Biopharma happenings, including deals and partnerships, and other news in brief: Astrazeneca, BCM, Biocortex, Biogen, Dayra, Capricor, CD, Clearside, Harbour, Harmony, Invivyd, Vaximm.
Clinical updates, including data readouts and publications: Bayer, Clearmind, Day One, Enlivex, Genenta, Genprex, Johnson & Johnson, Kelun-Biotech, Nervgen, Novo Nordisk, Parabilis, Pasithea.
The U.S. FDA said postmarketing reports of neutralizing antibodies to ADAMTS13, including one reported patient death, have prompted an investigation into Takeda Pharmaceutical Ltd.’s Adzynma (apadamtase alfa), a recombinant protein product approved in 2023 for use in adults and pediatric patients with congenital thrombotic thrombocytopenic purpura.
Otsuka Pharmaceutical Co. Ltd. filed an NDA with the U.S. FDA for centanafadine (formerly EB-1020), a new nonstimulant therapy for treating attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults. Centanafadine is a norepinephrine, dopamine and serotonin reuptake inhibito formulated as a once-daily extended-release capsule.
Phrontline Biopharma Suzhou Co. Ltd. closed a $60 million pre-A+ financing round led by Lapam Investment, with participation from nine other investors. The funds raised will support Phrontline’s development of next-generation antibody-drug conjugate (ADC) candidates.
In a phase II study, Novo Nordisk A/S’s amycretin reduced the weight of type 2 diabetes patients by 14.5% in 36 weeks, a statistically significant loss. The results also produced reduced hemoglobin A1C levels, an average of blood glucose that is used to monitor blood sugar control, below 7% in up to 89.1% of the participants.
More than six years after Novartis AG’s Zolgensma was approved for children under 2 with spinal muscular atrophy (SMA) with biallelic mutations in the survival motor neuron 1 gene, the U.S. FDA cleared a new version, under the brand name Itvisma (onasemnogene abeparvovec), for those 2 and older, including teens and adults with the same mutation.
It’s been a decade since Sandoz Inc. launched Zarxio, referencing Amgen Inc.’s Neupogen (filgrastim), as the first biosimilar in the U.S. Zarxio was expected to be the beginning of a biosimilar boom that would deliver big savings by finally providing direct competition for costly biologics. Neither the pipeline nor the uptake of biosimilars has lived up to expectations, as only 6% of the 313 biologics approved by the FDA’s CDER have been targeted by biosimilars and fewer than 5% are actually competing with the follow-ons.
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