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The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

The new company will harness splicing technology to innovate safer and more effective RNA therapies for severe genetic diseases.

The transaction, which was first announced in September 2024, expands Phillips Medisize’s inhalation drug delivery capabilities.

The $94 million (€90 million) Series A funding will be used to support the development of the company’s pipeline of nCycles, oral macrocycle drugs that will be focused on validated biologic targets.

The approval makes HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] the first and only facilitated subcutaneous immunoglobulin to be approved in Japan to treat these disorders.

FDA provides recommendations for those interested in participating in the agency's Advanced Manufacturing Technologies Designation Program.

The companies will advance the development of Innovent’s ADC candidate, IBI3009, which has received IND approvals in the US, China, and Australia.

FDA is reopening 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”, until March 3, 2025.

The BioPharm International® editors present our most popular technical articles from 2024.

The approval of Hikma Pharmaceuticals’ liraglutide injection marks the first generic version of Victoza, a GLP-1 receptor agonist.

Pointing to the continued circulation and evolution of COVID-19, WHO published a statement on the COVID-19 vaccine antigen composition to respond to variants of the virus.

With the launch of its cobas mass spectrometry solution, Roche brings fully automated mass spec analysis to the clinical lab.

EMA and HMA have published revised guidelines on identification of commercially confidential information and personal data used in marketing authorization applications.

The results garnered from the Phase IIb study failed to achieve statistical significance in the primary endpoint.

Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow.

Using Orexo’s powder-based drug delivery technology, the companies will develop mucosal vaccines in an inhaled formulation.

The company has formed Scinai Bioservices Inc., new US-based subsidiary operating out of Delaware that will serve biotech companies in early stage drug development.

EMA's committee gave recommendations for marketing authorization of 17 drugs in December, which include therapies for rare heart conditions, anemia, and liver disease.

In the latest of a series of acquisitions this year, AbbVie will acquire Nimble Therapeutics, which includes that company’s lead asset, an oral peptide for treating psoriasis.

AbbVie has completed its $1.4 billion acquisition of Aliada Therapeutics, giving it access to Aliada’s disease-modifying therapy for Alzheimer’s disease.

With the DKK 8.5 billion (US$1.2 billion) investment, Novo Nordisk will build a new modular and flexible production facility in Odense, Denmark, to produce multiple products for rare diseases.

The companies will develop a platform that can enable rapid development of DPI products.

Under the deals, the parties will advance therapeutics for fibrotic diseases, osteoarthritis, and Alzheimer’s disease.

The company will add a new laboratory facility at its Shanbally, Co. Cork, Ireland, manufacturing site.

The European Commission’s approval of the Catalent acquisition by Novo Holdings includes the related acquisition of three manufacturing sites by Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

Cellipont Bioservices and Xiogenix Partner on Advanced Filling Systems The companies will offer Cellipont’s clients access to Xiogenix’ fill/finish system for cell therapy production.

Under the deal, Novartis will in-license PTC518, an mRNA splice modulator for the huntingtin gene, which has the potential to be the first oral disease-modifying therapy for Huntington's disease.

Lilly will expand its recently acquired manufacturing facility in Wisconsin with a $3 billion investment, and Amgen will expand its North Carolina facility with a $1 billion investment.