Regulatory Index News w/c 08 July 2019

Here is a selection of this week's news from around the world


Another Alzheimer’s setback as Amgen, Novartis abandon BACE inhibitor trial

After a review of clinical data from the Generation Program studies, Novartis, Amgen and Banner Alzheimer's Institute have decided to discontinue investigation of the BACE1 inhibitor CNP520 (umibecestat) in two pivotal Phase II/III studies in the Alzheimer's Prevention Initiative Generation Program.

To read more follow this PharmaTimes link


ICER unconvinced peanut allergy drugs are better than just avoiding the food

A prominent drug pricing watchdog claims there isn't enough evidence to conclude patients with peanut allergies would benefit more from treatment than simply avoiding the food.
ICER, or the Institute for Clinical and Economic Review, evaluated three such treatments in a report released Wednesday.

To read more follow this BioPharmaDive link


German court blocks sale of Sanofi, Regeneron cholesterol drug

Amgen plans to enforce a court-granted injunction prohibiting sales in Germany of Sanofi and Regeneron's cholesterol drug Praluent, which competes with Amgen's rival Repatha. 

To read more follow this BioPharmaDive link


NHS England scraps 7 more drugs on prescription

NHS England has issued a new guidance scrapping seven medicines from its prescriptions list, estimating to save around £141 million a year. Among the treatments are hypertension medication aliskiren, minocycline for acne and emollient bath and shower preparations for dry and pruritic skin conditions.

To read more follow this PharmaTimes link


HPV vaccine to be offered to school-age boys

From September 2019, boys in school year eight will be offered the free Human Papilloma Virus (HPV) vaccine for the first time. Modelling produced by the University of Warwick estimate that the HPV vaccine programme could prevent over 64,000 cervical cancers and nearly 50,000 non-cervical cancers by 2058.

To read more follow this PharmaTimes link


BioMarin confirms timeline for hemophilia gene therapy, putting pressure on rivals

BioMarin Pharmaceutical plans on submitting its hemophilia A gene therapy to U.S. and European regulators sometime in the fourth quarter, which could bring approval decisions as early as mid-2020. Supporting the submissions for valrox are an ongoing Phase 1/2 study as well as an interim analysis of a Phase 3 investigation.

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

12th July 2019

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