A lack of available options for treating idiopathic pulmonary fibrosis (IPF) is driving plenty of development into the indication. The latest data come from Pliant Therapeutics Inc., which posted positive 12-week interim data from 21 participants in the 320-mg dose group’s active arm and eight in the placebo arm in its phase IIa study of PLN-74809 (bexotegrast).
Next week, Cidara Therapeutics Inc. will make its case for rezafungin, an injectable treatment for candidemia and invasive candidiasis in adults, before the U.S. FDA’s Antimicrobial Drugs Advisory Committee. When it convenes Jan. 24, the adcom will vote either yes or no if it believes the overall benefit-risk assessment is favorable for the use of rezafungin for treating candidemia/invasive candidiasis in adults with limited or no alternative treatment options.
A year and a half gone, two HIV vaccine studies shut down. That’s the case with the Janssen Pharmaceutical Cos. of Johnson & Johnson as the phase III Mosaico study of its HIV vaccine regimen was not effective in preventing infection compared to placebo. Based on a data and safety monitoring board’s report saying the study was not expected to hit its primary endpoint, Janssen discontinued the clinical trial more than a year ahead of its estimated March 2024 completion date.
Now there are three. Moderna Inc. has posted strong phase III study data on its mRNA respiratory syncytial virus (RSV) vaccine, keeping pace with Pfizer Inc. and GSK plc’s candidates, which have May PDUFA dates. Moderna’s top-line results of the ConquerRSV pivotal efficacy study of mRNA-1345 show the vaccine hit its primary efficacy endpoints of 83.7% against RSV-associated lower respiratory tract disease in older adults.
Now in its 10th year, Clarivate’s newly released Drugs to Watch 2023 report primarily features treatments targeted to a particular biomarker, signaling the advance and increasing potential of personalized medicines. The 15 drugs on the list are anticipated to either register sales of more than $1 billion by 2027 or be clinical game changers. Nine are predicted to hit $1 billion annual sales each in China by 2030.
Two companies who needed partners have found each other, as privately held Elicio Therapeutics Inc. will merge with Angion Biomedica Corp. in an all-stock deal.
Oramed Pharmaceuticals Inc. has had a lot of success with testing its oral insulin, until now. The company will discontinue it oral insulin clinical work in treating type 2 diabetes after ORMD-0801 failed to hit its phase III study’s primary and secondary endpoints. The late-stage stumble clobbered the company stock (NASDAQ:ORMP), which lost 76% of its value on Dec. 12 to close at $2.54 each.
Now in its 10th year, Clarivate’s newly released Drugs to Watch 2023 report primarily features treatments targeted to a particular biomarker, signaling the advance and increasing potential of personalized medicines. The 15 drugs on the list are anticipated to either register sales of more than $1 billion by 2027 or be clinical game changers. Nine are predicted to hit $1 billion annual sales each in China by 2030.
Once a rarity, billion-dollar deals are now coming fast and furious. Now three have appeared in only a few days. Gene therapy developer Voyager Therapeutics Inc. and Neurocrine Biosciences Inc. continued a longstanding partnership by agreeing to develop treatments for neurological diseases and for three new programs with rare CNS targets. Cytomx Therapeutics Inc. and Moderna Inc. entered a deal worth a potential $1.24 billion to Cytomx for generating and developing treatments in oncology and non-oncology. In the third deal, Royalty Pharma plc acquired an interest in Ionis Pharmaceuticals Inc.'s royalty in Biogen Inc.'s Spinraza (nusinersen) and Novartis AG's pelacarsen for up to $1.125 billion.
Fate Therapeutics Inc. is making big changes. The company told Janssen Biotech Inc. it was not interested in continuing the collaboration and option agreement cut in 2020 that could have brought Fate up to $3 billion. Fate also is halting four solid tumor natural killer (NK) cell programs to concentrate on two of its NK cell programs and two T-cell programs, all while reducing headcount to 220 employees in the first quarter of 2023.
