Global Markets

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…

Emergent to make Novavax’s Covid-19 vaccine candidate for Ph I trials

Emergent says Covid-19 vaccine candidate it is making for Novavax will be ready for trials within four months. Novavax hired Emergent BioSolutions to make the experimental vaccine this week. The vaccine was developed using Novavax’s recombinant protein nanoparticle platform and Matrix-M adjuvant technology. Emergent said it has already started work on making clinical trial supplies of the vaccine, explaining that drug substance will be produced at the Baltimore-Bayview facility while the product itself will be made at its Baltimore-Camden plant.…

Vaccines, plasma and stem cells: How industry hopes to take on COVID-19

The biopharma space has stepped up its efforts to both prevent and treat the coronavirus (SARS-CoV-2) that is threatening to bring the world to its knees. A month is a very long time when it comes to infectious diseases. The first cases and deaths from the novel coronavirus (COVID-19) led to a response to contain the virus, but the difficulties of containment and the nature of international travel means cases and deaths have become global. The latest statistics place the…

Coherus eyes ophthalmology biosimilars prize

In-licensing a Lucentis biosimilar goes “hand-in-hand” with its internally developed Eylea biosimilar, says Coherus BioSciences. Californian biosimilar developer Coherus acquired the US commercial rights in November to commercialize a version of Lucentis (ranibizumab) from Bioeq, a joint venture between Polpharma Group and Strüngmann Group. The ophthalmic monoclonal antibody pulled in US sales of CHF 1.83 billion ($1.9 billion) for Roche/Genentech in 2019. Concurrently, Coherus has a biosimilar candidate looking to take on Regeneron’s Eylea (aflibercept) in the form of CHS-2020.…

Sandoz optimistic on biosimilars as it reprioritizes US portfolio

Sandoz US president Carol Lynch talks about its changing US portfolio, which will emphasize biosimilars, as the Novartis unit is poised to divest most of its US generics portfolio to Aurobindo. Sandoz International GMBH is shrinking the size of its US footprint as it prioritizes complex generics and biosimilars in the region and divests much of its small molecule generics portfolio to India’s Aurobindo Pharma Ltd. US President Carol Lynch talked about the changing dynamics for the US business and the company’s…

Teva highlights fasinumab and Celltrion biosims deal as drivers

Teva says the monoclonal antibody (mAb) candidate fasinumab has “big potential” and expects to see Phase III data this year. The Israel headquartered generics firm spoke about fasinumab – the osteoarthritis pain drug – during its fourth quarter earnings call last week. CEO Kare Schultz told analysts “In novel biologics, we have a lot of different things going on. “The most exciting short-term is fasinumab that we are developing together with Regeneron and where we hope to see data this year…

Dupixent growth increases Regeneron’s manufacturing costs (again)

Regeneron says higher Dupixent (dupilumab) sales drove an increase in manufacturing and collaboration costs in Q4. In the US, Dupixent brought in revenue of $605 million (€554 million) in the final three months of 2019, up 136% on the comparable period a year earlier. Similarly, global net sales of the drug in the fourth quarter increased to $752 million, up from $319 million in 2018. Regeneron senior vice president Marion McCourt told analysts: “We continue to see strong prescribing trends…