Patrick Lavery

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.

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.

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.

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.

National Institutes of Health’s National Institute of Allergy and Infectious Diseases collaborated with the University of Sciences, Techniques and Technologies of Bamako, Mali to conduct the trials.

Imfinzi may be used alone, or with chemotherapy in tandem with the other approved treatment, Lynparza.

Yorvipath is a prodrug of parathyroid hormone (PTH) (1-34), designed to be administered once daily to provide continuous exposure to released PTH.

AstraZeneca and Daiichi Sankyo first entered into an agreement to develop Enhertu in March 2019, and the antibody-drug conjugate has since been approved for various groups in more than 65 countries.

The 94.3% efficacy of the Octapharma product was just a shade ahead of the 94.2% measured in a comparative product, Kcentra.

The virus, which is contagious and a common cause of respiratory illness, hospitalizes up to 160,000 people and is responsible for as many as 13,000 deaths in the United States every year.

AGX101 targets the cancer cells and vasculature of a tumor, and works to eliminate the tumor blood vessels, kill tumor cells capable of invasion or metastasis, and direct the immune system to attack the cancer.

The program, for which visits will be scheduled through September 2025, does not replace or supplement a regulatory inspection.

The reopening of comments addresses the addition of a warning to consumers that acetaminophen may cause skin irritation characterized by reddening, blisters, and rashes.

The new additions to the company’s equipment at its early phase clinical manufacturing facility in Oregon will allow for cleaning, filling, capping, and sealing, and also detecting defects in drug products.

Enamine’s library of 5400 TPD-related linkers, and 13,000 more linker molecules, is now being integrated into Cresset’s Spark tool for library searching.

Synovial sarcoma is a rare form of cancer impacting about 1000 adults in the United States each year, most of them men in their 30s or younger.

The HemoTemp II Blood Bag Temperature Indicator, which is an FDA-approved medical device, and the HemoTemp II Activator both were given the “Standards-Compliant” seal.

An additional 11 medicines were recommended for extension of therapeutic indications, while one negative opinion was issued.

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Plan.

Giroctocogene fitelparvovec is designed to allow patients to produce FVIII on their own for a time after a single infusion, an alternative to routine IV injections.

Combination products may be reviewed in a single application or in separate applications for each constituent part, and in rare cases, FDA may decide which type of application process is appropriate.

While the document does not address treatment or prevention of the long-term complications of ulcerative colitis or Crohn’s disease in children, it aims to help sponsors developing drugs for pediatric patients currently affected.

Roche voluntarily recalled Susvimo’s ocular implant, insertion tool, and initial fill kit when test results did not satisfy company standards.

Other indications for which the Sanofi treatment has been approved include atopic dermatitis, asthma, and chronic rhinosinusitis.

Kisunla (donanemab-azbt) reduced amyloid plaques in Phase III study participants by 84% after 18 months.