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US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval marks Elahere as the first and…
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US pharmaceutical company AbbVie (NYSE: ABBV) has entered into a collaboration and option-to-license agreement with EvolveImmune Therapeutics, Inc., an immunotherapy platform company backed by industry giants including Pfizer (NYSE: PFE) and BMS (NYSE: BMY). The partnership will focus on leveraging EvolveImmune’s T-cell engager platform to develop novel antibody-based therapies for…
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced the official market launch of its Juvéderm VOLUX dermal filler product in China. Juvéderm VOLUX is a hyaluronic acid-based product specifically designed for contouring the lower jaw area. It is used for injection onto the facial periosteum to enhance the…
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US pharmaceutical company AbbVie (NYSE: ABBV) has announced its financial results for the third quarter ended September 30, 2024, with net revenues of USD 14.46 billion, marking a 4.9% increase year-on-year at constant exchange rates. The US market contributed USD 11.148 billion in sales, while the International Market (excluding the…
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US pharmaceutical company AbbVie (NYSE: ABBV) has entered into a definitive agreement to acquire all outstanding equity of Aliada Therapeutics, Inc., a fellow US firm, for $1.4 billion in cash. The acquisition includes ALIA-1758, an anti-pyroglutamate amyloid beta (3pE-Aβ) antibody in development for the treatment of Alzheimer’s disease (AD). Aliada’s…
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AbbVie (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced a licensing agreement with Gedeon Richter Plc, aimed at strengthening the development of new potential targets for neuropsychiatric conditions. This collaboration builds upon the nearly two decades of successful partnership on central nervous system (CNS) projects, which…
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AbbVie (NYSE: ABBV), a leading pharmaceutical company based in the US, has received approval from the US Food and Drug Administration (FDA) for its drug Vyalev (ABBV-951, foscarbidopa and foslevodopa). Vyalev is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). This approval positions Vyalev…
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The China National Medical Products Administration (NMPA) has granted clinical trial approval to ABBV-706, a novel antibody-drug conjugate (ADC) developed by AbbVie (NYSE: ABBV), for the treatment of relapsed/refractory small cell lung cancer (SCLC) and other neuroendocrine tumors . ABBV-706 is a targeted therapy that binds to SEZ6, a protein…
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AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company in the U.S., has announced the filing of a first Biologics License Application (BLA) for telisotuzumab vedotin (Teliso-V), a first-in-class antibody-drug conjugate (ADC) targeting tumors that overexpress the c-Met protein. The U.S. Food and Drug Administration (FDA) has accepted the filing for…
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COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC) has granted market approval for its Tepkinly/Epkinly (epcoritamab), a CD3/CD20 bispecific T cell engager. The drug is indicated for third-line or later treatment of relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large…
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US pharmaceutical giant AbbVie Inc. (NYSE: ABBV) has announced the successful completion of its acquisition of Cerevel Therapeutics (Nasdaq: CERE), a biotech company based in Cambridge, Massachusetts. AbbVie will pay $45.00 per share for Cerevel, totaling an approximate acquisition value of $8.7 billion. The transaction, initially announced in December 2023,…
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has secured marketing approval from China’s National Medical Products Administration (NMPA) for its Juvéderm product line, specifically the Juvéderm越致 dermal filler. This crosslinked sodium hyaluronate gel, which includes lidocaine for comfort during treatment, is designed for injection into the middle to deep…
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AbbVie Inc. (NYSE: ABBV) has reported its financial results for the second quarter of 2024, demonstrating a solid year-on-year (YOY) growth of 5.6% in constant currency terms, reaching $14.462 billion in revenue. The company’s long-standing blockbuster drug, Humira (adalimumab), continues to face biosimilar competition, resulting in a 28.9% YOY decline…
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US-based biotechnology company Sionna Therapeutics has announced a significant licensing agreement with fellow US firm AbbVie Inc. (NYSE: ABBV), through which Sionna has acquired rights to two Phase II molecules and one Phase I candidate. These pipeline candidates are all modulators designed to treat cystic fibrosis (CF). The deal includes…
