Newco Immutrin Ltd. has raised £65 million (US$86.9 million) in a series A to take its lead antibody program through to clinical proof of concept in transthyretin amyloid cardiomyopathy.
Investors looking for midteen percentage weight loss findings in Zealand Pharma A/S’s phase II study of once-weekly amylin analogue petrelintide were clearly disappointed by the actual 10.7% mean body weight reduction, as shares (Copenhagen:ZEAL) fell 36% March 6. But from the company’s standpoint, the combination of efficacy and safety data from the Zupreme-1 study bode well for a phase III trial expected to start later this year.
In its fourth major biopharma deal since its 2019 founding, Repertoire Immune Medicines signed a partnership with Eli Lilly and Co. to develop tolerizing therapies for several autoimmune diseases, gaining an up-front payment of $85 million, with a potential $1.84 billion in development and commercial milestone payments coming later, along with tiered royalties.
The pressure on U.S. drug prices continues, with the CMS lining up the drugs for round 3 of negotiations, which will set maximum fair prices to go into effect in 2028. The slate includes 15 drugs and, for the first time, opens the negotiations to Part B drugs, as well as Part D. Consequently, seven of the 15 selected drugs are biologics.
Offering $2.2 billion for Rapt Therapeutics Inc. and gaining its long-acting lead drug, ozureprubart, for food allergy and other indications, GSK plc is positioning itself to compete with market leader Xolair (omalizumab), developed by Roche AG’s Genentech unit and Novartis AG.
Siemens Healthineers AG became the latest company to sign a licensing agreement with Alzpath Inc. to use its pTau217 antibody in the development of a blood-based diagnostic assay for Alzheimer's disease. Alzpath previously signed deals with the likes of Roche AG and Beckman Coulter Diagnostics Inc. to use its pTau217 antibody to create diagnostic tests based for early detection and monitoring of Alzheimer's.
Roche AG received CE mark for its cobas Bacterial Vaginosis/Candida Vaginitis assay, which will help to improve accuracy in detecting vaginitis in women. The molecular test identifies specific bacteria and yeast responsible for BV and CV from vaginal samples collected using the cobas PCR Media proprietary tube.
Roche AG received regulatory clearance from the U.S. and European authorities for a new diagnostic test that detects Bordetella infections, including whooping cough, as cases surge globally. The point-of-care test, which delivers PCR-accurate results in just 15 minutes, will help health care providers to quickly identify infections and act to prevent severe complications, onward transmission and deaths.
Roche AG’s Genentech unit landed another clinical victory with giredestrant that provided a major stock boost for competitor Olema Pharmaceuticals Inc. Made public were positive phase III data from the Lidera study testing selective estrogen receptor degrader and complete estrogen receptor antagonist (CERAN) as an adjuvant endocrine treatment for people with ER-positive, HER2-negative, early stage breast cancer (BC).
