Industry News

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

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 BioPharm International editors present our most popular video interviews 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.

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

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

A new platform allowing market authorization holders to report drug shortages has gone live.

The 340B program is under greater scrutiny with more transparency for drug access being demanded by industry.

GSK’s Biologics License Application for belantamab mafodotin (Blenrep) as part of a combination therapy has been accepted by the US regulatory body for review.

The approval of eladocagene exuparvovec-tneq (Kebilidi) marks the first FDA approval for a gene therapy to treat AADC deficiency.

With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.

Chancellor of the Exchequer, Rachel Reeves, has announced a £520 million (US$675 million) investment for manufacturing capacity in the United Kingdom, prompting academic and industry leaders to point out that funds should be used to train personnel.

The Novo Nordisk Foundation has committed DKK 600 million (US$87.4 million) towards the initial costs of the center housing the new supercomputer, which has the potential to accelerate drug discovery innovation.

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

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.

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.

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.

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

The agency is recommending the extension of the smallpox and mpox vaccine, Imvanex, to adolescents aged 12 to 17.

The critical APIs that this funding will contribute to are used in the treatment of asthma, diabetes, and anxiety disorders.

During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.

The finalists for the 2024 CPHI Pharma Awards are spread across 14 categories, which include future leaders, women of the year, and an “at the heart of pharma” category.

CDER’s Jonathan Chapman, senior policy advisor, and Takeda’s Paulien Groll, head of Compliance Excellence, discussed how companies can be proactive with their CAPA strategies instead of reactive, at the 2024 PDA/FDA Joint Regulatory Conference.

This is the company’s largest single investment in the Sweden Biomanufacturing Center, in Södertälje, which opened in 2021.

A coordinated and international response is needed to help control the latest mpox outbreak in Africa.