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44a Grünberger Straße, Berlin, BE, 10243, DE
The U.S. FDA approved the TYK2 inhibitor for the same indication in March.
By: Patrick Lavery
A first-in-human Phase I clinical trial will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM7004 in subjects with advanced solid tumors.
By: Charlie Sternberg
The comprehensive on-site inspection was conducted April 14.
As trade policy, regulatory scrutiny, and capital discipline reshape biologics development, sponsors are rethinking where and how commercial manufacturing is secured. Bora Biologics’ recent U.S. expansion and validated 2,000L scale-up reflect a broader shift toward demand-aligned, inspection-ready commercial capacity in the markets where products will ultimately be supplied.
Released By Bora Biologics
The new line of high-clarity PETG bottles is designed to support the demanding requirements of pharmaceutical and biopharmaceutical manufacturing environments.
The partnership will work to advance Novelty Nobility’s bispecific antibody drug candidate through process development and GMP manufacturing.
Offers a scalable platform from small process development batches to larger cGMP manufacturing runs.
It’s a novel, blood-based test to aid differentiation of schizophrenia and bipolar I disorder.
Michelle D’Angelo brings 25+ years of experience in the pharmaceutical and biotechnology CDMO sector.
Expands its portfolio in rare disease with sebetralstat, a differentiated oral, on‑demand treatment for hereditary angioedema.
Contract Pharma has launched Contract Pharma Stream, a new digital content hub designed to give pharmaceutical and biopharma professionals instant access to more than 30 live and on-demand webinars through one simple login.
By: Tim Wright
Panzara brings over 25 years of global neurology experience to Immunic.
Plans for GMP release for production by the end of 2026.
The single-tablet regimen of doravirine and islatravir will be available in U.S. pharmacies as soon as May 12.
The transaction, which is expected to close by end of Q2 2026, builds on UCB’s experience and leadership as an innovator in epilepsy.
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