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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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Deal dynamics between Chinese biotechs and global pharma companies are changing fast, with the biotechs seeking higher upfront payments and the Big Pharmas seeking more expansive platform deals.
The forecast makes pharma one of the fastest-growing manufacturing industries in the U.S.
Pfizer showcased multiple late-breakers at the American Society of Clinical Oncology’s annual conference but its biggest data are expected later this year.
Merck may not have had the splashiest presentation at the American Society of Clinical Oncology meeting, but the data show why the Big Pharma remains king of oncology, analysts say.
Eli Lilly and the Haisco Pharmaceutical Group have yet to disclose what specific indications they plan to prioritize.
When used alongside Merck’s Keytruda, Moderna’s personalized cancer vaccine halved the risk of death or disease recurrence in a mid-stage trial of advanced melanoma—a result analysts said could help “instill confidence” in the regimen.
Recent deals from Pfizer and Bristol Myers Squibb hint at Big Pharma’s more collaborative approach to partnering with Chinese companies.
Government backing, deep scientific talent and a robust pharma heritage are helping France punch above its weight, but turning research into investable companies remains a challenge.
ALS
For Peter Pitts, a former associate commissioner at the FDA, the appointment to the board of BrainStorm Cell Therapeutics is an opportunity to fulfill a promise he made long ago to a patient with ALS.
Practice-changing data in lung cancer, prostate cancer and more were on display over the weekend at the American Society of Clinical Oncology annual meeting in Chicago. Plus, early readouts on assets that could reshape the cancer landscape.