Ophthalmic diseases specialist Oculis Holding AG announced positive phase II data showing its serum-glucose corticoid kinase-2 activator OCS-05 protected nerve cells and improved vision in patients with acute optic neuritis. The placebo-controlled, randomized trial assessed the neuroprotective effect of OCS-05 in combination with standard-of-care steroid injections, against steroids alone, with a benefit seen in preserving both ganglions and retinal cell nerve fibers.
The U.K. is embarking on the biggest overhaul of clinical trials regulations in 20 years in a bid to retake ground that was lost following Brexit, when the Medicines and Healthcare products Agency was excised from the EMA’s regulatory system.
Roche Holding AG kicked off the new year (again) with a potential $1 billion deal, including $80 million up front, for exclusive rights to Innovent Biologics Inc.’s IBI-3009, a DLL3-targeting antibody-drug conjugate (ADC) candidate that recently entered a phase I study.
Driven by declining competitiveness, the new European Commission will start 2025 by getting to work on an EU-wide industrial strategy, proposing a number of policies with direct and indirect implications for the biopharmaceutical sector.
As 2025 gets underway, a new European Commission will start work on its new five-year mandate, with plans for multiple pieces of legislation that have implications for biotech and pharma – and the life sciences industry more broadly – due to be put forward.
After the funding feast sparked by the pandemic, European biotech has emerged from the famine that followed, with venture capital raised this year finally exceeding the 2020 total.After the funding feast sparked by the pandemic, European biotech has emerged from the famine that followed, with venture capital raised this year finally exceeding the 2020 total.
In a deal worth $100 million up front and up to $1.25 billion in milestone payments, Bioarctic AB licensed its pyroglutamate-amyloid-β (pyroglutamate-Aβ) antibody program to Bristol Myers Squibb Co. to advance treatments for Alzheimer’s disease.
Shares in Zealand Pharma A/S (CO:ZEAL) dropped 22.4% to as low as DKK587 (US$82.16) on Dec. 20, after the U.S. FDA issued a complete response letter (CRL) for glepaglutide in the treatment of short bowel syndrome.
Its lead program might have hit a safety snag, but Bioage Labs Inc.’s longevity data platform caught the attention of Novartis AG, which agreed to pay $20 million up front in a collaboration to identify drug targets for aging-related diseases. Taking into account potential long-term research, development and commercial milestones, the agreement could bring in up to an additional $530 million.
The Danish Medicines Agency is to ask the EMA’s pharmacovigilance committee to investigate a potential increased risk of an acute eye condition in diabetic patients being treated with the glucagon-like peptide-1 receptor agonist Ozempic (semaglutide).
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