Denmark warns against overtreatment with Ozempic
People with diabetes should try cheaper and milder treatments before getting Novo Nordisk’s Ozempic prescribed, says the Danish Health Authority.
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FDA approves cancer drug Epkinly from Genmab and Abbvie
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Unified EU patent system coming into force
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Pfizer’s RSV shot wins US approval following GSK’s to market
The second vaccine against respiratory syncytial virus has now gained market clearance.For subscribers
EU: Pharma manufacturers should help clean up drugs from wastewater
The pharmaceutical and cosmetic industries should foot the bill when their products end up as contaminants, the EU Commission proposes.For subscribers
US officials probe a new layer in opaque drug pricing, supply system
US authorities are looking into new groups that were formed to negotiate drug discounts but may actually be further obscuring how much the medicines cost.For subscribers
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.For subscribers
Novo Nordisk wins EU recommendation for label extension of long-acting growth hormone
The EMA’s expert committee has taken a positive stance on the Danish drugmaker’s treatment for children over three years with growth hormone deficiencies.For subscribers
Beta Bionics granted FDA approval for bionic pancreas
The iLet Bionic Pancreas uses an algorithm alongside a pump and a glucose monitor to make insulin dosing automatic.For subscribers
Drug companies are minting billions on unproven treatments with FDA shortcut
A shortcut is allowing drugs on the market that haven’t passed through final clinical testing on a Scout’s honor system, but companies are waiting on providing conclusive data – some near decades.For subscribers
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
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
Pfizer CEO says negotiating prices with US is like having "a gun to your head"
US plans to negotiate medicine prices for the country’s Medicare health program prompt several pharmaceutical companies to prepare for legal action, says Pfizer’s CEO.For subscribers
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
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
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
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
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
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
Denmark to reassess reimbursement for allergy medicines
A committee under the Danish Medicines Agency will go over allergy treatments, including immunotherapies.For subscribers
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.For subscribers
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
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
