The 2024 CPHI Pharma Awards comprise finalists spanning 14 categories and includes awards for 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 Behind the Headlines news roundup panel discussion covers news items such as the weight loss drugs battle between Novo Nordisk and Eli Lilly, entering new territory through Lilly’s partnership with HAYA Therapeutics and long non-coding sequence mining. There was much discussion on how the inflation reduction act and Medicare price controls may or may not pertain—given the uncertainty around the presidential election results, and subsequent policy directions. The Centers for Disease Control making cost free COVID-19 diagnostics and therapies available was also evaluated.

Rentschler Biopharma has expanded its service offerings at its Stevenage, UK, site with a new lentiviral vector manufacturing toolbox.

Among the design features of the machine is software-based tracking that is meant to ensure that products that are temperature-sensitive do not exceed their time limit in the solution.

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

Bio/pharma companies should be approaching their decarbonization journey as a strategic business move for the future as industry stakeholders are placing greater value on sustainability.

The approach makes use of clinical mass spectrometers that are already available in hospitals around the world.

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

The completed acquisition of Morphic expands Lilly's immunology pipeline with Morphic's oral integrin therapies for treating inflammatory bowel disease.

PiaSky (crovalimab) has previously been approved in countries such as the United States and Japan for monthly, subcutaneous use that may be self-administered with adequate training.

Opaganib was given orphan drug designation for the treatment of neuroblastoma in children, which is rare, but the most common infancy malignancy.

In a 24-week study of patients with PAH, six-minute walking distance improved by an average of 40.8 meters, and risk of death or clinical worsening was reduced by 82%.

The collaboration builds on Novartis’ acquisition of Chinook Therapeutics just over a year ago.

The approvals and authorizations come amid a late summer surge in the virus that is tracking a bit earlier than the early fall wave in the US in 2023.

Merck, known as MSD outside of the United States and Canada, will gain CN201, a next-generation bispecific antibody, from Curon Biopharmaceutical in a deal potentially worth up to $1.3 billion.

Vernal Biosciences’ CEO and founder, Christian Cobaugh, discusses the outsourcing landscape for mRNA production.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss submitting biologics license applications and working with suppliers.

The combination of Opdivo plus Yervoy is already established as a second-line treatment for patients with advanced hepatocellular carcinoma.

The International Coalition of Medicines Regulatory Authorities’ new Collaborative Hybrid Inspection Pilot program allows a CDMO to gain approval from multiple countries simultaneously, as opposed to separately phased inspections from different corners of the globe.

This Behind the Headlines news roundup panel discussion covers news items such as the resurgence of mpox in Africa, “medical tourism” in India, Eli Lilly’s new Boston CGT facilities, and contract development and manufacturing organization (CDMO) projected growth rates for the 2023–2029 period, and the reasons behind them.

Fasenra, which has been approved since 2019 in the United States in a pre-filled, single-use auto-injector form that can be administered either in a doctor’s office or at home, is now approved in China for age 12 and up.

Approximately 15% of all lung cancers diagnosed in the US are of the small-cell variety, and of those, 70% are considered extensive-stage.

Genentech will have access to Sangamo’s capsid delivery platform and epigenetic regulation capabilities to develop genomic medicines for certain neurodegenerative diseases.

NexoBrid, a topically administered biological product, is now authorized for use in all age groups in the United States, European Union, and Japan.

Breyanzi demonstrated an overall high response rate in adults with relapsed or refractory follicular lymphoma in a Phase II study.

The agreement specifies that Nanoform will provide non-GMP nanomaterial to Takeda for in-vivo studies, the first results of which should be delivered by early 2025.

A Phase III study showed that 62% of patients given Livdelzi achieved the primary endpoint of composite biochemical response after 12 months, compared to 20% of participants taking placebo.