J&J’s Tremfya Files for Ulcerative Colitis Indication with FDA, Building on Positive Late-Stage Data
The US Food and Drug Administration (FDA) has accepted an indication extension filing from Johnson...
Gastroenterology
Alvotech Scores FDA Nod for Interchangeable High-Concentration Biosimilar to Humira
The US Food and Drug Administration (FDA) has granted approval to Iceland-based Alvotech’s (NASDAQ: ALVO)...
Polpharma Biologics’ Biosimilar Candidate PB016 Shows Comparable Profiles to Takeda’s Entyvio
Polish biotechnology firm Polpharma Biologics has announced positive results from a comparability study for its...
Pfizer’s Velsipity Approved by European Commission for Moderately to Severely Active Ulcerative Colitis
The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P...
Takeda Reports Flat 9-Month Revenue Growth Amid Pipeline Optimization Efforts
Takeda (TYO: 4502), a leading Japanese pharmaceutical company, has released its financial results for the...
Novartis Acquires Calypso Biotech for USD 250 Million to Bolster IL-15 Pipeline
Novartis (NYSE: NVS) has finalized an agreement to acquire Netherlands-based Calypso Biotech, a 2013 spinout...
Takeda’s Takecab Receives NMPA Approval for Helicobacter pylori Eradication in China
Takeda (TYO: 4502), a Japan-based pharmaceutical company, has announced that it has received another indication...
ayer Partners with Changzhou Qianhong Bio-pharma to Advance Digestive Health Solutions
Germany-headquartered Bayer (ETR: BAYN) has entered into a partnership with China-based Changzhou Qianhong Bio-pharma Co.,...
Baheal Pharmaceutical Partners with AstraZeneca for Exclusive Distribution of Losec in China
China-based health services and distribution giant Baheal Pharmaceutical Group has announced a strategic partnership with...
Takeda’s Global Revenues Grow: Strong Performance in Plasma Therapies and Gastroenterology
Japan-based pharmaceutical giant Takeda (TYO: 4502) has released its financial results for the 6-month period...
Eli Lilly’s Omvoh Receives FDA Approval for Ulcerative Colitis Treatment
The US Food and Drug Administration (FDA) has granted regulatory approval to Eli Lilly (NYSE:...
Roche Agrees to Acquire Telavant for $7.1 Billion to Boost IBD Treatment Portfolio
Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) announced this week an agreement to purchase Telavant Holdings,...
Hong Kong WinHealth Pharma Enters Strategic Partnership with Nippon Shinyaku for Irsogladine
Hong Kong-based WinHealth Pharma Group Ltd has announced a strategic partnership with Nippon Shinyaku Co...
Sanofi Enters Collaboration with Teva for IBD Drug TEV’574 Development
Sanofi (NASDAQ: SNY) has entered into a collaboration agreement with Teva (NYSE: TEVA) for the...
Takeda Receives FDA Approval for Subcutaneous Entyvio as UC Maintenance Therapy
The US Food and Drug Administration (FDA) has granted Japan’s Takeda Pharmaceuticals (TYO: 4502) regulatory...
FDA Accepts Takeda’s Filing for Subcutaneous Entyvio as Maintenance Therapy for Crohn’s Disease
The US Food and Drug Administration (FDA) has accepted a filing from Japan-based Takeda (TYO:...
AbbVie’s Skyrizi Outperforms Janssen’s Stelara in Phase III Crohn’s Disease Trial
AbbVie (NYSE: ABBV) has announced early data from a Phase III trial that compared the...
Sandoz Inks Deal with Samsung Bioepis for Ustekinumab Biosimilar SB17
The Sandoz (SWX: SDZ) unit of Switzerland-based Novartis (NYSE: NVS) has announced the in-licensing of...
EMA and FDA Review AbbVie’s Skyrizi for Ulcerative Colitis Indication Extension
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted...
Sandoz Receives FDA Clearance for First Biosimilar to Biogen’s Tysabri
The Sandoz unit of Switzerland-based Novartis (NYSE: NVS) has received regulatory clearance from the US...