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In significant executive reshuffling, Pfizer Inc. (NYSE: PFE) and AbbVie (NYSE: ABBV) have both announced changes to their top leadership teams, particularly impacting their global research and development divisions. Pfizer’s Dr. Mikael Dolsten has stepped down from his role as Chief Scientific Officer (CSO) and President of Pfizer Research &…
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Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
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AbbVie (NYSE: ABBV), a major U.S. pharmaceutical company, has announced the acquisition of Celsius Therapeutics Inc., a biotechnology firm specialized in developing therapies for anti-inflammatory diseases. The transaction involves a cash payment of USD 250 million to acquire all equity interests in Celsius. Through this acquisition, AbbVie will obtain control…
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AbbVie (NYSE: ABBV) has announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Skyrizi (risankizumab), marking it for use in treating adults with moderate to severely active ulcerative colitis (UC). This approval positions Skyrizi as the first IL-23 specific inhibitor to be approved for…
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Private investment firm Tutanota has launched an unsolicited mini-tender offer to acquire up to 250,000 shares of AbbVie Inc. (NYSE: ABBV) at a price below market value, according to an announcement from the pharmaceutical company last week. AbbVie has made it clear that it does not endorse Tutanota’s offer and…
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AbbVie (NYSE: ABBV), a biopharmaceutical giant based in the US, has announced a licensing agreement with Beijing-based biotech FutureGen Biopharmaceutical Co., Ltd. The agreement centers around FutureGen’s preclinical asset, FG-M701, a next-generation TL1A antibody being developed for the treatment of irritable bowel disease (IBD). In this deal, AbbVie secures exclusive…
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The US Food and Drug Administration (FDA) has welcomed an experimental therapy, fosigotifator, developed by AbbVie Inc. (NYSE: ABBV) and Calico Life Sciences, into its Rare Disease Therapy Pilot Program. The investigational eIF2B activator is currently undergoing a Phase Ib/II clinical trial for the treatment of vanishing white matter (VWM)…
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AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced that its cutting-edge antibody-drug conjugate (ADC) telisotuzumab vedotin has been granted breakthrough therapy designation (BTD) in China. This designation is for the treatment of advanced or metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq)…
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Allergan Aesthetics, a division of AbbVie (NYSE: ABBV), has announced that it has received approval for a new indication from the National Medical Products Administration (NMPA) for its Botox (botulinum toxin type A) product. The drug is now approved for the temporary improvement of significant or very significant masseter muscle…
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AbbVie (NYSE: ABBV) has announced a partnership with US-based Gilgamesh Pharmaceuticals to develop a portfolio of next-generation therapies targeting psychiatric disorders. Under the agreement, Gilgamesh will receive an upfront payment of USD 65 million, with the potential for up to USD 1.95 billion in milestone payments and sales royalties. AbbVie…
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AbbVie (NYSE: ABBV) has announced positive results from a head-to-head Phase IIIb/IV clinical trial comparing its JAK inhibitor Rinvoq (upadacitinib) with Sanofi’s (NASDAQ: SNY) interleukin blocker Dupixent (dupilumab) in patients with moderate-to-severe atopic dermatitis. The trial demonstrated that Rinvoq was superior in improving eczema area and severity as well as…
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The European Commission (EC) has granted approval for Pfizer’s (NYSE: PFE) antibiotic Emblaveo (aztreonam + avibactam) for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), complicated urinary tract infections (cUTI), and infections caused by aerobic Gram-negative organisms in adults. The drug was reviewed under an accelerated assessment process…
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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that a late-stage clinical trial for its JAK inhibitor Rinvoq (upadacitinib) in combination with corticosteroids has successfully met the primary endpoint in patients with giant cell arteritis (GCA). The study demonstrated sustained remission from week 12 through week 52. The…
