FDA to support new orphan drugs through pilot program

Companies developing drugs for rare diseases can apply to be part of a new FDA pilot program, starting at the beginning of the year.

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EU lags behind the US and China in artificial intelligence

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Edward Lifescience specializes in heart disease and surgical monitoring. It is headquartered in Irvine, California. | Foto: Edward Lifesciences

Edwards Lifesciences subject to unannounced EU inspection

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There is a need to safeguard the European patent rules, which are currently being reformed in the EU. The protection of data "plays a central role in the development of new products", says Morten Bødskov, Minister for Industry, Business and Financial Affairs, to MedWatch. (ARCHIVE) | Foto: Thomas Borberg

Minister: Several countries are against key proposal in controversial EU reform

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EU Health Commissioner Stella Kyriakides has received an open letter from trade association Medtech Europe and 34 national organizations. | Foto: Julien Warnand/AP/Ritzau Scanpix

European trade association calls for comprehensive reform of MDR and IVDR

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J&J gets cancer drug approved in US – royalties coming to Genmab

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EMA launches investigation into Indian CRO after serious concerns about data quality
The Spanish Medicines Agency has conducted an inspection of Indian contract researchers, and now the European Medicines Agency is looking at all medicines approved based on their research.
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FDA is monitoring international probes into Novo, Lilly obesity drugs
Both the EU and UK have launched probes into reports of suicidal thoughts possibly tied to treatment with certain obesity drugs, and the US FDA is keeping an eye on developments.
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Norway to end reimbursement for Ozempic
Too many patients are receiving Ozempic outside the reimbursement clause in Norway, according to the Norwegian Medicines Agency.
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FDA will not act on European study of GLP-1 drugs
The European Medicines Agency announced last week that it will investigate GLP-1 drugs for suicide risk. The US counterpart is not planning to follow suit.
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Novo Nordisk's obesity and diabetes drugs under EU suicide risk assessment
The safety signals have been noted by the Icelandic Medicines Agency.
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Novo Nordisk sues US pharmacy to block knock-off
Novo Nordisk sued US pharmacies making and selling versions of semaglutide, the active ingredient in Wegovy, the company’s blockbuster weight-loss drug.
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European alliance sounds alarm on critical shortage of medical devices
In a letter to the European Commission, the Biomedical Alliance in Europe calls for action to prevent a looming shortage of medical devices, particularly for children and people with rare diseases.
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Competition council forces Coloplast to adjust prices in Denmark
The Danish Competition Council fears that Coloplast is abusing its dominant position to drive competitors out of the market for sales of ostomy products to Danish municipalities.
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CHMP recommends two drugs in June
Lundbeck might soon face further competition after US-based AbbVie has got hands on a European recommendation for migraine drug Aquipta. GSK has also won the committee’s thumbs-up.
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Novo Nordisk's obesity and diabetes drugs to be investigated for psychological side effects
The EMA is investigating whether suicidal thoughts could be a side effect of treatment with Novo’s weight-loss treatments.
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Novo Nordisk's obesity and diabetes drugs to be investigated for cancer risks
The European Medicines Agency will look into whether Wegovy and Ozempic increase the risk of thyroid tumors.
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Pfizer, GSK shots for RSV get backing for older adults
Wednesday, CDC advisers voted to recommend two new FDA approved RSV vaccines for older adults.
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Life science chiefs blast pharma law revision: "We’re falling behind to a level Europe has never seen before”
An EU reform including new data protection rules has been sharply criticized by leaders at Bayer, Novo Nordisk and Ipsen – forming lobbying group EFPIA, which fears the consequences on drug access.
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BMS sues US government over drug price negotiations
The drugmaker claims the US government has violated the fifth and first amendments to the US constitution.
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EU Council approves new fee structure for European Medicines Agency
A revision meant to ensure a cost-based and flexible fee structure at the European drug regulator has gained member states’ support.
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Furious patients demand action against Sandoz
Lack of sanctions against Sandoz after the contamination case is a source of great discontent among a group of Dicillin patients. According to authorities, the company has done nothing wrong.
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Eisai, Biogen clinch FDA advisers’ support for Alzheimer’s drug
Six advisers voted unanimously to recommend approval of the jointly developed drug, though certain risks were of concern.
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FDA panel back RSV vaccine for children from AstraZeneca, Sanofi
The monoclonal antibody received unanimous support from advisory panel members.
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