress ulcers. Strides Pharma Science (Strides) recently announced that its stepdown wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for the generic version of Sucralfate Oral Suspension, 1gm/10 mL, from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Carafate 1gm/10mL of AbbVie. Sucralfate is used to treat stomach ulcers, gastroesophageal reflux disease (GERD), radiation proctitis, and stomach inflammation and to prevent stress ulcers. Sucralfate Oral Suspension, 1gm/10 mL has a market size of ~US$ 124Mn as per IQVIA (March 2024). The Sucralfate Oral Suspension, 1gm/10 mL will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India. https://www.expresspharma.in/strides-receives-usfda-approval-for-sucralfate-oral-suspension-1gm-10-ml
- Source: drugdu
- 122
- May 25, 2024
CNS-Focused Rapport Therapeutics Preps IPO to Back Phase 2-Ready Epilepsy Drug

Rapport Therapeutics’ lead program could offer more targeted epilepsy treatment compared to currently available anti-seizure medications, which introduce many side effects. The IPO will support plans to develop the oral small molecule in focal epilepsy as well as chronic pain and bipolar disorder. By Frank VinluanRapport Therapeutics, a young biotech company with technology from the labs of Johnson & Johnson, is now preparing to enter the public markets to finance clinical research for a lead program that could help patients whose epilepsy doesn’t respond to currently available anti-seizure medications. Rapport’s IPO paperwork filed with securities regulators late Friday does not yet specify how many shares it plans to offer and in what price range. IPO research firm Renaissance Capital has penciled in a $100 million placeholder figure for the proposed stock offering. The biotech company, which is headquartered in Boston and maintains additional office and lab space in San Diego, ...
- Source: drugdu
- 81
- May 21, 2024
Positive Results from Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) in Patients with Giant Cell Arteritis

On April 18, AbbVie announced positive results from SELECT-GCA. Based on the results of this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, upadacitinib (RINVOQ®; 15 mg once daily) in combination with a 26-week hormone tapering regimen met the primary endpoint of sustained remissiona in adult patients with giant cell arteritis (GCA) from Week 12 to Week 52. In this study, 46% of patients treated with Rinvoq in combination with the 26-week hormone tapering regimen achieved sustained remission, compared to 29% of patients treated with placebo in combination with the 52-week hormone tapering regimen (p=0.0019). Dr. Kori Wallace, Vice President, Global Head of Clinical Development, Immunology at AbbVie, said, “Many patients with GCA continue to suffer from the potentially debilitating symptoms of the disease, and their treatment options are limited. These results demonstrate that there remains a significant medical need for this type of disease, and we are relentlessly committed to ...
- Source: drugdu
- 79
- April 25, 2024

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