Feliza Mirasol

Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.

RNA modalities will especially benefit from fuller adoption of continuous manufacturing platforms.

FDA has accepted Sanofi’s sBLA for the mAb and granted it priority review status for the targeted treatment of bullous pemphigoid.

The approval provides greater access to insulin treatment options.

Jason C. Foster, CEO and executive director of Ori Biotech, spoke on addressing bottlenecks in CGT manufacturing and what to expect in the CGT manufacturing space moving forward.

Jason C. Foster, CEO and executive director of Ori Biotech, discusses the milestone achievement in commercial-scale CGT manufacturing with the company’s IRO platform.

The value of outsourcing partnerships for next-gen biotherapeutics rests in the expertise and technologies that service providers bring to the table.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

Co-led by Andera Partners and Bpifrance, the Series B financing will go toward an ongoing Phase Ib/IIa clinical study for EG 427’s lead candidate and to advance the company’s genetic medicines platform.

This expanded label allows IZERVAY (avacincaptad pegol intravitreal solution) to be used without a limitation on duration of dosing for treating geographic atrophy.

The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.

The company plans to assess alternate payloads for its gene therapy program, which will shift its timeline.

On the back of FDA’s designation, March Biosciences is preparing to advance MB-105, a CD5-targeted CAR-T cell therapy, to a Phase II clinical trial in early 2025.

The approval makes Susvimo the first and only continuous delivery treatment for diabetic macular edema.

Development of new modalities of biotherapeutic molecules will rely on manufacturing, regulatory, and collaborative support.

Under this early stage R&D collaboration, the companies aim to engineer recombinant biologics for blocking Fc receptors, which play a key role in autoimmune diseases.

The committee’s recommendation was based on results from a Phase III trial that demonstrated a 27% reduction in the risk of death versus placebo.

Enduro Genetics will use the funding to expand its cell programming technology for scalable biomanufacturing with microbial cells at its Copenhagen, Denmark site.

Under the expanded distribution service, Distek’s BIOne Benchtop Controllers will now be made available across the UK and Ireland.

Under this collaboration, GSK and Oxford will combine their complementary expertise in the immune system, vaccines, and cancer biology.

The UK MHRA has granted approval for garadacimab for use in preventing angioedema attacks in patients 12 years old and older who have hereditary angioedema.

UK Biocentre will now utilize Azenta Life Sciences’ automated storage system, which gives the center storage capacity for more than 35 million biosamples.

The approval makes Enhertu (fam-trastuzumab deruxtecan-nxki) the first HER2-directed therapy in the United States for treating HER2-low or HER2-ultralow metastatic breast cancer.

FDA has approved an additional indication for LEQEMBI (lecanemab-irmb) as a once-every-four-weeks maintenance therapy for early Alzheimer’s disease.

The 2025 Pharmapack Awards recognize both commercial products and innovations that are shaping the future of pharmaceutical packaging.

Under the partnership, the companies will combine fully automated and digitalized technologies aimed at reducing CGT manufacturing timelines to 2.5 days.

The collaboration will combine Cytiva’s CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.

Biologic approvals, drug delivery advancements, GLP-1 generics, and the return of funding flow have been identified by Pharmapack as drivers for a record year in 2025.

The manufacturing agreement is expected to run through December 2030, subject to change, with production to take place at Samsung Biologics’ Songdo, South Korea, site.

Lonza will develop spray-dried formulations for an intranasally delivered biologic using a reformulated biologic drug candidate for obesity in Iconovo’s pipeline.