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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.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
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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.
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Analysts, investors and partner Summit Therapeutics had all been keenly awaiting the overall survival update, after previous data from Akeso’s HARMONi-6 trial left them wanting.
FDA inspectors found Alchymars failed to adequately maintain equipment used to make active pharmaceutical ingredients for the U.S. market. Over-the-counter drugmakers GC America and Sato Pharmaceutical also received warning letters.
As Summit Therapeutics’ Chinese partner prepares to reveal data for a key trial at ASCO, analysts consider the impact on rivals Merck, Bristol Myers Squibb and BioNTech.
Replimune’s resubmission for RP1 for melanoma comes amid the departures of FDA leaders in place at the time of the drug’s first two rejections, last summer and again in April.
Beren Therapeutics is seeking approval in Neimann-Pick disease type C, an application the FDA was set to decide on by August 17. The new target action date is November 17.
Pfizer continues its dealmaking spree by striking a back-heavy partnership with China’s Innovent Biologics to assemble a pipeline of antibody-based therapies for cancer.
More than half of biotech and pharma job seekers have been looking for their next opportunity for six months or longer, and more than a quarter have searched for over a year, according to a BioSpace LinkedIn poll. Job seekers share their frustrations.
The antisense oligonucleotide was even more effective in patients with relatively low viral activity. More than one-quarter of these individuals had undetectable levels of the virus in the blood for at least six months after stopping treatment.
Kailera Therapeutics is advancing a pipeline of weight loss medicines that mirrors Eli Lilly’s: an injectable GLP-1/GIP dual agonist like Zepbound, an oral GLP-1 like Foundayo and a triple-G therapy like retatrutide.
Decnupaz is the first antibody-drug conjugate for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare and aggressive blood cancer.