Regulatory Index News: 27/06/2018

Welcome to your Regulatory Index News update today. FDA restrictions alongside positive clinical trial results makes for an interesting read.

FDA announces restrictions on Merck & Co.’s Keytruda and Roche’s Tecentriq for first-line bladder cancer patients

Merck and Roche face further challenges after the FDA has restricted the indications for patients with urothelial cancer not eligible for cisplatin-containing therapy. This follows the FDA's previous warning in May 2018 where the data monitoring committees had seen early signs of decreased survival in patients using Merck & Co.'s Keytruda (pembrolizumab) or Roche's Tecentriq (atezolizumab) as monotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the PD-L1.  Please click here to read more on this from a PharmaTimes article.


Novo Nordisk see positive results from two Phase 3 trials for their diabetes drug semaglutide

In what has become a crowded market, Novo Nordisk is looking to make a case for its oral glucagon-like peptide (GLP)-1 analogue drug semaglutide, bolstered by the results of its PIONEER 4 and PIONEER 7 studies. This follows positive data from two other studies that read out earlier this year, which are part of their programme of ten Phase 3a studies, with the remainder of results expected later this year. The addition of the oral GLP-1 to Novo's already approved injectable version under the brand name Ozempic is key to their plans for maintaining their place as a leader in diabetes treatment. Please click here to read more on this from a BioPharmaDive article.

Preliminary results from a Phase 1/2 study of Duchenne muscular dystrophy add billions to Sarepta Therapeutics’ value

Duchenne muscular dystrophy (DMD) patients lack a protein vital for muscle strength and support but preliminary results from a Phase 1/2 study of DMD patients found the first three boys dosed with Sarepta’s therapy had shortened versions of that protein in amounts somewhere between 38.2% and 53.7% the normal level. In addition to this data, albeit in a limited number of patients, no serious events have been observed in the trial so far. Sarepta is focussed on rare neuromuscular diseases, such as DMD, and through its access to RNA-targeting and gene therapy technologies has created a pipeline of DMD treatments.  Please click here to read more on this from a BioPharmaDive article.



Lorna Osborn

Date Published

27th June 2018

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