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Pfizer secures $1.5 billion to develop obesity drug
Following the high-profile bidding war with Novo Nordisk over Metsera, Pfizer is taking the next step in its obesity strategy. Investment firm Blackstone will now provide up to $1.5 billion to finance the development of a drug designed to be administered once a month.
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FDA turns down Novocure’s brain metastases device
The US Food and Drug Administration (FDA) has rejected Novocure’s application for marketing approval of Optune Mya, a medical device for the treatment of brain metastases in patients with non-small cell lung cancer.
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FDA approves Bayer’s first-in-class stroke drug
The US Food and Drug Administration (FDA) has approved a new type of medicine to reduce the risk of recurrent stroke.
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Zolgensma gene therapy under investigation after tumour reports
The FDA is investigating a potential cancer risk in patients treated with Zolgensma, a gene therapy for spinal muscular atrophy (SMA).
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Updated: Egetis receives SEK 5.3 billion takeover bid from US company
US-based ANI Pharmaceuticals has made a SEK 5.3 billion takeover bid for Swedish Egetis Therapeutics. Chairman Mats Blom tells Life Science Focus why the board decided to consider a sale, despite the company's ambitions to grow independently.
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Pharmaceutical executives play down AI hype – see no quick path to cures
Leading pharmaceutical executives are questioning Silicon Valley’s promises that AI can soon cure most diseases, the Wall Street Journal writes in an article. So far, no AI-designed drug has been approved by the US FDA.
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Egetis sells FDA voucher for 190 million dollars
Swedish biotech Egetis Therapeutics is selling the priority review voucher it recently received following the U.S. approval of its drug Emcitate. The price tag is USD 190 million, half of which will go to the company.
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Lilly’s triple-G drug outperforms Ozempic in head-to-head trial
Eli Lilly’s investigational drug retatrutide delivered more than twice the weight loss of rival Novo Nordisk’s Ozempic in a head-to-head phase 3 trial.
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Abbott sharpens cancer test – detects smaller traces of tumour DNA
A single tumour DNA molecule among more than a million others. That is how small a trace of cancer Abbott’s upgraded Oncodetect test is designed to detect in the blood. The technology has now also demonstrated improved performance in clinical studies.
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Xbrane wins long-awaited FDA approval for eye drug biosimilar
After a long and winding road, Xbrane has now received FDA approval for Lucamzi, a biosimilar to the eye drug Lucentis.
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UK ends uncertainty over CE marking for medical devices
Medical device manufacturers will be spared duplicate certification processes to access the British market. The UK government has decided to recognise CE marking indefinitely, a move welcomed by industry.
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Inossia raises SEK 88m – targets US approval
The Swedish medtech company Inossia, which is developing an additive for bone cement, has completed an oversubscribed SEK 88 million share issue.
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AstraZeneca wins new FDA approval for serious kidney disease
A new treatment indication has opened up for AstraZeneca’s Ultomiris following positive results from a phase III trial. The FDA has approved the drug for a rare kidney disease, although its long-term clinical benefits have yet to be established.
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New hair loss pill delivers positive Phase 3 results
A new tablet formulation of a drug originally developed to treat high blood pressure has shown promising results against hereditary hair loss.
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Saniona moves depression drug closer to first-in-human trial
The Swedish-Danish research company Saniona has submitted an application to the FDA to begin testing its oral drug candidate in patients with major depressive disorder.
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Danish health minister: Europe must act on China
Danish politicians and medtech industry representatives are calling for closer cooperation between hospitals and companies to boost innovation. Danish Health Minister Ida Auken also warns that Europe must act to keep pace with growing competition from China.
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EMA backs Revolution’s pancreatic cancer drug after rapid review
A new drug that has shown very promising results in metastatic pancreatic cancer has been recommended for approval in the EU following a record-fast review process.
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Teva wins FDA approval for schizophrenia injection
The US Food and Drug Administration (FDA) has approved Teva’s Weltruza, the first long-acting olanzapine injection that can be administered subcutaneously once a month to adults with schizophrenia.
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Ambu expands their bronchoscopy offering
Ambu's bronchoscope offering has been cleared for use in the pediatric segment.
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Xbrane reaches milestone with biosimilar to blockbuster cancer drug
Swedish biotech Xbrane is taking another step in developing a biosimilar to Bristol Myers Squibb’s blockbuster cancer drug Opdivo. All patients have now been enrolled in the pivotal trial, bringing the company closer to a potential multibillion-dollar market.
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Abbott gets FDA nod for updated heart failure system
Abbott has received approval from the U.S. Food and Drug Administration (FDA) for updates to its implantable heart monitoring system.
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Viatris to buy Pacira for $1.65 billion
Viatris is acquiring Pacira BioSciences for $1.65 billion, strengthening its portfolio with two high-margin, non-opioid pain treatments.
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Pfizer wins new FDA approval for Tukysa in breast cancer
Pfizer is strengthening its position in HER2-positive breast cancer. The FDA has approved Tukysa as a first-line maintenance treatment after a phase III trial showed that the combination extended progression-free survival by 8.6 months.
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Roche's Tecentriq gets FDA nod after strong colon cancer data
A combination of Tecentriq and chemotherapy cut the risk of recurrence or death by half in patients with stage III colon cancer and dMMR tumours. The results have now paved the way for a new FDA approval.
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