Global Markets

In the pipeline: Surge of cell and gene therapies likely in 2020

Over 20 cell and gene-based therapies are expected to be filed or to receive approval decisions over the next 18 months, according to the Alliance for Regenerative Medicine (ARM). Earlier this year, the US Food and Drug Administration (FDA) laid out its action plan to deal with the large upswing in the number of investigational new drug (IND) applications for cell and gene therapies it is receiving. “The FDA commissioner has anticipated that he thinks there will be between 10-20…

Novavax poised to step up to Executive Order with recombinant flu vaccine

President Trump has called for the modernization of influenza vaccine manufacturing. With its recombinant vaccine NanoFlu set to enter Phase III, Novavax says it offers the solution. Last week, the White House issued an ‘Executive Order [EO] on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health’ (reprinted below) aimed at addressing the “critical shortcomings” in the manufacture of such products. “Most influenza vaccines are made in chicken eggs, using a 70-year-old process that requires…

Biosimilars: Low cost + high approval rate = good return for Amgen

Amgen says biosimilars represent an opportunity to get to market without the risk or cost of a novel biologic, so long as you have the capabilities. Within the biosimilar space, Amgen is curiously conflicted. It is one of the largest and most successful developers of such products, yet the firm is defending several of its novel blockbuster biologics from other biosimilar makers. In the US, where, Amgen has three approved products, launching two of them – Mvasi and Kanjiti, versions…

China laws settle CDMO status but leave regulator lacking capacity for oversight

New GMP and licensing laws will reshape biopharma contracting in China. But exactly what the sector will look like will depend on how they are implemented and enforced by the country’s regulator, says an expert. The Chinese National People’s Congress passed final amendments to the country’s Drug Administration Law (DAL) on August 26. The law introduces a suite of measures, including a marketing authorisation holder (MAH) system similar to those in place in the US and EU. It also reforms…

Samsung BioLogics to establish US footprint with development labs

Korean CDMO Samsung BioLogics will open labs in either the Boston or San Francisco area early 2020 on the back of demand for its development services. In 2017, Samsung BioLogics added the ‘D’ to its contract development and manufacturing organization (CDMO) credentials by announcing plans to offer customers cell line and process development (PD) services on top of its well-established clinical and commercial production services. In the 18 months since launching these services, the South Korean firm has undertaken 33…

Boston T-Cell Party? News from #BiotechWeekBoston

Industry has convened in Boston this week to celebrate the success of biotech and discuss the bioprocesses of the future. Bioprocess Insider brings together the best of social media as Bioprocess International, Biopharm America and the Cell & Gene Therapy congress combine for #BiotechWeekBoston.

Berkeley Lights takes Beacon workflow tech to China

Berkeley Lights has opened an office in Shanghai to expand the reach of its automated biological workflow platform for cell line development and antibody discovery. The office, located in Pudong, Shanghai, will provide Berkeley Lights regional marketing and pre-sales service in China and the Asia Pacific (APAC) region. The decision to open an office in the region reflects the importance of the Chinese market for the bioprocessing space, said Yue Geng, head of Asia Pacific at Berkeley Lights. “China represents…

Novartis to take on Biogen with Tysabri biosimilar pact

Novartis division Sandoz has teamed with Polpharma for the commercialization rights to a Phase III biosimilar of Biogen’s multiple sclerosis monoclonal antibody Tysabri (natalizumab). The deal sees Sandoz enter into an agreement with Polpharma Biologics to commercialize and distribute worldwide the Polish biopharma firm’s natalizumab program, currently in Phase III trials. The molecule is being developed as a biosimilar of the relapsing-remitting multiple sclerosis (RRMS) monoclonal antibody Tysabri, which pulled in $1.86 billion (€1.7 billion) for Biogen in 2018. “Polpharma…

Celltrion turns to CDMO Lonza for infliximab biosimilar

Supply of drug substance from Lonza’s stainless-steel facility in Singapore will complement production of Remsima (infliximab) within its own network, Celltrion says. Remsima is Celltrion’s biosimilar of J&J’s autoimmune best-seller Remicade (infliximab), approved by the EMA in 2013 and by the US FDA in 2016. It became the first biosimilar monoclonal antibody to be launched in Europe in 2015 and according to the Korean drugmaker it captured over 50% of the EU infliximab market by the third quarter 2018. While…

Bavarian Nordic looks to go big on back of smallpox vaccine

Smallpox vaccine developer Bavarian Nordic says it will expand its infectious disease and cancer pipeline and grow its manufacturing network, possibly through M&A. Danish vaccine maker Bavarian Nordic laid out its growth vision during it second quarter 2019 financial call, and said it hopes to be a leading and profitable biotech company by 2023. To do this, the firm will look to its smallpox vaccine business as a starting point. Bavarian Nordic has a long-term contract for the manufacturing and…