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U.S. FDA Approved RMATs on the Rise

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With recent news from Sangamo Therapeutics and Krystal Biotech, the count of announced RMAT (“Regenerative Medicine Advanced Therapy”) designations has risen to 30.

Krystal Biotech received an RMAT designation for its gene therapy KB103 on June 24, 2019. KB103 is being studied for its wound closure capacity in patients with severe generalized recessive dystrophic epidermolysis bullosa (“RDEB”). The FDA also granted a RMAT designation for Sangamo Therapeutics’ SB-525, an investigational gene therapy being developed in collaboration with Pfizer to treat severe hemophilia A. SB-525 is the first hemophilia A gene therapy to receive RMAT designation. [Read more…]

Definition of the Regenerative Medicine Industry?

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The Regenerative Medicine (RM) Industry is a rapidly growing market with more than 700+ companies worldwide developing products for therapeutic for use in humans. As with any growing industry, the question becomes, how do you define the Regenerative Medicine Industry?

To answer this question, it is important to look at the key components that compose the human body, which are:

  • Genes
  • Cells
  • Tissues
  • Organs

[Read more…]

RegMed Innovative Spikes on Heels of CAR-T, Gene Therapy, & Digital Pill Approvals

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The regenerative medicine industry is a high-value, fast-growth market. With two CAR-T approvals, as well as the first gene therapy and digital pill approvals in the United States, we have had a lot of FDA “firsts.”

The market gathered momentum when the Swiss pharmaceutical giant Novartis made history as the first company to win FDA approval for a CAR-T cell therapy in the U.S. in August 2017 (Kymriah). In October 2017, Kite Pharma became the second company to get FDA approval of a CAR-T cell therapy (Yescarta), further “snowballing” the effect. [Read more…]

2017 Marks the 1st Year That Regenerative Medicine Disrupted Healthcare

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The regenerative medicine industry has been rapidly expanding over the past few years, making it a high-value, fast-growth market. Key drivers for the market include high rates of clinical trials, accelerated pathways for product approvals, new technologies to support cell and gene therapy manufacturing, and the potential for cell therapies to revolutionize healthcare.

The regenerative medicine market gained major momentum when the Swiss pharmaceutical giant Novartis made history as the first company to win FDA approval for a CAR-T cell therapy in the U.S. in August 2017 (Kymriah). In October 2017, Kite Pharma became the second company to get FDA approval of a CAR-T cell therapy (Yescarta).

With swelling momentum to support the CAR-T technology, there are now close to 40 companies developing redirected T cells or NK cells for therapeutic use. [Read more…]

RoosterBio Launches New cGMP Stem Cell Product Portfolio

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RoosterBio Launches New cGMP Stem Cell Product Portfolio, Maintaining Unwavering Commitment to Driving the Explosive Regenerative Medicine Industry

Next Generation Products are Harbinger of Paradigm Shift in the Adult Stem Cell Industry

RoosterBioFrederick, MD, USA. September 14, 2017 – RoosterBio Inc, today, proudly announces the launch of its CliniControl™ (CC) product portfolio, clinically-relevant starting and ancillary materials that generate unprecedented efficiencies in adult stem cell manufacturing, accelerating clinical translation of human Mesenchymal Stem/Stromal Cell (hMSC)-based therapies.  The CliniControl product portfolio will radically simplify major steps in product development and clinical translation, improving the likelihood of commercial success for RoosterBio customers.

The first in the CliniControl line of products, RoosterNourish™-MSC-CC bioprocess medium sets the new standard of industry-leading performance.  RoosterNourish-MSC-CC is a first-in-class, standardized, xeno-free (XF) bioprocess medium engineered to support not only 2D (plastic adherent), but also 3D suspension culture of hMSCs in allogeneic and autologous therapeutic manufacturing.  Formulated specifically for clinical research process and product developers, RoosterNourish-MSC-CC yields superior media productivity, leading to drastically reduced cost of goods as compared to other hMSC culture media.   The highly productive RoosterNourish medium is designed for batch 2D and fed-batch 3D cultures and seamlessly translates between culture platforms enabling scalable hMSC culture,  delivering robust, reproducible and standardized results at a commercially-viable cost of goods.  [Read more…]

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