In late May, a patient died after receiving Rocket Pharmaceuticals’ investigational gene therapy for Danon disease, spurring the hold. After lowering the dose and changing the regimen of immune modulators patients receive, the company has received FDA clearance for the trial to continue.
Rocket Re-Ignites Phase II Trial After FDA Lifts Clinical Hold Read More »
The Texas judge’s decision — which picked apart Elevance’s argument on mathematical grounds — could cost Elevance $375 million, though the insurer could still appeal.
Elevance loses Medicare Advantage star ratings suit Read More »
The CDC no longer recommends COVID-19 vaccines for healthy children and healthy pregnant women, a position that has been opposed by leading medical societies.
American Academy of Pediatrics Contradicts CDC, Recommends COVID-19 Shot for Kids Read More »
Regulations aiming to lower the cost of vital medicines will instead end up restricting access and disincentivizing R&D.
Look to Competition, Not Mandates, to Lower Drug Prices Read More »
With its structural changes, CSL expects to generate $500 to $550 million in annualized savings over the next three years.
CSL Overhauls Business With Vaccine Spinout, 15% Layoffs Read More »
The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new guidance follows the surprising return of CBER Head Vinay Prasad, who has previously argued for prioritizing OS.
FDA Looks to Raise Survival Bar for Cancer Drug Approvals in New Draft Guidance Read More »
A draft copy of an upcoming MAHA report reveals a strategy in lockstep with recent HHS actions such as reviving the Task Force on Safer Childhood Vaccines; Viking Therapeutics reports robust efficacy from mid-stage oral obesity candidate but is tripped up by tolerability concerns; Novo Nordisk wins approval for Wegovy in MASH; and Lilly takes
MAHA Report Emphasizes Vaccines, Safety Vexes Viking’s Obesity Win, Novo Gains Momentum Read More »
El infarto de miocardio, conocido comúnmente como ataque al corazón, sigue siendo una de las principales causas de enfermedad y muerte en todo el mundo. Cuando ocurre, una parte del músculo cardíaco se queda sin oxígeno debido a una arteria bloqueada. Esta falta de …
Posible tratamiento precoz tras un infarto de miocardio Read More »
La aleatoriedad es increíblemente útil. Las personas solemos recurrir a métodos como sacar pajitas, lanzar dados o tirar una moneda al aire para tomar decisiones justas que no dependan de la lógica. Los números aleatorios permiten a los auditores hacer selecciones …
Usan la mecánica cuántica para crear una fábrica de números aleatorios Read More »
Media coverage can help biopharma executives connect with, inform and inspire the public. In this column, Kaye/Bassman’s Michael Pietrack and three communications experts share how to make the most of these opportunities.
Leadership Lab: 4 Ways Biopharma Leaders Can Prepare for Media Interviews Read More »
