Issue 3.13
Sustainability has become a paramount consideration for global industries seeking to find a balance between meeting the needs of the current population without compromising future generations...
Sustainability has become a paramount consideration for global industries seeking to find a balance between meeting the needs of the current population without compromising future generations...
With an increasing proportion of niche therapies entering the development pipeline, the bio/pharma industry is having to pivot to more agile processes that work for smaller batch sizes..
As industry sharpens its focus on personalized medicine and orphan drugs, manufacturers are being required to adapt to the new process requirements of these more niche drugs...
For many years, the bio/pharma supply chain was operated primarily around cost optimization, which resulted in consolidation of API and raw material sourcing into a handful of global…
For decades, the bio/pharmaceutical industry operated with a scale-up philosophy, which led to companies building increasingly massive facilities, housing large-volume stainless-steel bioreactors, to meet global demand for biologics...
Advanced therapy medicinal products (ATMPs) are groundbreaking, innovative treatments for many patients once considered untreatable...
Since the first DCAT Annual Dinner, which was held in 1926, New York City has played host to the multifaceted global event, DCAT Week...
Thanks to the foundational work of the Human Genome Project, which was completed over two decades ago in 2003, biopharmaceutical research and development has made great strides forward...
Traditional blockbuster therapies — high-volume, broad-scope drugs — are being rapidly superseded by high-precision, niche therapeutic platforms that target specific genetic pathways...
Traditionally, randomized controlled trials (RCTs) have been thought of as the gold standard when it comes to demonstrating the efficacy of an investigational drug product...
The clinical trial sector is currently experiencing an evolution thanks to various technological and approach innovations that is equivalent to the transition from paper to Electronic Data Capture…
The margin for error within drug development is becoming ever narrower, as R&D costs continue to rise, competition pressures intensify, and regulatory expectations grow…
THE BIG READ
Serán Bioscience Secures Investment to Expand Commercial Manufacturing
4 min read • 3 weeks ago
The investment, led by Biospring Partners, will support Serán Bioscience’s expansion into commercial-scale production and state-of-the-art manufacturing facilities in Bend, Oregon.
The Norwegian biotech plans to use the raised capital to expand its circular RNA platform and secure complementary…
The Lithuanian CDMO has opened a new facility in Vilnius that can support advanced and personalized therapies, including…
By combining Nottingham’s development capabilities with its expanded Haverhill site, Codis creates an integrated UK pathway spanning early-stage…
THE BIG READ
Nanoform Highlights CESS Benefits Versus Spray-Dried ASDs
4 weeks ago
According to the company, its commercial-scale nanoparticle manufacturing technology could reduce production costs and solvent use while increasing drug loading.
The company has managed to raise USD 70 million, which it will use to progress its lead candidate…
Through this certified status, the CDMO will be able to offer its customers targeted, multiplex protein biomarker analysis…
Although the trial did not meet its primary endpoint, EyePoint reported a 42% reduction in overall treatment burden,…
THE BIG READ
Bridging the Pipeline Gap
5 min read • 2 weeks ago
With the rise of increasingly complex biologics, innovators are leaning toward specialized service providers to bridge the gap between early breakthrough science and commercial manufacturing reality.
Ahead of CPHI Milan, Event Director Tara Dougal shares insights on the key themes, new dedicated zones, and…
Ahead of CPHI Milan 2026, Professor Hanns-Christian Mahler from ten23 health, explores how expanding dose volumes, flexible CDMO…
As demand for patient-centric chronic disease treatments grows, Nanexa CTO Mårten Rooth discusses how atomic layer deposition enables…
THE BIG READ
Lifecore Biomedical Signs Major Commercial Site-Transfer Deal
3 weeks ago
The Minnesota injectables CDMO has signed a technical transfer and manufacturing agreement for a currently marketed, high-viscosity injectable, marking its seventh late‑stage commercial program and 11th pipeline addition…
A global licensing agreement worth up to EUR 1.165 billion will leverage Nanexa's PharmaShell technology to develop long-acting…
The Minnesota injectables CDMO has signed a technical transfer and manufacturing agreement for a currently marketed, high-viscosity injectable,…
Through this acquisition, Eli Lilly will strengthen its immunology capabilities by gaining access to a first-in-class antibody-degradation platform…
THE BIG READ
Roche Gets Nod from European Commission for Susvimo
4 weeks ago
The European Commission has approved the ranibizumab 100 mg/mL injectable solution (Susvimo) from Roche as a treatment of neovascular age-related macular degeneration.
The U.S. regulatory body has approved AstraZeneca’s Etcamah in combination with CDK4/6 inhibitors, to treat adults with HR‑positive,…
A combination therapy from Gilead and Merck has met its clinical efficacy endpoint, demonstrating non-inferiority to existing daily…
AstraZeneca’s camizestrant has faced a regulatory setback in the U.S., with the FDA extending its review, seeking clearer…
THE BIG READ
Codis Appoints Steven Facer in New Role as Chief Commercial Officer
4 weeks ago
The newly created role will bring the CDMO’s sales, marketing, and business development teams under a unified commercial strategy across the U.S. and UK.
SPONSORED CONTENT: As the biopharmaceutical landscape increasingly demands integrated technical operations, GCCs are expanding beyond back-office efficiency, reveals…
As the divide between upstream output and downstream capability in bioprocessing expands, it is becoming necessary for the…
Experts from Alcami break down the latest innovations in lipid-based permeation matrices, continuous direct compression, and advanced analytical…
The World Orphan Drug Congress is Europe's largest and most established orphan drug and rare disease meeting.
The ESGCT Annual Congress brings the gene and cell therapy community together in Hamburg.
Future Labs Live USA is a marketplace and benchmark for laboratory and analytical excellence.
PODD brings pharma, biotech, and drug delivery industries together to assess delivery needs, partnerships, and innovative technologies.