Therapeutic Class Archives - Page 47 of 53 - BioProcess InternationalBioProcess International

Shire buys sanaplasma AG to support immunology business

Shire adds 14 centers to its European-based plasma collection network through an acquisition aimed at extending long-term plasma supply. Plasma is essential to the manufacture of immunoglobulin therapies for certain rare immunological diseases. Shire, which prides itself on orphan and hemophilia drugs, has more than 100 plasma collection centers in the US and Austria and has further expanded its presence through the acquisition of sanaplasma AG. “The transaction was an acquisition of 100% of sanaplasma AG,” Shire spokesperson Paris Barker…

Sanofi prepped for production after EU Nanobody success

by Dan Stanton

Ten weeks after acquiring Ablynx, Sanofi has received European approval for lead Nanobody-based drug Cablivi (caplacizumab). In June this year, Sanofi acquired Belgian biotech Ablynx for €3.9 billion ($3.5 billion), adding the firm’s pipeline of biotherapeutics based on the small-sized antibody, or Nanobody, technology. Now the French biopharma firm is set to commercialize lead product caplacizumab (anti-vWF Nanobody) in Europe under the brand name Cablivi after the European Commission granted it marketing authorization for the treatment of rare blood-clotting disorder…

Vendors ‘awakening’ to the needs of cell and gene therapy makers

by Dan Stanton

Equipment suppliers are vying to fill gaps in processing say cell and gene therapy experts, but understanding what end-users need will be central for success. In 2017, the US FDA approved two chimeric antigen receptor T (CAR-T) cell therapies. Since then there have been several other cell and gene therapies approved across several markets, including Europe’s first allogeneic stem cell in the form of Takeda’s Alofisel (darvadstrocel). And with several hundred cell and gene candidates moving through the clinical stages…

False biosimilar communications: Originators rebuff Pfizer’s claims

by Dan Stanton

Pfizer has accused Amgen, J&J and Roche of sending misleading communications about biosimilars in a Citizen Petition asking the US FDA to issue guidance on such behavior. In a Citizen Petition published on August 22, Pfizer said communication tools intended to incentivize the adoption of and switching of biosimilars have led to a robust uptake of biosimilars in Europe, but in the US “payer reimbursement policies are in fact impeding adoption of biosimilars.” The firm continued: “Dissemination of false or misleading…

Gilead says CA plant will supply Yescarta to EU until 2020

by Dan Stanton

Kite’s manufacturing plant in El Segundo, California, will supply Europe with the newly approved CAR-T therapy Yescarta while a facility in The Netherlands is being prepared. Gilead Sciences has received marketing authorization from the European Commission (EC) for its chimeric antigen receptor T (CAR-T) cell therapy Yescarta (axicabtagene ciloleucel). The therapy is approved to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). “Across the European Union, it is estimated that…

Mustang to make ‘bubble boy’ candidate from newly opened cell therapy plant

by BPI Staff

A gene therapy for children with X-linked severe combined immunodeficiency (X-SCID) will be made at Mustang Bio’s facility in Massachusetts, which opened in June. Biotech firm Mustang Bio has partnered with St. Jude Children’s Research Hospital to develop a lentiviral gene therapy for the rare disease, commonly known as bubble boy disease, caused by a lack of immune cells necessary to fight off viruses, bacteria and fungi. As the therapy progresses through early-phase clinical trials, Mustang will begin to manufacture…

WuXi Biologics launches bispecific antibody tech

by Dan Stanton

WuXi Biologics says it can expedite the development of bispecific antibodies by up to 18 months compared to current offerings through its new ‘WuXiBody’ platform. The Chinese contract development and manufacturing organization (CDMO) WuXi Biologics announced the additional service offering during its 2018 interim results and said its proprietary tech can potentially transform the bispecific industry. “We can take any two sequences of the MAbs [monoclonal antibodies] and engineer into WuXiBody bispecific in two to three months. The resulting bispecifics…

Astellas paying $110m for UK-based gene therapy firm

by BPI Staff

The acquisition of Quethera accelerates Astellas Pharma’s entry into the ophthalmic gene therapy space, the firm says. Japanese drugmaker Astellas has bought Cambridge, UK-based preclinical biotech for as much as £85 million (US$110 million) and will take over development of its lead candidate, a proposed gene therapy for the treatment of refractory glaucoma through an intraocular pressure (IOP)-independent mechanism. “This acquisition demonstrates Astellas’ commitment to proactively incorporate state-of-the-art scientific and technological advances and turn them into value for patients,” a…

Samsung Bioepis: From biosimilars to novel biologics

by Dan Stanton

Following success with several biosimilars, bringing a novel biologic into the clinic is the “next logical step” in becoming a fully integrated biopharma firm, says Samsung Bioepis. Almost a year to the date it announced a co-development agreement, Samsung Bioepis and Takeda Pharmaceuticals are preparing to begin a Phase I trial for its lead candidate, SB26, also known as TAK-671. The news signals the latest stage in the development of Samsung Bioepis – a joint venture between South Korean contract…

Alnylam’s success brings first RNAi therapeutic to US

by Dan Stanton

The US Food and Drug Administration (FDA) has approved the first ever RNA interference (RNAi) therapy: Alnylam’s Onpattro (patisiran). Alnylam announced last week Onpattro has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The product was hailed by the FDA as the first in a new class of drugs: small interfering ribonucleic acid (siRNA) treatments. “New technologies like RNA inhibitors, that alter the genetic drivers of a disease, have the…