News
The positive ADHD data for Otsuka Pharmaceutical’s centanafadine is good news in what has of late been a mixed bag for the neuropsychiatric space.
FEATURED STORIES
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
The headcount reduction will save money that the company will use in developing mavorixafor, its CXCR4 antagonist that last year received FDA approval to treat WHIM syndrome, in the larger patient population with chronic neutropenia.
Bristol Myers Squibb will make even deeper cuts to its organization to enhance efficiencies as it faces the 2028 loss of exclusivity for its blockbuster drugs Eliquis and Opdivo.
Viracta’s closure comes on the heels of its delisting from Nasdaq last month and multiple rounds of layoffs last year.
Despite the discontinuations, CEO Pascal Soriot said AstraZeneca’s December 2020 acquisition of Alexion was a “fantastic” deal for the pharma.
Kuro Oncology and partner Kyowa Kirin are on track for an NDA submission for ziftomenib in the second quarter of this year.
Most employers are expecting to hire this year, according to BioSpace data and Recruitment Manager Greg Clouse, who noted that companies are looking to do more than just replace people lost to turnover.
Wegovy sales increased by more than 100% over 2024. But that wasn’t enough to satiate analysts who want to know why Novo Nordisk can’t access more patients, particularly in the U.S.
Valerio only has cash to last three months, according to the DNA decoy specialist. The news comes less than six months after the company acquired Emglev Therapeutics to advance antibodies for autoimmune and inflammatory conditions, as well as cancers.
BioSpace Senior Editor Annalee Armstrong headed to the J.P. Morgan Healthcare Conference with a months-long story idea brewing. Unfortunately, it was one she’s written before.
Before garnering approval on Tuesday, Onapgo had been rejected twice by the FDA.