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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.
The funding includes $500 million in cash from Blue Owl and CPP Investments in exchange for a 5% royalty on future global net sales of acoramidis to treat transthyretin amyloid cardiomyopathy.
From ALS to depression to Huntington’s disease, many neuroscience-focused companies are anticipating key data over the next few months.
Whether this year’s crop of IPOs—Alto Neuroscience, ArriVent Biopharma, CG Oncology, Kyverna Therapeutics and Metagenomi—will trade below their offering prices remains to be seen.
The pharma execs may be served with subpoenas to appear before the Senate health committee to explain why their products are much more expensive in the U.S. than in other countries, according to chairman Sen. Bernie Sanders.
Nearly two decades in the making, the companies expect to close the deal in the first half of 2024, after which Taro Pharmaceutical will become a privately held entity and will no longer trade on the New York Stock Exchange.
A legislative proposal, if passed into law, could cost the United States up to 1.2 million jobs and lead to more than 130 fewer FDA approvals over a 10-year period, according to a new report.
CBER Director Peter Marks recently spoke in favor of single-arm trials in certain situations, but clinicians and ethicists say there are several variables to consider.
The bladder cancer-focused biotech is looking to be one of the first companies out of the gate with an initial public offering in 2024.
Regulatory authorities worldwide are tightening their monitoring mechanisms and launching their own investigations after reports of secondary malignancies potentially linked to chimeric antigen receptor T cell therapies.
Taiwanese contract development and manufacturing organization Bora will purchase Minnesota-based Upsher-Smith Laboratories, expanding operations into the U.S. for the first time.
The FDA’s Complete Response Letter identified problems with the drug candidate’s chemistry, manufacturing and controls, parent company Shin Nippon Biomedical Laboratories announced Thursday.
The Swiss pharma’s Phase III trial of ligelizumab in patients with peanut allergies has been terminated, according to a ClinicalTrials.gov update on Tuesday.
The San Diego-based startup, specializing in allogeneic engineered Treg and CAR-Treg cell therapies, plans to be in Phase I clinical trials in multiple indications in 2024.
Despite offering discounts that reach as high as 85%, Humira biosimilars are finding it difficult to take market share away from the AbbVie blockbuster, according to a new report from Samsung Bioepis.
The sweeping changes are meant to “reduce hierarchies” and “accelerate decision-making” as Bayer weathers several business crises and continues to suffer from the fallout of its disastrous Monsanto acquisition.
In a changing landscape, top companies are increasingly embracing remote work.