Feliza Mirasol is the science editor for Pharmaceutical Technology and Pharmaceutical Technology Europe.
2025 Pharmapack Winners Showcase Innovations in Pharma Packaging and Drug Delivery
Winners in this year's Pharmapack Awards include both commercial products and innovations that are shaping the future of pharmaceutical packaging.
Trenchant BioSystems Partners with Autolomous to Form Integrated Automated CGT Manufacturing Platform
The collaboration will combine fully automated and digitalized technologies to reduce CGT manufacturing timelines to 2.5 days.
Cytiva Collaborates with Cellular Origins to Deliver Automated Manufacturing for CGTs
Cytiva will combine its CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.
Samsung Biologics Scores Major Manufacturing Deal Worth Over $1.4 Billion with European Pharma Company
Production is set to take place at Samsung Biologics’ Songdo, South Korea, site, and the agreement will run through December 2030, subject to change.
Pharmapack Reports on Key Trends for 2025
Pharmapack identifies biologic approvals, drug delivery advancements, GLP-1 generics, and the return of funding flow as drivers for a record year in 2025.
Lonza and Iconovo Team Up on Intranasal Biologic Candidate
Lonza will work with Iconovo to develop spray-dried formulations for an intranasally delivered biologic using a reformulated biologic drug candidate for obesity.
PackGene and GC4K Team Up Along with Weill Cornell Medicine for Gene Therapy to Treat Rare Neurological Disease
Through this global alliance, PackGene, Weill Cornell Medicine, and GC4K, an Australian non-profit, intend to deliver a custom-tailored gene therapy solution to treat hereditary spastic paraplegia type 56, a particularly rare neurological disease.
J&J Gets FDA Fast Track Designation for Alzheimer’s mAb, Posdinemab
Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.
Argobio and University of Southern Denmark Launch New Next-Gen RNA Company, Inverna Therapeutics
Using splicing technology, the new company aims to innovate safer and more effective RNA therapies for severe genetic diseases.
With New Funding, Orbis Medicines to Develop Oral Macrocycles as Alternative to Biologic Drugs
With the new $94 million (€90 million) funding, the company will develop its pipeline of oral macrocycle drugs, nCycles, against validated biologic targets.
Takeda Receives Japanese Regulatory Approval for HYQVIA Subcutaneous Injection for Treating Agammaglobulinemia or Hypogammaglobulinemia
With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.
Roche Forms Partnership Worth Potentially More than $1 Billion with Innovent to Develop Novel ADC for SCLC
Under the agreement, the companies will advance development of IBI3009, Innovent’s ADC candidate, which has received IND approvals in the US, China, and Australia.
FDA Announces Reopening of Comment Period Regarding HCP Immunogenicity Risk from Follow-on Recombinant Peptides
The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.
Bispecific Antibody Development and Where It’s Headed
In a discussion on bispecific antibody development, Atul Mohindra, head of Biologics R&D at Lonza, points out the challenges and successes of these molecules as well as the field’s future direction from a CDMO perspective.
First Generic of a GLP-1 Injection Gets FDA Nod to Treat Type 2 Diabetes
FDA's approval of Hikma Pharmaceuticals’ liraglutide injection makes this product the first generic version of Victoza, a GLP-1 receptor agonist.
Roche Introduces New Mass Spectrometry Analyzer
The launch of Roche's cobas mass spectrometry solution will bring fully automated mass spec analysis to the clinical lab.
Prasinezumab Misses Primary Endpoint in Roche’s Phase IIb Study, but Has Potential in Treating Early Stage Parkinson’s Disease
Results from a Phase IIb study missed the primary endpoint by failing to achieve statistical significance.
Process Development Benefits from Automated Analytical Technologies
Cytiva's Nicolas Pivet, vice-president and general manager, Technology Solutions, emphasizes how automation benefits process development, particularly in the analytical space.
Orexo and Abera Partner to Develop Nasal Powder Vaccines
The companies will use Orexo’s powder-based drug delivery technology to develop mucosal vaccines in an inhaled formulation.
Scinai Immunotherapeutics Establishes US CDMO Business Unit
Scinai Bioservices Inc. has been established in Delaware as the company's new US-based subsidiary, which will serve biotech companies in early stage drug development.
AbbVie to Boost Immunology Pipeline with Acquisition of Nimble Therapeutics
AbbVie's latest acquisition target is Nimble Therapeutics, which will give AbbVie a lead asset, an oral peptide for treating psoriasis.
Talking mRNA–LNP Formulation Trends (Part Two)
In the second part of a video interview, Colin McKinlay, PhD, senior director, Chemistry and Delivery Technologies, at Nutcracker Therapeutics, discusses trends and the future direction of mRNA–LNP development.
Addressing Challenges in mRNA and LNP Manufacturing (Part One)
Colin McKinlay, the senior director of Chemistry and Delivery Technologies at Nutcracker Therapeutics, discusses current challenges in mRNA and LNP manufacturing as well as innovations that meet these challenges.
Intertek Teams Up with CrystecPharma on Formulation and Development of Dry Powder Inhaler Products
The partners will aim to establish a platform that enables rapid development of DPI products.
GSK Enters into Strategic Collaborations with Relation and Muna to Advance Drug Development
With these agreements, the respective parties will work to advance therapeutic candidates for treating fibrotic diseases, osteoarthritis, and Alzheimer’s disease.
BioMarin to Increase Production Capacity with €60 Million Expansion at Ireland Facility
With this investment, BioMarin will add a new laboratory to its Shanbally, Co. Cork, Ireland, manufacturing facility.
Novo Nordisk Gains Manufacturing Sites from Novo Holdings and Novavax while EC Approves Catalent Acquisition
The European Commission has approved Novo Holdings' acquisition of Catalent, which includes the related sale of three manufacturing sites to Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.
Novartis Enters $2.9 Billion License Agreement with PTC Therapeutics for Huntington’s Disease Development Program
Novartis will in-license PTC's PTC518 program, which has the potential become the first oral disease-modifying therapy for Huntington's disease.
Exploring Opportunities for LNP Delivery in mRNA
LNPs have gained solid ground as a drug delivery system for mRNA due to their success in the vaccines arena.
Lilly and Amgen Each Announce Major Expansions of US Manufacturing Sites
Lilly is investing $3 billion to expand its recently acquired manufacturing facility in Wisconsin, while Amgen is investing $1 billion to expand its facility in North Carolina.