News dal mondo
19
Mar
As Iran war squeezes Middle East drug shipments, experts warn of longer-term effects on US manufacturing, generics
Some three weeks into the U.S. and Israel’s war with Iran, the expanding conflict’s impact on energy prices and shipping in the region has become impossible to ignore. While much of the immediate concern, insofar as it pertains to trade, has centered on the flow of oil through the Strait of Hormuz, a resulting rise in transportation and energy costs could echo across industries, including that for pharmaceuticals. And with the war embroiling Iran’s neighbors, generic exports, drugs for clinical trials and local shipments of biologics that rely on cold chains in the region are likely to face increasing pressure if the conflict persists, multiple experts and news outlets have cautioned in recent days. “As disruptions escalate around the Strait of Hormuz, the most affected shipments are often medicines for clinical trial distribution,” Alex Guillen, global SME for pharma and life sciences at Boston-based supply chain visibility firm Tive, said in an emailed statement to Fierce Pharma, cautioning that there “will be an impact on commercial distribution as well.” With regards to marketed drugs, "ultra-cold chain shipments carrying biologics are the most vulnerable to disruption,” Guillen added. ...[FiercePharma]
08
Mag
Farmaceutica, Gemmato: 'per Testo unico deadline entro dicembre'
"Il Testo unico sulla legislazione farmaceutica, che ha come obiettivo quello compendiare 800 fra...
08
Mag
Min. Salute Gemmato: “Testo unico farmaceutico entro dicembre 2026”
Il sottosegretario alla Salute indica la tabella di marcia della riforma. Al centro accesso ai farmaci...
08
Mag
Precursori droghe: controllo esteso a 9 nuove sostanze dal 18 settembre 2026
Regolamento delegato (UE) 2026/314 della Commissione del 9 febbraio 2026 recante modifica del regolamento...
08
Mag
US FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight
The U.S. Food and Drug Administration (FDA) on Wednesday unveiled a one-day inspectional assessment...
le ultime news
24 Feb
Industry clamors for clearer guidance on transition to ICH M4Q(R2)
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20 Feb
NerPharma acquistata da un colosso farmaceutico francese
20 Feb
Generic industry against giving fee breaks to firms setting up operations in the US
20 Feb
US FDA: svolta storica: basterà un solo studio registrativo per approvare i nuovi farmaci
11 Feb
AIFA - Aggiornamento della Nota esplicativa relativa alla procedura del “silenzio/assenso” in accordo con la nuova EC Classification Guideline sulle variazioni
11 Feb
AIFA - Nuova modalità Multi-Beneficiario per i pagamenti online delle tariffe previste dal D.M. 6 dicembre 2016
09 Feb
Pharma expert discusses effort to standardize CMC quality information