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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has entered into a partnership with France-based biopharmaceutical firm Medincell (EPA: MEDCL) to develop up to six long-acting injectable treatments across multiple therapeutic areas. As per the agreement, Medincell will receive an upfront payment of USD 35 million, with the potential for…
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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, last week released interim results from a Phase III open-label trial of its CGRP receptor antagonist, Aquipta/Qulipta (atogepant), for the prevention of migraines in patients with chronic or episodic migraine. The data, collected between weeks 13 to 16, indicated that the average…
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Regenxbio (NASDAQ: RGNX), the development partner for AbbVie’s (NYSE: ABBV) gene therapy ABBV-RGX-314, has announced results from a Phase I/IIa trial focused on wet age-related macular degeneration (wAMD). This announcement complements the preliminary results shared earlier in the year. The 2-year data from the trial indicate that a single administration…
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced the market launch of its premium skincare product line, SKINMEDICA, in China. Known for its safety, efficacy, and clinical use backed by extensive medical research, SKINMEDICA is poised to offer Chinese consumers healthier and more confident skin solutions. This move…
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AbbVie (NYSE: ABBV) has announced its acquisition of Landos Biopharma (NASDAQ: LABP), a biopharmaceutical company specializing in autoimmune diseases. The deal includes an upfront payment of USD 137.5 million plus a potential clinical milestone payment of USD 75 million, with the transaction expected to close in the second quarter of…
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This week, the U.S. Food and Drug Administration (FDA) granted full approval to AbbVie’s (NYSE: ABBV) antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer following up to three prior therapies. This approval marks an upgrade from the 2022…
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The China National Intellectual Property Administration (CNIPA)’s Patent Re-examination Board (PRB) has reportedly invalidated two patents associated with AbbVie (NYSE: ABBV)’s JAK inhibitor, upadacitinib, listed in China’s version of the ‘Orange Book’. This ruling, highlighted by Lusheng Law Firm’s Terry Lu, could set a critical precedent for innovative pharmaceutical companies,…
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AbbVie (NYSE: ABBV) has entered into a strategic partnership with France-based OSE Immunotherapeutics (EPA: OSE) to develop the potential first-in-class immunotherapy OSE-230, which is currently in the pre-clinical stage for the treatment of chronic and severe inflammation. Under the terms of the agreement, AbbVie will acquire exclusive global rights to…
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The US Food and Drug Administration (FDA) has granted approval to Iceland-based Alvotech’s (NASDAQ: ALVO) Simlandi, marking it as the first interchangeable high-concentration, citrate-free biosimilar to AbbVie’s (NYSE: ABBV) immunosuppressant Humira (adalimumab). Humira faced patent expiration in the US last year, leading to biosimilar competition. Simlandi is approved for various…
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AbbVie (NYSE: ABBV), a leading US pharmaceutical company, has announced that Rick González, who has been at the helm since the company’s separation from Abbott (NYSE: ABT) in 2013, will retire from his role as CEO. González will transition to the position of executive chairman of the board of directors,…
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AbbVie (NYSE: ABBV) has expanded its collaboration with Scripps Research’s Calibr-Skaggs Institute, securing licensing rights to the institute’s investigational switchable CAR-T (sCAR-T) platform, which has shown promising early-stage results. The agreement entails an upfront payment, along with potential milestone payments and royalties, allowing AbbVie to access the program for up…
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AbbVie (NYSE: ABBV) reported revenues of $54.3 billion for 2023, reflecting a 5.9% year-on-year decline at constant currency rates, as the company grapples with the erosion of its flagship immunosuppressant, Humira (adalimumab). While the neuroscience and aesthetics segments showed resilience with revenue increases of 18.5% and 0.9%, generating $7.7 billion…
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AbbVie (NYSE: ABBV), a leading pharmaceutical company in the US, has licensed to Canada-based Enigma Biomedical Group (EBG) its cutting-edge F18 PET imaging biomarkers. These biomarkers are designed to detect the presence of four-repeat (4R) tau protein in patients who may have neurodegenerative diseases. The agreement holds potential for aiding…
