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AbbVie’s Skyrizi Outperforms Janssen’s Stelara in Phase III Crohn’s Disease Trial
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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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EMA and FDA Review AbbVie’s Skyrizi for Ulcerative Colitis Indication Extension
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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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Cordavis Launches First Biosimilar: Novartis’ Hyrimoz to Compete with Humira
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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…
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European Commission Approves AbbVie’s Aquipta for Migraine Prevention in Adults
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The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its drug Aquipta (atogepant), marking a significant milestone in the prevention of migraine in adults with four or more migraine days per month. Aquipta becomes the first once-daily oral calcitonin gene-related peptide (CGRP) receptor antagonist to receive…
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GuangDong Pharmaceutical Association Releases Updated Off-Label Drug List for 2023
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The GuangDong Pharmaceutical Association has released the 2023 version of its off-label drug list, marking the 9th edition since its inception in 2015. The list serves as a reference tool rather than a recommendation guide. Contributors to this comprehensive list include Class 3A hospitals from various provinces across China, including…
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Mabwell Secures Licensing Deal with Morocco’s Sothema for Biosimilar Humira
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced a significant licensing and commercialization agreement with Sothema, the leading pharmaceutical company in Morocco, for its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab). According to the agreement, Sothema will handle local filling finish, registration, and commercialization of the biosimilar…
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AbbVie and Calibr Announce Strategic Collaboration to Advance Preclinical Research
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AbbVie (NYSE: ABBV) and US-based Calibr, the nonprofit drug discovery division of San Diego research institute Scripps Research, have unveiled a strategic collaboration aimed at advancing preclinical research. This partnership builds on previous work with Scripps that has already led to the development of several preclinical and early clinical drug…
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AbbVie’s Aquipta and Novartis’s Piqray Receive Regulatory Approvals in Mexico
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Mexico’s Federal Commission for Protection against Health Risks (COFEPRIS) has granted registration approvals to two innovative drugs: AbbVie’s (NYSE: ABBV) analgesic Aquipta (atogepant) and Novartis’ (NYSE: NVS) cancer therapy Piqray (alpelisib). This marks a significant milestone for both companies, expanding access to these treatments in the Mexican market. Aquipta: A…
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Major Pharma Companies Pledge Support for 250,000 Genomes Sequencing Project
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This week, leading pharmaceutical companies AbbVie (NYSE: ABBV), Amgen (NASDAQ: AMGN), AstraZeneca (AZ; NASDAQ: AZN), Bayer (ETR: BAYN), and Merck have committed to funding the whole-genome sequencing (WGS) of 250,000 individuals. This significant commitment is in support of the Alliance for Genomic Discovery (AGD), a partnership led by Illumina (NASDAQ:…
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Chile Expands Financial Coverage for AbbVie’s RSV Prophylaxis Synagis
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Chile’s Ministry of Health (MINSAL) has announced an immediate expansion in the coverage under its Financial Protection System for High-Cost Diagnosis and Treatments for AbbVie’s (NYSE: ABBV) respiratory syncytial virus (RSV) prophylaxis, Synagis (palivizumab). The biologic drug is now provided free of charge to families of infants weighing under 2.5…
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Harbour BioMed Reports First-Ever Profit in H1 2023 Interim Financial Results
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Harbour BioMed (HKG: 2142), a biotech company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced its interim financial results for the period ending June 30, 2023. In a preliminary review of unaudited figures, the company reported a net profit for the first time, expecting…
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AbbVie’s Rinvoq Receives NMPA Approval for Moderate to Severe Crohn’s Disease Treatment
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US pharmaceutical firm AbbVie (NYSE: ABBV) has announced receiving market approval from the National Medical Products Administration (NMPA) for its Rinvoq (upadacitinib), a selective JAK inhibitor, to treat moderate to severe active Crohn’s disease in adult patients who have a poor or intolerant response or a contraindication to one or…
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Jacobio Pharma Retakes Global Rights to SHP2 Inhibitors After Terminating AbbVie Agreement
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China-based Jacobio Pharma (HKG: 1167) has announced the cancellation of a licensing agreement with US pharmaceutical company AbbVie (NYSE: ABBV), which implies that Jacobio will regain global rights to the out-licensed SHP2 inhibitors. This decision was made as part of an asset portfolio and strategy review. Initially, the deal was…
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Sinocelltech Group Launches Biosimilar Version of AbbVie’s Humira in China
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China-based Sinocelltech Group Ltd (SHA: 688520) has officially commercialized its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab), marking a significant milestone in the Chinese biosimilar market. The company has delivered the first batch of the biosimilar product, achieving commercialization in less than two weeks following regulatory approval. Humira’s Global…
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AbbVie Inc. Files Lawsuit Against BeiGene Over BTK Inhibitor Brukinsa
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US-based AbbVie Inc., (NYSE: ABBV), the company behind the first-in-class Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib), has taken legal action against BeiGene’s (NASDAQ: BGNE) BTK inhibitor Brukinsa (zanubrutinib). The lawsuit was filed by AbbVie subsidiary Pharmacyclics in the Delaware District Court on the day it was awarded a new…
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Sinocelltech Group Receives NMPA Approval for Biosimilar Version of Humira
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of AbbVie’s (NYSE: ABBV) Humira (adalimumab). This approval encompasses all indications previously approved for Humira, which include a wide range of conditions such as rheumatoid…
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Q1 2023 financial report: AstraZeneca leads innovation in China, Sanofi’s sales in China decline
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Several multinational companies (MNCs) have released their Q1 2023 financials, showing a varied performance over the quarter. AstraZeneca’s China Innovation BoomAstraZeneca (AZ, NASDAQ: AZN) CEO Pascal Soriot warned that Europe is lagging behind China in fostering innovation and access to medicines. This statement came during the company’s Q1 2023 earnings…
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AbbVie’s China General Manager Ou Silang Steps Down, Intercon’s Colzi to Take Interim Role
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Ou Silang, Vice President and China General Manager of US pharmaceutical major AbbVie (NYSE: ABBV), has decided to leave his post, according to an internal email. Intercon’s Senior Vice President Alberto Colzi will step in to take over temporarily until a successor is appointed. Ou Silang’s Tenure and BackgroundOu Silang…
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Shanghai Fosun Pharmaceutical Gets NMPA Approval for FCN-338 Phase II Study
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline drug candidate, FCN-338. The study will assess the efficacy of FCN-338 in treating malignant hematological diseases of the…
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Pharmaron Secures UK Government Grant to Expand Viral Vector Manufacturing Facility
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China-based Contract Development and Manufacturing Organization (CDMO) Pharmaron Beijing Co., Ltd (HKG: 3759, SHE: 300759) has announced the receipt of a substantial grant from the UK government’s Life Sciences Innovation Manufacturing Fund (LSMIF). The grant will facilitate the expansion of Pharmaron’s existing viral vector and DNA manufacturing facility in Liverpool,…
