A second complete response letter issued by the U.S. FDA for Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy Ebvallo (tabelecleucel) for Epstein-Barr virus positive post-transplant lymphoproliferative disease is “a complete reversal of position” by the agency, which had previously confirmed the single arm Allele trial was enough to support a BLA under the accelerated approval pathway, the company said.
Moving away from a one-size-fits-all approach, the U.S. FDA's CBER released details Jan. 11 about how it’s leveraging its growing experience with cell and gene therapies (CGTs) to exercise greater regulatory flexibility in chemical, manufacturing and control requirements for the products.
With rumors regarding a couple of potential mega-mergers making the rounds, the week of the annual J.P. Morgan Healthcare Conference kicked off with the official disclosure of some billion-dollar collaborations, leading with Abbvie Inc.’s exclusive licensing deal with Remegen Co. Ltd. for PD-1/VEGF-targeted bispecific antibody RC-148.
And another firm has reached a most-favored nation (MFN) pricing deal with the White House. Johnson & Johnson announced Jan. 8 a voluntary agreement with the Trump administration aimed at improving access and lowering prices for medications in the U.S., in exchange for exempting the pharma firm’s products from tariffs.
Radiopharma-focused Aktis Oncology Inc. priced its recently upsized IPO, selling 17.65 million shares at $18 apiece, the high end of its pricing range, raising gross proceeds of $318 million, a hopeful sign that 2026 might signal an opening of the IPO window for biopharma.
The U.S. FDA signaled during a Type B meeting that existing data could support a BLA filing for Moonlake Immunotherapeutics AG’s sonelokimab to treat the skin disease hidradenitis suppurativa (HS), despite one of two pivotal phase III trials missing the mark.
Debate over Vanda Pharmaceuticals Inc.’s Hetlioz (tasimelteon) for use in jet lag disorder looks to continue after the U.S. FDA rejected the latest supplemental NDA submission, with the agency’s Center for Drug Evaluation and Research concluding the application cannot be approved in its current form.
Takeda Pharmaceuticals Co. Ltd.’s oral tyrosine kinase 2 inhibitor, zasocitinib (TAK-279), met the co-primary endpoints and all ranked secondary endpoints in two pivotal phase III studies in patients with moderate to severe plaque psoriasis.
Having nailed down alignment with the U.S. FDA in December on a phase III trial that will start in the middle of this year, Immuneering Corp. updated the overall survival and safety data from an ongoing phase IIa trial testing atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients (n=34), with more than 13 months median follow-up time.
News of Eli Lilly and Co. purchasing Ventyx Biosciences Inc. for $14 per share arrived after market close Jan. 7, following unconfirmed rumors of the buyout that drove shares up by more than 52% at one point.
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