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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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Medtronic issues second recall after 184 serious patient injuries
Medtronic is recalling parts of its oesophageal pH monitoring system following reports that the capsule may fail to attach or detach from the delivery device as intended. A total of 184 serious patient injuries have been reported.
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Sweden appoints its first professor of HTA
Susanna Wallerstedt has been appointed Sweden’s first professor of health technology assessment (HTA) at the University of Gothenburg and Sahlgrenska University Hospital. Her role will encompass research, education and clinical work, with a focus on advancing evidence-based healthcare.
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Canada backs reimbursement for BioArctic’s Leqembi
Bioarctic's Leqembi receives positive reimbursement recommendation in Canada.
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Eli Lilly to acquire Merida Biosciences for up to 2.9 billion dollars
US pharmaceutical company Eli Lilly has entered into a definitive agreement to acquire biotech company Merida Biosciences for up to 2.875 billion dollars in cash, including an initial payment and contingent milestone payments.
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Elekta secures €100 million loan from EIB
Swedish radiation therapy company Elekta has secured a €100 million loan from the European Investment Bank (EIB).
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Aqilion could be up for sale after receiving an indicative offer
Swedish biotech company Aqilion has received an indicative offer for all of its shares, potentially paving the way for a takeover of the company.
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Lifecare acquires 80 percent of Ocean TuniCell
Medical technology company Lifecare has signed an agreement to acquire 80 percent of Ocean TuniCell, thereby gaining control of the company’s laboratory and production infrastructure in Bergen, including cleanrooms and quality systems.
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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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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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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 transmitted infections (STIs).
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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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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 company’s submission of both a public list price and a confidential discounted price in its application.
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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 phase-out, pointing instead to existing regulations, a forthcoming review and continued research.
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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 operations, and the stock fell in Wednesday’s pre‑market trading.
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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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Lundbeck enters into AI partnership in the US
Lundbeck plans to accelerate strategy development and commercialization with American AI-partners.
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