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Phase III results approach for Cinclus – “We are hopeful”
Cinclus Pharma, which is developing new therapies for acid-related diseases, has now completed all planned patient visits in an ongoing Phase III trial. Preliminary topline results are expected later this year.
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AbbVie wins FDA approval for new Parkinson’s treatment
A new drug for Parkinson’s disease has been approved in the US
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After Phase III setback – Diamyd sees effect in long-term follow-up
Following its major Phase III setback earlier this year, Diamyd Medical is reporting new positive data. A long-term follow-up of an older study suggests that retogatein may delay progression to insulin-requiring type 1 diabetes in a genetically defined
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AstraZeneca receives EU approval for asthma treatment
AstraZeneca has received approval of its asthma treatment Trixeo Aerosphere in the EU.
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FDA clears 3.95 million dollar gene therapy
For the first time, there is now an approved gene therapy for Sanfilippo syndrome type A. The disease is extremely rare, and the treatment is among the most expensive in the world — with a list price of nearly four million dollars.
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Pepaxti gets regulatory boost – Oncopeptides shares jump
Oncopeptides is moving closer to expanding the use of its multiple myeloma drug Pepaxti in Europe. The Swedish biotech company’s shares rose by around 20 per cent in early trading on Friday following the regulatory announcement.
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FDA approves first SMA therapy targeting muscle loss
A new type of medication for the rare genetic disease spinal muscular atrophy (SMA) has been approved in the United States.
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Etcamah misses main goal after recent FDA approval
AstraZeneca’s tablet therapy Etcamah for breast cancer has failed to meet the primary endpoint in a Phase III study, the company reports. The announcement comes just a week after the drug received approval in the United States for another form of breast
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Regulatory milestone strengthens Xinnate’s EB program
Xinnate has received a notification from the U.S. Food and Drug Administration (FDA) that may bring significant advantages in the development of the company’s treatment for the skin disease Epidermolysis Bullosa (EB).
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Novartis hit by another major setback – shares plunge
Novartis has suffered another major pipeline setback. A key drug candidate acquired through its $12bn takeover of Avidity has failed in phase III, sending the company’s shares down around 10 per cent.
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Novo Nordisk halts two more heart drug trials
Novo Nordisk is discontinuing two Phase III trials of its drug candidate ziltivekimab in heart failure and inflammation.
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Four in ten children shed obesity in Novo trial
A phase III study testing semaglutide in children with obesity met its primary endpoint, Novo Nordisk reports.
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“Not the results we hoped for” – Novartis’ heart study shows no benefit
Novartis’ drug candidate pelacarsen, aimed at a well‑known cardiovascular risk factor, failed to reduce the risk of heart attack, stroke and cardiovascular death in a large Phase III trial.
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Astra Zeneca receives US approval for Etcamah
The pharmaceutical company Astra Zeneca has received accelerated FDA approval for Etcamah in combination with a CDK4/6 inhibitor for advanced HR-positive, HER2-negative breast cancer with an ESR1 mutation.
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AbbVie’s myeloma candidate hits both goals in Phase III
The pharmaceutical company Abbvie's etentamig met both primary endpoints in the Phase III CERVINO study in relapsed or refractory multiple myeloma.
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A turning point for personalized cancer vaccines – ”The field is moving quickly now”
The progress of a new personalised drug candidate for skin cancer is raising great hopes in the research community. ”It strengthens confidence in the entire class of neoantigen‑based vaccines”, says Sara Mangsbo, professor of cancer immunotherapy at Uppsala University.
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BTK inhibitor shows efficacy in MS – without liver toxicity
A new MS treatment from Novartis has met its targets in two Phase III studies – without showing the liver-related side effects that have previously characterized the drug class.
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AstraZeneca combination shows promise in advanced lung cancer
AstraZeneca and China's Hutchmed have reported positive phase III results for a combination of their cancer drugs Tagrisso and Orpathys in advanced lung cancer.
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GSK’s potential blockbuster makes Swedish comeback
Following the withdrawal of its marketing authorisation and an earlier recommendation against its use, GSK’s Blenrep is making a comeback in Sweden. The Swedish New Therapies Council (NT-rådet) now recommends the drug from the second line of treatment for multiple myeloma.
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Nykode raises NOK 286m to accelerate drug development
Norwegian biotech company Nykode Therapeutics has completed a private placement of approximately NOK 286m before costs.
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Jazz wins approval for potential $2bn blockbuster
Jazz Pharmaceuticals has received the green light for Ziihera as a first-line treatment for HER2-positive advanced gastric cancer. The approval opens up a significantly larger market for the drug, which the company believes could achieve peak sales of more than $2bn.
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BioArctic chair: “First, you need to know where you’re going”
He has been a researcher, doctor, investor and business leader. But when Eugen Steiner explains BioArctic’s success, he keeps coming back to the same thing: its vision. Speaking to Life Science Focus, he discusses CEO recruitment, the founders’ determination and why Sweden risks falling behind in clinical research.
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Melanoma data sends Moderna shares skyrocketing
A vaccine candidate from Moderna and Merck & Co almost halved the rate of skin cancer recurrence in a late-stage trial, the two companies report. The announcement sent Moderna’s share price soaring by more than 170 per cent.
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Coloplast delays introduction of new incontinence system
Originally scheduled for release within the financial year ending in september this year, Coloplast now expects the FDA clearence of its Intibia system no earlier than october next year.
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