BioWorld News

Ambrosia Biosciences Inc., named after the drink of the Greek gods, secured a $100 million series B to advance its preclinical pipeline of oral obesity drugs. The startup formed after Pfizer Inc. shuttered its Boulder, Colo.-based research facility that the pharma gained through its 2019 acquisition of Array Biopharma Inc. “We caught wind that was happening, and we really used that as the nexus for the formation of Ambrosia,” Nick Traggis, founder and CEO of Ambrosia, told BioWorld News. “Think of it as kind of putting the band back together.” Read Brian Orelli, PhD’s report in BioWorld News: https://lnkd.in/eentfKJk (Access this exclusive content with a Premium BioWorld subscription: https://lnkd.in/ex_sZAtE) #biopharma #newco #financing #GLP1 Clarivate for Life Sciences & Healthcare

The European Medicines Agency (EMA) has given initial endorsement to a new approach to early toxicity testing in which live animals will be replaced by virtual counterparts. The virtual control groups (VCGs) will be derived from data generated in animals that have been used as controls in previous studies. The historical database has been brought together in an EU-funded project to which 20 pharma and crop sciences companies contributed. EMA’s endorsement comes in the form of a draft ‘qualification opinion’ that says VCGs could be acceptable for specific – and very limited – use in non-GLP dose range-finding in rats. The momentum has come from an EU-funded public-private research program VICT3R, which has developed a methodology for generating virtual control groups from a historical database of control animals based on the archives of 20 companies taking part in the project. The consortium has also carried out comparisons with live animal control data previously submitted in marketing authorization applications, to show that using VCGs could generate the same results. Read Nuala Moran’s report in BioWorld News: https://lnkd.in/err-yR7g (Access this exclusive content with a Premium BioWorld subscription: https://lnkd.in/ex_sZAtE) #biopharma #AnimalTesting #VirtualControlGroups #NewApproachMethodology Clarivate for Life Sciences & Healthcare Image credit: Ralf - stock.adobe.com

Med-tech M&A activity surged in the first quarter of 2026, with deal value reaching $41.86 billion, marking one of the strongest quarterly openings in recent years. The largest med-tech M&A transaction of Q1 was Abbott Laboratories‘ $21 billion acquisition of Exact Sciences Corp. in March, followed by BD's (Becton, Dickinson and Co.) combination of its Biosciences and Diagnostic Solutions business with Waters Corporation Corp. in a $17.5 billion transaction that closed in February. Read the report in BioWorld News: https://lnkd.in/e2MEXSNs (Access this exclusive content with a Premium BioWorld subscription: https://lnkd.in/ex_sZAtE) #medtech #deals Clarivate for Life Sciences & Healthcare

Lipocine Inc. says no ‘brexit’ just yet, brexanolone bid may have life post-phase III fizzle Read Randy Osborne’s report in BioWorld News (free with one-time registration): https://lnkd.in/eanuDKGr #biopharma #PostPartumDepression Clarivate for Life Sciences & Healthcare

The FDA’s CRL for idebenone in Leber hereditary optic neuropathy (LHON) underscores the challenges of rare disease drug development – and may shift momentum toward gene therapy. GenSight Biologics' Lumevoq continues to advance despite regulatory and manufacturing hurdles. Read Marian (YoonJee) Chu’s report in BioWorld News: https://lnkd.in/e3bTBVkM (Access this exclusive content with a Premium BioWorld subscription: https://lnkd.in/ex_sZAtE) #biopharma #regulatory #raredisease #genetherapy #LHON Chiesi Group Clarivate for Life Sciences & Healthcare

Korsana Biosciences is making the leap to the public market via a merger with Cyclerion. The agreement, which is backed by a $370 million private placement from Korsana’s investors, solidly positions the newly merged company as it heads toward the clinic with KRSA-028, a next-generation shuttled antibody targeting amyloid beta for the treatment of Alzheimer’s disease, and builds out a pipeline of neurodegenerative disease candidates. Read the full article in BioWorld News: https://lnkd.in/gqr4h_xe (Access this exclusive content with a BioWorld Premium subscription: https://lnkd.in/ex_sZAtE; this article also ran in a previous issue of BioWorld: https://lnkd.in/gh98stRq) #neurology #deals #preclinical #biopharma #research #science Clarivate for Life Sciences & Healthcare

A new pan-cancer study is redefining how researchers target BAP1-mutant cancers, linking a core DNA damage recognition defect to a potential combination therapy strategy. Researchers from Duke-NUS Medical School in Singapore discovered that the loss of BAP1 – a mutation found in mesothelioma, cholangiocarcinoma, renal cell carcinoma and uveal melanoma – creates a specific defect in how cancer cells recognize and repair DNA damage. Leveraging that weakness, the team demonstrated that dual inhibition of LSD1 and PARP1 drove synergistic tumor killing across multiple preclinical models. Although researchers previously thought BAP1 played a role in DNA repair, first author Jing Han Hong told BioWorld News that the study reframes the role of BAP1 more precisely, which is to enable cells to recognize damage in the first place. The work provides a rare example of translating tumor suppressor biology into a rational therapeutic approach and could open the door to biomarker-driven trials across tumor types. Read the article for free with one-time registration: https://lnkd.in/gUZue3R9 #oncology #preclinical #research #DNAdamage #PARP Clarivate for Life Sciences & Healthcare   

With cases of peripheral artery disease (PAD) rising across the U.K., and lower limb amputations continuing to increase, med-tech companies joined forces with parliamentarians and health care professionals to push for urgent reform of the vascular sector. Despite progress in cardiac and stroke care, as well as new technologies, thousands of major lower-limb amputations happen each year. A new white paper proposes a number of measures to reform the sector centered on a community-first model of vascular care, which will deliver earlier diagnosis, better outcomes and greater efficiency. Read Shani Alexander’s report in BioWorld News: https://lnkd.in/e2PFS5fW (Access this exclusive content with a Premium BioWorld subscription: https://lnkd.in/ex_sZAtE) #medtech #PAD #PeripheralArteryDisease #VascularCare Clarivate for Life Sciences & Healthcare

Deviant strain: PepGen stock pressured by phase II ‘outlier,’ investors Dyne to know more Read Randy Osborne’s report in BioWorld News: https://lnkd.in/eHHbMNxq (Access this exclusive content with a Premium BioWorld subscription: https://lnkd.in/ex_sZAtE) #biopharma #MyotonicDystrophy Clarivate for Life Sciences & Healthcare

Eli Lilly and Company and Co. anticipates a speedy launch following a speedy U.S. FDA approval of #Foundayo (orforglipron) as the second oral weight-loss glucagon-like peptide-1 (GLP-1) receptor agonist to enter the U.S. market and the first new molecular entity cleared under the FDA Commissioner’s National Priority Review pilot program. Read more in BioWorld News (free with one-time registration): https://lnkd.in/eskHbqvX #biopharma #FDA #obesity #GLP1 #approval #orforglipron Clarivate for Life Sciences & Healthcare Image credit: MichaelVi - stock.adobe.com