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Nobel laureate’s CRISPR biotech shuts down as funding runs out
Caribou Biosciences was one of the early companies to embrace CRISPR gene-editing technology. Now, the biotech is being forced to halt development of its cancer therapies, despite having a candidate ready for phase III.
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Natural Cycles sharpens Nordic focus with new regional chief
After nearly a decade at Natural Cycles, Sofie Askervall has stepped into the newly created role of Head of Nordics. “Right now, we are looking closely at Norway,” she says.
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Orexo seeks SEK 250 million to fund pipeline and DOJ settlement
Orexo had SEK 118.7 million in available cash at the end of August. The Uppsala-based company now wants to raise a further SEK 250 million to fund its development pipeline and the expected DOJ settlement.
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Novo's facility remediation delays haemophilia A drug
The FDA has informed Novo that the BLA review of the antibody denecimig for the treatment of haemophilia A is still ongoing with no new timeline.
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Under-pressure CSL strikes billion-dollar deal – bets on new phase II candidate
Job cuts, a lowered earnings forecast and concerns over its vaccine business have put CSL under pressure. Now the Australian pharmaceutical giant is making a major bet on a Swiss drug candidate for rare kidney and liver diseases.
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New heart valve can expand as children grow
The US Food and Drug Administration (FDA) has approved a surgically implanted heart valve for children with a special feature: it can be expanded as the child grows.
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Invisible hearing implant launched – entire device sits beneath the skin
A cochlear implant in which all components, including the microphone, are implanted beneath the skin is now being launched across Europe. According to Ingeborg Hochmair, CEO and co-founder of MED-EL, the idea has been nearly 50 years in the making.
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Kodiak shares more than double after positive eye drug results
A successful Phase III trial in age-related macular degeneration sent shares in US-based Kodiak Sciences soaring on Monday.
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Egetis lands FDA approval: “Biggest milestone in the company’s history”
Swedish Egetis Therapeutics has secured FDA approval for its rare disease drug Emcitate, clearing the way for a US launch within weeks. “We are transitioning from a late-stage development biotech company into a commercial company,” CEO Nicklas Westerholm
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AstraZeneca bets $2bn on Summit’s cancer drug
AstraZeneca is investing 2 billion dollars in US-based Summit Therapeutics to accelerate the development of the cancer drug ivonescimab in combination with antibody-drug conjugates, or ADCs.
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Swedish Alzheimer’s project wins 19 million dollar US research grant
An Alzheimer’s research project led by associate professor Sebastian Palmqvist at Lund University has been awarded 19.4 million dollars in US research funding. The aim is to develop a new FDA-approved blood test for the disease within five years.
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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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Saline recalled after potentially dangerous mix-up
A batch of potentially mislabelled IV infusion bags is being recalled in the US by Otsuka ICU Medical. The company is warning that accidental injection of the product could have potentially fatal consequences.
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Multicancer blood test moves closer to FDA approval
A blood test designed to detect signals from more than 50 types of cancer before symptoms appear could be on its way to FDA approval, after an advisory panel of experts issued a favourable recommendation.
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US lawsuits target GLP‑1 manufacturers over alleged link to vision damage
Dozens of patients in the United States have sued Novo, the manufacturer of Ozempic and Wegovy, alleging that the drugs caused vision loss.
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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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Stem cell setback in infant heart condition
U.S.-based Longeveron plans to implement cost‑saving measures and “explore strategic options” after a Phase II trial failed to meet its primary endpoint in a rare congenital heart condition in infants.
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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 cancer.
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Alzinova strengthens its cash position ahead of Phase II study
The Swedish research company Alzinova has initiated the start‑up phase of its Phase II study in Alzheimer’s disease – and is simultaneously announcing a rights issue of up to SEK 51 million to help finance the study.
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US boost for Lundbeck’s Cushing’s drug candidate
Lundbeck has received orphan drug designation from the US FDA for asedebart, Lu AG13909, for the treatment of endogenous Cushing’s syndrome.
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Marie Gårdmark: Are FDA and EMA drifting apart?
Are FDA and EMA beginning to drift apart on what it takes to approve new medicines? And what could that mean for drug development on both sides of the Atlantic? Marie Gårdmark explores the question in a column.
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Sobi gains regulatory momentum with new FDA Fast Track designation
Sobi has secured a US FDA Fast Track designation for pacritinib, advancing the drug’s development as a potential treatment for the rare and severe autoinflammatory disorder VEXAS syndrome.
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SmartCella secures key patents in the US and Japan
Swedish drug-delivery company SmartCella has secured the main patent for its Extroducer device in the US and Japan, completing global protection following the European approval granted in 2024.
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