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MedWatchMonday29 May 2023
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CHMP recommends two drugs in May

One drug to diagnose prostate cancer and one to treat epileptic seizures are all the EMA’s expert committee has nominated for full approval during its meeting this month.
  • Novo Nordisk wins EU recommendation for label extension of long-acting growth hormone
  • CHMP recommends nine drugs in April – first RSV vaccine nears finish line

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Foto: Novo Nordisk / Pr

Novo Nordisk wins EU recommendation for label extension of long-acting growth hormone

For subscribers

Foto: Manuel Balce Ceneta/AP/Ritzau Scanpix

FDA approves cancer drug Epkinly from Genmab and Abbvie

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Foto: Fabrice Coffrini

Pfizer CEO says negotiating prices with US is like having "a gun to your head"

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Foto: Beta Bionics/pr

Beta Bionics granted FDA approval for bionic pancreas

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Foto: Manuel Balce Ceneta/AP/Ritzau Scanpix

Drug companies are minting billions on unproven treatments with FDA shortcut

For subscribers

  • Foto: Lars Krabbe

    WHO moves health office from Moscow to Copenhagen

    Due to Russia’s invasion of Ukraine, WHO has decided to change the location of its European office to Copenhagen from Moscow.

    For subscribers

  • Margrethe Vestager, EU Commission's executive vice president for ”A Europe Fit for the Digital Age" | Foto: Jennifer Jacquemart / European Unio

    Europe's AI Act could take more than a year to adopt

    Getting new rules adopted as fast as possible for the use of AI is crucial says the EU Commission’s lead on ”A Europe Fit for the Digital Age.”

    For subscribers

  • Foto: European Parliament / Mathieu Cugnot

    EU Parliament picks chief negotiator for upcoming pharma revision

    Negotiations for a new EU pharmaceuticals legislation are set to begin before the summer.

    For subscribers

  • Foto: René Schütze

    EU report recommends healthcare investments based on experiences from Covid-19

    Increased monitoring of infectious disease is among the initiatives that should help the EU prepare better for future public health crises.

    For subscribers

  • There is a political agreement on artificial intelligence coming to the EU, says European Commissioner for Competition Margrethe Vestager | Foto: Jens Dresling

    EU Commission expects agreement on AI this year

    EU Commissioner for Competition Margrethe Vestager says that member states are likely to reach agreement later this year.

    For subscribers

  • Foto: Rob Acket/ema

    CHMP recommends nine drugs in April – first RSV vaccine nears finish line

    Eli Lilly, GSK, and BMS, among others, were the recipients of good news after the EMA committee’s meeting this month. 

    For subscribers

  • For sundhedskommissær Stella Kyriakides minder EU's nye lægemiddelreform om Beatles-sangen "The Long and Winding Road". Allerede nu møder den massiv kritik. | Foto: Kenzo Tribouillard

    Pharma industry taking to the barricades after presented extensive EU pharma reform

    Plans to radically transform EU patent protection for new drugs are unanimously rebuked by industry. Novo Nordisk’s CEO hopes to push the reform in a more favorable direction.

    For subscribers

  • ”An incentive meant to broaden access that is impossible to live up to is not an incentive at all," says Lars Fruergaard Jørgensen | Foto: Stine Bidstrup

    Novo Nordisk CEO on EU pharma reform: "The stupidest thing I’ve heard"

    Shortening data protection in the EU is a total misfire, opines Lars Fruergaard Jørgensen, CEO of Novo Nordisk. 

    For subscribers

  • Slimming down the EMA will help speed up review of drug applications | Foto: Piroschka Van De Wouw/Reuters/Ritzau Scanpix

    EU's massive pharma reform targets drug assessments within 180 days at most

    The European Commission seeks to reduced case processing of new medicines with an extensive new pharma law revision – one tool being slashing the number of committees under the EMA.

