Mar
16
2021

Solutions Exist To Regenerative Medicine's Most Pressing Manufacturing Challenges

In Vivo

Experts share what they believe are the solutions to key manufacturing challenges, such as lowering cost of goods and centralized manufacturing, in the cell and gene therapy sector.

Mar
12
2021

PDUFA VII to feature $4M fee, focus on cell, gene therapies

BioCentury

FDA and biopharma industry representatives have agreed on most elements of the next Prescription Drug User Fee Act deal, including an increase in the application fee to about $4 million by 2027 from the current $2.9 million level, sources briefed on the negotiations told BioCentury.

Mar
10
2021

Could Automation Rescue CAR-T Manufacturing?

In Vivo

Manufacturing constraints have prevented even the most pioneering cell therapy companies from meeting patient demand for their life-saving treatments. They are still in the works, but could fully automated, closed manufacturing platforms be potential game changers?

Mar
03
2021

Regenerative medicine companies enjoy record year

BioWorld

With the massive amounts of capital raised by global public and private biopharmaceutical companies last year generating approximately $134 billion – a total that was almost double the previous record of about $69 billion raised in 2015 – it is not surprising that financing for the regenerative medicine and advanced therapy sector also set an annual record.

Feb
03
2021

After challenging year, cell and gene therapy industry poised for further growth in 2021

Healios

Challenges presented by the COVID-19 pandemic did not stop progress in research or clinical development of gene and cell therapies, according to a state-of-the-industry briefing by Alliance of Regenerative Medicine.

Feb
03
2021

Commission (finally) releases Europe’s Beating Cancer plan

Politico

The Alliance for Regenerative Medicine applauded the plan’s links to the European Health Data Space. That proposal could facilitate the assessment for cutting-edge cancer therapies, for example, by gathering real world evidence and data, according to the group, which represents cell and gene therapy companies.

Jan
31
2021

A record year for the financing of ATMPs

MedNous

“As we begin 2021 bolstered by this exceptional growth, healthcare systems need to fully prepare for the coming wave of ATMP approvals,” writes ARM’s Paige Bischoff.

Jan
15
2021

Cell and Gene Therapies Shatter Prior Records, with Continued Growth Expected

BioSpace

Cell and gene therapies achieved record growth in 2020, surpassing prior high points in terms of financings and approvals. Janet Lambert, CEO of the Alliance for Regenerative Medicine (ARM), painted a rosy picture despite a few challenges at the 2021 Cell & Gene State of the Industry Briefing during this year’s Biotech Showcase, held virtually January 11-15.