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AbbVie (NYSE: ABBV) has announced the progression of lutikizumab to Phase III clinical trials following the IL1α/1β antagonist’s successful performance in a mid-stage trial for patients with moderate-to-severe hidradenitis suppurativa (HS) who had failed anti-TNF therapy. The study successfully met its primary endpoint, demonstrating a 35% higher clinical response rate…
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AbbVie (NYSE: ABBV) has announced the launch of its dopamine replacement therapy, Produodopa (foslevodopa + foscarbidopa), in the European Union (EU) for the treatment of advanced Parkinson’s disease (PD). The therapy is indicated for patients experiencing severe motor fluctuations, hyperkinesia, or dyskinesia, and when other treatments fail to adequately control…
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AbbVie (NYSE: ABBV) has entered into a collaboration agreement with Umoja Biopharma, a US-based company specializing in next-generation in-situ CAR-T cell therapies. Under the partnership, the two companies will develop up to four programs targeting selected cancer therapies chosen by AbbVie. AbbVie has also secured an exclusive option to license…
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AbbVie (NYSE: ABBV) and Alpine Immune Sciences (SWX: ALPN) have made the decision to prematurely cease enrollment in a Phase II trial for the T-cell stimulatory pathways inhibitor acazicolcept in systemic lupus erythematosus (SEL). This move allows for an early assessment of the trial data and enables Alpine to redirect…
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
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AbbVie (NYSE: ABBV) and Genmab (NASDAQ: GMAB) have presented Phase I/II clinical data for their T-cell engager, Tepkinly/Epkinly (epcoritamab), in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of therapy. Interim results, with a median follow-up of 17.4 months, showed that the…
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AbbVie (NYSE: ABBV) has announced its agreement to acquire Cerevel Therapeutics (NASDAQ: CERE) for approximately $8.7 billion, with the transaction expected to close in mid-2024, pending customary conditions. This acquisition is set to enhance AbbVie’s neuroscience portfolio by incorporating Cerevel’s promising drug candidates, which boast multibillion-dollar sales potential across various…
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AbbVie (NYSE: ABBV) has enlisted the expertise of BigHat Biosciences, a US-based company specializing in machine learning and wet lab platforms, to discover and develop next-generation antibodies for multiple therapeutic targets in oncology and neuroscience. BigHat will receive an upfront payment of USD 30 million, with the potential for up…
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AbbVie (NYSE: ABBV) has reached an agreement to acquire fellow U.S. biotech ImmunoGen (NASDAQ: IMGN) for an equity value of approximately USD 10.1 billion. The transaction is anticipated to close in mid-2025, pending the fulfillment of customary regulatory conditions. This acquisition will enhance AbbVie’s portfolio with Elahere (mirvetuximab soravtansine), an…
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AbbVie (NYSE: ABBV) has unveiled data from a Phase 2 trial of its potential first-in-class antibody-drug conjugate (ADC) telisotuzumab-vedotin, which targets c-Met protein-overexpressing, EGFR-wild-type, advanced/metastatic nonsquamous non-small cell lung cancer (NSCLC). The trial results showed an overall response rate (ORR) of 35% in patients with high c-Met levels and 23%…
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AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the European Medicines Agency (EMA) and granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (r/r) follicular lymphoma (FL). These regulatory decisions are backed by…
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AbbVie (NYSE: ABBV) has initiated legal action in the US to safeguard its blockbuster drug Rinvoq (upadacitinib) from generic market entries by Switzerland-based Sandoz (SWX: SDZ) and Indian pharmaceutical companies Aurobindo Pharma (NSE: AUROPHARMA), Hetero Labs, Intas Pharmaceuticals, and Sun Pharmaceutical (NSE: SUNPHARMA). Despite holding patents on the JAK inhibitor…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an agreement to purchase Caraway Therapeutics, a US-based pre-clinical company, for a potential total of USD 610 million, which includes upfront and milestone payments. This acquisition will enhance MSD’s portfolio with a range of small-molecule candidates targeting neurodegenerative and rare diseases.…
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US pharmaceutical giant AbbVie (NYSE: ABBV) has entered into a strategic partnership with Sinopharm Group Co., Ltd, (HKG: 1099) a leading Chinese pharmaceutical company, to improve access to novel drugs and explore standardized patient management practices in China. Expanding Access and Patient SupportThe collaboration will utilize Sinopharm’s extensive SPS+ professional…