    For subscribers

  • There is no reason to punish Sandoz further after the company permanently withdrew Dicillin from the market, says the Danish Medicines Agency | Foto: Lægemiddelstyrelsen/pr

    Danish Medicines Agency assesses Dicillin scandal: "Few deviations" from GMP not grounds for non-compliance

    Sandoz or its CMO shouldn’t be sanctioned for patients being infected with multiresistant bacteria after antibiotic treatment, says Denmark’s drug authority. 

    For subscribers

  • Grazax, marketed by ALK as a treatment for grass pollen allergies, is among drugs up for reimbursement reassessment in Denmark | Foto: Christian Charisius/Ritzau Scanpix

    Denmark to reassess reimbursement for allergy medicines

    A committee under the Danish Medicines Agency will go over allergy treatments, including immunotherapies.

    For subscribers

  • Foto: Abacus Medicine / Pr

    Abacus to speed up new business leg leveraging upcoming EU drug law

    New EU pharma legislation fits perfectly with a new business model, says Abacus Medicine.

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  • Foto: Andrew Kelly/Reuters/Ritzau Scanpix

    Bluebird reaches FDA’s doorstep with sickle cell therapy as application filed

    The drug delayed by safety scares now finally makes it to the US drug regulator’s desk for review. 

    For subscribers

  • The FDA's panels will vote on whether Lundbeck and Otsuka's data sufficiently shows there areAlzheimer's patients who stand to benefit from treating agitation with brexipiprazole | Foto: Jens Dresling/Politiken/Ritzau Scanpix

    Lundbeck and Otsuka await important exam results on Friday for potential Alzheimer's drug

    Huge financial rewards are at stake for Lundbeck and partner Otsuka today as two expert panels under the US drug authority assess a potential treatment for agitation in Alzheimer’s patients.

    For subscribers

  • FDA rejects Eli Lilly's inflammatory bowel disease drug citing production plans

    The US-based drugmaker has received a blow, putting Lilly firmly behind competitors on the USD 20bn market for ulcerative colitis treatments.

    For subscribers

  • Headquarters of the Danish Medicines Agency in central Copenhagen | Foto: Lægemiddelstyrelsen/pr

    Denmark indulges Sandoz, keeps CMO behind contaminated Dicillin under wraps

    European patients have been infected with multiresistant bacteria after being treated with Sandoz’s antibiotic Dicillin. Still, the Danish Medicines Agency does not want to reveal the culprit.

    For subscribers

  • Foto: Kevin Grønnemann

    FDA points out shortcomings in Ascendis application

    The market clearance decision for a drug candidate could be delayed in the United States, Ascendis Pharma warns.

    For subscribers

  • Foto: Rob Acket/ema

    CHMP recommends nine drugs in March

    A total of 21 new drugs have been recommended for approval in 2023.

    For subscribers

  • Foto: George Frey

    Novo Nordisk helps Canada resolve Ozempic issue

    Americans were reportedly crossing the border seeking the diabetes drug with a strong weight-loss effect until barred from purchases.

    For subscribers

  • Foto: Ida Marie Odgaard/Ritzau Scanpix

    WHO mulls over labeling obesity drugs as essential medicines

    A request to consider a Novo Nordisk obesity drug as an essential medicine was submitted by three doctors and a scientist in the US.

    For subscribers

Latest news

  • Top news from MedWatch this week – 26 May
  • CHMP recommends two drugs in May – 26 May
  • Demant proposes partial Oticon Medical divestment to ease competition concerns – 26 May
  • GN considers Covid-19 situation far less critical than six months ago – 26 May
  • Almirall to collaborate with Spanish research center on skin cancer treatment – 26 May
  • Novo Nordisk wins EU recommendation for label extension of long-acting growth hormone – 26 May
  • Novo Nordisk's semaglutide shows potential against addiction – 26 May
  • Researchers fear falling from favor with Novo Nordisk Foundation – 26 May
  • Cochlear sees no other suitors for Demant's implants business – 25 May
  • GN CEO on new capital plan: "You should always have a plan B" – 25 May
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