Global Markets

UK orders smallpox vaccine in response to monkeypox occurrences

Bavarian Nordic has supplied volumes of its smallpox vaccine for personnel involved in the treatment of two UK patients diagnosed with monkeypox. At the time of going to press, two patients have been diagnosed with the potentially fatal but rare disease monkeypox in the United Kingdom. Both are believed to have contracted the disease in Nigeria, where there has recently been a monkeypox outbreak. While there is no specific treatment or vaccine for the viral zoonotic disease, Public Health England…

Prefab sprouts in China as BeiGene selects GE for MAb facility

Much of Asia lacks traditional biomanufacturing infrastructure according to GE Healthcare, which says prefabricated facilities like its KUBio platform can support the rapid biologics growth in the region. BeiGene Ltd inked a deal with GE Healthcare in 2015 to install the bioprocessing vendor’s FlexFactory platform at its clinical monoclonal antibody facility in Suzhou, China. Three years on and the Chinese biotech firm has chosen GE Healthcare’s prefabricated biomanufacturing facility offering KUBio for commercial production of cancer MAbs at a site…

Eli Lilly on M&A: Balancing the science with the shareholders

Many early-phase acquisitions do not make sense for shareholders despite having promising assets, says Lilly’s CFO Joshua Smiley. About a third of Lilly’s pipeline comes from M&A. Speaking to attendees at the Morgan Stanley Healthcare Conference Broker Conference Call this month, Eli Lilly CFO Joshua Smiley said his firm is “interested in doing early stage clinical deals where we see compelling scientific rationale in our key therapeutic areas and that we can upgrade our pipeline.” But deals also need to…

Biocad teams with SPH to build Chinese biomanufacturing plant

Russian drugmaker Biocad and Shanghai Pharmaceuticals Holding (SPH) have formed two joint ventures to develop and make originator and biosimilar antibodies in China. At the Eastern Economic Forum (EEF), a memorandum of understanding has been signed between the two companies, establishing two joint ventures aimed at developing and manufacturing several monoclonal antibodies intended for the Chinese market. “The project itself is focused on four molecules and two original products,” Biocad spokesperson Irina Kenyukhova told BioProcess Insider. “Due to the fact…

Sanofi prepped for production after EU Nanobody success

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

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

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…

KBI boosts analytical services with Belgium expansion

The laboratories in Belgium will help international biopharma firms consolidate their outsourced analytical work to meet EU regulations, says KBI Biopharma. Contract development and manufacturing organization (CDMO) KBI Biopharma has opened laboratories in Leven, Belgium offering analytical development, formulation development, biopharmaceutical characterization and cGMP quality control testing. According to CEO Tim Kelly, the lab expansion was first announced in 2015, when the CDMO was acquired by JSR Corporation. “JSR’s decision to expand its A3 production capacity in Leuven created an…

Sartorius opening life sciences launchpad to grow German talent and innovation

Bioprocessing vendor Sartorius has launched a Life Science Factory in Göttingen, Germany offering labs, co-working spaces and consulting services for life science entrepreneurs. Life Science Factory, an independent non-profit division of Sartorius, aims to set-up a launch pad for life science startups in Germany. According to spokesperson Timo Lindemann, the project will begin next year with more than 500m2 for co-working, experiments and events, available for rent by entrepreneurs, before being transferred to a new 3,000m2 nearby facility in 2021.…

Gilead says CA plant will supply Yescarta to EU until 2020

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…