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MedWatchThursday5 October 2023
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Foto: Andrew Kelly

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.
  • Media: This is why the FDA has reprimanded Novo Nordisk following US plant inspection
  • FDA delays decision on chikungunya vaccine from Valneva

For subscribers



Foto: Colourbox

EU lags behind the US and China in artificial intelligence

For subscribers



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

For subscribers


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

For subscribers


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

For subscribers


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

For subscribers


  • It seems that not everything has gone by the book for Indian contract researchers in the city of Kharadi. | Foto: Arun Sankar

    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.

    For subscribers


  • Foto: Manuel Balce Ceneta/AP/Ritzau Scanpix

    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. 

    For subscribers


  • Foto: David J. Phillip/AP/Ritzau Scanpix

    Norway to end reimbursement for Ozempic

    Too many patients are receiving Ozempic outside the reimbursement clause in Norway, according to the Norwegian Medicines Agency.

    For subscribers


  • Foto: Andrew Kelly

    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.

    For subscribers


  • Foto: Finn Frandsen/Ritzau Scanpix

    Novo Nordisk's obesity and diabetes drugs under EU suicide risk assessment

    The safety signals have been noted by the Icelandic Medicines Agency.

    For subscribers


  • Foto: Jim Vondruska

    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. 

    For subscribers


  • In a letter addressed to EU Health Commissioner Stella Kyriakides, the Biomedical Alliance strongly urges that concrete actions are implemented to prevent the critical shortage of medical devices.

    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. 

    For subscribers


  • Foto: Coloplast / Pr

    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. 

    For subscribers


  • Foto: Peter Dejong/AP/Ritzau Scanpix

    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. 

    For subscribers


  • 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.

    For subscribers


  • Foto: Ida Marie Odgaard

    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.

    For subscribers


  • Foto: Olivia Loftlund/Ritzau Scanpix

    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.

    For subscribers


  • (ILLUSTRATION / ARCHIVE) | Foto: Yves Herman

    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.

    For subscribers


  • Bristol Myers Squibb owns blood thinner Eliquis along with Pfizer. Analysts expect it to feature among ten drugs initially chosen for price negotiations in the Medicare program in September.

    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.

    For subscribers


  • Minister of Health and Elderly Affairs Sophie Løhde is pleased the EU Council has agreed to revise the fee structure of the EMA | Foto: Jens Dresling

    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.

    For subscribers


  • Authorities and citizens met up at the Danish Medicines Agency's facilities at Islands Brygge, Copenhagen. | Foto: Jan Unger

    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.

    For subscribers


  • Foto: Issei Kato/Reuters/Ritzau Scanpix

    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.

    For subscribers


  • Foto: Dado Ruvic/Reuters/Ritzau Scanpix

    FDA panel back RSV vaccine for children from AstraZeneca, Sanofi

    The monoclonal antibody received unanimous support from advisory panel members.

    For subscribers


Latest news

  • Novo Nordisk suffers Wegovy defeat to Viatris in patent court –
  • Pharmaceutical industry to grow 4% annually towards 2030 –
  • Zealand Pharma CEO: "We've never been stronger" –
  • Eli Lilly's head of diabetes and obesity retires –
  • DNB expects ALK's tablet sales to recover in 2024 –
  • Eli Lilly makes acquisition in Denmark: Takes over company with 12 employees –
  • Investment bank: Novo Nordisk's patent victory is a small win as price negotiations loom –
  • Novo Nordisk's semaglutide to be studied for positive effect on alcoholics –
  • Olympus appoints new chief medical officer –
  • Low share price may knock Galecto off the stock exchange –
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