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Home » Newsletters » BioWorld

BioWorld

Feb. 8, 2024

View Archived Issues
Eya and DNA illustration

Street likes Luna wet AMD phase II but Adverum wanes

With Adverum Biotechnologies Inc.’s preliminary safety and efficacy data made public from the ongoing Luna phase II trial testing gene therapy ixoberogene soroparvovec (ixo-vec) in wet age-related macular degeneration (AMD), Wall Street promptly began stacking the results against those of competitors. CEO Laurent Fischer pointed out that ixo-vec boasts the “highest rate of injection-free patients of any study of any program at any dose.” Read More

Biontech and Autolus collaborate to advance their CAR T programs

Autolus Therapeutics Inc. has picked up plenty of financial momentum, about $600 million worth, in its runup to a November 2024 PDUFA date for its CD19 CAR T therapy. Helping propel that momentum is Biontech SE, another CAR T therapy developer. For $50 million cash, Biontech bought the rights to use Autolus’ manufacturing and commercial infrastructure in the U.K. so it can advance its CAR T-cell BNT-211 program in the clinic. Read More
3D dollar sign

Kyowa pays $100M up front for Bridgebio’s infigratinib in Japan

Palo Alto, Calif.-based Bridgebio Pharma Inc. will hand over development and sales of its rare bone growth disorder therapy, infigratinib, in Japan to Kyowa Kirin Co. Ltd. under its latest exclusive licensing deal. Read More

Regenxbio’s Hunter syndrome gene therapy hits pivotal trial goals

Regenxbio Inc. plans to file a BLA this year seeking accelerated approval for gene therapy candidate RGX-121 to treat young children with mucopolysaccharidosis type II, also known as Hunter syndrome, based on positive data from the phase I/II/III Campsiite trial, which not only hit the biomarker endpoint but also indicated potential systemic benefits. Read More
Pills spilling out of bottle onto money

US Senate drug pricing hearing moves beyond ‘CEO-whack-a-mole’

The Feb. 8 U.S. drug pricing hearing before the Senate Health, Education, Labor and Pensions Committee started out as a spectacle in which Chair Bernie Sanders (I-Vt.) rehashed his usual talking points as he lectured the CEOs of Bristol Myers Squibb Co., Johnson & Johnson and Merck & Co. Inc. about how their companies charge so much more for their drugs in the U.S. than in other countries. But despite the show-trial aspects of the hearing, or what Ranking Member Bill Cassidy (R-La.) called Sanders’ ongoing “CEO-whack-a-mole” agenda, some facts came through that could lead to pricing reforms if Congress has the bipartisan will to do so. Read More

Appointments and advancements for Feb. 8, 2024

New hires and promotions in the biopharma industry, including: 60 Degrees, Biocorrx, Domain, Zymeworks. Read More

Financings for Feb. 8, 2024

Biopharmas raising money in public or private financings, including: Kyverna, Kyverna, Neurona, Sana. Read More

In the clinic for Feb. 8, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biocomposites, Briacell, Cassava, Denali, Hemostemix, Hutchmed, Invizius, Prokarium, Regenxbio, Theriva. Read More

Other news to note for Feb. 8, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Camino, Cantabio, Genprex, Myrobalan. Read More

Regulatory actions for Feb. 8, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alector, BMS, Immix, Inhibikase, Innovent. Read More

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