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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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FDA Breakthrough Device Designation lifts Neola shares
Lund-based Neola Medical has been granted the FDA’s Breakthrough Device Designation for Neola, the company’s medical device for continuous lung monitoring in preterm born babies.
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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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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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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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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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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 suppressed to very low levels.
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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 obesity drugs were no longer in a shortage situation.
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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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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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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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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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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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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 treatment for both initiation and maintenance therapy
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Implantica secures FDA approval: “Culmination of many years of development”
Swedish-founded Implantica has received Premarket Approval (PMA) from the FDA for RefluxStop, its implant-based treatment for acid reflux.
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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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New FDA setback for Xspray – stock plunges
The Swedish research company Xspray Pharma has received yet another negative decision from the U.S. Food and Drug Administration (FDA), linked to the company’s Italian third‑party manufacturer.
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Trump expected to pick Heidi Overton to lead the FDA
Donald Trump is expected to nominate Heidi Overton as the new commissioner of the US Food and Drug Administration (FDA), according to several international media outlets.
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LEO Pharma acquires dermatology drug for 435 million USD
LEO Pharma strengthens its dermatology portfolio by acquiring the late-stage drug candidate dersimelagon.
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Lantheus challenges Eli Lilly with FDA-approved Alzheimer’s tracer
Eli Lilly has until now had the US market for tau PET imaging in Alzheimer’s disease to itself. The pharmaceutical giant is now facing competition after the FDA approved radiopharmaceutical company Lantheus Holdings’s Tauklarify.
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Hansa chair: “Too many boards spend far too much time looking inwards”
Following a change of chief executive and a sharper strategic focus, Hansa Biopharma is entering a decisive phase in the US market. As the company prepares for what comes next, chair Peter Nicklin is clear about his own role: to lead the board, but never dominate it.
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Tuff vecka för Fresenius Kabi – dubbla återkallanden
Fresenius Kabi återkallar ett parti av en av sina biosimilarer i USA sedan produkten visat sig innehålla glaspartiklar. Missen uppdagades bara en vecka efter att bolaget i ett annat ärende upptäckt felmärkta sprutor med ett särskilt starkt opioidläkemedel.
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Lilly sues six companies over black market sales of experimental weight loss drug
Eli Lilly is suing six companies in the United States accused of selling illegal versions of the company’s upcoming triple‑acting weight‑loss drug, retatrutide.
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