The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19…

Treg cell therapies are at the forefront of a collaboration between Regeneron (Nasdaq:REGN) and privately-held Sonoma Biotherapeutics, as they work together to discover, develop, and commercialize novel therapies for autoimmune diseases. This partnership combines Regeneron’s VelociSuite technologies with Sonoma Biotherapeutics‘ expertise in gene-modified T cell (Treg) therapies. Under the terms of the agreement, Regeneron will…

The generic and biosimilar company Sandoz, a Novartis (NYSE:SIX) subsidiary, has received FDA approval for its Humira biosimilar Hyrimoz (adalimumab-adaz) injection. AbbVie’s (NYSE:ABBV) megablockbuster Humira is a biologic medication with indications for an array of autoimmune conditions, including rheumatoid arthritis, Crohn’s disease and psoriasis. Sandoz’s biosimilar will likely be priced significantly lower than Humira’s. This…

The European Medicines Agency (EMA) is backing a series of measures to reduce the risk of serious side effects associated with Janus kinase (JAK) inhibitors, limiting their use in high-risk individuals. Similarly, Health Canada is recommending updated labeling for the drug class to disclose the risk of serious cardiovascular events and cancer. The agency is…

Janssen (NYSE:JNJ) has announced positive data from the first randomized controlled trial to test the safety and efficacy of combination therapy with an interleukin (IL)-23p19 subunit antagonist (guselkumab) and a tumor necrosis factor-alpha (TNFα) antagonist (golimumab) in ulcerative colitis. In the Phase 2a VEGA study, 48% of patients who received combination induction therapy with guselkumab and…

Johnson & Johnson’s Janssen subsidiary has released positive data from an ongoing analysis of the Phase 2a VEGA clinical study of guselkumab and golimumab. The trial focused on adults with moderately to severely active ulcerative colitis (UC). The study tested the efficacy of 12 weeks of combination induction therapy with the interleukin-23 subunit p19 inhibitor…

New York City-based Kallyope is one of the few biotechs focused solely on the gut-brain axis.  The privately-held company has built a cross-disciplinary team that weaves together advanced technologies in sequencing, bioinformatics, neural imaging, human genetics, and cellular and molecular biology to interrogate the hormonal and neural signaling pathways that comprise the gut-brain axis.  The…

AbbVie (NYSE:ABBV) has announced that FDA has approved Skyrizi (risankizumab-rzaa) as the first interleukin-23 (IL-23) inhibitor to treat adults with moderately to severely active Crohn’s disease (CD). Skyrizi is also FDA-approved as a treatment for moderate to severe plaque psoriasis and active psoriatic arthritis. IL-23 inhibitors have surged in popularity recently, given their ability to…

Bristol Myers Squibb (NYSE:BMY) has won FDA approval for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). The agency also approved Opdivo with Yervoy (ipilimumab) for ESCC. Both approvals cover ESCC regardless of programmed death-ligand 1 (PD-L1) status.…

Johnson & Johnson’s (NYSE:JNJ) Janssen unit announced new Phase 2 GALAXI 1 data at Digestive Disease Week (DDW), showing substantial rates of clinical-biomarker and endoscopic response and clinical remission through 48 weeks of Tremfya (guselkumab) therapy for Crohn’s disease. The company also announced long-term pooled safety analyses for Stelara (ustekinumab) at the DDW event May…

AbbVie (NYSE:ABBV) has revealed positive topline results from the U-ENDURE Phase 3 study investigating 15- and 30-mg doses of Rinvoq (upadacitinib) in adults with moderate to severe Crohn’s disease. Recipients who received either dose met the co-primary endpoints of endoscopic response and clinical remission, AbbVie announced. More than one-third (36%) of participants who received 15…

The clinical-stage company First Wave BioPharma (Nasdaq:FWBI) saw its share price fall by more than 40% to $0.37 in after-hours trading today after releasing new clinical trial data. To save money, the company will initiate austerity measures, cutting headcount by about 20% and closing clinical operations site in Hayward, California and a facility in Langlade, France.…

Pfizer (NYSE:PFE) has announced that the Phase 3 ELEVATE 12 study of etrasimod met primary and key secondary endpoints. The primary endpoint in the trial involved clinical remission in patients with severely active ulcerative colitis (UC) at week 12. Etrasimod is an experimental once-daily selective sphingosine 1-phosphate (S1P) receptor modulator similar to Bristol-Myers Squibb’s Zeposia…

