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With the failure in chronic spontaneous urticaria, Evommune’s story is now centered on its anti-IL-18 therapy EVO301, Oppenheimer said, which in February elicited a 33% placebo-adjusted improvement in eczema severity.
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Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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As with any new year, 2024 presents new possibilities; though new and existing challenges are also poised to shape its trajectory. BioSpace reflects on the recent JP Morgan Healthcare Conference and future outlook with key opinion leaders who share their thoughts on the economic climate.
Amid a hot antibody-drug conjugate market in oncology, Gilead Sciences announced Monday that its ADC Trodelvy did not reach a primary endpoint in a non-small cell lung cancer trial.
With initial public offering activity continuing to gain momentum in early 2024, ArriVent Biopharma in a Monday SEC filing laid out the company’s plans to go public.
The immunotherapy combination reduced the risk of disease progression or death by 79% versus chemotherapy in certain metastatic colorectal cancer patients, according to Bristol Myers Squibb.
Johnson & Johnson’s small molecule FGFR kinase inhibitor is now indicated for patients with susceptible FGFR3 mutations who progressed after at least one line of systemic therapy.
The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.
BioSpace’s Employment Outlook report investigates anticipated job search activity and hiring outlook in 2024 as well as how the current workforce is currently faring
The blank check company Thursday filed with the SEC for the initial public offering. While a specific business for Helix Acquisition Corp. II has not yet been identified, the fund will target biotech.
Amit Dagar, a former Pfizer employee, was found guilty of insider trading by a federal jury in New York involving clinical trial results for COVID-19 antiviral Paxlovid that he profited from.
From ALS to depression to Huntington’s disease, many neuroscience-focused companies are anticipating key data over the next few months.