News|Articles|March 26, 2025

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Join on June 3-4 in Cologne, Germany to gain insights from leading regulatory authorities, academics, and industry practitioners who define how biologics, vaccines, and advanced therapeutic medicinal products (ATMPs) are evaluated. Discover the latest technologies, learn best practices, and understand how to design an efficient manufacturing process.

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November 13th, 2026

The BioPharm Brief: FDA’s Fast-Track Pilot Reportedly Stalls, a Long-Acting Bispecific for Atopic Dermatitis, and a Twice-Yearly Obesity Approach

FDA has reportedly shelved its Commissioner’s National Priority Voucher pilot and paused publishing complete response letters, Zai Lab’s IL-13/IL-31Rα bispecific ZL-1503 shows a 40- to 50-day half-life that points to dosing every 12 weeks, and Wave Life Sciences reports 1-year INLIGHT data for its INHBE-silencing siRNA WVE-007 in obesity.

November 13th, 2026

What 3 Principles Guide Merck's Biologics and ADC Capacity Placement?

Merck's Dr Dave Maraldo outlines 3 principles for placing manufacturing capacity and how end-to-end ADC supply chains could shift platform thinking.

Quincke's edema, allergic reaction of angioedema. stroke. | Image credit: © velimir - © velimir - stock.adobe.com

November 13th, 2026

Ionis Reports 2-Year Donidalorsen (Dawnzera) Data in HAE Prophylaxis

Donidalorsen sustained a 95% reduction in hereditary angioedema attacks over 2 years, and patients switching from other prophylaxis saw a 71% drop.

Illustration of a hand in a dark suit holding a magnifying glass over a glowing blue badge with the letters “FDA” surrounded by stars, against a dark background with blurred lights. | Image Credit: © Abul - stock.adobe.com

November 13th, 2026

FDA Reportedly Pauses National Priority Voucher Pilot and Pauses CRL Publication

FDA has effectively paused its Commissioner’s National Priority Voucher pilot and appears to have halted new complete response letter postings, according to reports. HHS says work on the program is ongoing.

small interfering RNA bound to a messenger RNA, cartoon model with semi-transparent surface. siRNAs are synthetic RNA interference tools used for inducing temporary reduction of mRNA expression. | Image Credit: © petarg - © petarg - stock.adobe.com

November 13th, 2026

Wave Reports 1-Year INLIGHT Data for INHBE siRNA WVE-007 in Obesity

A single 240 mg dose of WVE-007 cut visceral fat while preserving lean mass for 1 year, as Activin E fell by up to 88% across INLIGHT dose groups.

Photograph of a person in jeans holding their bare foot, with red, patchy, bumpy rashes covering the backs of both hands, the wrist, and the top of the foot. | Image Credit: © InfiniteStudio - stock.adobe.com

November 13th, 2026

Zai Lab’s Long-Acting Atopic Dermatitis Bispecific Points to Every-12-Week Dosin

A single dose of Zai Lab’s long-acting bispecific ZL-1503 produced at least 90% inhibition of an atopic dermatitis signaling biomarker through Week 12 in healthy volunteers. Its 40- to 50-day half-life supports a target of dosing every 12 weeks.

November 12th, 2026

Sponsors Should Plan CMC Earlier When a First-in-Human Study Could Be Pivotal, Says Former FDA Reviewer Paz Vellanki

In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.

November 12th, 2026

The BioPharm Brief: An AI-Designed Multibody ADC Enters the Clinic, Blackstone Backs Pfizer’s Monthly GLP-1, and enGene Readies a Bladder Cancer BLA

FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.

Engage with Industry Leaders on Viral Clearance & Viral Safety at 2025 Summit

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FDA Reportedly Pauses National Priority Voucher Pilot and Pauses CRL Publication

Zai Lab’s Long-Acting Atopic Dermatitis Bispecific Points to Every-12-Week Dosin

What 3 Principles Guide Merck's Biologics and ADC Capacity Placement?

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Ionis Reports 2-Year Donidalorsen (Dawnzera) Data in HAE Prophylaxis