Spectrum Pharmaceuticals had been talking up its chances of getting an accelerated approval for their EGFR TKI poziotinib for non-small cell lung cancer off of positive data from the first cohort in Phase II. Instead, they’re trying to convince investors they still have a shot at a mid-stage approval now
US pharma giant seeks to expand footprint beyond cancer treatment as its biggest product nears patent cliff
→ Carole Nuechterlein said on LinkedIn that she is retiring as head of the Roche Venture Fund “next spring.” Nuechterlein has held this position since…
FDA’s Center for Biologics Research and Evaluation fires Nicole Verdun and Rachael Anatol from cell and gene therapy leadership; Director Vinay Prasad adds new roles.
Two of HHS Secretary Robert F. Kennedy Jr.’s new appointees to the CDC’s vaccine advisory board have previously served as paid expert witnesses for plaintiffs…
HHS Secretary Kennedy’s new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
FDA approves Moderna’s mNEXSPIKE Covid vaccine for ages 12+ with risk factors and all 65+. CEO Stéphane Bancel welcomes approval of shot that uses lower…
The CDC officially axed Covid shot recommendations for pregnant women from its vaccine schedule, following a social media announcement earlier this week from HHS chief…
Summit Therapeutics’ ivonescimab shows 48% PFS benefit but misses OS endpoint in Phase 3 lung cancer trial; drug’s regulatory future unclear after mixed EGFR+ NSCLC…
The Trump administration has killed two awards worth $766 million to help Moderna develop a bird flu vaccine, according to the company.
The US’ stance on Covid-19 vaccines under HHS chief Robert F. Kennedy Jr. is coming into focus with a new approval framework, new immunization guidance…
