A new drug has been approved by the US Food and Drug Administration for polycythemia vera, a rare disease that causes the bone marrow to make too many red blood cells, which can thicken the blood and cause clots. Besremi (ropeginterferon alfa-2b-njft) is the first approved medicine for this disease that patients can take, irrespective of their treatment history. It is also the first interferon therapy specifically approved for polycythemia vera.
Robert Califf, a professor of medicine at the Duke University School of Medicine, is to be nominated to lead the US Food and Drug Administration – a position he held during the final year of the Obama administration and will return to under the Biden presidency. A cardiologist, Dr Califf has been vice chancellor for clinical and translational research at Duke and was founding director of the Duke Clinical Research Institute, where he led many clinical trials.
Syncona Ltd has taken the lead in financing a new cell therapy company that is developing induced pluripotent stem cell (iPSC) derived medicines. Clade Therapeutics, located in Cambridge, US, has a platform technology that ‘cloaks’ human pluripotent stem cells and their adult derivatives enabling the development of immune compatible cell transplantation therapies. The company is initially focused on demonstrating the potential of cloaked immune cells as cancer treatments.
Johnson & Johnson Inc, whose Janssen business unit is active throughout Europe, is to split into two separate companies by spinning off its consumer healthcare products division from its more lucrative pharmaceuticals and medical devices business. Announced on 12 November, the demerger is expected to be completed in 18 to 24 months.
Evotec SE completed a public share offering on the US Nasdaq market on 9 November, raising a total of $435 million from the base offering and giving it more resources to pursue a strategy as development partner for the global biopharma industry. The share offering came after a third quarter during which revenue increased by 23% to €159.7 million on the strength of ongoing partnerships with large pharma companies.
MorphoSys AG increased spending on research and development by 88% in the third quarter and by 60% in the first nine months of 2021 as it continued to invest in new products and absorb programmes from Constellation Pharmaceuticals Inc, a developer of drugs in the field of epigenetics which it acquired in July. Constellation has two clinical-stage cancer programmes and several products in preclinical development.
Organon, a recent spin-off of Merck & Co Inc, is to expand its portfolio of assets in reproductive health with the acquisition of Forendo Pharma Ltd of Finland. Organon has agreed to pay up to $954 for the Finnish company, a figure that includes potential outlays for the achievement of certain development, regulatory and commercial milestones. Forendo’s lead product is being developed for endometriosis, a chronic condition that affects up to one in 10 women of reproductive age.
Agomab Therapeutics NV is to acquire Origo Biopharma SL of Spain for an undisclosed sum in order to advance its strategy of targeting growth factor signalling pathways for the development of new therapies. The acquisition comes less than a year after Agomab, which is based in Belgium, raised $74 million in a Series B financing round led by Redmile Group of San Francisco, with participation from Cormorant Asset Management LLC of Boston, US.
Takeda Pharmaceutical Co Ltd is to acquire the cell therapy company GammaDelta Therapeutics Ltd, exercising an option that it obtained in 2017 from the UK company’s venture capital sponsor Abingworth LLP. Takeda is to make a pre-negotiated upfront payment for GammaDelta as well as potential development and regulatory milestone payments. In 2017, Takeda committed to invest up to $100 million in GammaDelta which included an equity investment.
AstraZeneca Plc expects revenue this year, excluding results from its Covid-19 vaccine Vaxzevria, to increase by a low twenties percentage, in line with earlier guidance. The forecast follows the publication of third quarter results on 12 November which showed total revenue of $9.9 billion, up by 50% from a year earlier. The results incorporate revenue from Alexion Pharmaceuticals Inc, a recent acquisition, as well as receipts from Vaxzevria.Total revenue for the nine month-period was $25.4 billion, up by 32%.