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Yabao Pharmaceutical’s SY-009 Receives NMPA Approval for Phase II Clinical Trial in Constipation
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Yabao Pharmaceutical Group Co., Ltd (SHA: 600351), a Chinese pharmaceutical company, has announced that SY-009 capsules, a sodium-glucose linked transporter-1 (SGLT-1) inhibitor co-developed with Eli Lilly & Co., (NYSE: LLY) have received approval from the National Medical Products Administration (NMPA) to proceed to a Phase II clinical study for the…
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J&J Halts Mid-Stage Trial for Tremfya in Giant Cell Arteritis Due to Efficacy Concerns
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S.-based healthcare company, has reportedly discontinued a mid-stage trial for its autoimmune drug Tremfya (guselkumab) in the treatment of giant cell arteritis, according to a report from BioSpace. An emailed statement from J&J cited “insufficient efficacy findings” as the reason for this…
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AbbVie’s Skyrizi Secures FDA Approval for Ulcerative Colitis, Expands Treatment Portfolio
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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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J&J’s Tremfya Meets Primary Endpoints in Phase III Crohn’s Disease Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that a Phase III trial for its dual-acting biologic Tremfya (guselkumab) has successfully met its composite co-primary endpoints in patients with moderately to severely active Crohn’s disease (CD) when compared to placebo. The study also demonstrated that the IL-23-focused subcutaneous maintenance therapy…
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Sandoz’s Partner Samsung Bioepis Scores EC Approval for Stelara Biosimilar Pyzchiva
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Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J; NYSE: JNJ) IL-12/23 blocker Stelara (ustekinumab), developed in partnership with South Korea’s Samsung Bioepis. Both biologics are indicated for the treatment of plaque psoriasis, psoriatic arthritis,…
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Takeda Scores FDA Nod for Subcutaneous Vedolizumab to Treat Inflammatory Bowel Disease
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The US Food and Drug Administration (FDA) has granted Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese pharmaceutical company, registration authorization for a subcutaneous formulation of its alpha4beta7 integrin antagonist Entyvio (vedolizumab). This new formulation is intended for use as a maintenance therapy in patients with moderately to severely active…
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Bristol Myers Squibb’s Zeposia Fails to Meet Primary Endpoint in Crohn’s Disease Trial
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that a Phase III study for its S1P receptor modulator Zeposia (ozanimod) in patients with moderate-to-severe active Crohn’s disease (CD) did not meet its primary endpoint of clinical remission at week 12. The trial’s outcome means that Zeposia joins a number of…
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AbbVie Acquires Landos Biopharma to Boost Autoimmune Disease Pipeline
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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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J&J’s Tremfya Files for Ulcerative Colitis Indication with FDA, Building on Positive Late-Stage Data
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The US Food and Drug Administration (FDA) has accepted an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for its IL-23p19-subunit inhibitor Tremfya (guselkumab) as a potential treatment for moderately to severely active ulcerative colitis (UC). The regulatory body will now review data from a late-stage study that…
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Alvotech Scores FDA Nod for Interchangeable High-Concentration Biosimilar to Humira
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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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Polpharma Biologics’ Biosimilar Candidate PB016 Shows Comparable Profiles to Takeda’s Entyvio
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Polish biotechnology firm Polpharma Biologics has announced positive results from a comparability study for its late-stage biosimilar candidate PB016, which references Takeda’s (TYO: 4502) inflammatory bowel disease (IBD) blockbuster Entyvio (vedolizumab). The study’s data indicate that PB016 demonstrates similar pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety profiles compared to the…
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Pfizer’s Velsipity Approved by European Commission for Moderately to Severely Active Ulcerative Colitis
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The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P receptor modulator Velsipity (etrasimod) as a treatment for patients aged 16 and older with moderately to severely active ulcerative colitis (UC). The approval applies to patients who have had an inadequate response, lost response, or…
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Takeda Reports Flat 9-Month Revenue Growth Amid Pipeline Optimization Efforts
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Takeda (TYO: 4502), a leading Japanese pharmaceutical company, has released its financial results for the 9-month period ended December 31, 2023, reporting a revenue of JPY 3.2 trillion (USD 21.9 billion) with a 0.0% growth at constant exchange rates (CER). The company’s performance was impacted by declines in oncology, neuroscience,…
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Novartis Acquires Calypso Biotech for USD 250 Million to Bolster IL-15 Pipeline
