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ROBO Medical’s Innovative Gastrointestinal Endoscopic Instrument Gains NMPA Approval
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China’s National Medical Products Administration (NMPA) has approved ROBO Medical’s gastrointestinal endoscopic surgical instrument control equipment, an innovative product now eligible for clamping and pulling diseased tissues during submucosal dissection of esophagus and stomach endoscopy. Product InnovationThis product, the first home-grown digestive endoscopic integrated robot in China, features a flexible…
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Eli Lilly Acquires Organovo’s FXR Program for Inflammatory Bowel Disease
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US-based Organovo Holdings, Inc. (NASDAQ: ONVO), a clinical-stage biotech focused on inflammatory bowel disease (IBD), announced that its FXR program, including lead asset FXR314, has been acquired by Eli Lilly and Company (NYSE: LLY). The transaction grants Lilly global commercial and intellectual property rights to the program. Transaction DetailsUnder the…
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Eli Lilly’s Q4 Sales Soar 45% to $13.53B on Strength of GLP-1 Drugs
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Eli Lilly & Co. (NYSE: LLY) reported a robust finish to 2024, with Q4 revenues climbing 45% year-on-year (YOY) to reach USD 13.53 billion. The surge was primarily fueled by its GLP-1 drugs Mounjaro and Zepbound (tirzepatide). Excluding these incretin-focused drugs, Lilly’s overall portfolio still expanded by 20% YOY. For…
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Thederma’s TAN-118 Receives Tacit Clinical Approval from China’s CDE for Global Trials
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Shanghai-based Thederma has announced that its drug candidate TAN-118 has obtained tacit clinical approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. This follows the clearance received from the US FDA in October of the previous year, indicating that TAN-118, an AhR…
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Sino Biopharmaceutical’s Chia Tai Tianqing Secures Exclusive Promotion Rights for Naldemedine in China
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced an exclusive market promotion agreement between its subsidiary Chia Tai Tianqing and Ping An-Shionogi Co., Ltd, a joint venture between China-based commercial insurance firm Ping An Insurance (Group) Ltd and Japanese pharmaceutical firm Shionogi & Co., Ltd. Under this initially 11-year accord,…
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TenNor Therapeutics Partners with Grand Life Sciences for Rifasutenizol Commercialization in China
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China-based TenNor Therapeutics has entered into an exclusive commercialization cooperation agreement with compatriot firm Grand Life Sciences, appointing the latter as the sole commercial promotion service provider in mainland China, Hong Kong, and Macau for TenNor’s rifasutenizol (TNP-2198), a treatment for Helicobacter pylori (H. pylori) infection. Financial Terms and ResponsibilitiesUnder…
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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.…
