Ana Mulero

Ana Mulero

Freelance writer

Ana Mulero is a freelance writer based in Puerto Rico and Florida. She can be reached at anacmulero@outlook.com, on LinkedIn and on X @anitamulero.

M&A activity surges and IPOs return as the biotech industry navigates a changing business landscape marked by strategic consolidation and renewed investor focus on innovation.
From gene-corrected cell therapies to a new CAR-T, the cell and gene therapy space looks to expand its reach into the market.
From the rising trend of royalty financing to other adaptive funding strategies, firms think outside the box in responding to unprecedented challenges.
From Statera Biopharma and Sorrento Therapeutics to Aceragen and Infinity Pharmaceuticals, 2023 has seen a record high 28 bankruptcies in the biotech space so far. Here’s why.
Biopharma companies buying stock in one another did not used to be an unusual practice, but experts told BioSpace this is becoming less common due to greater market volatility.
Insilico’s AI platform has attracted interest from a growing number of biopharma companies. Meanwhile, several other firms highlight their own AI technologies.
The new legislation could increase healthcare spending overall while reducing biopharma’s return on investment on biologic drugs.
The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
Industry advocates argue price negotiation via the IRA may jeopardize the prices relied upon by biosimilar manufacturers to recoup their investments.
The initiatives coincide with an increase in the volume of data submitted to CDER and CBER—particularly in cell and gene therapy.
The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.
FDA
Efforts are underway to fast-track approval for costly gene therapies and make them affordable to a wider patient group via reimbursement through Medicare and Medicaid.
FDA
The FDA’s Center for Biologics Evaluation and Research is aiming to recreate the success achieved with the rapid development of COVID-19 vaccines under a program of the same name.
After 12 years on the market, the FDA announced it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena.
The money saved on canceling the existing studies is intended to fund the advancement of two other oncology pipeline assets.