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FDA OKs new once-daily HIV combo pill
The U.S. Food and Drug Administration has approved a new once‑daily tablet from Gilead Sciences for the treatment of adults whose HIV infection has already been...
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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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Uppsala startup wins Gates Foundation support
Uppsala‑based Readily Diagnostics has been awarded USD 970,000 from the Gates Foundation to develop a test for some of the world’s most common sexually transmit...
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ZEISS debuts DORC EVA NEXUS for cataract surgery at ESCRS
Now spanning ZEISS Retina and Cataract Workflows, the EVA NEXUS™ ophthalmic surgical system from ZEISS comes in a cataract-only configuration, bringing a tailor...
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FDA wins GLP‑1 dispute – setback for makers of copycat drugs
A U.S. federal appeals court has ruled that the FDA followed the correct procedure when the agency determined that Novo Nordisk’s and Eli Lilly’s diabetes and o...
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Oxcia secures EMA orphan drug status for novel IPF therapy
The Swedish research company Oxcia has been granted orphan drug designation by the EMA for its drug candidate for idiopathic pulmonary fibrosis (IPF).
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Roche’s first ‘ready-negotiated’ price wins TLV approval
Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) has decided to reimburse Roche’s breast cancer drug Itovebi (inavolisib). The decision follows the comp...
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Breakthrough in pancreatic cancer – new drug wins FDA approval
A new type of medicine that has shown very strong results against pancreatic cancer has been approved by the FDA through a record‑fast process.
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EU rejects calls to phase out PVC in pharma packaging
Three MEPs are calling for a shift from PVC to more recyclable materials in pharmaceutical packaging. The European Commission says there are no plans for a phas...
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Ambu obtains US and EU clearances for new neurology solutions
Danish endoscopy specialists hopes to broaden its neurology portfolio with new regulatory clearences.
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Boston Scientific drops after new cyberattack – “A global disruption”
Boston Scientific is the latest in a growing line of major medtech companies to be hit by cyberattacks. The company reports “a global disruption” to its operati...
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Licensing breakthroughs propel AlzeCure to first‑ever profit
With two out‑licensed Alzheimer projects now in place, Sweden’s AlzeCure Pharma is reporting a profit for the first time since the company was founded in 2016. ...
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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 signi...
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Lundbeck enters into AI partnership in the US
Lundbeck plans to accelerate strategy development and commercialization with American AI-partners.
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From space to the world’s first fertility app: “Physics had always been my only dream”
She was user number one. Today, more than six million women worldwide have used the fertility app Natural Cycles, which is now rapidly expanding its offering. B...
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Long‑acting asthma drug Exdensur gains reimbursement in Sweden
A new long‑acting asthma medication has now been included in the Swedish reimbursement system following a decision by TLV, making it available to patients in Sw...
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Nordic partnership aims for faster cancer diagnostics – ”Minutes instead of weeks”
Stratipath of Sweden is partnering with Finland‑based Aiforia to accelerate AI‑powered cancer diagnostics.
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Leqembi Iqlik launches as start‑dose option
The Alzheimer’s drug Leqembi, discovered by the Swedish company BioArctic and developed by Eisai, has now been launched in the United States as a subcutaneous t...
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Cyberattacks surge – the medtech companies hit this year
Healthcare has long been a target for cyberattacks, resulting in operational disruption and the theft of sensitive data. This year, however, growing numbers of ...
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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...
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Roche bets on muscle‑preserving obesity drug in $2.3 billion deal
Roche's subsidiary Genentech is investing in a new type of medicine designed to reduce fat mass while preserving or increasing muscle mass.
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Study: Nearly 90% of biomedical papers show signs of AI assistance
The use of AI in scientific writing may be far more widespread than previous estimates have suggested. In a new study, almost nine out of ten biomedical papers ...
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A single inhaler, three medicines: EU approves new asthma therapy
A triple therapy for asthma delivered in a single inhaler has been approved in the EU and will now become available to Swedish patients.
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EU backs Lundbeck’s Cushing’s drug candidate
Danish pharmaceutical company Lundbeck has been granted orphan designation by the European Commission for its drug candidate asedebart for the treatment of endo...
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