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. Read More

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. Read More

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. Read More

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. Read More

The field of gene therapy is experiencing major advances driven by precise editing technologies, such as base and prime editing, and by the design of increasingly sophisticated vectors to deliver payloads that could reverse the effects of diseases. However, in the transition to in vivo applications many approaches still fail in their attempt to effectively reach target tissues or cells. Read More

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. Read More

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. Read More

Managing Editor Anette Breindl talks about covering research breakthroughs that later became industry defining. Read More

New hires and promotions in the biopharma industry, including: Biocardia, Galvanize. Read More

Biopharmas raising money in public or private financings, including: Azitra, Enlivex, Fibrobiologics, Mindimmune, Scilex, Vaxil, Verrica. Read More

Clinical updates, including data readouts and publications: Bayer, Clearmind, Day One, Enlivex, Genenta, Genprex, Johnson & Johnson, Kelun-Biotech, Nervgen, Novo Nordisk, Parabilis, Pasithea. Read More

Biopharma happenings, including deals and partnerships, and other news in brief: Astrazeneca, BCM, Biocortex, Biogen, Dayra, Capricor, CD, Clearside, Harbour, Harmony, Invivyd, Vaximm. Read More

Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Alvotech, Avenzo, Merck. Read More