JCR Gets Its Brain-Penetrating Hunter Therapy Out of Japan for the First Time, Through the UAE
IZCARGO, a therapy engineered to cross the blood-brain barrier, won its first marketing authorization outside Japan five years after launching there.
Topics
Crysvita Reaches One-Month-Old Infants in the EU, and Buys Two More Years of Orphan Exclusivity
The European Commission approved Crysvita for infants as young as one month with XLH, a decision that also buys Kyowa Kirin two more years of orphan exclusivity.
Spain rewrites its drug-pricing rulebook, and the price of a generic will now fall as it sells more
Spain’s new draft Medicines Law will cut the price of generics and biosimilars automatically as their market share grows, replacing a system where prices froze after one initial discount.
A Father’s Liver, One Incision: the First Single-Port Robotic Liver Transplant Lands in a Six-Year-Old
A six-year-old with a rare genetic liver disorder became the first patient to receive a liver transplant through a single robotic incision, donated by his father.
NICE Backs Finerenone for 280,000 Heart Failure Patients
Half of England’s heart failure patients have spent decades watching the other half get all the drugs. That’s the context for what NICE did this week. On 16 July, the institute published final draft guidance recommending finerenone for adults with chronic heart failure with preserved or mildly reduced ejection fraction. NICE estimates up to 280,000 … Read more
NICE Slashes Medicines Evaluation Times by 30%
NICE recommended 66 new treatments last year and rejected seven but 25 evaluations were terminated before anyone ruled on them.
Germany Defies Pharma Backlash, Hikes Drug Rebate to 15.5%
Germany’s lawmakers had no shortage of warnings. Drugmakers objected. Trade groups objected. So did opposition voices inside the country’s own government. The reform passed anyway. Late on Friday, the Bundestag, Germany’s lower house of parliament, approved a health insurance financial reform package by 318 votes to 284, with four abstentions. That is not a comfortable … Read more
NHS Gives Green Light to Life-Changing SMA Treatments
NICE has recommended routine NHS access to nusinersen and risdiplam for spinal muscular atrophy.
EU Critical Medicines Act Fights Dangerous Supply Crisis
The EU’s Critical Medicines Act takes direct aim at the supply chain vulnerabilities that leave patients without essential drugs when it matters most.
NICE backs digital asthma tools for NHS use as evidence builds
The UK health watchdog National Institute for Health and Care Excellence (NICE) has recommended a suite of digital platforms to help people with asthma better manage their condition, signalling growing confidence in app-based tools as part of routine care, while stopping short of full endorsement pending further evidence. In draft guidance published yesterday, NICE said … Read more