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Monday29 May 2023

Monday29 May 2023

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.

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Foto: Novo Nordisk / Pr

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

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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

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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.
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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.”
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EU Parliament picks chief negotiator for upcoming pharma revision
Negotiations for a new EU pharmaceuticals legislation are set to begin before the summer.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Denmark to reassess reimbursement for allergy medicines
A committee under the Danish Medicines Agency will go over allergy treatments, including immunotherapies.
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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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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.
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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.
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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.
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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.
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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.
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CHMP recommends nine drugs in March
A total of 21 new drugs have been recommended for approval in 2023.
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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.
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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.
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