Global Markets

BAT biotech using tobacco to make COVID-19 vaccine candidate

British American Tobacco (BAT) will use its tobacco-based expression technology to make a not-for-profit vaccine candidate targeting the novel coronavirus. The vaccine candidate has been developed by Kentucky BioProcessing (KBP), the wholly owned subsidiary of the Big Tobacco firm BAT. “KBP recently cloned a portion of the genetic sequence encoding the selected coronavirus antigen – a substance which induces an immune response in the body and the production of antibodies,” a BAT spokesperson told this publication. “This sequence was then…

Supporting Small and Virtual Companies for Clinical Trials

SPONSORED   The virtual pharma business model has gradually become a popular alternative to traditional pharma. As an integrated service provider, Yourway offers the logistical support from study design to packaging needed by virtual and small companies entering into clinical trials. Yourway is a large organization that has flexible solutions embedded in our offering, and this nimbleness and agility help us to provide optimal solutions to virtual pharma companies. Virtual pharma companies are not bound to an organization’s internal, in-house service…

Novartis close to EU approval for Zolgensma at last

Novartis’s AveXis unit has received a CHMP nod for the spinal muscular atrophy gene therapy at its latest meeting, sending it on the final steps to market in the EU. After several delays plus a row over a controversial lottery-style managed access program in Europe, Novartis gene therapy Zolgensma (onasemnogene abeparvovec) has finally been granted a positive opinion by the EU’s Committee for Medicinal Products for Human Use (CHMP). The committee has recommended a conditional marketing authorization of Zolgensma for the…

In brief: CDMO Cobra collaborates on coronavirus vaccine

Cobra Biologics and the Karolinska Institutet with EU Horizon 2020 emergency funding in hand have teamed to develop a DNA vaccine against COVID-19. Contract development and manufacturing organization (CDMO) Cobra Biologics and Swedish medical university form part of a consortium called OPENCORONA aimed at developing and manufacturing a DNA vaccine against the novel coronavirus (COVID-19) set to be delivered to patient muscle to generate  a viral antigen on which the immune system then reacts. The consortium, which also includes Karolinska…

J&J to expand vaccine capacity as part of $1bn BARDA coronavirus collaboration

Johnson & Johnson (J&J) says it will leverage and expand facilities in The Netherlands and Pennsylvania in efforts to reach one billion doses of a potential COVID-19 vaccine. In February, J&J teamed up with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS) to develop a vaccine against the novel coronavirus (COVID-19). At the time the company said it would work to upscale production and manufacturing capacities, leveraging its AdVac and PER.C6…

Vaccine production plant forms part of Canada’s COVID-19 response

The University of Saskatchewan’s (USask) has received funding from the Canadian government to construct a pilot manufacturing plant to support trials of a COVID-19 vaccine candidate. Like many governments, Canada’s is ploughing funds into tackling the coronavirus pandemic currently sweeping the globe. A CAD 275 million ($195 million) fund for COVID-19 health research has been announced, and includes several investment in USask’s Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac), which it says is one of the largest and most…

Rapid response vaccine capacity vital for pandemics, BIO-Europe

Experts fighting COVID-19 say governments and industry must invest in vaccine plants that can be brought online during future pandemics. The call came during the online conference BIO-Europe Spring plenary session. Moderna CEO Stéphane Bancel – whose RNA vaccine entered Phase I trials weeks after the SAR-COv2 sequence was published – told delegates rapid scale-up is vital during a pandemic. “The piece we are missing is infrastructure – Moderna is using a development plant to make vaccine for trials and…

COVID-19: Chinese biomanufacturer CMAB returns to full operations

As doors close in Europe and the US, there is some hope in China with CMAB Biopharma returning to full operations following the COVID-19 pandemic. As the novel coronavirus (COVID-19) continues to close down normal life in Europe, there are signs that normality is beginning to return in China, the country where the outbreak was first reported. According to data from Johns Hopkins University, daily increases in coronavirus cases in China have dropped to fewer than a hundred compared to…

One billion doses: CureVac gains $88m to support capacity for COVID-19 mRNA vaccine

CureVac – the German biotech at the center of a Donald Trump acquisition rumor – has received a grant from the European Commission to expedite construction of a plant set to make a potential mRNA vaccine against coronavirus. The European Commission (EC) offered up to €80 million ($88 million) of financial support to German firm CureVac this week in its efforts to support the development and manufacture of a potential vaccine to treat the novel coronavirus (COVID-19). At the time…

Compounders complain they can’t make these four drugs once they’re deemed biologics

After 23 March, the US FDA won’t allow any more bulk compounding of four oft-compounded drug substances, disrupting patient care, compounders say. Major disruptions in patient access to compounded versions of four bulk drug substances may result from the US Food and Drug Administration’s (FDA’s) decision, announced 5 March, to regulate them beginning 23 March as biologics licensed under the Public Health Service Act, drug compounding industry groups say. The announcement said outsourcing facilities complained four substances on the FDA’s preliminary list would be…