Apr
22
2021

Cell Therapy Enforcement Discretion Ending, But US FDA Still Faces Challenge Going After Bad Actors

Pink Sheet

Planned 31 May revocation of enforcement discretion for certain cell therapy products without IND or BLA is important, but experts say the FDA’s next moves are what will really shape the field and patient safety moving forward.

Apr
22
2021

Time's up for questionable cell and tissue products, says Marks

Regulatory Focus

The Alliance for Regenerative Medicine (ARM), a trade association representing regenerative medicine firms, applauded Marks’ words and the end of the discretionary enforcement era.

Apr
18
2021

Cell and gene therapy: The next frontier in pharmaceutical services

Chemical & Engineering News

The US Food and Drug Administration has approved only 7 cell and gene therapy drugs, but the new product pipeline is teeming with approximately 1,200 experimental therapies, more than half in Phase 2 clinical trials.  And the number of cell and gene therapy developers is rising rapidly; the Alliance for Regenerative Medicine estimates 1,100 such ventures in 2020, an increase of about 10% over 2019.

Apr
16
2021

Cell and Gene Continue Their Hot Streak, Says ARM

POLITICO Pro

Coronavirus or not, the progress of advanced medicines like gene and cell therapies steamed ahead in 2020, according to the latest annual report out from the Alliance for Regenerative Medicine today.

Apr
13
2021

Lilly, Arch join Deerfield in backing new gene therapy biotech Jaguar

Biopharma Dive

Record levels of funding are flowing into cell and gene therapy companies like Jaguar and Taysha. Last year, nearly $20 billion was invested in companies in the sector, more than 50% higher than the previous record set in 2018, according to numbers compiled by the Alliance for Regenerative Medicine.

Apr
13
2021

To read the full story, subscribe or sign in. Record deal volume in Q1, but M&A values hit five-year low

BioWorld

With less uncertainty surrounding the pandemic, the biopharma industry appears on track to shift efforts back to its internal programs and possibly meet, if not exceed, the record-breaking deal level of 2020. Strong financial markets, however, may continue to hold M&As down.

Apr
12
2021

Federal agency says pharma should pay higher Medicaid rebates if certain trials aren’t finished on time

STAT News

The Alliance for Regenerative Medicine argued that the MACPAC recommendation would hurt “vulnerable” patient populations disproportionately and deter investment over the longer term.

Apr
08
2021

Regulators Call for More Harmonization On Ultra-Rare ATMPs

Pink Sheet

More regulatory harmonization in the ultra-rare disease space is desirable and would make treatments for these conditions more commercially viable, said regulators at the online Cell and Gene Meeting on The Mediterranean, organized by the Alliance for Regenerative Medicine.