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Novartis (NYSE: NVS) has finalized an agreement to acquire Netherlands-based Calypso Biotech, a 2013 spinout from Merck that specializes in targeting interleukin-15 (IL-15). Under the terms of the deal, Calypso will receive an upfront payment of USD 250 million, along with potential milestone payments totaling up to USD 175 million.…
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Takeda’s Takecab Receives NMPA Approval for Helicobacter pylori Eradication in China
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Takeda (TYO: 4502), a Japan-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Takecab (vonoprazan) to eradicate Helicobacter pylori (HP) when combined with appropriate antibiotics. The vonoprazan-based quadruple regimen, which includes bismuth, is the first of its…
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ayer Partners with Changzhou Qianhong Bio-pharma to Advance Digestive Health Solutions
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Germany-headquartered Bayer (ETR: BAYN) has entered into a partnership with China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550), focusing on the digestive enzyme field. The collaboration aims to explore and promote product development in the digestive tract health sector, with no financial details disclosed. Focus on Digestive Tract Health and…
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Baheal Pharmaceutical Partners with AstraZeneca for Exclusive Distribution of Losec in China
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China-based health services and distribution giant Baheal Pharmaceutical Group has announced a strategic partnership with AstraZeneca (AZ, NASDAQ: AZN), securing exclusive retail distribution rights for the renowned digestive drug Losec (omeprazole) in mainland China. The financial details of this agreement have not been disclosed. This partnership follows Baheal’s previous acquisition…
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Takeda’s Global Revenues Grow: Strong Performance in Plasma Therapies and Gastroenterology
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Japan-based pharmaceutical giant Takeda (TYO: 4502) has released its financial results for the 6-month period ending September 30, 2023, with global revenues hitting JPY 2.1 trillion (USD 14.0 billion). This represents a 6.4% year-on-year (YOY) increase in reported terms, or a more modest 1.4% growth at constant exchange rates (CER).…
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Eli Lilly’s Omvoh Receives FDA Approval for Ulcerative Colitis Treatment
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The US Food and Drug Administration (FDA) has granted regulatory approval to Eli Lilly (NYSE: LLY) for its interleukin-23p19 antagonist, Omvoh (mirikizumab), as a treatment for moderately to severely active ulcerative colitis (UC) in adults. This approval is a significant milestone for Eli Lilly, expanding its portfolio in the inflammatory…
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Roche Agrees to Acquire Telavant for $7.1 Billion to Boost IBD Treatment Portfolio
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Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) announced this week an agreement to purchase Telavant Holdings, a biotechnology firm co-owned by UK’s Roivant Sciences (NASDAQ: ROIV) and US-based Pfizer (NYSE: PFE). The acquisition will grant Roche rights to RVT-3101, a potential best-in-class and first-in-class anti-TL1A subcutaneous antibody, in the US and…
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Hong Kong WinHealth Pharma Enters Strategic Partnership with Nippon Shinyaku for Irsogladine
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Hong Kong-based WinHealth Pharma Group Ltd has announced a strategic partnership with Nippon Shinyaku Co Ltd’s wholly owned subsidiary in Tianjin, China, focusing on the promotion of Gaslon N (irsogladine). While specific financial details of the collaboration remain undisclosed, this partnership marks a significant step for both companies in the…
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Sanofi Enters Collaboration with Teva for IBD Drug TEV’574 Development
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Sanofi (NASDAQ: SNY) has entered into a collaboration agreement with Teva (NYSE: TEVA) for the joint development and commercialization of Teva’s Phase II drug candidate, TEV’574, targeting inflammatory bowel diseases (IBD). This investigational molecule is designed as a potential best-in-class anti-TL1A therapy aimed at treating ulcerative colitis (UC) and Crohn’s…
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Takeda Receives FDA Approval for Subcutaneous Entyvio as UC Maintenance Therapy
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The US Food and Drug Administration (FDA) has granted Japan’s Takeda Pharmaceuticals (TYO: 4502) regulatory approval for the subcutaneous version of its alpha4beta7 integrin inhibitor, Entyvio (vedolizumab), as a maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous Entyvio. This decision comes…
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FDA Accepts Takeda’s Filing for Subcutaneous Entyvio as Maintenance Therapy for Crohn’s Disease
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The US Food and Drug Administration (FDA) has accepted a filing from Japan-based Takeda (TYO: 4502) for a subcutaneous version of the alpha4beta7 integrin inhibitor Entyvio (vedolizumab). This new formulation is intended as a maintenance therapy for adult patients with moderately to severely active Crohn’s disease (CD) who have been…
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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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Sandoz Inks Deal with Samsung Bioepis for Ustekinumab Biosimilar SB17
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The Sandoz (SWX: SDZ) unit of Switzerland-based Novartis (NYSE: NVS) has announced the in-licensing of ustekinumab biosimilar SB17 from South Korea’s Samsung Bioepis. The agreement covers the markets of Canada, the European Economic Area (EEA), Switzerland, UK, and the US. The biosimilar references Johnson & Johnson (J&J; NYSE: JNJ) subsidiary…
