Novartis today announced that its supplemental Biologics License Application (sBLA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by the US Food and Drug Administration (FDA) for Priority Review.
New drug approvals all but screeched to a halt in 2016, with a measly 22 new OKs after a pair of bountiful years. But the FDA wasted no time in 2017, signing off on 12 drugs in the first quarter alone—besting its record for the same period of any year in recent history.
FLX Bio, Inc., a biopharmaceutical company focused on the discovery and development of oral small-molecule drugs to activate the immune system against cancer, today announced the completion of a $60 million Series C private financing. The financing included new investments from GV (formerly Google Ventures) and other undisclosed investors as well as existing investors including The Column Group, Kleiner Perkins, Topspin Partners and Celgene Corporation.
Spark Therapeutics $ONCE has scored an historic FDA approval of Luxturna, the world’s first such AAV-delivered gene therapy designed to cure a rare eye disease triggered by a genetic mutation. The drug is OK’d for RPE65 mutation linked retinal dystrophy. The treatment uses a viral vector to insert the correct copy of a gene retinal cells need to create a protein that turns light into electric signals which can restore vision lost to the disease. As with the earlier pioneering approval of the world’s first CAR-T, FDA commissioner Scott Gottlieb did the honors in recognizing the importance of this approval. And he says the agency will make sure that the regulatory path is straight and clear for the rest of the field looking to following Spark’s footsteps. “We’re at a turning point when it comes to this novel form of therapy and at the FDA, we’re focused on establishing ...
Gilead Sciences, Inc. GILD and its newly acquired cell therapy subsidiary -Kite Pharma- announced that they have inked an agreement to acquire Cell Design Labs, Inc. for $567 million. Gilead will also acquire 12.2% of Cell Design shares which are owned by Kite Pharma.
Obsidian Therapeutics, Inc., a biotechnology company dedicated to the development of next-generation cell and gene therapies with pharmacologic operating systems, announced the completion of a $49.5 million Series A financing to further build its technology platform and advance its lead programs toward clinical development.
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and NIH Director Francis Collins testified on Thursday before the House Energy & Commerce Committee on how their agencies have worked to implement provisions from the 21st Century Cures Act passed and signed by President Barack Obama a month before he left office.
Fresh off the heels of its CAR-T approval, Novartis expanded its oncological arsenal with a $3.9 billion acquisition of French cancer firm Advanced Accelerator Applications.
Torque Therapeutics has come out of stealth mode to launch with a $21 million Series A financing. It is looking to raise another $14 million, according to its filing with the U.S. Securities and Exchange Commission (SEC).
US regulators have placed on hold studies of French drugmaker Cellectis’ CAR-T therapy following a patient fatality.
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