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AbbVie (NYSE: ABBV) has entered into an option agreement with Aldeyra Therapeutics (NASDAQ: ALDX), a US-based biopharmaceutical company, to acquire a development, manufacturing, and commercialization license for the reactive aldehyde species (RASP) modulator, reproxalap. The agreement grants AbbVie co-exclusive rights in the US and exclusive rights in all other territories…
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The US Food and Drug Administration (FDA) has issued regulatory approval for Novartis’ (NYSE: NVS) IL-17A-targeting drug Cosentyx (secukinumab) for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa (HS). This approval positions Cosentyx as a new entrant in the HS biologic therapy market, potentially challenging AbbVie’s (NYSE: ABBV) Humira…
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AbbVie (NYSE: ABBV) released its Q3 2023 financial report last week, revealing a 6.0% year-on-year (YOY) decline in net revenues for the first nine months of the year, amounting to USD 40.0 billion. The decrease was attributed to underperformance across most business areas, with the exception of neuroscience, which reported…
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US-based pharmaceutical company AbbVie (NYSE: ABBV) has announced the receipt of two additional indication approvals from China’s National Medical Products Administration (NMPA) for its drug Rinvoq (upadacitinib). The selective JAK inhibitor is now approved for treating adult patients with active radiologically negative axial spinal arthritis (axSpA) who show a poor…
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AbbVie (NYSE: ABBV) announced this week a strategic collaboration with US-based Lupus Therapeutics aimed at accelerating the late-stage development of the JAK inhibitor Rinvoq (upadacitinib) for the treatment of systemic lupus erythematosus (SLE). This partnership marks a significant step in expanding the therapeutic applications of Rinvoq, which is already approved…
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AbbVie (NYSE: ABBV) has announced late-stage results for its JAK inhibitor Rinvoq (upadacitinib) in the treatment of moderate-to-severe atopic dermatitis, a skin condition characterized by inflammation and itching. The data, released this week, highlights the drug’s performance over an extended period of two years. Sustained Efficacy in Atopic DermatitisThe primary…
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AbbVie (NYSE: ABBV) has announced the acquisition of US-based biotechnology company Mitokinin, exercising an exclusive right obtained in 2021. The acquisition was contingent upon the successful completion of pre-clinical studies on Mitokinin’s lead program, a potential first-in-class PINK1 activator for the treatment of Parkinson’s disease (PD). Details of the AcquisitionAbbVie…
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The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE) Cibinqo (abrocitinib) and Everest Medicines’ (HKG: 1952) cefepime-taniborbactam are slated for priority reviews. These drugs target specific patient populations: teenage patients aged 12 years and above with refractory, moderate to severe atopic dermatitis (AD) who…
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Juvéderm VOLUMA with Lidocaine, expanding its indications to include nose augmentation procedures. Product Description and BenefitsJuvéderm VOLUMA with Lidocaine is a cross-linked sodium hyaluronate gel designed…
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AbbVie (NYSE: ABBV) has announced early data from a Phase III trial that compared the IL-23 inhibitor Skyrizi (risankizumab) with Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen’s Stelara (ustekinumab) in patients with moderate-to-severe Crohn’s disease (CD) unresponsive to anti-TNF therapy. The blinded efficacy assessment revealed that Skyrizi achieved clinical…
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The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted for review indication extension filings for AbbVie’s (NYSE: ABBV) interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) for the treatment of moderately to severely active ulcerative colitis (UC). This development marks a further expansion of Skyrizi’s potential applications…
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced a licensing and supply agreement with Filipino firm UNILAB, focusing on Mabwell’s biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab). According to the deal terms, UNILAB will handle the local regulatory filing and marketing efforts in the Philippines. Financial details…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) unit Sandoz’s biosimilar product, Hyrimoz (adalimumab), which references AbbVie’s (NYSE: ABBV) Humira, has been announced as the first product offered by Cordavis, a newly launched biosimilars-focused subsidiary of US health solutions company CVS Health (NYSE: CVS). The biologic is planned for launch during Q1…