News

Pluri’s newly launched CDMO business will manufacture two novel cell therapy product candidates for Kadimastem.

The acquisition adds a Phase III therapeutic peptide candidate to AstraZeneca’s late-stage pipeline for rare diseases.

The acquisition of EyeBio adds a late-phase antibody drug candidate for diabetic macular edema and neovascular age-related macular degeneration to Merck’s pipeline.

The company plans to invest approximately €900 million (US$983 million) to expand its peptide platform at its Colorado, US, site and in Europe.

The acquisition adds NM26, a Phase II-ready bispecific antibody for treating atopic dermatitis, to Johnson & Johnson’s immune-mediated and inflammatory disease portfolio.

With the acquisition, Olink will join Thermo Fisher’s Life Sciences Solutions business.

Through a multi-year collaboration, Pfizer and Evotec aim to conduct early discovery research for therapeutics against metabolic and infectious diseases.

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.

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

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

A strategic partnership between LenioBio and Labscoop is aimed at making scalable cell-free protein synthesis technology more accessible across North America.

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

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

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.

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

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

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

The Celsius Therapeutics acquisition will add CEL383, a potential first-in-class anti-TREM1 antibody for IBD, to AbbVie’s portfolio.

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%.

With the Proteologix acquisition, Johnson & Johnson gains two bispecific antibody early phase assets for immune-mediated diseases.

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

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

Novo Nordisk plans to invest $4.1 billion in a second fill/finish manufacturing facility in Clayton, N.C., boosting its current 2024 investments into production to $6.8 billion.

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

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

FDA has granted expanded approval to Sarepta Therapeutics for Elevidys to treat DMD in non-ambulatory patients, in addition to ambulatory patients.

Immunology company argenx gets its third FDA-approved indication for VYVGART Hytrulo for treating chronic inflammatory demyelinating polyneuropathy.