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In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
ALS
Biogen’s Qalsody won FDA approval in 2023 to treat a rare, genetic form of amyotrophic lateral sclerosis. On Tuesday, QurAlis presented interim Phase 2 data showing the potential of a similar drug to more broadly treat the neurodegenerative disease.
As Q1 earnings arrive, three biotechs have big quarters ahead, with two—Amylyx and Neumora Therapeutics—betting at least partly on novel assets for obesity.
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Johnson & Johnson exceeded fourth-quarter earnings estimates, reporting nearly $21.4 billion in revenue, as its pharma business faces a patent cliff with Stelara competition entering the market.
The French drugmaker is buying California-based biotech Inhibrx to gain access to its clinical-stage drug candidate for alpha-1 antitrypsin deficiency, as it tries winning over investors with potential blockbusters.
Although the FDA did not outright say there is a causal secondary malignancy relationship, it asked BMS, Gilead, J&J and Novartis to add warnings to the labels of six CAR-T therapies noting the potential risks.
Novartis spin-off Sandoz will make an upfront cash payment for the entire Cimerli ophthalmology franchise, including inventories, software and sales and reimbursement teams.
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.
FDA
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.