Parvus Therapeutics Inc.'s PVT-201 has received orphan drug status from the U.S. FDA for the treatment of primary biliary cholangitis (PBC), an autoimmune disease of the liver.
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
Another failure with allosteric tyrosine kinase 2 (TYK2) inhibitor VTX-958 put an end to internal work with the compound, and shares of Ventyx Biosciences Inc. (NASDAQ:VTYX) fell July 29 to $2.24, down 71 cents or 24%, after the firm disclosed results from the phase II, 109-subject trial in moderately to severely active Crohn’s disease (CD).
Ensho Therapeutics Inc. launched in July after licensing a pipeline of four oral α4β7 inhibitors for inflammatory and gastrointestinal disorders, including inflammatory bowel disease (IBD), from EA Pharma Co. Ltd. “Millions of people worldwide are living with IBD,” Ensho founder, president and executive chair Neena Bitritto-Garg recently told BioWorld, “and while there are a number of approved medications to address the symptoms of IBD, it remains a difficult-to-treat disease with high relapse rates for a considerable proportion of patients.”
Those affected by primary biliary cholangitis (PBC) are fighting back against the recommendation by the EMA that the marketing authorization for Ocaliva (obeticholic acid), a second-line treatment used by 7,000 patients in Europe, be withdrawn. Earlier today, July 25, patients and their supporters staged a protest outside the European Commission building in Brussels to oppose EMA’s position that Ocaliva’s conditional license should be revoked.
Xinthera Inc. has disclosed integrin α4β7 (LPAM-1) antagonists reported to be useful for the treatment of inflammatory bowel disease, colitis, pouchitis, gastroenteritis, eosinophilic esophagitis and lung inflammatory disease.
The use of artificial intelligence (AI) in drug discovery has shown promise in recent years with a growing number of new compounds moving forward in the pipeline.
In the third-largest acquisition announced this year, pharma giant Eli Lilly and Co. is buying oral integrin therapies developer Morphic Holding Inc. for $3.2 billion. Morphic stock (NASDAQ:MORF) got a tremendous boost from the acquisition, with shares closing 75% upward at $55.74 each on July 8, the day the deal was announced.
The U.S. FDA granted Signum Surgical Ltd. de novo marketing clearance for its Biohealx technology as a treatment for anal fistula. Biohealx is a single use, bioabsorbable implant, designed to not only to treat the condition in a minimally invasive procedure but also promote healing, prevent fistula recurrence and protect patient continence.
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