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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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After showing some unfavorable results for its data, AC Immune on Monday announced it will be getting back its Alzheimer’s disease candidates from Roche’s Genentech.
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.
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.