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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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GSK to close German vaccine plant – 641 jobs at risk
Demand for traditional flu vaccines is declining. GSK is now consolidating production in Canada and closing its plant in Dresden, putting 641 jobs at risk.
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Tandem Health raises $100m to expand in Europe
Swedish AI company Tandem Health has raised $100m. The funding will be used to strengthen the company’s position in Europe.
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Sectra scales up in Denmark’s new eastern region
When Region Hovedstaden and Region Sjælland merge to form Region Østdanmark, Sectra’s medical imaging service Sectra One will be expanded to all hospitals in the region.
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Getinge aims to expand in transplantation – with an eye on China
The Swedish medtech company Getinge plans to expand within organ transplantation in Europe and Asia, says CEO Mattias Perjos.
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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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How SweTrial aims to bring more clinical trials to Sweden
Sweden has lost ground in clinical trials. SweTrial now aims to reverse the trend, but both the Swedish Medical Products Agency and the pharmaceutical industry point to the same bottleneck: capacity within the healthcare system.
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Artisan Partners demands board changes at Novartis after share-price plunge
Artisan Partners, one of Novartis’ 20 largest shareholders, is demanding changes to the pharmaceutical company’s board and tighter oversight of acquisitions after two setbacks in clinical trials. Reuters reports this.
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Breakthroughs in narcolepsy recognized by Lasker Awards
This year’s Lasker Awards are presented to researchers behind discoveries that have led to breakthroughs in narcolepsy and hemophilia – and to one of Hollywood’s most prominent patient activists.
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Novonesis to invest €600 million in India factory
Danish biosolutions manufacturer Novonesis has decided to invest massively in its Indian factory.
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Denmark a leader in EU clinical trials: “We should never accept unnecessary delays”
A principal of quick processing as well as engaging in ongoing dialogue with sponsors has helped Denmark to lead EU in clinical trials.
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Nordic newcomer on an acquisition drive – snaps up four Swedish distributors
Over the past five years, Medu Group has built a Nordic distribution business. “We aim to become one of the major Nordic distributors in medtech,” says Magnus Schüldt, CEO of Medu Sverige.
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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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“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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Dialysis company hit with $15M bill after massive patient data breach
A cyberattack last year exposed the personal data of millions of patients at dialysis provider DaVita. Now the bill has arrived for the company: 15 million dollars in damages.
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Lithuania accelerates life science ambitions with major cell therapy investment
A new center for cell therapy and personalized medicines has opened in the Lithuanian capital, Vilnius.
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Chinese approval for Leqembi auto-injector
BioArctic’s partner Eisai has received approval in China for the subcutaneous auto-injector formulation of Leqembi as an initial treatment for early Alzheimer’s disease, according to a press release.
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Swedish‑developed CT scanner cleared in Europe: “Very exciting”
GE Healthcare’s photon‑counting computed tomography (PCCT) system, Photonova Spectra, has now received CE Mark, enabling the Swedish‑developed technology to be sold across the European market.
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The newborn injection more parents are choosing to decline
A vitamin K injection has long been routine for newborn babies, protecting them against rare but potentially serious bleeding. But in the US, a growing number of parents are choosing to decline the injection – a trend also seen in Sweden.
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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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“If we can’t import it, we want to make it ourselves”
In an unassuming industrial estate in Häggvik, north of Stockholm, outpatient pharmacy Atrimus RX runs its operations. Here, founder Nicky Nadem combines a global search for medicines available under special licence with a new venture into 3D-printed medicines – aiming to tackle shortages and give patients, particularly children, the right dose from the outset.
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U.S. patent clears path for Elicera’s glioblastoma CAR‑T
Elicera Therapeutics announced on Friday that the company has received advance notice of the approval of a U.S. patent related to its CAR‑T cell candidate ELC‑401.
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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. “Our focus now is to make our collaboration projects work, and then keep pushing ahead with our other programs,” says CEO Martin Jönsson.
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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. But there was a time when particle physics was all Elina Berglund Scherwitzl could think about.
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