Search Results for “AbbVie” – media

Uncovering the truth of AbbVie’s $8.7 billion lesson

M&A is a metaphysics, with heaven on one side and hell on the other, tempting prominent names to enter. The latest to enter “hell” is AbbVie. On November 11, AbbVie announced that emraclidine, the “ace project” acquired by acquiring Cerevel for $8.7 billion at the end of last year, failed to reach the expected endpoint in two Phase II studies for schizophrenia, which cast a shadow on its future. As soon as the news came out, AbbVie’s stock price plummeted 12.57%, and its market value evaporated by more than $40 billion overnight. Once, this merger and acquisition was a “model” in the industry. From the first acquisition invitation to the final acquisition of Cerevil, AbbVie took less than two months. Fast, accurate, and ruthless, it foreshadowed AbbVie’s determination to deal with the patent cliff. But now, everything is coming to nothing. This once again allows us to see the “variables” ...
- Source: drugdu
- 48
- November 15, 2024
AbbVie looks to add an eighth indication for JAK inhibitor Rinvoq

AbbVie is set to expand the indication list for its immunology blockbuster, Rinvoq (upadacitinib). The company has submitted applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek approval for the use of Rinvoq as a treatment for giant cell arteritis. Rinvoq blocks the activity of Janus kinase (JAK) enzymes in the JAK-STAT signalling pathway, which plays a role in the release of pro-inflammatory cytokines. It has been approved by the FDA to treat seven autoimmune conditions, namely atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Rinvoq is one of the top revenue-generating therapies for AbbVie, raking in approximately $4bn in sales last year, per the company’s financials. The therapy’s revenue is expected to soar over the next decade, with Rinvoq expected to pull in over $12bn in sales by 2030, as ...
- Source: https://www.pharmaceutical-technology.com/news/abbvie-looks-to-add-an-eighth-indication-for-jak-inhibitor-rinvoq/
- 83
- July 17, 2024
AbbVie and Future Gen Biopharm Announce License Agreement to Co-Develop Next Generation Inflammatory Bowel Disease Therapies

On June 13, 2010, AbbVie and Future Gen Biopharm announced the signing of a license agreement to co-develop FG-M701, a next-generation TL1A antibody in preclinical development for the treatment of inflammatory bowel disease (IBD). FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target for inflammatory bowel disease. Uniquely engineered to have potentially best-in-class functional properties compared to first-generation TL1A antibodies, FG-M701 is designed to provide improved efficacy and reduced dosing frequency in the treatment of inflammatory bowel disease. Dr. Jonathon Sedgwick, Senior Vice President and Global Head of Discovery Research at AbbVie, said that the prevalence of inflammatory bowel disease continues to rise, and many people with ulcerative colitis and Crohn’s disease do not respond to current therapies. AbbVie’s mission is to raise the standard of care by pursuing transformative therapies to help more patients with autoimmune diseases achieve remission. We look forward to working with ...
- Source: drugdu
- 114
- June 17, 2024
AbbVie’s Telisotuzumab Vedotin (Teliso-V) Included in CDE’s List of Breakthrough Therapeutic Varieties

Recently, the Center for Drug Evaluation (CDE) of the State Drug Administration formally included AbbVie’s clinically developed sterile lyophilized powder for infusion, Telisotuzumab Vedotin (Teliso-V), into the list of breakthrough therapeutic drug varieties for the treatment of advanced/late stage c-Met protein (OE) with high expression of c-Met protein (OE) with disease progression occurring during or after platinum-based drug therapy. metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq) non-small cell lung cancer (NSCLC) patients. About Telisotuzumab Vedotin (Teliso-V) Teliso-V is an investigational first-in-class antibody-coupled drug (ADC) targeting the c-MET protein in patients with tumors overexpressing c-Met, a receptor tyrosine kinase that is overexpressed in many solid tumors, including NSCLC. Its efficacy safety as monotherapy in previously treated patients with c-Met overexpressing NSCLC will be further evaluated in the randomized Phase 3 study TeliMET NSCLC-01 (Study M18-868) For more information on the Teliso-V clinical trial, please visit https://clinicaltrials.gov/. Currently, there ...
- Source: drugdu
- 118
- June 13, 2024
EMA endorses AbbVie’s Skyrizi for ulcerative colitis

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has granted AbbVie’s ulcerative colitis (UC) drug Skyrizi (risankizumab) a positive recommendation for approval. The committee’s recommendation was based on results from two Phase III studies. In the INSPIRE trial (NCT03398148), 20.3% of patients in the Skyrizi treatment group achieved clinical remission, compared to 6.2% in the placebo group. Furthermore, in the Phase III COMMAND study (NCT03398135), 51% of patients treated with Skyrizi 180 mg and 48% of patients treated with Skyrizi 360mg demonstrated endoscopic improvement in week 52. Skyrizi is a monoclonal antibody therapy that inhibits interleukin-23 (IL-23). This reduces anti-inflammatory processes. In the 31 May press release, Dr Edouard Louis, the head of gastroenterology at University Hospital CHU of Liège Belgium said: “These results suggest that risankizumab may help patients coping with the challenging symptoms of ulcerative colitis, which include abdominal pain, bowel urgency and ...
- Source: drugdu
- 110
- June 4, 2024
AbbVie, Gilgamesh Pharmaceuticals Agree to Terms on a Collaboration to Develop Advanced Therapies for Psychiatric Disorders