Tens of millions of Americans have immune-mediated inflammatory diseases (IMIDs), including conditions as diverse as rheumatoid arthritis, psoriasis, multiple sclerosis and inflammatory bowel disease. Because such diseases have an inflammatory component, a single biologic could treat multiple IMIDs. “We are committed to investigating inflammatory pathways to develop therapies that can potentially address the immense unmet…

AbbVie (NYSE:ABBV) has announced that the FDA will prolong the review period for Skyrizi (risankizumab-rzaa) to treat moderate to severe Crohn’s disease in patients 16 years and older. The agency decided to extend the Prescription Drug User Fee Act (PDUFA) action date for the indication by three months to review additional data submitted from the…

Having recently sold an equity stake in Samsung Bioepis for up to $2.3 billion, Biogen (NSDQ:BIIB) has announced a licensing deal with Xbrane Biopharma (STO:XBRANE), a Swedish biosimilar developer. The agreement relates to the development of Xcimzane, a preclinical monoclonal antibody referencing Cimzia (certolizumab pegol) from UCB. Having first won FDA approval in 2018 for moderate to…

Robotic drug-delivery pill company Rani Therapeutics Holdings (NSDQ:RANI) has added Lisa Rometty to its board of directors. Rometty is the president of CVS Kidney Care. Previously, she worked as an executive at Syneos Health and IBM Watson Health. “I’m delighted to welcome Lisa to our Board,” said Talat Imran, CEO of Rani Therapeutics, in a statement. “Lisa’s…

Eli Lilly and Company (NYSE:LLY) announced that its interleukin-23 subunit p19 inhibitor mirikizumab achieved its primary endpoint of clinical remission at 52 weeks in the Phase 3 LUCENT-2 study. Lilly says mirikizumab is the first anti-IL23p19 to demonstrate maintenance of clinical remission in a Phase 3 ulcerative colitis study. Janssen (NYSE:JNJ) has ongoing clinical trials…

AbbVie (NYSE:ABBV) has released positive top-line results from U-EXCEED, which showed that Rinvoq (upadacitinib) hit both primary endpoints of clinical remission and endoscopic response at week 12 of a Phase 3 induction study focused on patients with Crohn’s disease. Upadacitinib is a selective and reversible JAK inhibitor first FDA approved in 2019 for treating adults with…

Johnson & Johnson’s Janssen division (NYSE:JNJ) has released topline results from the Phase 2 GALAXI 1 clinical study testing the potential of TREMFYA (guselkumab) in patients with moderately to severely active Crohn’s disease (CD). The study found that nearly two-thirds (65%) of TREMFYA (guselkumab) recipients achieved clinical remission at week 48. The trial used the…

Janssen (NYSE:JNJ) has released new positive data for Stelara (ustekinumab) as first-line therapy in ulcerative colitis (UC) and treatment persistence in Crohn’s disease (CD). The data indicated that the monoclonal antibody Stelara was “the best choice” as a “first-line therapy in bio-naive patients with moderately to severely active ulcerative colitis and Crohn’s disease,” said Dr.…

Janssen’s Stelara (ustekinumab) was associated with a rate of safety events similar to that of placebo during the control phase of a range of clinical trials. The Johnson & Johnson (NYSE:JNJ) subsidiary shared the data related to adults 60 and older at the virtual United European Gastroenterology Week (UEGW). The study pooled safety data from…

Assembly Biosciences (NSDQ:ASMB) is halting the development of the hepatitis drug ABI-H2158 (2158) after observing elevated alanine aminotransferase (ALT) in participants in a Phase 2 trial. High ALT levels can indicate liver damage. “Patient safety is always our priority, which is why we have elected to discontinue the development of 2158,” said Dr. John McHutchison,…

Acute pancreatitis, involving a sudden inflammation of the pancreas, is a major unmet need in gastroenterology. Severe cases can land patients in the ICU for weeks or months, while treatment options are relegated to support. The condition causes approximately 330,000 hospital admissions annually, according to a 2018 study. Some 20,000 people in the U.S. die from…

Scientists at the Ben-Gurion University of the Negev (BGU) in Israel and Yonsei University in Seoul have identified a potential strategy to treat inflammatory bowel diseases (IBD). The method involves using peptides to reduce the effects of succinate, a proinflammatory molecule that gut bacteria release. The breakthrough could lead to a companion tool to diagnose and treat…