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Perfecting microbial manufacturing processes means taming its greatest asset: speed. This rapid process for creating biologics also means a race against time, where success hinges on conquering three key challenges: designing a robust microbial strain, optimizing fermentation for industrial scale, and ensuring consistent high-yield product yield.

This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.

Analysts at Guggenheim Partners expect Voyxact to see “broad commercial uptake” given its relatively broad label compared with previous accelerated approvals for IgA nephropathy.

The discounts should be compared against the drugs’ “ultimate net price” rather than their indicated list price to gauge the true impact of the negotiations, BMO Capital Markets analysts said.

Imfinzi is the first immunotherapy approved for perioperative use to treat gastric and gastroesophageal junction cancers.

A coordinated national effort is emerging to bring alternatives to animal testing into routine preclinical use, backed by a fresh FDA roadmap and a global coalition of scientific and industry partners. 

The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.

The FDA approved an intrathecal form of Novartis’ spinal muscular atrophy gene therapy Zolgensma on Monday, broadening access to patients two years and older in what one Stanford Medicine professor called a “game changing advance” for the field.

At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.

Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts at BMO Capital Markets.

Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.

Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or refractory multiple myeloma, results analysts at Guggenheim Securities called “remarkable.”

● CANDID-CNS™ is the new state-of-the-art AI model for BBB penetration: it achieves 87% AUPRC on bRo5 small molecules compared to 56% by Pfizer’s CNS MPO. ● CANDID-CNS™ distinguishes CNS penetrant stereoisomers at 68% compared to 50% by Pfizer’s CNS MPO. ● Published in the Journal of Chemical Information and Modeling, CANDID-CNS™ presents a breakthrough in AI Drug Discovery by unlocking the potential of bRo5 and stereochemistry to significantly expand the chemical space of small molecules that can be developed into CNS therapeutics.

Event to Take Place December 11th at 4:30 P.M. ET