GSK’s application for using Jemperli (dostarlimab) plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer has been accepted by the EMA.

The US currently relies heavily on imports from China and other overseas nations for APIs needed to manufacture drug products of critical importance to US patients.

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.

This acquisition will give AbbVie acces to Celsius Therapeutics' lead drug candidate, CEL383, a potential first-in-class anti-TREM1 antibody for treating IBD.

Vabysmo, already approved for patients with RVO in the US and Japan, would be the first bispecific antibody treatment for the condition in Europe.

The typical cycle of ceasing and then reinitiating fremanezumab treatments may actually result in increased monthly migraine days, the study said.

Johnson & Johnson gets two bispecific antibodies in early phase development for immune-mediated diseases through its Proteologix acquisition.

GRPR, or gastrin-releasing peptide receptor, is part of the bombesin G protein-coupled receptor family and has been found to be overexpressed in multiple cancers.

Results of a Phase III trial showed that Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death associated with EGFR-mutated non-small cell lung cancer by 44%.

This $4.1 billion investment to build a second fill/finish manufacturing facility in Clayton, N.C., boosts Novo Nordisk's current 2024 investments in production to $6.8 billion.

Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.

Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.

Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.

Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.

FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.

In the premiere 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 the challenges involved in changing an excipient supplier.

The pairing of Abzena and Argonaut Manufacturing Services is the result of several years’ worth of collaborative work between the two companies.

This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.

A new initiative will advance access to quality medicines and vaccines in Africa.

The transaction, announced June 20, follows Bora’s purchase of Minnesota-based Upsher-Smith Laboratories earlier in 2024.

Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.

The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.

The $58 million investment has resulted in a 72,000-square-foot facility with a dedicated LC–MS space and molecular suites and will bring as many as 350 new jobs onto the campus.

PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.

Yimmugo, which was introduced in Europe at the end of 2022, could be on the market in the US within months.

The research collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.

Nadia Sellami, PhD, global segment lead for gene and cell therapy at PacBio, talks about long-read sequencing for cell and gene editing in a video interview.