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This represents Alector’s second failed neurodegenerative asset in a year, after an AbbVie-partnered asset missed in Alzheimer’s last November. On latozinemab for frontotemporal dementia, Alector was working with GSK, which fronted $700 million in 2021 to collaborate on two programs.
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Contingent value rights are rising in a down market, helping to close the gap between buyer and seller expectations in biotech transactions.
Executives at Novartis have not been shy about a desire to buy more companies, with cardiovascular a big focus. In total, the Swiss pharma has put $17.23 billion on the line in M&A and licensing deals this year.
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.
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Mika Health, a global digital therapeutics developer specializing in meeting the needs of cancer patients, in collaboration with AstraZeneca and Daiichi Sankyo, announced at the HLTH Europe conference, a digital initiative to improve the experience of women receiving breast cancer treatments.
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Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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Six months after his controversial departure from the top spot at the FDA’s biologics division, Peter Marks has landed at Eli Lilly, joining former colleague Rachael Anatol, who was ousted from the agency not long after Marks.
MapLight laid out the terms of its planned IPO in a regulatory filing on Monday, providing greater detail about what the funds will be used for.
Of the three highest bidders, Pfizer’s purchase proposal for Metsera was the lowest, regulatory documents reveal. The New York pharma, however, offered the smoothest transaction with the greatest likelihood of success.
Skye Bioscience’s nimacimab fell short of investor and company expectations, but showed encouraging weight-loss results when combined with Wegovy, according to analysts at William Blair.
Amgen will offer its lipid-lowering drug Repatha directly to patients for $239 per month, representing a nearly 60% reduction from the current wholesale acquisition cost of $527.70.
A new survey from CRB showed that most manufacturing initiatives in the U.S. made in response to tariffs are coming from Big Pharma companies, while smaller biotechs are left to hope “the situation doesn’t get worse.”
The inaugural 40 Under 40 cohort includes CEOs, leaders who have founded or co-founded their company and executives from a range of disciplines. Winners’ accomplishments include shaping drug development, achieving key FDA milestones and launching a new field of study.
Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.
A new group of CDC advisors voted last month to separate the chickenpox vaccine from the measles, mumps, rubella components of the MMRV shot due to concerns over febrile seizures, while recommending a more risk-based approach to COVID-19 immunizations that mirrors recent FDA approvals.
The hold was placed earlier this year when the FDA asked for more preclinical data, but the agency was slow to respond due to ‘strain’ on its capacity, according to Neurizon.