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Ocular Therapeutix’s lead asset is Axpaxli, being developed for wet age-related macular degeneration. A Phase III study is underway, with data expected this quarter.
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It doesn’t matter how many times you have traversed Union Square; no one knows which way is north, or where The Westin is in relation to the Ritz Carlton. A Verizon outage brought that into focus on Wednesday.
Primarily known as an immunology and neuroscience company, AbbVie wanted to put the biopharma world on notice during its J.P. Morgan presentation: its oncology portfolio is underappreciated. This week, the Illinois-based company dove into the sizzling PD-1/VEGF space with a licensing deal with China-based RemeGen.
Buying vaccine biotech Dynavax was an easy choice for Sanofi despite antivaccine moves by the Trump administration.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference. Meanwhile, Biogen proposes to acquire struggling neuro partner Sage, and obesity dominates discussions as Pfizer goes “all in.”
Lykos Therapeutics is currently working out ways to fund an additional Phase III study for its MDMA-assisted PTSD therapy following an FDA setback last year.
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
JPM25 is in full swing as several pharma powerhouses—including Merck, Lilly and Amgen—detail their strategies for growth in the coming year.
BioSpace recaps 2024’s top venture capital rounds in biopharma, from Xaira Therapeutics’ blockbuster $1B raise to back-to-back series from obesity-focused Metsera that totaled more than $500M in a space that has garnered more than a fivefold increase in VC dollars this year.
The updated guidance, which was largely driven by lower-than-anticipated sales of GLP-1 blockbusters Mounjaro and Zepbound, sent Eli Lilly’s shares cratering by as much as 8% Tuesday, even as the company forecasted robust 2025 revenue.
Biopharma executives were busy Monday, striking high-value deals and providing updates on cancer, obesity and vaccine pipelines.
J.P. Morgan kicked off with a flurry of deals, with Eli Lilly, GSK and Gilead all announcing deals potentially worth more than $1 billion while J&J committed $14.6 billion to buy Intra-Cellular. These moves have reinvigorated sentiment across the biopharma industry.
The FDA accepted Biogen and Eisai’s BLA for a subcutaneous administration of the anti-amyloid antibody Monday as the partners await the regulator’s decision on a new intravenous regimen following an underwhelming launch riddled with coverage and accessibility barriers.
In exchange for its investigational gene therapies, Regenxbio will receive $110 million upfront and up to $700 million in milestones. After hitting an all-time low of $6.95 at close of business yesterday, the stock surged on the news by nearly 20% before markets opened Tuesday.