The US Food and Drug Administration will receive a marketing authorization application from Genmab and partner Abbvie in the second half of this year.
The Danish Medicines Agency has been told for the second time that the price of the obesity drug is not in line with the effect it provides.
Bavarian Nordic’s smallpox vaccine Imvanex has previously been used off-label to protect close contacts from monkeypox in several countries. The Danish vaccine firm is now working with the EMA to expand the label in an ”accelerated process.”
The Science Based Targets initiative has approved Coloplast’s carbon emission reduction goals.
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Encouraging pre-clinical results for Evaxion’s EVX-BV2 candidate have led the firm to add a second target indication, gonorrhea.
A new grant from the Novo Nordisk Foundation has been used to establish a new educational facility which will aim to improve the quality of Danish research and teaching within diabetes and endocrinology.
After postponing the decision in April, the British medicines council NICE has now ruled that Adtralza can be recommended to treat atopic dermatitis.
Japanese firm Fujifilm Diosynth Biotechnologies is investing DKK 11bn (USD 1.5bn) in its factor in Northern Zealand, Denmark. The expansion will provide 450 jobs.
Fujifilm’s expansion to its factory in Hillerød means that the life science sector has announced DKK 12bn (USD 1.7bn) in facility investments in Denmark since May.
While bills to introduce a price cap on insulin are being discussed in the US Senate, Sanofi has beaten them to the punch and reduced the price of insulin products for US diabetes patients without insurance.
Six years after Biophero was established, the Danish firm has been acquired by a US-based group.
Through its 10-year plan, the Lundbeck Foundation intends to increase its range of long-term assets by acquiring a further three to five companies. The foundation has now appointed a head of strategic investments.
The US authorities see potential for a groundbreaking treatment in talquetamab, which is being developed by Janssen based on Genmab’s technology.
Experiences from Danish climate partnerships are among the tools that can be leveraged when Novo Nordisk CEO Lars Fruergaard begins stepping up efforts in the life science sector’s central organs in Brussels. ”I’ve been fired up by the intimacy and shared vision we could see in Denmark,” he tells MedWatch.
There are still issues with Stallergenes Greer’s factory in Antony, the Agence Nationale de Sécurité du Médicament has concluded.
There is currently no approved vaccine for RSV, which causes serious illness and can be deadly for newborns and the elderly. The race to come first to the vaccine market is heating up, while more companies are close to completing phase III studies. Get an overview of their progress here.
US-based Eargo, which is run by a Dane, has entered an agreement with an investment firm which is injecting USD 100m into the company.
More Americans will be offered a monkeypox vaccine.
According to Novo Nordisk, a firm based in India has made a copy of its obesity drug, Saxenda. Novo is now fighting to get the copy off the market in a US court.
The European Medicines Agency (EMA) will investigate whether Imvanex, which is already approved for smallpox, can be authorized within the monkeypox indication.
Bavarian Nordic’s RSV vaccine candidate has been awarded priority status by both the US and EU authorities. That sends a positive signal to potential partners, says CEO Paul Chaplin.
Elisabeth Svanberg has joined the board of Leo Pharma.
The priority status accelerates the approval process once phase III studies are complete.
Hearing aid firm Audientes has, as expected, applied to delist from Nasdaq’s First North exchange in Copenhagen.
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