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The company is investing $76 million to increase ADC manufacturing capacity at its St. Louis, Mo. facility.

The companies expect to accelerate the clinical development of MRT-6160, a Phase I drug candidate, as well as explore further therapeutic opportunities across multiple indications.

Merck is acquiring the Yale-spinout, which develops direct DNA modification-enabled cancer treatments.

Laks Pernenkil, Brian Feth, and Alex Philippidis go behind the headlines to discuss the impact of recent news, including FDA’s drug shortage list update, Nobel prize winners in microRNA and AI, and a big-potential research win for RNA editing.

Pfizer’s bivalent RSV prefusion F vaccine has been approved by FDA to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

The Cambridge-GSK Translational Immunology Collaboration builds on an existing scientific relationship between the biopharma company and the university, with the aim of improving outcomes for patients.

As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.

The merger will create a specialty company, REGiMMUNE/Kiji TX, for regulatory T cells.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

The agency’s CHMP recommended drugs to treatments for hemophilia, two biosimilars for psoriasis, and two flu vaccines at their October meeting.

Through the collaboration, Merck will use Mestag’s proprietary RAFT platform to investigate the pathogenic role that fibroblasts play in inflammatory diseases.

The establishment of this new center aims to expedite R&D processes, reduce costs, and potentially lead to accelerated discovery of new candidate therapies.

The new center's design will prioritize integration of the entire supply chain, with the aim of accelerating product development and autonomous production capacity in alignment with EU priorities.

SK pharmteco will be the preferred manufacturing partner for AVG-101, AaviGen’s lead gene therapy product.

Evonik's plant-based squalene, PhytoSquene, used in parenteral drug delivery applications, won the CPHI Excellence in Pharma Award in the “Sustainability” category.

The draft joint network strategy for the EU until 2028 will be open for public consultation until Nov. 30, 2024.

This year's CPHI award winners emphasize achievements in pharma excellence.

Thermo Fisher Scientific's launch of its Accelerator Drug Development follows expansions of sites in Cincinnati, Ohio, and Bend, Ore., earlier in 2024 to enable R&D, manufacturing, and testing.

The annual survey predicts that four of the five biggest biologics capacity holders in 2028 will comprise CMOs, which will control 45% of all CMO capacity in Asia.

Cellevate's nanofiber microcarriers are the first on the market for use in manufacturing viral vectors used in gene therapy production, according to the company.

The agency is working with the European medicines regulatory network to improve the assessment and approval process for new medications.

This Behind the Headlines news roundup panel discussion on recent news items includes updates regarding sickle cell therapies (e.g,, Pfizer’s withdrawal of Oxbryta and Vertex’s choosing of Lonza as the commercial manufacturer of Casgevy); Emergent BioSolutions $400 million BARDA contract for an mpox vaccine; and the first in a generation novel schizophrenia drug, Cobenfy (xanomeline and trospium chloride). The panel also examines investment revival with ARCH Ventures $3 billion biotech fund raise and the $3.6 billion for Flagship Pioneering. Rounding things out is a discussion on COVID-19-associated childhood myopia and patent thickets artificially keep the price of drugs high.

SGD Pharma plans to showcase its siliconized molded glass vials at CPHI Milan as part of its range of sustainable products and services.

Results from the CPHI annual survey show that 49% of industry respondents are “highly positive” on the contract services sector seeing growth over the next 18 months.

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

The two companies are partnering to provide logistics and manufacturing services to biotechnology and pharma companies.

Under the long-term supply agreement, Lonza will manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.