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The companies have restructured their existing collaboration into a licensing agreement that invests in mRNA development.

LenioBio and Labscoop's new strategic partnership is aimed at increasing access to scalable cell-free protein synthesis technology across North America.

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

A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.

The company is referring to its search for innovative approaches as crowdsourcing and will award at least one cash prize.

This collaboration aims to support and accelerate clinical development of advanced and novel technologies.

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.

No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.

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.