The joint venture aims to address unmet needs in the treatment of mood and anxiety disorders through novel neuroplastogens.AbbVie and Gilgamesh Pharmaceuticals have announced a partnership focused on the development of therapies for psychiatric disorders. The collaboration seeks to leverage AbbVie’s experience in psychiatry and Gilgamesh’s research platform that focuses on neuroplastogens, which works to treat psychiatric conditions while minimizing adverse effects attributed to psychedelic compounds. According to the companies, the overall goal is to provide new opportunities in areas that haven’t provided manysolutions for patients with mood and anxiety disorders through the use of neuroplastogens. Under terms of the deal, AbbVie is expected to focus on future development and commercialization activities, while Gilgamesh will receive $65 million as an upfront payment. Upon the completion of specific milestones, including option fees and tiered royalties on net sales, Gilgamesh could potentially receive up to $1.95 billion.1 “Significant unmet need remains for ...
- Source: drugdu
- 106
- May 16, 2024
UK’s NICE recommends AbbVie’s Aquipta to treat migraines

The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending the use of AbbVie’s migraine drug Aquipta (atogepant), for NHS use in adults in England. Aquipta is an oral calcitonin gene-related peptide receptor antagonist that is used for the prevention of both chronic and episodic migraines. In the final draft guidance that was released on 11 April, the drug is recommended as an option for the prevention of migraines in adults who have at least four migraine days per month, only if at least three preventive medicines have failed. The drug received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2023 following positive data from two Phase III clinical trials, ADVANCE (NCT03777059) and PROGRESS (NCT03855137), which assessed a 60mg once-a-day dose of Aquipta in adults with episodic and chronic migraine, respectively. Data from both trialsshowed that Aquipta offered ...
- Source: drugdu
- 153
- April 13, 2024
AbbVie’s Produodopa approved by SMC to treat Parkinson’s disease patients in Scotland

The progressive neurological disorder affects approximately 12,400 people in Scotland AbbVie’s Produodopa (foslevodopa-foscarbidopa) has been accepted by the Scottish Medicines Consortium (SMC) for use within NHS Scotland to treat advanced levodopa-responsive Parkinson’s disease (PD). PD patients with severe motor fluctuations and hyperkinesia or dyskinesia when previous available combinations of PD medicinal products have not provided satisfactory results and who are not eligible for deep brain stimulation will be eligible for the treatment. Affecting around 12,400 people in Scotland, PD is a progressive neurological disorder that results from the loss of dopamine-producing brain cells and is characterised by tremor, muscle rigidity, slowness of movement and difficulty with balance. Patients with advanced PD are marked by more severe and complex symptoms, including severe motor deficits, a risk of falling and cognitive problems. The SMC’s decision is supported by data from two phase 3 clinical trials, M15-741 and M15-736, which demonstrated that Produodopa ...
- Source: drugdu
- 159
- March 15, 2024
FDA Approves AbbVie’s Juvederm Voluma XC for the Treatment of Moderate to Severe Temple Hollowing

Don Tracy, Associate Editor This marks the first time that a hyaluronic acid dermal filler has received FDA approval for temple hollowing. Allergan Aesthetics, an AbbVie company, announced that the FDA has approved Juvéderm Voluma XC to treat moderate to severe temple hollowing in adults over 21 years of age. According to the company, the medication has the ability to yield results that last up to 13 months with peak treatment, with approximately 80% of test subjects reporting satisfaction with the outcomes. With this regulatory action, Juvéderm Voluma becomes the first hyaluronic acid (HA) dermal filler indicated for moderate to severe temple hollowing to be approved by the FDA.1 “The approval of Juvéderm Voluma XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs,” said Carrie Strom, president, Allergan Aesthetics, SVP, AbbVie, in a press release. “This is the first US FDA approval of ...
- Source: drugdu
- 121
- March 7, 2024
AbbVie and OSE Immunotherapeutics Announce Collaboration to Develop Novel Monoclonal Antibody for the Treatment of Chronic Inflammatory Diseases

On February 28, 2010, AbbVie and OSE Immunotherapeutics, an immunotherapeutics company, announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to address serious chronic inflammatory diseases, which is currently in preclinical studies. OSE-230 is a first-of-its-kind monoclonal antibody designed to activate the G protein-coupled receptor (GPCR) target ChemR23, which may provide a novel mechanism for relieving chronic inflammation by regulating macrophage and neutrophil function. Dr. Jonathon Sedgwick, Senior Vice President and Global Head of Discovery Research at AbbVie, said: “This collaboration underscores our commitment to expanding our immunology portfolio, with the ultimate goal of raising the standard of care for patients suffering from inflammatory diseases worldwide. We look forward to applying our expertise in immunology drug development to advance the development of OSE-230. Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, said: “We are pleased to partner with AbbVie, a global leader in the development and commercialization of ...
- Source: drugdu
- 82
- March 6, 2024

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