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FDA
Amid one of the industry’s steepest patent cliffs, the regulator Thursday approved Sandoz’s Tyruko, the first biosimilar for treating relapsing multiple sclerosis in adults. Sandoz is a division of Novartis.
The world’s largest buyer of biopharma royalties is paying $300 million up front and $200 million in milestone payments for Ferring Pharmaceuticals’ FDA-approved bladder cancer drug Adstiladrin.
As the FDA’s recent rejection of Biogen and Sage’s zuranolone for major depressive disorder highlights, biopharma companies will need to tackle emerging challenges to bring more of these drugs to patients.
While some biopharma companies seek an effective and non-addictive alternative to opioids, others are looking to make opioids themselves safer.
FDA
In the next two weeks, the FDA will hand out regulatory verdicts to BMS, Outlook Therapeutics and BioLineRx.
The Danish drugmaker is leveraging Thermo Fisher Scientific as Wegovy demand surges and amid production problems with manufacturer Catalent, Reuters reported on Wednesday.
Data suggests divarasib could be more potent than already approved KRAS inhibitors from Amgen and Mirati, but the study’s authors caution against cross-trial comparisons.
The company appears to be terminating the development of two Phase I antibody-drug conjugates in cancer, ABBV-011 and the Pfizer-partnered ABBV-647.
After slimming down its infectious diseases and vaccines business, Johnson & Johnson now appears to be ending research and development at a Dutch-based unit, except for a few programs.
The consumer healthcare brand is joining the growing biosimilars market in the U.S. with its new subsidiary Cordavis, which will market a Humira biosimilar as its first product.
To successfully compete against one another and Big Pharma for top talent, biotech companies need to do a better job of selling themselves.
After identifying structural variations in the 19-gauge filter needle included in some eye injection kits, Apellis has advised doctors to only use 18-gauge kits already in circulation and that will be distributed.
Spurred by an “inadvertent” disclosure, Roche’s Genentech on Wednesday released interim and immature overall survival findings for its anti-TIGIT antibody tiragolumab in non-small cell lung cancer.
Under the $1.4 billion Project NextGen initiative, Regeneron was awarded a $326 million grant for its preventive monoclonal antibody, while Johnson & Johnson got $10 million to bankroll startups.
The RET kinase inhibitor showed “statistically significant and clinically meaningful improvements” in progression-free survival compared to Exelixis’ Cabometyx and Sanofi’s Caprelsa.
The biotech’s experimental vaccine has shown a neutralizing response to XBB sublineages of COVID-19, which currently dominate new cases in the U.S. and Europe.
As competition for life sciences talent peaks, BioSpace has undertaken research to determine what employers can do to ensure they don’t lose out on talent they actually want to hire and retain.
If people are your greatest asset, it is imperative that your organization maintains a positive employer brand presence and talent pipeline. This report covers how you can build a strong employer brand with prospective employees, current employees - and former employees.
In challenging conditions, how can employers optimize the employee experience to retain their top talent and make the most of their current teams?
In the 2020 US Life Sciences Diversity & Inclusion report, BioSpace dives into how different segments of employees experience and perceive policies, attitudes and actions. Our data suggests that there are significant disparities between segments.