Two sNDAs, one from Bristol Myers Squibb Co. (BMS) and the other from Mirum Pharmaceuticals Inc., have received U.S. FDA approval to further expand their treatment indications.
The U.S. FDA has approved Beigene Co. Ltd.’s Tevimbra (tislelizumab-jsgr) as a monotherapy for treating adults with unresectable or metastatic esophageal squamous cell carcinoma following prior chemotherapy that did not include a PD-1 inhibitor. A humanized IgG4 anti-PD-1 monoclonal antibody, tislelizumab is designed to minimize binding to Fc-gamma receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
The U.S. FDA’s Oncology Drugs Advisory Committee, in two separate sessions, took up the matters of Carvykti (ciltacabtagene autoleucel) from Johnson & Johnson and the Bristol Myers Squibb Co. product Abecma (idecabtagene vicleucel) – specifically, whether the benefits of each CAR T therapy outweigh the risks in relapsed or refractory multiple myeloma (MM).
Antibody-drug conjugate (ADC) specialist Tubulis GmbH has closed a hefty €128 million (US$139.4 million) series B2 round, more than double the €60 million it raised in its series B1 two years ago.
After hearing two conflicting presentations of the safety and efficacy of Geron Corp.’s imetelstat, the U.S. FDA’s Oncology Drugs Advisory Committee (ODAC) voted 12-2 March 14 that the drug’s benefit outweighed its risks as a treatment for transfusion-dependent anemia in adults with low- to intermediate-1 risk myelodysplastic syndromes in patients who have failed or no longer respond to erythropoiesis stimulating agents (ESAs), or who are not eligible for ESA treatment.
Hyundai Bioscience Corp. is set to become the largest shareholder of ADM Korea Inc., a Seoul, South Korea-based contract research organization (CRO) firm, by purchasing 5.02 million shares for ₩20.4 billion (US$15.5 million) – a 23% stake.
Asgard Therapeutics AB has raised €30 million (US$32.8 million) in a series A round to advance a novel approach to cancer immunotherapy, in which it is proposed to reprogram cancer cells into functional antigen-presenting dendritic cells in vivo, activating a host immune response against the tumor.
There’s no denying that Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb Co.’s Abecma (idecabtagene vicleucel) show clinical benefit as they seek to move up in the line of treatment for relapsed or refractory multiple myeloma. But the question that will be put to the U.S. FDA’s Oncology Drugs Advisory Committee March 15 is whether the benefit outweighs a risk of early deaths seen with both CAR T therapies.
Nine-year-old IFM Therapeutics LLC has notched yet another big deal as Novartis AG will acquire all the outstanding capital stock of IFM Due Inc., a subsidiary of privately held IFM in an agreement that began five years ago. The newest deal brings IFM $90 million up front and makes it eligible for up to $745 million in milestone payments for a deal value of $835 million.
Technology of genomically recoded organisms borne out of Yale and Stanford university laboratories and housed at Khosla Ventures-backed Pearl Bio received validation on March 12 through a $1 billion deal signed with Merck & Co. Inc. Cambridge, Mass.-based Pearl, which emerged from stealth last year, is eligible for the funds through up-front, option and milestone payments, plus potential royalties on sales of deal-related products that gain approval. The synthetic biology company aims to create a new class of multi-functionalized therapeutics with tunable properties. The deal with Rahway, N.J.-based Merck will focus on new cancer biologics.
RSS
